Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries for the Military Treatment Facilities (PRIORITI-MTF)
Phase: NA
Conditions: Leg Injuries, Trauma
Sponsor: Major Extremity Trauma Research Consortium

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
i 
Major Extremity Trauma Research Consortium (METRC): 
Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic 
Injuries  
The PRIORITI-MTF Study  
 
 
Sponsored by: DOD TATRC 
 
Contract Number: W81XWH-12-2-0032 
 
Principal Investigator/Protocol Chair: Ellen MacKenzie, PhD  
 & Joseph Hsu, M.D. 
 
Medical Monitor: Marc Swiontkowski, MD 
 
Version 8 
 
August 31, 2015 
 
This template is adapted from the ICH guidance document E6 (Good Clinical Practices), 
Section 6. 
 
Confidentiality Statement 
 
This document is confidential and is to be distributed for review only to investigators, 
potential investigators, consultants, study staff, and applicable independent ethics 
committees or institutional review boards.  The contents of this document shall not be 
disclosed to others without written authorization from METRC (or others, as applicable), 
unless it is necessary to obtain informed consent from potential study participants. 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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Signature Page  
 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations and ICH guidelines. 
The Lead Principal Investigator (Protocol Chair) should sign Signature Page 1.  A copy of this 
Signature Page 1 should be filed with the holder of the Regulatory documents and a copy should 
be maintained at the site. 
 
Principal Investigator:  _______________________________________________ 
                                                                    Print/Type 
 
Signed: 
 
Date: 
 
 
Name/Title 
 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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Table of Contents 
Signature Page..................................................................................................................... 
ii 
List of General Abbreviations/Terminology…………………………………………… 
List of METRC Abbreviations/Terminology…………………………………………… 
Protocol Summary…………………………………………………………………….. 
6 
7 
8 
1. KEY ROLES………………………………………………………………………...... 
11 
2. BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE………...... 
12 
2.1 Background Information…………………………………………………………….. 
12 
2.2 Rationale……………………………………………………………………………… 
14 
3. STUDY OBJECTIVES………………………………………………………………. 
14 
3.1 Primary Objective…………………………………………………………………… 
14 
3.2 Secondary Objectives………………………………………………………………… 
14 
3.3 Exploratory Objectives………………………………………………………………. 
14 
4.  STUDY OVERVIEW………………………………………………………………… 
15 
5. STUDY POPULATION……………………………………………………………… 
16 
5.1 Description of the Study Population………………………………………………… 16 
     5.1.1 Participant Inclusion Criteria………………………………………………………….. 
16 
     5.1.2 Participant Exclusion criteria………………………………………………………….. 
17 
     5.1.3 Co-Enrollment Guidelines………………………………………………………………. 
17 
5.2 Strategies for Recruitment…………………………………………………………… 17 
6. STUDY PROCEDURES………………………………………………………………. 18 
6.1 Screening and Enrollment…………………………………………………………… 
18 
     6.1.1 Screening……………………………………………………………………….... 
18 
     6.1.2 Consent and Enrollment…………………………………………………………. 
19 
     6.1.3 Assessing Capacity to Consent and Consenting a Proxy Respondent…………… 
19 
     6.1.4 Informed Consent Process or Assent for a minor………………………………… 19 
6.2 Baseline Data Collection……………………………………………………………... 
19 
     6.2.1 Medical Record Review…………………………………………………………. 
20 
     6.2.2 Clinical Assessment……………………………………………………………… 
20 
     6.2.3 Participant Interview…………………………………………………………….. 
20 
6.3 Participant Follow up and Data Collection………………………………………… 
21 
     6.3.1 Follow-up Visit Schedule………………………………………………………… 
21 
     6.3.2 Clinical Assessments……………………………………………………………… 21 
     6.3.3 Participant Interviews……………………………………………………………. 
21 
     6.3.4 Retention…………………………………………………………………………. 
22 
     6.3.5 Final Study Visit………………………………………………………………….. 
22 
     6.3.6 Early Termination Visit…………………………………………………………... 
22 
6.4 Study Endpoints………………………………………………………………………. 22 
     6.4.1 Primary Endpoint………………………………………………………………… 
22 
     6.4.2 Secondary Endpoint……………………………………………………………… 
25 
     6.4.3 Exploratory Endpoint…………………………………………………………….. 
26 
     6.4.4 Substudy Endpoint………………………………………………………………... 26 
7. STUDY TREATMENTS………………………………………………………………. 27 
7.1 Study Treatment #1…………………………………………………………………... 27 

 
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     7.1.1 Description of Treatment…………………………………………………………. 27 
     7.1.2 Potential Risks and/or adverse effects……………………………………………. 27 
7.2 Study Treatment #2 …………………………………………………………………. 
27 
     7.2.1 Description of Treatment………………………………………………………… 
27 
     7.2.2 Potential Risks and/or adverse events……………………………………………. 27 
8. ASSESSMENT OF SAFETY……………………………………………………… 
27 
8.1 Definitions…………………………………………………………………………. 
28 
     8.1.1 Adverse event………………………………………………………………………….. 
28 
     8.1.2 Unanticipated problem………………………………………………………………. 
28 
     8.1.3 Serious Adverse Event……………………………………………………………….. 
29 
8.2 Methods and Timing for Assessing, Recording, and Analyzing, Managing Safety 
Parameters…………………………………………………………………….. 
29 
     8.2.1 Methods and Timing of Assessment……………………………………………………. 
29 
     8.2.2 AE/SAE Grading and Relationship Assignment……………………………………… 
29 
     8.2.3 Recoding and Documentation………………………………………………………….. 
30 
     8.2.4. Management of Adverse Events……………………………………………………….. 
30 
8.3 Adverse Event Reporting Procedures………………………………………………. 
30 
     8.3.1 Local Reporting Requirements………………………………………………………….. 30 
     8.3.2 SAE and Unanticipated Problem Reporting Requirements…………………………. 30 
     8.3.3 METRC Coordinating Center Reporting Responsibilities………………………….. 
31 
     8.3.4 Department of Defense Reporting Requirements……………………………………. 
31 
8.4 Reporting Pregnancy………………………………………………………………… 
32 
8.5 Type and Duration of the Follow-up of Participants After Adverse Events…….. 
32 
8.6 Modifications of Study Agent(s)/Intervention(s) for a Participant……………….. 
32 
8.7 Halting Rules for the Protocol………………………………………………………. 
32 
8.8 Stopping Rules for an Individual Participant/Cohort……………………………… 32 
8.9 Premature Withdrawal of a Participant…………………………………………… 
32 
8.10 Replacement of a Participant Who Discontinues Study Treatment……………. 
32 
9. MONITORING ……………………………………………………………………… 
33 
9.1 Site Monitoring Plan…………………………………………………………………. 
33 
9.2 Safety Monitoring Plan………………………………………………………………. 
33 
     9.2.1 Safety Review Plan by the DSMB……………………………………………………… 
33 
10. STATISTICAL CONSIDERATIONS……………………………………………… 
33 
10.1 Overview and Study Objectives…………………………………………………… 
33 
10.2 Sample Size Considerations……………………………………………………….. 
33 
10.3 Randomization……………………………………………………………………… 
34 
10.4 Missing Data and Measures to Minimize Bias……………………………………. 
34 
10.5 Planned Interim Analysis…………………………………………………………… 34 
10.6 Analysis Plan………………………………………………………………………… 34 
11. QUALITY CONTROL AND QUALITY ASSURANCE………………………….. 
36 
11.1 Data Quality Assurance…………………………………………………………….. 
36 
11.2 Training and Certification of Centers……………………………………………... 
36 
12. ETHICS/PROTECTION OF HUMAN SUBJECTS………………………………. 
37 
12.1 IRB/Ethics Committee……………………………………………………………… 
37 
12.2 Exclusion of Women, Minorities, and Children (Special Populations)………… 
37 

 
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12.3 Participant Confidentiality………………………………………………………. 
37 
12.4 Study Discontinuation……………………………………………………………. 
38 
13. DATA HANDLING AND RECORD KEEPING………………………………... 
38 
13.1 Data Management Responsibilities…………………………………………….... 
38 
13.2 Data Capture Methods……………………………………………………………. 
38 
13.3 Types of Data………………………………………………………………………. 
39 
13.4 Source Documents and Access to Source Data/Documents…………………….. 
39 
13.5 Study Records Retention…………………………………………………………. 
39 
13.6 Protocol Deviations……………………………………………………………….. 
39 
14. PUBLICATIONS POLICY………………………………………………………… 
39 
15. SCIENTIFIC REFERENCES…………………………………………………….. 
39 
16. APPENDICES………………………………………………………………………. 
46 
     Appendix A: Study Contacts Roster 
 
     Appendix B: Protocol Committee 
 
     Appendix C: Data Collection Schedule 
 
     Appendix D: Consent Template 
 
     Appendix E: Evaluation to Give Consent 
 
     Appendix F: Study Brochure Insert 
 
     Appendix G: Draft Case Report Forms 
 
     Appendix H: Sample Letter to Participants 
 
     Appendix H: Study Interviews  
 
     Appendix I:  Study Video Draft 
 
     Appendix J:  Study Advertisement Templates 
 
 
 
 

 
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List of General Abbreviations/Terminology 
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CIB 
Clinical Investigator’s Brochure 
CIOMS 
Council for International Organizations of Medical Sciences 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DCC 
Data Coordinating Center 
DSMB 
Data and Safety Monitoring Board 
DSMC 
Data and Safety Monitoring Committee 
FDA 
Food and Drug Administration 
FWA 
Federal-Wide Assurance 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IEC 
Independent or Institutional Ethics Committee 
IDEO 
Intrepid Dynamic Exoskeletal Orthosis 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
MedDRA © 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NDA 
New Drug Application 
OHRP 
Office for Human Research Protections 
OHSR 
Office for Human Subjects Research 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SMC 
Safety Monitoring Committee 
SOP 
Standard Operating Procedure 
WHO 
World Health Organization 
 

 
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List of METRC Abbreviations/Terminology 
 
AFIRM  
The Armed Forces institute of Regenerative Medicine 
AI 
Associate Investigators (Site) 
CDMRP                          
Congressionally Directed Medical Research Program   
CCCS  
 
 
 
Civilian Core Clinical Sites   
 
CPO  
 
 
 
Certified Prosthetist/Orthotist 
DOD  
 
 
 
Department of Defense 
DOD CRMRP 
DOD Clinical and Rehabilitative Medicine Program  
DOD HRPO 
DOD Human Research Subject Protection Office.   
DOD PRORP  
Department of Defense Peer Reviewed Orthopaedic 
Research Program  
Master Consent Form 
Template consent form designed for study by the MCC  
Master IRB application 
Template IRB application designed for study by the MCC  
MCC  
 
 
 
METRC Coordinating Center of the Consortium  
MCC Study Manager 
Principal site contact for Research Coordinators at sites 
MTF Core Clinical Sites 
Military Treatment Facilities Core Clinical  
NMCSD 
 
 
 
Naval Medical Center San Diego 
O&P Tech 
 
 
 
Orthotics and Prosthetics Technician  
OETRP 
 
 
 
Orthopaedic Extremity Trauma Research Program 
PPM  
 
 
 
Policy and Procedure Memorandum 
SCC 
 
 
 
 
Satellite Clinical Site 
RC 
 
 
 
 
Site Research Coordinator 
RS 
 
 
 
 
Site Research Staff  
Study Number  
 
 
Protocol identification number 
Study Principal Investigator  
Lead Investigator on a protocol 
Study Protocol Committee 
Protocol development  
REDCap 
Research Electronic Data Capture System  
USAMRMC                                        United States Army Medical Research and Material 
Command 
WRNNMC 
Walter Reed National Naval Medical Center 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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PROTOCOL SUMMARY  
 
Title: Patient Response to an Integrated Orthotic and Rehabilitation Initiative for 
Traumatic Injuries. The PRIORITI-MTF Study  
Sponsor: DOD PRORP 
 
Type of study: Before-after study design; participants serve as their own controls 
 
Objectives: The primary objective of this study is to examine the benefits (and cost-benefits) of 
an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic 
Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but 
designed for scalability in the broader military environment (i.e. beyond San Antonio Military 
Medical Center where the program was developed). 
 
Participants will be evaluated at baseline (T0), immediately following 4 weeks of physical 
therapy with the IDEO (T2), at 6 months following completion of all physical therapy (T3) and 
at 12 months following completion of all physical therapy (T4).  See Figure 1.  
 
Specific Aim #1: To assess immediate improvements in functional performance following 
completion of the PRIORITI program. Functional performance will be measured using well-
validated assessments of speed, agility, power, and postural stability. Hypotheses to be tested 
include:   
a. Compared to baseline (T0), functional performance will be significantly better immediately 
following completion of the PRIORITI program (T8)  
 
Specific Aim #2: To assess long-term improvements in both functional performance and patient 
reported outcomes 1 year after completion of the PRIORITI program.  Principal hypotheses to be 
tested include:   
a. Compared to baseline (T0), functional performance will be significantly better at one year 
following completion of the PRIORITI program (T4) 
b. Compared to baseline (T0) patient reported outcomes will be significantly better at one 
year following completion of the PRIORITI program (T4)   
 
Specific Aim #3: To document patterns of device use, use of ambulatory aids, shoe wear and 
patient reported satisfaction associated with the IDEO.  Participants will be asked about their 
satisfaction with comfort, cosmesis, ease of use, and durability.  As this is primarily a descriptive 
analysis, no hypotheses will be tested. 
 
Specific Aim #4:  To assess the economic impact of the PRIORITI program by (i) measuring 
one-year costs associated with participation in PRIORITI and compare these costs to those 
projected under standard of care; and (ii) estimating lifetime cost-effectiveness of the PRIORITI 
program relative to standard of care.  As this is primarily a descriptive analysis, no hypotheses 
will be tested. 
 
Study design: The effectiveness of the PRIORITI program will be evaluated using a before-after 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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study design where participants serve as their own controls.   
 
Study duration: 3 years (6 month planning and training, 10 month accrual, 12 month final follow-
up, 8 month analysis and writing).  
 
Sample size: 90 participants will be consented to participate in this study.  
 
Number of study sites: 3 Military Treatment Facilities (MTF’s).  
 
Inclusion criteria  
1. Ages 18-60  
2. Currently one or more years out from a traumatic unilateral lower extremity injury at or 
below the knee  
3. Healed fractures and able to fully weight bear 
4. Evidence of either: 
a. Weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury 
(defined as less than 4 out of 5 on manual muscle test)  
b. Limited ankle dorsiflexion (< 10 degrees) and /or limited ankle plantarflexion (< 
20 degrees) resulting from leg injury 
c. Mechanical pain with loading to hindfoot/midfoot (>= 50 mm on a 0-100 mm 
visual analogue scale assessing average daily pain)  
d. Ankle or Hindfoot fusion or candidate for ankle or hindfoot fusion 
e. Candidate for amputation secondary to ankle/foot impairment  
 
Exclusion criteria  
1. Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central    
      
 nervous system pathology. 
2. Non-ambulatory  
3. Surgery on study limb anticipated in next 6 months  
4. Medical or psychological conditions that would preclude functional testing (ex. severe 
 traumatic brain injury, stroke, renal failure, heart disease, severe anemia) 
5. Neurologic, musculoskeletal or other conditions affecting contralateral extremity 
 preventing the study of a healthy control limb  
6. Unable or unwilling to participate in two 4-week PT programs  
7. Pregnancy 
8. Non-English speaking 
 
Outcome measures  
Physical impairment will be determined using objective performance measures of agility (4 step 
square test and Illinois Agility Test), strength and power (sit to stand test and timed stair ascent), 
speed (self selected walking speed and 40 yard shuttle run), and postural stability (single leg 
stance).   
Levels of participation will be measured using self reported measures of return to usual major 
activity (work, active duty, school, home management) and the Paffenbarger Activity Scale 
(PPAQ) that measures participation in light, moderate and vigorous recreational or sports 
activities.  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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Patient reported function and health related quality of life as measured using the total and 
dimension specific sub scales of the Short Musculoskeletal Functional Assessment (SMFA).  
Statistical analysis: We are interested in assessing immediate and long-term improvements in 
functional performance and self reported outcomes. One-sided paired t-tests will be used to test 
for improvements in outcomes, comparing baseline data to later outcomes. Differences in means 
between follow up and baseline will be reported along with 95% confidence intervals.  
Analysis of costs and benefits of PRIORITI will include an analysis of costs and outcomes 
observed over a 12-month period as well as cost-effectiveness projected over the patient lifetime.  
Safety monitoring: The Medical Monitor is responsible for monitoring serious adverse events 
(SAEs) as the study progresses to ensure patient safety. The Medical Monitor may convene a 
meeting of the DSMB to evaluate any SAEs that he/she determines require immediate attention. 
Data Safety and Monitoring Board (DSMB):  The DSMB is an independent body responsible 
for evaluating recruitment, safety and outcome data. The DSMB has the authority to stop the 
study based on its findings.  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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1. KEY ROLES  
Protocol Committee- Responsible for developing a detailed study protocol, provides oversight on 
study progress and acts to correct deficiencies in the conduct of the study. This committee also 
drafts the main publications related to the study. 
Steering Committee- Steering Committee is the decision making body of the Consortium and 
makes decisions regarding study design issues, study procedures, allocation of study resources 
and priorities for meeting competing demands of the Consortium and individual studies. The 
Steering Committee is composed of Site Investigators from each core METRC clinical center, 
the Department of Defense Program Officer for METRC, the orthopaedic consultants from the 
Army, Navy and Air Force, regional representatives of Satellite Clinical Centers, and the 
Director, Deputy Director, Principal Biostatistician and Principal Economist of the Coordinating 
Center. The Steering Committee is responsible for approving the protocol.   
METRC Coordinating Center- Responsible for maintaining all study documentation, developing 
and maintaining the master IRB application and consent, circulating any changes to study 
documents including protocols, case report forms, and IRB materials to each participating center, 
providing daily oversight and management of study implementation, providing payment to sites 
for patients enrolled, performing site monitoring, data quality control and analysis of study 
results.   
Core Clinical Sites- Responsible for the conduct of clinical studies including patient enrollment, 
performing study procedures, data collection and conducting study follow-up visits.  
Publications Committee- Responsible for reviewing manuscripts prior to journal submission and 
reviewing presentations prior to presentation; for mediating and settling disputes and conflicts 
among study investigators over publication or presentation priorities, authorship, and any other 
issues related to publications or presentations; for preparing and maintaining a list of concepts 
for publications and preparing and maintaining a list of approved METRC publications, which 
shows the status of each manuscript from initiation through publication. 
DSMB- Independent Data and Safety Monitoring Board (DSMB) appointed by DOD, 
responsible for monitoring the accumulated interim data as the trial progresses to ensure patient 
safety and to review efficacy, evaluate recruitment, and assess overall data quality.  
Medical Monitor- Responsible for providing medical guidance and overseeing patient safety for 
the study. The MM participates in determining the course of action necessary to meet safety 
goals and objectives. This is achieved through the review of safety reports; resolving safety 
issues; and interacting with Principal Investigators.  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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2. BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
2.1 Background Information 
 
High-energy open fractures, blast, gunshot wound and crush injuries to the distal tibia, ankle, 
hind foot and midfoot are common challenges to military and civilian trauma surgeons 1-20. 
Management of these injuries is complicated by soft tissue injury, ectopic bone, contamination, 
and neurovascular injuries.  Surgical advances have increased capabilities for limb salvage 11-15. 
But while prosthetic advances and amputee rehabilitation have facilitated high level function 
following amputation 16, similar advances in orthotics and rehabilitation for limb salvage patients 
have been nearly nonexistent.  Orthotic options for limb salvage patients have mostly been 
limited to plastic posterior leaf spring ankle foot orthosis (AFOs).  Many limb salvage patients 
have been unable to achieve their desired functional goals due to volumetric muscle loss 17, 
ectopic bone, chronic pain and nerve injury 8,13.   In the current military conflict, complications 
and the inability to achieve the desired level of activity have contributed to high rates of late 
amputation 18-20. 
 
Current Orthotic Options. Ankle foot orthoses are frequently prescribed for patients with ankle 
dorsiflexion and plantarflexion weakness due to a variety of etiologies from cerebral palsy in 
children to trauma and stroke in adults. Numerous types of AFOs exist for different clinical 
scenarios, each with specific clinical goals for their use. In particular, AFOs are used to 
counteract both ankle plantarflexion and dorsiflexion weakness by providing support to the ankle 
joint to prevent excessive activation of the opposing muscle groups (i.e. to counteract large 
plantarflexion moment in dorsiflexion weakness, and large dorsiflexion moment with 
plantarflexion weakness). Patients with deficiencies in both of these muscle groups have 
significant challenges with normal gait, as they are unable to create the large torques and powers 
needed to overcome these limitations without assistance. Conventional rigid AFOs typically 
consist of a hard plastic mold extending from the metatarsal heads to the proximal leg. These 
place the ankle in a neutral position and help to prevent excessive plantarflexion during swing 
phase that may lead to a “steppage gait,” and ensure that the heel contacts the ground at initial 
strike (first rocker). These AFOs do not provide any assistance with plantarflexion, and cannot 
contribute to push-off at terminal stance (third rocker) 34-37. 
 
In an effort to provide more plantarflexion power, the “energy-storing AFO” was designed. The 
design typically involves a carbon fiber material at the posterior aspect of the AFO. 
Biomechanical data suggests that deformation of the carbon fiber spring which occurs during 
ankle dorsiflexion in stance (second rocker) is returned during the third rocker allowing for more 
powerful plantarflexion during step-off. The hope is these devices will allow patients with both 
plantarflexion and dorsiflexion weakness to have more normal ankle biomechanics and increased 
ankle power. This, in turn, may lead to increased gait velocity, decreased work of ambulation, 
and may allow the patient adequate power to run 34-37. Energy-storing carbon fiber orthoses have 
been shown to improve abnormal gait patterns, temporal-spatial parameters, increase stride 
length, ankle power and range of motion in small series of patients 38-41. However, these studies 
largely address pediatric patients with cerebral palsy, myelomeningocele or other motor 
disorders, or adults with hemiplegia. No study to date has investigated the use of energy-storing 
orthoses in a traumatic limb salvage population. 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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The Intrepid Dynamic Exoskeletal Orthosis (IDEO) and Return to Run (RTR) Clinical Pathway.  
The Intrepid Dynamic Exoskeletal Orthosis (IDEO) (Figure 1) is a custom, energy-storing 
carbon fiber orthosis specifically developed at the Center for the Intrepid, San Antonio Military 
Medical Center (SAMMC) for trauma patients undergoing limb salvage.  The IDEO device is an 
FDA exempt device under 21 CFR 890.3475 and 21 CFR 890.3410.  It incorporates a 
posteriorly mounted carbon fiber strut with a proximal ground reaction cuff and distal 
supramalleolar AFO.  The proximal ground reaction cuff is a circumferential support 
fashioned in the style of a patellar tendon bearing prosthetic located at the proximal 
leg, with a posterior attachment to the proximal end of the carbon fiber strut.  The 
distal supramalleolar AFO spans from the posterior attachment to the distal end of the 
carbon fiber strut, around the ankle joint and under to foot to the toes.  A cushioned 
heel allows for shock absorption during the loading response.  The laminated carbon 
fiber foot plate, which is inspired by prosthetic running feet, is rigid resulting in 
deformation primarily through the posteriorly positioned carbon fiber strut.  This 
maximizes strut dynamics and power.  The plantarflexed position of the footplate 
combined with a gradual roller shape allows for increased deflection and energy 
storage as the tibia progresses forward from mid to terminal stance.  This also allows 
for forefoot loading during agility and running activities.  The modular design allows for 
alignment adjustment, the ability to change strut stiffness based on individual patient strength 
gains, and facilitates donning and doffing to accommodate volumetric muscle changes from 
strength gains or edema. The IDEO will be labeled with the following information for use in this 
study: “CAUTION--Investigational device. Limited by Federal law to investigational use.”  
 
 
To maximize an individual’s potential success in utilizing the IDEO, a high intensity, sports 
medicine based approach to rehabilitation was developed in collaboration with the departments 
of orthopaedics, physical therapy and orthotics/prosthetics at the Center for the Intrepid and the 
San Antonio Military Medical Center.   The multidisciplinary Return to Run (RTR) clinical 
pathway focuses on strength, agility and speed with the goal of enabling patients to return to 
running, sports and military deployment 21, 23.    Running was chosen as a surrogate for the return 
to high level function based on the successes of amputation rehabilitation programs 42.  Also, 
working alongside similar patients who have been fitted with an IDEO provides a built-in 
support group and helps build self efficacy, which is one of the most important predictors of 
good outcomes and return to usual activity.  The early success of this clinical pathway showed 
80% return to running 23. In addition to success in high level rehabilitation goals, the RTR 
Clinical Pathway has returned wounded warriors to duty to include deployment 21, 43-44.    
 
Preliminary Studies to Support the Efficacy of the IDEO and RTR Clinical Pathway.  In a small 
study of 18 subjects with unilateral dorsiflexion and/or plantarflexion weakness, the functional 
performance of the IDEO was compared against two commercially available orhthoses and no 
orthosis.  All participants in this study also completed physical therapy component of the Return 
to Run Clinical Pathway. Performance wearing the IDEO was compared to that wearing the 
Allard BlueRocker™ (BR), a rigid plastic posterior leaf spring (PLS), and no brace (NONE) 22. 
Subjects were evaluated on six functional tests wearing the IDEO, BR, PLS, and NONE. Brace 
order was randomized and 5 trials were completed for each measure. Performance was 
Figure 1: The IDEO 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
14 
 
significantly better in the IDEO on all functional measures compared to all other bracing 
conditions (p <0.004), with the exception of the sit-to-stand five times, in which there was only a 
significant improvement against the BR (p =0.014).  The forty yard dash improved by 37% over 
the PLS and NONE, and by 28% over the BR.  The BR demonstrated a significant improvement 
in the forty yard dash compared to NONE (p =0.033), and self-selected walking velocity on level 
terrain over NONE and PLS (p <0.028), but no significant difference was found between the 
PLS, BR and NONE in any other functional measure. This study did not, however, evaluate the 
impact on patient reported outcomes of the improvements in functional performance 43.   
 
 
2.2 Rationale 
 
The development of a new custom energy-storing ankle foot orthosis (AFO), the Intrepid 
Dynamic Exoskeletal Orthosis (IDEO), integrated with the RTR Clinical Pathway designed to 
optimize the patient’s adaptation to the IDEO, may significantly improve limb salvage outcomes, 
reduce the number of delayed amputations, and provide both service members and civilians who 
undergo limb salvage a higher quality of life 21-24.  While some initial studies point to the benefits 
of the IDEO, these studies were performed using a small number of patients treated at one 
military treatment facility (where the IDEO was developed and refined), using measures of 
functional performance assessed in a controlled environment 22.  Data are needed to replicate the 
positive results of this study at other military treatment facilities and provide evidence that 
improvements in performance translate into longer term improvements in functional outcomes 
and quality of life.  
 
 
3. STUDY OBJECTIVES 
 
3.1 Primary Objective 
To assess immediate and long-term improvements in functional performance and self reported 
outcomes in patients who are currently one or more years out from a traumatic unilateral lower 
extremity injury at or below the knee and have chronic muscle weakness and/or limited range of 
motion at the ankle that translates into functional deficits that interfere with daily activities and 
overall quality of life.  
 
3.2 Secondary Objectives 
To document patterns of device use, use of ambulatory aids, shoe wear and patient reported 
satisfaction associated with the IDEO.  Participants will be asked about their satisfaction with 
comfort, cosmesis, ease of use, and durability.  
 
To assess the economic impact of the PRIORITI program by (i) measuring one-year costs 
associated with participation in PRIORITI and compare these costs to those projected under 
standard of care; and (ii) estimating lifetime cost-effectiveness of the PRIORITI program relative 
to standard of care. 
 
3.3 Exploratory Objectives 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
15 
 
N/A 
 
 
4.  STUDY OVERVIEW 
The study is a clinical investigation (study) to evaluate the effectiveness of the IDEO, an 
investigational FDA-regulated medical device. The effectiveness of the PRIORITI program will 
be evaluated using a before-after study design where participants serve as their own controls.   
A total of 85 participants at military treatment facilities will be identified at least 1 or more years 
after their injury. To ensure we are enrolling a ‘stable’ population, we will exclude individuals 
whose fractures and soft tissues injuries are not healed at the time of screening or for whom 
additional surgery is planned within the next six months.   
 
The study will be conducted by the Major Extremity Trauma Research Consortium (METRC) 
(www.metrc.org).  Specifically, participants will be recruited, consented and evaluated at 3 of 
METRC’s core military sites.  
 
The study procedures are summarized in the Figure below. 
 
  Figure 1: Overview of Study Procedures 
 
 
 
At the time of enrollment into the study (T0), all participants (those who have screened 
eligible and have consented) will be asked to complete a battery of performance tests to measure 
their baseline assessments of strength, agility, speed and postural stability.  They will also 
complete several standardized assessments of self-reported functional activity, participation in 
major usual activity and sports and leisure activities, presence of pain, and overall well being.   
At this time, basic information about the participants, their injury and their use of health and 
rehabilitation services in the previous year will be collected.   After completing these baseline 
assessments, the Study Site Certified Prosthetist/Orthotist (CPO) will take a cast of the leg and 
other pertinent measures that are needed for fabrication of the IDEO.  The CPO will then 
fabricate the IDEO brace locally. The final fabricated device given to each subject will be 
labeled with the following information: “CAUTION--Investigational device. Limited by Federal law 
to investigational use.”  
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
16 
 
During the following 2-4 weeks participants will engage in a home physical therapy (PT) 
program as directed by the study team. The length of the home physical therapy program is 
dependant on the time required to fabricate the IDEO™.The focus of the Pre-IDEO PT is 
conditioning and building self-efficacy.  It will build on the principles of the Return to Run 
Clinical Pathway developed at the CFI.  
 
Following 2-4 weeks of home PT (T1), the participant will be fitted with the IDEO and engage 
in four weeks of Post-IDEO PT at the study center. During these 4 weeks, adjustments to the 
brace will be made and the participants will learn how to optimize the use of the brace.    
 
At the end of the four weeks of post-IDEO PT (T2), performance testing will be repeated and 
overall satisfaction with the device assessed. The purpose of these assessments is to measure any 
immediate gains in function. Participants will then be formally ‘discharged’ from the PRIORITI 
program.  They will be given the number of the Study Site Orthotist to call if any concerns arise 
with the IDEO and its fit.  The costs associated with all visits to the orthotist during the 12 month 
follow-up period will be covered by the study.    
 
At 6 months following the completion of the PRIORITI program (T3), participants will be 
contacted by the Study Coordinator and asked to participate in a brief interview by phone.  The 
main purpose of this phone call is to keep participants engaged in the study and motivate them to 
come back to the hospital for the final visit at 12 months.  We will also use this opportunity to 
ask them questions about their functioning, satisfaction with the brace and use of services 
(overall and specific to the IDEO). This interview will last about 15 minutes.  During the call the 
he coordinator will remind the participant of the 12 month follow up visit. If the participant is 
living outside of the research site area, the coordinator will inform the participant that travel 
expenses can be covered for the 12 month follow up visit. (See appendix K). 
 
At 12 months following the completion of the PRIORITI program (T4), participants will be 
asked to return to the Study Center to repeat the performance tests and self reported measures of 
outcome and satisfaction with the IDEO. Additional questions regarding use of services (overall 
and specific to the IDEO) will also be asked. 
 
 
5. STUDY POPULATION 
 
5.1 Description of the Study Population  
 
A total of 85 participants will be enrolled from 3 METRC Military Treatment Facilities over a 10 
month period.  
 
Consenting procedures are described in detail in Sections 8 and 13 of this protocol. 
 
5.1.1 Participant Inclusion Criteria 
1. Ages 18-60  
2. Currently one or more years out from a traumatic unilateral lower extremity injury at or 
below the knee  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
17 
 
3. Healed fractures and able to fully weight bear 
4. Evidence of either: 
a. Weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury 
(defined as less than 4 out of 5 on manual muscle test)  
b. Limited ankle dorsiflexion (< 10 degrees) and /or limited ankle plantarflexion (< 
20 degrees) resulting from leg injury 
c. Mechanical pain with loading to hindfoot/midfoot (>= 50 mm on a 0-100 mm 
visual analogue scale assessing average daily pain)  
d. Ankle or Hindfoot fusion or candidate for ankle or hindfoot fusion 
e. Candidate for amputation secondary to ankle/foot impairment  
 
5.1.2 Participant Exclusion criteria  
Patients who satisfy any of the following exclusion criteria will be ineligible for enrollment in 
the study: 
1. 
Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central 
 
nervous system pathology. 
2. 
Non-ambulatory  
3. 
Surgery on study limb anticipated in next 6 months  
4. 
Medical or psychological conditions that would preclude functional testing (ex. severe 
 
traumatic brain injury, stroke, renal failure, heart disease, severe anemia) 
5. 
Neurologic, musculoskeletal or other conditions affecting contralateral extremity 
 
preventing the study of a healthy control limb  
6. 
Unable or unwilling to participate in two 4-week PT programs  
7. 
Pregnancy 
8. 
Non-English speaking 
 
5.1.3 Co-Enrollment Guidelines 
We do not anticipate this patient population will be eligible for other METRC studies. 
 
5.2 Strategies for Recruitment and Screening  
 
Eligible study participants will be identified in several ways as outlined below. 
 
The study center will reach out to orthopaedic surgeons, physical medicine and rehabilitation 
physicians and physical therapists practicing in the military and veterans community to educate 
them about the study and ask for referrals of patients they believe may meet the inclusion and 
exclusion criteria.  
 
The participating study centers will query their orthopaedic registries and identify patients they 
treated one or more years ago for a severe traumatic lower extremity injury.  These individuals 
will be sent a letter and brochure (explaining the study, its risks and requirements) from their 
treating physician or the director of orthopaedics if their treating physician is no longer 
practicing at the facility, and encouraged to contact the center if they think they meet the study 
criteria (See Appendix H for draft).   
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
18 
 
We will mount a direct advertising campaign to include local radio and newspaper 
advertisement, targeting appropriate media outlets frequented by service members and veterans. 
These advertisements may be produced locally or by the METRC Coordinating Center to 
maximize our target audience.   We will also launch a social media campaign, using the 
advertisement attached as Appendix J.  This advertisement directs potential participants to the 
PRIORITI website where they are able to access additional information and use our eligibility 
application.  www.prioriti-mtf.org 
 
• LinkedIn 
There are several groups we would like to utilize on LinkedIn for the purposes of 
posting our advertisement.  The only contact information on the ad is the 
PRIORITI website.  We do not intend to facilitate forum discussions, rather 
interested participants will directed to the PRIORITI website.  The groups we 
intend to target are the following: 
o US Military Veterans Network  
o Wounded Warrior Project  
o Society of Orthotics and Prostetics  
o Disabled American Veterans  
o Stryker, Inc. 
o Hanger, Inc.  
o Orthopaedic Trauma Association 
o Society for Orthotics and Prosthetics 
o The Trauma Network 
o The Lower Extremity Review 
o US Department of Veterans Affairs 
 
• Twitter 
We will use a Twitter account to tweet study inclusion information to selected 
groups and members.  We will contact respected members of those groups 
(Surgeons, Military personnel etc) and request that they retweet our invitation to 
be involved in the study. Tweets will contain a unique URL directing participants 
to the PRIORITI Website. 
 
• Magazine Advertisements 
We plan to purchase a ¼ to ½ page advertisement (Appendix J) that will be 
printed in various Veterans magazines.  Three magazines we plan to target are: 
 
o Disabled American Veterans  
o American Veteran Magazine (AMVETS) 
o The Journal 
 
• Blogs 
There are blogs we would like to utilize for the purpose of posting our advertisement.  
The only contact information on the ad is the PRIORITI website.  We do not 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
19 
 
intend to facilitate forum discussions, rather interested participants will directed to 
the PRIORITI website.  The groups we intend to target are the following: 
 
o http://americanveteranmagazine.blogspot.com/ 
o http://www.blogs.va.gov/VAntage/ 
o http://warriorcare.dodlive.mil/ 
 
• YouTube 
We have an approved recruitment video that is currently posted on the PRIORITI 
Website.  We would like to post the video on YouTube.  Prior to posting we 
would modify the video such that the introduction specifies that interested parties 
should visit the PRIORITI website for more information and confirmation of 
eligibility. 
 
• Local Radio Advertisements 
We will utilize the radio script to create a radio advertisement.  Both the MCC 
and local sites will be permitted to run this advertisement on radio stations to 
broaden the scope of our recruitment efforts.  (Appendix G) 
 
• Local News Paper Advertisement 
The MCC and local sites will place the approved advertisement (Appendix J) in 
local newspapers. 
 
• Facebook 
We will initiate an IDEO brace Facebook page.  We will use the IDEO logo as the 
profile photo and a picture of the brace on a leg as the background photo.  The 
page will use approved advertisement verbiage to provide potential participants 
with information about the study and brace.  Interested participants will be 
directed to www.PRIORITI-MFT.org.  We will adjust the privacy settings such 
that any “wall posts” will require approval by the page editor (a member of the 
MCC staff).   
 
 
To assist in recruitment, a printed brochure and a video are being  produced that describe the 
IDEO and PRIORITI program, the goals of the study, who is potentially eligible for the study 
and what would be expected of individuals who agree to participate in the study. The recruitment 
materials will be produced in collaboration with communications experts as well as 1-2 
consumers who meet the general inclusion criteria for the study.  All recruitment materials will 
be made available on a website, www.prioriti-mtf.org. This website will also be accessible 
through the METRC website, www.METRC.org.  (A draft of the video script is included in J). 
 
The goal is to develop an effective but efficient process of finding potentially eligible individuals 
for the study.  Individuals who learn about the study through any of the methods described above 
will be encouraged to contact the local study center if they meet the following criteria: 
 
✓  Is between the ages of 18 and 60 and able to walk (with or without an assistive device) 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
20 
 
✓  Had a traumatic injury to their leg (at or below the knee) one or more years ago for 
which they were initially hospitalized overnight in a hospital   
✓ Can answer yes to one or more of the following questions: 
o Are you limited in what or how much you are able to do at home, at work or at 
school because of your leg injury? 
o Are you limited in the types or frequency of sports and recreational activities 
you would like to do because of your leg injury?  
o Are you dissatisfied with the recovery you have made from your leg injury?   
 
 
6. STUDY PROCEDURES 
 
6.1 Screening and Enrollment 
 
6.1.1 Screening for Eligibility  
 
As shown in the Figure 2, potential participants in this study 
will contact the research team at each MTF through physician 
or self-referral.  All referrals will be asked to talk to the 
Research Coordinator at the local study site.  Potential 
participants can self-refer through the website, www.prioriti-
mtf.org.  A screening CRF will be completed on every 
potentially eligible participant and entered into REDCap, the 
METRC electronic data capture system in order to document 
screen failures.  
 
At the time of initial screening, the Research Coordinator will 
describe the study and if the patient is still interested, will 
obtain oral consent to conduct a brief telephone screen. The 
interview will consist of the following:  
 
• Questions about the injury and its initial treatment to 
confirm the individual is 1 or more years out from a 
traumatic injury of the lower extremity (at or below 
the knee) (to include: cause of the injury, when it 
occurred, where the person was hospitalized and for 
how long and a description of the injury);  
• The Short Form Musculoskeletal Function Assessment 
(SMFA) to determine whether the individual is 
impaired or bothered by their level of function due to their leg injury.   
 
Individuals meeting the initial screening criteria will be mailed a consent form and will receive a 
follow up phone call within 5 business days. If at that time the patient decides to participate, the 
Research Coordinator will schedule an appointment to come to the study center for testing and 
final screening to confirm that the patient meets the final inclusion/exclusion criteria for the 
Figure 2 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
21 
 
study. The final (in person) screen will consist of a clinical assessment, medical history, and 
interview.   
 
6.1.2 Consent and Enrollment 
 
A prototype consent has been prepared for the PRIORITI study and is attached in Appendix D. 
Individual sites may add material but may not delete material thought to be necessary for 
informed consent. Clinical sites may reformat and reword information to conform to their local 
requirements. The consent form will describe the purpose of the study, the procedures to be 
followed, and the risks and benefits of participation. Copies of the signed consent forms will be 
given to the patient, and this fact will be documented in the patient’s record.  
 
Informed consent will take place at the study center before beginning the final in-person screen. 
The conversation will be initiated by the Research Coordinator and surgeon investigator 
together. Patients will be provided a pamphlet describing the study, the risks and benefits of 
participation and what will be expected of them if they choose to participate. After reviewing all 
components of the informed consent form, the surgeon investigator and the Research 
Coordinator will answer any questions the patient has about participating in the study. Consent 
will be obtained in accordance with principles of GCP and ICH guidelines. 
 
Following completion of informed consent, the surgeon investigator will conduct a clinical 
assessment, medical history, and interview to confirm eligibility. Patients who are ineligible will 
not continue in the study and will be withdrawn.  
 
All patients must be able to provide informed consent; there will be no consent by Legally 
Authorized Representatives. 
 
All study materials will be provided in English.   
 
Additionally, after completion of informed consent, the participant information will be entered 
into REDCap where a study number will be assigned and final eligibility criteria confirmed. 
 
6.1.3 Assessing Capacity to Consent and Consenting a Proxy Respondent 
N/A 
 
6.1.4 Informed Consent Process or Assent (for a minor) 
N/A 
 
6.2 Baseline Data Collection 
 
Once consented into the study, baseline data regarding participant characteristics, injury 
characteristics, fracture classification and medical history/co-morbidities will be collected and 
entered into the REDCap data collection system. An x-ray will be obtained to confirm healing of 
the fracture and to identify presence of post-traumatic osteoarthritis.  This x-ray will be used to 
confirm suitability of the IDEO for the individual.  If, based on the x-ray, a decision is made that 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
22 
 
the patient is not suitable to receive the intervention, he or she will be withdrawn from the study.  
Participants who remain eligible will complete a performance assessment and a brief interview. 
 
For patients treated acutely (initially at the time of the injury) in an institution other than the 
recruiting institution, permission will be sought from the participant to access the medical 
records pertaining to the initial hospitalization.  
 
The data collected at baseline are described below. These data are summarized in Appendix C.   
 
6.2.1 Baseline Clinical Assessment and Medical History 
• Study Injury Characteristics   
o Mechanism, Type, Side of Injury  
o Classification of Fracture (AO/OTA and Gustilo) 
o Presence of other limb and non-limb injuries (ICD-9CM codes) 
• Current Limb Status  
o ROM and Strength of study limb 
o Radiographic Evaluation of Healing (from x-ray) 
o Evidence of PTOA (from x-ray) 
o VAS Pain and Use of Narcotics   
• Height and Weight  
• Co-morbidities  
• Smoking History  
 
6.2.2 Performance Assessments 
• 4 Square Step Test 
• Illinois Agility Test 
• Sit to Stand 
• Timed Stair Ascent 
• Self Selected Walking Speed 
• Shuttle Run 
• Single Leg Stance 
 
6.2.3 Participant Interview 
• Age, gender, race and ethnicity, education, and income (past year) 
• Marital status 
• Usual major activity status  
• If working, what type of work and physical demands of the job; Work Productivity 
(WPAI)  
• Job Motivation  
• Multidimensional Scale of Perceived Support (MSPS) 
• Health insurance  
• Self Efficacy to perform major usual activity    
• Short Musculoskeletal Function Assessment (SMFA) 
• Veterans Health Survey (VR-12)  
• Paffenbarger Activity Scale (PPAQ)  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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• Brief Pain Inventory (BPI) 
• Patient Health Questionnaire Dépression Scale (PHQ-9) 
• Post Traumatic Stress (PCL Checklist)   
• Shoe Wear and Use of Ambulatory Aids  
• Hospitalizations in Past Year  
• Use of Orthotic Services in Past Year  
• Use of PT/OT Services in Past Year   
• Use of Other Services Related to the Injury in Past Year  
 
If, during the course of completing the PHQ-9 or PCL via participant self-report survey or 
interview, a participant has a PHQ-9 score indicating major depressive disorder (>=20) or has a 
PCL score indicating clinically significant PTSD (>=30), the participant will be notified and 
advised to contact his/her physician or to visit the emergency department.   
  
If on the PHQ-9 item #9, the participant reveals that he/she has thoughts of being better off dead 
or of hurting themselves in any way, more often than “not at all,” the coordinator will ask the 
following questions to the participant: 
  
1 
Interviewer: 
Let me ask another question, have you thought of hurting yourself in any 
way?  
  
Participant: 
Yes       No        
  
If no: “It is difficult having thoughts like this.  You should talk to your 
doctor about these thoughts, as you may benefit from treatment for 
depression.”  Continue with interview. 
  
If yes: Continue with following questions. 
2 
Interviewer: 
Does your doctor know about this?  
  
Participant: 
Yes       No        
  
If yes: “It is difficult having thoughts like this.  You should talk to your 
doctor about these thoughts, as you may benefit from treatment for 
depression.”  
Continue with interview. 
  
If no: Continue to following questions. 
3 
Interviewer: 
Have you talked to another clinician, like a counselor or psychologist, 
about how you have been feeling lately? 
  
Participant: 
Yes       No      
  
If yes: “It is difficult having thoughts like this.  You should talk to your 
doctor about these thoughts, as you may benefit from treatment for 
depression.”  Continue with interview. 
  
If no and if in-person: “I am not a clinician, but we want a clinician on the 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
24 
 
study to talk with everyone who tells us they have been feeling this way 
recently. I would like Dr. ________ or Dr. ________ to speak with you 
today. If you are having thoughts of hurting yourself, the best thing to do is 
to go to the emergency department or call the National Suicide Prevention 
Hotline (1-800-273-8255).” 
  
If no and if on phone: “I am not a clinician, but we want a clinician on the 
study to talk with everyone who tells us they have been feeling this way 
recently. I would like Dr Stephen Wegener to give you a call today or 
tomorrow. If you are having thoughts of hurting yourself, the best thing to 
do is to go to the emergency department or call the National Suicide 
Prevention Hotline (1-800-273-8255).” 
 
 
6.3 Participant Follow up and Data Collection 
 
The follow up visit schedule for this study will be closely related to the timing of brace fitting 
and PT participation. Follow up will occur immediately following post-IDEO PT (T2), 6 months 
following completion of all PT (i.e. post PRIORITI) (T3), and 12 Months post PRIORITI (T4). 
Each visit will have an interval of time surrounding the ideal date for the visit during which the 
visit may be completed and the data included in the trial database. This interval is approximately 
1-2 weeks before or after the ideal date for a visit.   
 
The data collected at follow-up are described below.  These data are summarized in Appendix C.   
 
6.3.1   Performance Assessments (at,T2, T4)   
• 4 Square Step Test 
• Illinois Agility Test 
• Sit to Stand 
• Timed Stair Ascent 
• Self Selected Walking Speed 
• Shuttle Run 
• Single Leg Stance 
 
6.3.2   Clinical Assessment at T4 
• Weight  
• ROM and Strength  
• VAS Pain and Use of Narcotics  
   
6.3.3   Participant Interviews at T2   
• Use and Satisfaction with Brace (OPUS & CFI)  
• Shoe wear and ambulatory aids 
 
6.3.4   Participant Interviews at T3 
• ALL ITEMS ASKED AT T2 PLUS:  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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• Short Musculoskeletal Function Assessment (SMFA) 
• Veterans Health Survey (VR-12) 
• Usual major activity status 
• If working: Work Productivity (WPAI) 
• Hospitalizations in past 6 months    
• Use of Orthotic Services in past 6 months    
• Use of PT/OT Services in past 6 months    
• Use of other Services in past 6 months    
 
 6.3.5   Participant Interviews at T4   
• ALL ITEMS ASKED AT T3 PLUS:  
• Income (past year)   
• Health Insurance (current) 
• Self Efficacy 
• Multidimensional Scale of Perceived Support (MSPS) 
• Activities- Paffenbarger Activity Scale (PPAQ) 
• Brief Pain Inventory (BPI) 
• Patient Health Questionnaire Dépression Scale (PHQ-9) 
• Post Traumatic Stress Disorder using the PCL Checklist 
 
6.3.4  Retention  
 
Every effort will be made to retain participants in the study.  The study participants will receive 
an honorarium in recognition of their time and effort.  We will provide them with challenge coin 
designed specifically for the METRC and (for those not on active duty), a total of $300 to cover 
the costs of travel to and from the centers for the physical therapy and follow-up assessments and 
keep in contact with them throughout the one-year follow-up (by mail and phone). This sum will 
be distributed as follows: $50 at baseline (T0), $75 at T1, $75 at T2 and $100 at T4. We will also 
keep participants engaged through use of study updates on the METRC webpage and distribution 
of follow-up reminders and trinkets imprinted with the study logo. 
6.3.5  Final Study Visit   
 
Participants will complete the study at month 12. Any ongoing SAE’s will be followed to 
resolution. The study will cover the travel expenses for participants that have moved out of the 
area so that they can participate in the 12 month follow up visit.  Expenses that will be covered 
include:  transportation to and from the study center (airfare, bus fare or mileage reimbursement), 
lodging expense (up to 1 night, if needed), meal per diem of 50.00 per day (2 day maximum).  
 
 
 
6.3.6 Early Termination Visit 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
26 
 
Should a participant terminate the study prematurely, if at all possible, all procedures required at 
the month 12 (T4) visit will be performed at his/her final visit.  
 
6.4  Study Endpoints 
 
6.4.1 Primary Endpoints 
 
The primary endpoints are functional performance and self reported functioning as measured 
suing the Short Form Musculoskeletal Assessment (SMFA) and the Veterans Health Survey 
(VR-12).  
 
Functional Performance The performance test battery includes a dyad of a “less demanding” 
test and a “more demanding” test for three of the domains. At the study initiation visit, the 
treating surgeon will clinically evaluate the participant’s health, weight bearing and ambulatory 
status and will provide written approval in order to proceed with the performance tests. Prior to 
and during the performance tests, the participant will be reminded that he/she can stop these 
activities at any point if he/she feels unsafe. Participants in the study will complete the “less 
demanding” test first and, if the score meets a critical threshold, they will move on to complete 
the “more demanding” test.  This approach will provide information on higher level functioning 
without risking the safety of those with significant impairment.  These dyads are summarized in 
the table below. 
 
Details of each of these assessments are provided 
below.  
• The Four Square Step Test (FSST) is a dynamic 
test of balance and agility. It requires participants 
to rapidly change direction while stepping 
forward, backward, and sideways, over a low 
obstacle 54.  The test has demonstrated reliability 
and validity through correlation with existing 
balance tests and a positive predictive value of 
86% 54.  The FSST does not require any special 
equipment and   requires little space, and is timed using a stopwatch.  Raters place four canes 
(or piping) in a cross on the floor (all four canes lay 
flat on the floor).  The participant then steps as fast                                                                        
as possible into each square in a designated sequence (see Figure 3).   
• The Illinois Agility Test 54 is a commonly used test to measure agility by requiring the 
patient to turn in different directions and at different angles. The test requires the patient to 
 
Less Demanding Tests 
More Demanding Tests 
Agility 
4 Square Step Test  
Illinois Agility Test  
Strength/Power  Sit to Stand (5x) 
Timed Stair Ascent (12 steps) 
Speed 
Self Selected Walking Speed (15 ft) 
10 Meter Shuttle Run  
Postural 
Stability  
Single Leg Stance  
 
Figure 3: the Four Square Step Test  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
27 
 
navigate through a series of cones placed 3.3 meters apart as quickly as possible.  It is simple 
test to administer and requires little equipment. The test is timed using a stopwatch and 
requires 10 meters of length, 5 meters of width, and 8 cones (or markers of some kind).   
• The 5x Sit to Stand Test (STS5) 54-61 is a commonly performed to assess lower extremity 
strength, endurance, and mobility. This test measures time to complete 5 full stands from a 
sitting position. It is simple, inexpensive, rapid, and reproducible, has demonstrated a highly 
significant relationship with age and has correlated well with measures of knee flexor and 
extensor muscle strength 61. Participants sit in a straight back chair 44.5 cm high and 38 cm 
deep and are asked to fold their arms across their chests and to stand up from a sitting 
position once. If they successfully rise, they are asked to stand up and sit down 5 times as 
quickly as possible. Time to stand is measured using a stopwatch. Raw scores can be 
transformed into a rate per minute to accurately assess change in those who were unable to 
perform the test at any point. 
• Timed Stair Ascent: The timed stair ascent is an objective measure of mobility and power 62 
that requires the patient to demonstrate greater strength and range of motion than level 
ground walking. Patients are asked to climb a flight of stairs at their maximal rate, with or 
without holding onto the railing.   The rater uses a stopwatch to time the patient’s ascent up 
12 stairs of normal rise and run.  The inclusion of this test provides data on higher levels of 
functional performance because of the level of challenge involved in climbing stairs 
• Self-selected walking velocity over level terrain (SSWV-L) is a commonly used measure 
of speed and general physical capacity.62-64. Subjects will be asked to walk 30 feet on a level 
surface, as fast as they can, with or without an assistive device. Use of assistive devices will 
be recorded, as described above. The time it takes for subjects to complete the task is 
measured with a stop watch and recorded as feet per second (ft/sec).  Use of a stopwatch has 
been found to have excellent concurrent validity with the gold standard of infrared timing 
gates, with an inter-rater reliability of 0.99 for tests of walking speed 64. Four feet per second 
is considered an appropriate cut-off for impaired speed, since 4.2 ft/sec is an approximate 
gait velocity for adults, 20-59 years old 63.  
 
• 10 Meter Shuttle Run (40D): The 10 meter shuttle run assesses speed.  Research staff will 
measure out a continuous 10 meter stretch that is free of obstacles.  This test requires the 
person to run or walk back and forth between two parallel lines as fast as possible. Patients 
will start in a standing position and run or walk at their self-selected maximal rate 10 meters 
and back, for a total of 20 meters.  The rater uses a stopwatch to keep time. The Shuttle Run 
test is easy to administer and requires little equipment and space. Patients are able to run or 
walk at their own pace, and the test is appropriate for patients at both lower and higher levels 
of functional ability.  
 
• Single Leg Stance: The single leg stance is a measure of postural stability 66. Participants 
will be asked to stand with arms crossed and pick one foot off the ground bending the knee to 
90 degrees. The rater uses a stopwatch to time how long participants hold this stance up to 60 
seconds. This test is done on both legs.  
 
Self -Reported Measures of Function will be assessed at baseline (T0) and at one-year (T4).     

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
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Overall Function and Well Being will be measured using two instruments.   The Short 
Musculoskeletal Function Assessment (SMFA) will be used to measure overall function and well 
being 67-68. The SMFA is a shorter version of the 101-item Musculoskeletal Function Assessment 
(MFA) questionnaire. The SMFA is a 46-item questionnaire consisting of the dysfunction and 
bother index. The Dysfunction Index includes 34 items for assessing patient function.  Subscores 
for the following 4 domains can be calculated: Daily Activities; Arm and Hand Function; 
Mobility and Emotional Status.  The Bother Index consists of 12 items designed to detect how 
much patients are bothered by functional items. The SMFA has been evaluated for reliability, 
validity and responsiveness in patient populations 67. This scale has been chosen because it is a 
short, reliable, patient reported assessment of functional status that has been specifically 
designed for and validated in patients with musculoskeletal conditions, including acute injury 67-
68. 
 
We will also use the Veterans RAND 12 item Health Survey (VR-12) as a generic health status 
measure from which a VR-6D can be computed for a cost-utility analysis 69-70. The VR-12 is a 
multipurpose short-form generic measure of health status.  It was developed to be a much 
shorter, yet valid, alternative to the VR-36 for use in large surveys of general and veteran 
populations.  The 12 items in the VR-12 are a subset of those in the VR-36 and includes 1-2 
items from each of eight health concepts:  physical functioning, role limitations due to physical 
health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role 
limitations due to emotional problems and mental health (psychological distress and 
psychological well being).   
 
6.4.2 Secondary Endpoints 
   
Secondary Outcomes include additional self reported measures of participation, pain, depression 
and post traumatic stress.  We will also be the use and satisfaction with the IDEO and related 
services.   
 
•     Labor Force Participation and Work Productivity will be assessed using standard 
questions used in other METRC studies. Participants will be asked what they were doing 
most of the time during the previous two weeks.  If participants are working, the Work 
Productivity and Activity Impairment (WPAI) questionnaire will be administered.  The 
WPAI measures work time missed and work and activity impairment because of a specified 
health problem during the past 7 days (for questionnaire: 
http://www.reillyassociates.net/WPAI_SHP.html) 71. The validity of the WPAI has been 
established in a number of diseases 72-73. In addition, the WPAI has proven a useful tool when 
measuring the relative difference between treatment groups in clinical trials and in subjects 
with and without disease.  
 
•    Participation in Sports and Leisure Activities will be assessed using the Paffenbarger 
Activity Scale (PAS) 74. At T0 (baseline) and at T4 (one year post fitting of the IDEO), 
patients are asked to identify up to 5 activities performed within the past 3 months.  The 2000 
version of the Compendium of Physical Activities 75 will be used to classify each activity 
according to its intensity level based on the rate of energy expenditure expressed as 

 
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29 
 
metabolic equivalents (METS).  Activities will then be classified as light (< 3 METS) 
moderate (3-6 METS) or vigorous (> 6 METS).   
 
•    Pain will be measured using the Brief Pain Inventory (BPI). The BPI is a widely used, 15-
item measure of pain intensity and interference with daily life 76.  The questionnaire assesses 
three key pain domains: pain intensity, pain interference, and efficacy of pain treatments or 
medications. It has been extensively validated in both English and Spanish. Overall study 
limb as well as knee and ankle specific pain intensity will be measured using the 0-10 visual 
analogue scale used in the Brief Pain Inventory. Pain intensity will be measured both at rest 
and during ambulation. The BPI pain intensity domain is compatible with the IMMPACT 
guidelines for assessing pain in clinical trials and the FDA Guidance for Industry on the use 
of Patient-Reported Outcome Measures 77. At each clinical follow up, the treating surgeon 
will also record the type (grouped as acetaminophen, opioids, GABA analogues (like 
Neurontin or Lyrica), and NSAIDs (like Ibuprofen or Naproxen), and other) and frequency of 
pain medication use. 
 
•    Depressive Symptoms will be assessed using the nine item depression scale of the Patient 
Health Questionnaire (PHQ-9) 78.  The PHQ-9 is a well validated tool for assisting clinicians 
in diagnosing depression. There are two components of the PHQ-9: (1) assessing symptoms 
and functional impairment to make a tentative depression diagnosis, and (2) deriving a 
severity score. The PHQ-9 is based directly on the diagnostic criteria for major depressive 
disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). 
 
•    Post Traumatic Stress (PTSD) will be measured using the standard PTSD Checklist (PCL), 
a 17-item measure that elicits responses for each of the DSM-IV disorders that comprise the 
diagnostic criteria for PTSD (intrusive, avoidant, and arousal symptoms) 79. The 
psychometric properties of the PCL have been well established and it is the most widely used 
measure of PTSD. Both civilian and military versions are available.   
 
  
• 
Use and Satisfaction with the IDEO and Related Services.  At T2 (following completion 
of the physical therapy program), and at T3 and T4, each patient will complete a brief battery 
of questions to assess their use and overall satisfaction with the IDEOTM and related services. 
We will include both the Orthotics and Prosthetics Users’ Survey (OPUS) 81-82 and elements 
of a survey developed at the Center for the Intrepid (designed specifically for comparing the 
satisfaction of the IDEO with other braces) 22.  The OPUS was developed by Heinemann et 
al. using well established contemporary measurement technology for instrument 
development. The OPUS consists of an 11-item measure for satisfaction with devices and a 
10-item measure for satisfaction with services.  Items pertaining to device satisfaction 
include:  weight, comfort, pain associated with use, ease of use, cosmesis, durability, fit and 
effect of the device on clothing (i.e., dimensions). Items used to measure satisfaction with 
services, include wait time, respect, communication, consumer’s input, team approach, and 
training with the device. Lastly, participants will be asked if they ever considered amputation 
of their injured limb, if so, why, and if they now favor limb salvage or amputation.  
 

 
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30 
 
 
6.4.3 Exploratory Endpoints 
N/A 
6.4.4 Substudy Endpoints 
N/A 
 
 
 
7. STUDY TREATMENTS 
 
The PRIORITI intervention consists of two components: (1) custom fitting of the IDEO; and (2) 
the Return to Run physical therapy program designed specifically for recipients of the IDEO. 
Each is described below together with specifics regarding the training of Study Site staff to 
ensure fidelity of the intervention across sites.  
 
All braces will be fabricated by trained Certified Prosthetist/Orthotists (CPOs) at each 
participating MTF. Training for fabrication of the IDEO is described below. The two 
participating study MTF sites will each identify 1-2 physical therapy assistants and 1 CPO and 1 
O&P tech who will provide the services necessary for measuring, fabricating and fitting the 
IDEO and providing the PT.  Only PTAs and orthotists who have been trained for the study (see 
below) will be allowed to provide services to PRIORITI participants.   
 
7.1    Fabrication and Fitting of the IDEO.   The IDEO design for this study will be the 
modular version, since it has the advantage of modifying alignment in a simpler manner, 
adjusting strut stiffness for limitations or gains of individuals, and limiting fabrication responses 
needed for fissuring or fracturing of components of the device with use. The IDEO is constructed 
primarily of laminated, reinforced carbon fiber to withstand high impact forces and cyclical 
loading.  The main components of the IDEO are the proximal cuff, strut, and foot plate.  These 
components are described in further detail in Appendix J. The IDEO is a class 1 exempt device.  
A provisional patent was filed in April, 2011 by Ryan Blanck, CPO in conjunction with the 
United States Government, as represented by the Secretary of the Army (Application Serial No. 
61/518,801).   
 
The team at the Center for the Intrepid (CFI) will train the CPOs from the other two military 
treatment facilities in IDEO fabrication. Training will consist of a 6-8 week internship working 
with the San Antonio team to learn the processes of measurement, fabrication, and fitting of the 
brace. Training materials will be developed through this process and used in subsequent training 
sessions. Once able to replicate the process, the CPOs will return to WRNNMC and NMCSD to 
implement the program at their institutions   
 
7.2    Physical Therapy Protocol.   As indicated above, participants enrolled in PRIORITI will 
participate in the Return to Run physical therapy regimen.  During Phase 1 (pre-IDEO) 
participants will engage in a home physical therapy program as prescribed by the study team for 
2-4 weeks.  During Phase 2 (post-IDEO), participants will receive 3 sessions of PT a week for an 
additional 4 weeks.  Participants will be encouraged to test the IDEO under load in real world 

 
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31 
 
conditions and report their experience to the study team. Each PT session will last for 
approximately 90 minutes.    During phase 2, participants will be encouraged to complete home 
exercises to complement the therapy they are receiving in the clinic.  
 
 
To help ensure standardization of the PT protocol across centers, several procedures will be put 
in place.  First, the PTAs providing the pre-IDEO and post-IDEO physical therapy must have 
some documented training in sports medicine and experience working with limb trauma patients. 
They will be trained in the PT protocol at a 3-day training at the Center for the Intrepid in San 
Antonio.  The 3 days will be devoted to the PT protocol with ample use made of demonstrations 
and practice sessions. As mentioned above, training videos will be produced and provided to the 
PTs or PTAs for reference.  Second, the PTAs will be required to document the therapy provided 
at each session.  This documentation will be reviewed on an ongoing basis by the investigators to 
assure the fidelity of the intervention. Third, the PTAs will participate in bi-weekly video 
conference calls together with Mr. Owens at which time individual cases will be reviewed and 
difficulties in providing the PT and keeping patients engaged in the program will be discussed.  
 
 
8. ASSESSMENT OF SAFETY 
 
The study will monitor and report adverse events to ensure patient safety. Definitions and 
procedures for reporting adverse events are designed to satisfy 45 CFR Part 46, Subpart A; the 
“Common Rule”, shared by 17 Departments and Agencies as well as 21 CFR 312, the FDA 
regulation for adverse events.  The Common Rule requires written procedures and policies for 
ensuring reporting of “unanticipated problems” involving risks to participants to IRBs, 
appropriate institutional officials, and the Department or Agency Head.  
The medical monitor (MM) is responsible for providing medical guidance and overseeing patient 
safety for the study. The MM participates in determining the course of action necessary to meet 
safety goals and objectives.  This is achieved through the review of Serious Adverse Event 
reports; resolving safety issues; and interacting with Principal Investigators. 
Each participating site is responsible for ensuring that all local IRB requirements for reporting 
adverse events (both internal and external) are met.   
 
8.1 Definitions 
 
8.1.1 Adverse event 
 
Any untoward or unfavorable medical occurrence in a human subject, including abnormal sign 
(e.g., abnormal physical exam or laboratory finding), symptom or disease temporally associated 
with the subject’s participation in the study, whether or not considered related to the subject’s 
participation.  
 
8.1.2 Unanticipated problem 
 
Any incident, experience, or outcome that meets all of the following criteria: 

 
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(1) is unexpected, in terms of nature, severity, or frequency, given the research 
procedures that are described in the protocol and informed consent document and the 
characteristics of the patients eligible for the study. 
 
(2) is related or possibly related to treatment/procedures under study; possibly related 
means there is a reasonable possibility that the incident, experience, or outcome may 
have been caused by the study procedures or treatments. 
 
(3) suggests that the participation in the study may place subjects or others at a greater 
risk of harm (including physical, psychological, economic, or social harm) than was 
previously known or recognized. 
 
Please note that not all adverse events are unanticipated problems and only some unanticipated 
problems are in fact adverse events.  For instance, if a laptop containing study data is stolen, this 
is an unanticipated problem but it is not an adverse event since it is not an untoward or 
unfavorable medical occurrence in a human subject 
 
8.1.3 Serious Adverse Event 
 
A serious adverse event is defined as: 
1. Death 
2. Unanticipated events related to rigor of participating in the Return 
to Run PT Program; or events related to IDEO brace fit or wear. 
3. Other events that are unexpected AND serious AND related or 
possibly related to the study 
 
8.2 Methods and Timing for Assessing, Recording, and Analyzing, Managing Safety 
Parameters 
 
8.2.1 Methods and Timing of Assessment  
 
Adverse events may be discovered during regularly scheduled visits or through unscheduled 
patient contacts between visits.  Adverse events related to study procedures would be assessed 
during the index hospitalization and at each study visit.  They will be recorded on study data 
forms whether or not they are thought to be associated with the study. 
 
8.2.2 AE/SAE Grading and Relationship Assignment 
 
Adverse event grading:  Adverse events will be graded using standard criteria. The study 
physician will determine relationship of event to the study procedure.  
GRADE 1 (Mild) Transient or mild discomfort (< 48 hours); no medical intervention/therapy 
required 
 
 
 
GRADE 2 (Moderate) Mild to moderate limitation in activity - some assistance may be 
needed; no or minimal medical intervention/therapy required 
 
 

 
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GRADE 3 (Severe) Marked limitation in activity, some assistance usually required; medical 
intervention/therapy required, hospitalizations possible 
 
GRADE 4 (Life-threatening) Extreme limitation in activity, significant assistance required;  
significant medical intervention/therapy required, hospitalization or hospice care probable. 
 
Relationship Assignment The relationship of the adverse event to participation in the study will 
be assessed as either:  
 
 
Definitely related  
Probably related 
Possibly related 
Unlikely related 
Unrelated    
 
8.2.3 Recording and Documentation  
 
Sites will maintain source documents including but not limited to (laboratory and radiology 
reports, clinical notes and discharge summaries). After review of initial and final reports by the 
medical monitor, the events may be reclassified at their discretion. 
 
8.2.4. Management of Adverse Events 
 
Adverse Events and Serious Adverse Events will be managed according to protocol guidelines. If 
specific guidelines do not exist, AEs/SAEs will be managed according to the medical judgment 
of the treating physician. 
 
8.3 Adverse Event Reporting Procedures 
 
8.3.1 Local Reporting Requirements.  
 
 
Study sites must always follow and comply with their own local institution’s adverse event 
reporting requirements, which may differ from those adopted by the PRIORITI Study.  
Depending on the local requirements, a site may report events locally and not report those events 
to the METRC Coordinating Center. Each participating site is responsible for ensuring that all 
local IRB requirements for reporting adverse events (both internal and external) are met.   
 
8.3.2 SAE and Unanticipated Problem Reporting Requirements 
 
All Serious Adverse Events that are Unexpected AND related or possibly related to the study 
must be reported to the Medical Monitor and METRC Coordinating Center within 72 hours of 
being made aware of the event.  
 
In addition, Unanticipated Problems (UPs) that are not adverse events must also be reported to 
the METRC Coordinating Center within 14 calendar days after the event has been discovered.    

 
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SAEs/UPs will be reported to the METRC Coordinating Center by entering the SAE/UP form 
into REDCAP. REDCap is programmed to automatically send an email to the Coordinating 
Center for both SAEs and Ups, and to the Medical Monitor in the case of an SAE.  
 
The Medical Monitor for this study is: 
Mark Swiontkowski, MD, FACS 
Department of Orthopedic Surgery 
2450 Riverside Ave., R200 
Minneapolis, MN 55454 
Telephone: (612) 273-7951     
Fax: (612) 273-7959 
E-mail: swion001@umn.edu  
 
8.3.3 METRC Coordinating Center Reporting Responsibilities  
 
As appropriate and per METRC policies, the Coordinating Center will send a copy of each report 
received about an event judged reportable to all clinical sites, with instructions for each to 
forward the report to their IRB.  
 
Copies of the report will also be sent to the DoD, the Study PI, and to the Medical Monitor. The 
MCC will maintain a list of such events for reporting and review at Steering Committee 
meetings. 
 
8.3.4 Department of Defense Reporting Requirements 
 
The following are reporting requirements and responsibilities of the Principal Investigator to the 
United States Army Medical Research and Materiel Command’s (USAMRMC) Office of 
Research Protections (ORP), Human Research Protection Office (HRPO). 
        (1)  The protocol will be conducted in accordance with the protocol submitted to and 
approved by the USAMRMC ORP HRPO and will not be initiated until written 
notification of approval of the research project is issued by the USAMRMC ORP 
HRPO.   
        (2)  Accurate and complete study records will be maintained and made available to 
representatives of the U.S. Army Medical Research and Materiel Command as a part 
of their responsibility to protect human subjects in research.  Research records will be 
stored in a confidential manner so as to protect the confidentiality of subject 
information.   
        (3)  All unanticipated problems involving risk to subjects or others, serious adverse events 
related to participation in the study and subject deaths related to participation in the 
study will be promptly reported by phone (301-619-2165), by email 
(hsrrb@.amedd.army.mil), or by facsimile (301-619-7803) to the USAMRMC, Office 
of Research Protections, Human Research Protection Office.  A complete written 
report will follow the initial notification.  In addition to the methods above, the 
complete report will be sent to the U.S. Army Medical Research and Materiel 
Command, ATTN: MCMR-RP, 504 Scott Street, Fort Detrick, Maryland 21702-5012.   

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
35 
 
        (4)  Suspensions, clinical holds (voluntary or involuntary), or terminations of this research 
by the IRB, the institution, the Sponsor, or regulatory agencies will be promptly 
reported to the USAMRMC ORP HRPO. 
        (5)  Any deviation to the protocol that may have an adverse effect on the safety or rights of 
the subject or the integrity of the study will be reported to the USAMRMC ORP 
HRPO as soon as the deviation is identified.   
        (6)  Major modifications to the research protocol and any modifications that could 
potentially increase risk to subjects will be submitted to the USAMRMC ORP HRPO 
for approval prior to implementation.  All other amendments will be submitted with 
the continuing review report to the USAMRMC ORP HRPO for acceptance. 
        (7)  A copy of the approved continuing review report and the local IRB approval 
notification will be submitted to the USAMRMC ORP HRPO as soon as these 
documents become available.  A copy of the approved final study report and local IRB 
approval notification will be submitted to the USAMRMC ORP HRPO as soon as these 
documents become available.   
        (8)  The knowledge of any pending compliance inspection/visit by the FDA, OHRP, or 
other government agency concerning this clinical investigation or research, the issuance 
of Inspection Reports, FDA Form 483, warning letters or actions taken by any 
Regulatory Agencies including legal or medical actions and any instances of serious or 
continuing noncompliance with the regulations or requirements that relate to this 
clinical investigation or research will be reported immediately to USAMRMC ORP 
HRPO.   
 
Unanticipated problems involving risk to volunteers or others, serious, unexpected adverse 
events related to participation in the study and all volunteer deaths related to participation in the 
study will be promptly reported by phone (301-619-2165), by e-mail (hsrrb@amedd.army.mil), 
or by facsimile (301-619-7803) to the U.S. Army Medical Research and Materiel Command’s 
Office of Research Protections, Human Research Protections Office.  A complete written report 
will follow the initial notification.  In addition to the methods above, the complete report will be 
sent to the U.S. Army Medical Research and Materiel Command, ATTN:  MCMR-RPH, 504 
Scott Street, Fort Detrick, Maryland 21702-5012 
 
8.4 Reporting Pregnancy 
 
N/A 
 
8.5 Type and Duration of the Follow-up of Participants After Adverse Events 
 
Study patients who experience an SAE will be followed until resolution of the event, and a final 
report will be submitted to the medical monitor, and the coordinating center. 
 
8.6 Modifications of Study Agent(s)/Intervention(s) for a Participant  
N/A 
8.7 Halting Rules for the Protocol  
N/A 

 
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36 
 
 
8.8 Stopping Rules for an Individual Participant/Cohort 
N/A 
 
8.9 Premature Withdrawal of a Participant 
 
A participant may be withdrawn from the study without consent if the sponsor decides to end the 
study. Other reasons for removing a participant without consent may include but are not limited 
to non-adherence with the protocol and/or therapy, and inappropriate behavior towards study 
personnel.  
 
8.10 Replacement of a Participant Who Discontinues Study Treatment  N/A  
 
9. MONITORING  
 
9.1 Site Monitoring Plan 
 
The METRC Coordinating Center will be responsible for site monitoring consistent with 
ICH/FDA guidelines. Monitoring will include a combination of remote and on-site visits of 
participating clinical research sites to review the individual subject records, including consent 
forms, case report forms, supporting data, and medical records (physicians’ progress notes, 
nurses’ notes, individuals’ hospital charts), to ensure protection of study subjects, compliance 
with the protocol, and accuracy and completeness of records. The monitors also will inspect 
sites’ regulatory files to ensure that regulatory requirements are being followed.  
 
The site PI will make study documents (e.g., consent forms, case report forms) and pertinent 
hospital or clinic records readily available for inspection by the local IRB, the site monitors, the 
DOD, the Office for Human Research Protections (OHRP), or other regulatory authorities for 
confirmation of the study data. 
 
9.2 Safety Monitoring Plan 
 
9.2.1 Safety Review Plan by the DSMB 
 
A DSMB is not required for this study. A Medical Monitor has been appointed and will review 
any SAEs, unanticipated problems involving risk to participants or others and all deaths. 
 
 
10. STATISTICAL CONSIDERATIONS 
 
10.1 Overview and Study Objectives 
The primary objective of this study is to assess immediate and long-term improvements in 
functional performance and self reported outcomes following completion of the PRIORITI 
program.  
 

 
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37 
 
Secondary objectives include documenting patterns of device use, use of ambulatory aids, shoe 
wear and patient reported satisfaction associated with the IDEO, and assessing economic impact 
of the PRIORITI program.   
 
10.2 Sample Size Considerations  
A total of 85 patients will be consented and enrolled by the military core METRC centers 
(approximately 25-30 from each center); data collected from these participants will be used to 
test the research hypotheses.  
 
We anticipate a low dropout rate (<5%) because highly motivated individuals will self-select 
themselves into the program. We will also provide a modest compensation to participants who 
are not on active duty for their time and travel. For power calculations we assume we will have 
complete follow-up data on 80 of the 85 participants who enroll. All functional and satisfaction 
outcomes are continuous. In Specific Aim 1a and Specific Aims 2a and 2b, we plan to test for 
improvements in outcomes at a specified point in time after enrollment (8 weeks for Specific 
Aim 1a and 1 year for Specific Aims 2a and 2b) as compared to baseline. One-sided paired t-
tests will be used. Differences in means between follow-up and baseline will be reported along 
with 95% confidence intervals. The proposed sample size yields 80% power to detect an effect 
size (mean of the difference in outcomes between follow-up and baseline divided by the standard 
deviation of the difference) of 0.28 (a modest treatment effect). To put this effect size in 
perspective, Patzkowski et al., reports effect sizes for FSST, TSA, SSWV-L and 40D of 
approximately 0.6, 0.7, 1.0 and 1.0, respectively.  
 
Based on the above considerations, the targeted sample size for the study is 85 patients.   
 
10.3 Randomization 
 
N/A 
 
10.4 Missing Data and Measures to Minimize Bias 
 
Missing data is a serious concern that complicates the interpretation of the study results.  We will 
address this issue from both a study conduct and analysis perspective.  Regarding study conduct, 
we will: 
1. Limit participant burden and inconvenience in data collection 
2. Select high quality investigators 
3. Provide pre-study training of investigators as well as on-study reinforcement 
4. Reimburse investigators based on follow-ups completed not on per-patient basis. 
5. Monitor and report missing data rates during the study 
6. Emphasize the importance of full participation in the study during the consent 
process. 
7. Collect information on the reasons for missing data. 
8. Actively engage participants and educate them about the importance of participation 
9. Hold regular Protocol Committee meetings to discuss strategies for follow-up    
10. Set targets for acceptable rates of missing data and terminate sites not meeting targets.  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
38 
 
 
While these efforts will help to minimize missing data, we recognize that missing data is 
inevitable. With this in mind, we will conduct sensitivity analyses to evaluate the robustness of 
the study results to various untestable assumptions about the missing data mechanism. In 
addition to unadjusted analyses, which rely on the missing completely at random assumption 
(testable), we will also estimate treatment effects (utilizing relevant auxiliary information) under 
the missing at random assumption. Further, we will explore the effect of departures from the 
missing at random assumption using pattern-mixture and selection modeling techniques.  
 
10.5 Planned Interim Analysis 
N/A 
 
10.6 Analysis Plan 
All analyses will be conducted under the supervision of our senior statistician, Dr. Daniel 
Scharfstein and METRC’s senior economist, Dr. Greg Delissovoy.  
 
Specific Aims #1 and #2: Assessing Immediate and Long-term Improvements in Functional 
Performance and Self-Reported Outcomes. As described above, one-sided paired t-tests will be 
used to test for improvements in outcomes at a specified point in time after enrollment as 
compared to baseline. Differences in means between follow-up and baseline will be reported 
along with 95% confidence intervals. 
 
 
To the extent possible, we will explore how improvement correlates with characteristics of the 
participants, the type and extent of their injury, baseline measures of impairment, and the percent 
of pre and post IDEO PT sessions attended (as we expect some variation in adherence to the PT 
regimen). Differences in improvement will be examined using stratified analyses and regressions 
where the change in outcomes is the dependent variable. We will also conduct the analysis 
including and excluding participants who complete less than 1/3 of the PT sessions. 
 
Specific Aim #3: Documenting Patterns of Use and Satisfaction with the IDEO. This aim is 
largely descriptive in nature. To the extent possible, patterns of use and satisfaction will be 
compared with other studies reported in the literature. Also, variations in device satisfaction will 
be modeled as a function of patient characteristics and baseline measures of impairment using 
the appropriate regression techniques. 
 
Specific Aim #4. Assessing the Economic Impact of PRIORITI. Relative to standard of care 
(SOC), the PRIORITI program may increase or decrease costs of care. Provision of the IDEO 
device, the associated rehabilitation program, need for special shoe wear, and any adjustments, 
repairs or replacements needed during the lifetime of wear represent added costs relative to SOC. 
However, the PRIORITI program could potentially reduce certain types of resource use and costs 
relative to SOC. For example, if the IDEO device offers greater mobility (without use of 
ambulatory aids) or reduced pain, participants might decrease follow-up visits or use of pain 
medications relative to standard of care. Use of the IDEO could also lead to fewer delayed 
amputations. Labor force participation, return to duty, and productivity of participants enrolled in 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
39 
 
the PRIORITI program could also improve relative to SOC and this has economic benefit from 
both the patient and societal perspectives. 
 
Our analysis of the costs and benefits of PRIORITI will involve two components: (1) analysis of 
costs and outcomes as observed during the 12-month study period; and (2) cost-effectiveness 
projected over the patient lifetime. 12 Month Costs and Outcomes Difference in one-year cost 
for the PRIORITI group relative to standard of care will be evaluated based on difference in 
means. Confidence intervals for difference will be estimated using a bootstrapping procedure 
that is robust for the anticipated right-skewed distribution of costs. If average cost is greater for 
the PRIORITI group, a cost-effectiveness ratio will be calculated using a metric such as 
incremental cost per unit change in Short Form Musculoskeletal Function Assessment (SMFA), 
or incremental cost per unit change in VR-12. 
 
Lifetime Cost-Effectiveness. If superior to standard care, the PRIORITI program could have a 
major impact on the patient’s long-term functional status and quality of life. To gain insight on 
this proposition, a cost-effectiveness model will be constructed that simulates the long-term 
course for two identical patient cohorts, IDEO and standard of care. Model parameters will be 
derived from the study data, literature review, and expert opinion. Markov modeling will be used 
in order to characterize patient health state over time. For example, a small portion of patients 
who initially undergo limb reconstruction, later elect amputation. This would represent a change 
of “health state” in a Markov model and the probability of transition from the “limb 
reconstruction state” to “amputation state” will be derived from literature review. Similarly, 
patient preference (utility) for various health states associated with recovery from traumatic 
injury will also estimated and used to calculate quality-adjusted life years, to be derived suing the 
VR-6D. Overall findings of this analysis will be stated in terms of incremental cost per quality 
adjusted life-year for PRIORITI relative to standard of care.  
 
 
11. QUALITY CONTROL AND QUALITY ASSURANCE  
 
11.1 Data Quality Assurance 
 
Quality Control (Q/C) and Quality Assurance (Q/A) procedures that apply to all studies are 
outlined in the METRC Manual of Operations (MOP).  A certification process (also outlined in 
the MOP) will be used as a basis for training and certification of the study personnel involved in 
data collection.  In addition to consortium wide training and certification procedures, additional 
requirements may be added based on the nature of the study.  Ongoing data edits and audits will 
be performed to ensure collection of quality data. The continuous and timely flow of data from 
the centers to the MCC is an essential prerequisite for maintaining data quality. Monthly 
enrollment reports will be distributed to each center that will summarize recruitment, data 
completion and timeliness of data entry. These reports will also include a set of queries generated 
by REDCap and sites will be asked to address these queries within 10 business days. 
 
 
11.2 Training and Certification of Centers 
 

 
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40 
 
All participating centers together with their respective study personnel will undergo certification 
that includes training, local site IRB, and a knowledge assessment on the study design and 
procedures.  Training will include one-on-one brace fabrication training with each site’s 
designated CPO, RTR program training with each site’s designated study PTA. In addition, the 
research coordinators will receive training related to protocol submission, participant 
recruitment, study implementation, and data collection at the site level.  
 
12. ETHICS/PROTECTION OF HUMAN SUBJECTS 
 
12.1 IRB/Ethics Committee 
 
IRB approval will be obtained from the MCC at Johns Hopkins Bloomberg School of Public 
Health, the DoD, and each participating clinical site according to METRC policies and 
procedures. Sites that recruit patients will submit METRC study recruitment materials to their 
organization’s IRB prior to use at that facility. 
 
Sites must provide the Coordinating Center with a copy of the initial IRB approval notice and 
subsequent renewals as well as copies of the IRB approved consent statements. 
No site can begin work related to this study until the site has been certified by the MCC in 
accordance with METRC policies and procedures. 
 
12.2 Exclusion of Women, Minorities, and Children (Special Populations) 
 
The proposed study anticipates recruiting a significant proportion of racial/ethnic minorities 
(African-Americans, Asian-Americans and Hispanics) as well as non-Hispanic white subjects. 
The study will not include children or prisoners. 
 
12.3 Participant Confidentiality 
 
It is the investigator’s responsibility to conduct the protocol under the current version of 
Declaration of Helsinki, ICH Guidelines, Good Clinical Practice, and rules of local IRBs. The 
investigator must ensure that the patient’s anonymity be maintained in their data submission to 
the Data Coordinating Center.  
 
Patients will be identified only by an identification code but not by their name, SSN, or hospital 
medical record number. Study Site Investigators will maintain a separate confidential enrollment 
log, which matches identifying codes with the patients’ names and addresses available only to 
local clinic staff certified by the MCC to participate in the study.  
 
All study forms, reports, and other records that are part of the study data collection materials will 
be identified by coded number to maintain patient confidentiality. All paper records will be kept 
in locked file cabinets. All electronic records of study data will be identified by coded number. 
Clinical information will not be released without written permission of the patient, except as 
necessary for monitoring by the sponsor (MCC), IRB, DOD, or DSMB. Consent procedures and 
forms, and the communication, transmission and storage of patient data will comply with 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
41 
 
individual site IRB and DOD requirements for compliance with The Health Insurance Portability 
and Accountability Act (HIPAA). 
 
12.4 Study Discontinuation  
 
Participants will be informed that they may discontinue the study at any time, for any reason. 
They will be assured that the medical care, which they receive at the participating facility will 
not be affected should they elect to discontinue participation in the study.  
 
 
13. DATA HANDLING AND RECORD KEEPING 
 
13.1 Data Management Responsibilities 
 
Instructions concerning the recording of study data on case report forms will be provided by the 
MCC. Each study site is responsible for transmitting the data in a timely fashion. 
 
The research coordinators at each site will obtain the information necessary to complete the case 
report forms (CRFs) from several sources including but not limited to, the patient's medical 
record, clinical evaluations and patient interviews. These forms will NOT contain the patient’s 
name, SSN, or hospital medical record number; they will be identified only by a unique patient-
specific study number.    
 
The Site Research Coordinator will enter non-personally identifiable information into a central 
and secured web-based data management system being implemented for all Consortium studies, 
known as REDCap. This data management system has incorporated state-of-the-art features for 
electronic data collection and is configured in accordance with best practices for information 
technology and research data management.   
 
All research data, in hard copy or electronic form, will be stored and managed in a secure 
manner following applicable federal regulations and ICH guidelines and according to 
institutional policies and practices. Hard copy documents containing subject data, patient 
identifiers and contact information will be stored in secure, locked containers (file cabinets, 
drawers, etc.) in accordance with standard document management practices.  
 
At all times only MCC-certified key personnel specifically designated and authorized by the 
Principal Investigator shall have access to any research related documents, including electronic 
data and medical records.  All such personnel will be properly trained and supervised regarding 
the management and handling of confidential materials. The Principal Investigator assumes full 
responsibility for such training, supervision, and conduct.  This information will be available for 
audit by study monitors and representatives of the local IRB, the MCC, the DOD, and the OHRP. 
 
13.2 Data Capture Methods 
 
Data will be collected in real time by the investigator or study coordinator directly on paper Case  

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
42 
 
Report Forms (CRFs), which will serve as source documents for the study. Source documents, 
which will include both the CRFs and other supporting medical records (e.g radiology reports, 
clinical notes and discharge summaries), will be signed by PI, other site Investigator, or Research 
Coordinator as indicated in the CRF instructions. The Research Coordinator or an MCC-certified 
staff member working under the supervision of the research coordinator, will enter the data from 
the CRFs into the REDCAP database.  
 
13.3 Types of Data 
 
Data will include medical and surgical histories, radiology reports, clinical evaluations, 
performance assessments, adverse events and patient interviews. 
 
13.4 Source Documents and Access to Source Data/Documents 
 
Source documents including CRFs, radiographic reports, patient surveys, medical records, etc. 
will be maintained at the site and will be made available to study monitors, and representatives 
of regulatory agencies including the MCC, DOD, IRB, and OHRP.  
 
13.5 Study Records Retention 
 
Study records will be maintained in accordance with current ICH guidelines.  Data will be 
maintained for five years following the end of research-related activities.  At the end of this 
period, each site will provide the Coordinating Center a signed verification that these data have 
been destroyed. 
 
13.6 Protocol Deviations 
 
Records of protocol deviations will be noted on the Protocol Deviation CRF (AF05) with the 
reason for the deviation recorded, as well as any action taken to mitigate the deviation. This 
information will be entered into REDCap. These records will be provided to the site’s IRB in 
accordance with local reporting requirements and be made available to study monitors. 
 
 
14. PUBLICATIONS POLICY 
Publications will be written in accordance with the METRC publication policy (available on the 
METRC website: www.metrc.org). 
 
 
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33. Doukas WC, Hayda RA, Frisch, HM, Andersen RC, Mazurek MT, Ficke JR, Keeling 
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34. Desloovere K, Molenaers G, Van Gestel L, Huenaerts C, Van Campenhout A, 
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44. Dougherty PJ, Carter PR, Seligson D, Benson DR, Purvis JM. Orthopaedic Surgery 
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17. APPENDICES 
APPENDIX A: STUDY CONTACT ROSTER 
Principal Investigator (Protocol Chair) 
 
Joseph R. Hsu, MD 
Department of Orthopaedic Surgery 
Carolinas Medical Center 
1320 Scott Avenue 
Charlotte, NC 28204 
Phone (704) 355-6969 
Fax (704) 355-8708  
Email: joe.r.hsu@gmail.com  
 
 
METRC Coordinating Center Study Principal Investigator 
 
Ellen MacKenzie, PhD 
Johns Hopkins Bloomberg School of Public Health 
Dept. Health Policy and Management 
624 N. Broadway Room 544 
Baltimore MD, 21205 
Phone: 410- 614-4024 
Email: emackenz@jhsph.edu 
 
 
 
 
DOD Program Officer 
 
Joseph C. Wenke, PhD  
Program Manager  
United States Army Institute of Surgical Research  
3400 Rawley E. Chambers Avenue, Bldg. 3611  
Fort Sam Houston TX, 78234-6315  
Phone: 210-916-3742; Cell: 210-288-2431  
Email: Joseph.Wenke@us.army.mil   
 
Medical Monitor 
 
Marc Swiontkowski, MD  
Professor of Orthopaedic Surgery 
University of Minnesota  
2512 South 7th Street 
Suite R200 
Minneapolis, MN 55454 
Phone: (612) 273-8000 
Email: swion001@umn.edu 
 
 
METRC Coordinating Center  
 Director of Protocol Development 
 
Jennifer DeSanto, RN, MS 
Johns Hopkins Bloomberg School of Public Health 
Dept. of Health Policy and Management 
624 N. Broadway Room 353 
Baltimore MD, 21205 
Phone: 410-614-3723 
Email: jdesanto@jhsph.edu 
 
 
 
METRC Coordinating Center  
Director of Data Management 
 
Anthony Carlini, MS 
Johns Hopkins Bloomberg School of Public Health 
Dept of Health Policy and Management 
624 N. Broadway Room 501 
Baltimore MD, 21205 
Phone: 410-502-8455 
Email: acarlini@jhsph.edu 
 
 
 
 
 
 

 
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APPENDIX B: PROTOCOL COMMITTEE 
Ellen MacKenzie, PhD 
 
Johns Hopkins Bloomberg School of Public Health 
 
Joseph R. Hsu, MD 
 
 
Carolinas Medical Center 
 
LTC Donald A Gajewski, MD 
Center for the Intrepid, San Antonio Military Medical 
Center 
 
John Ferguson, CPO 
Center for the Intrepid, San Antonio Military Medical 
Center  
 
Johnny G. Owens, MPT 
Center for the Intrepid, San Antonio Military Medical 
Center 
 
Rebecca Hooper, PT, PhD 
 
Center for the Intrepid, San Antonio Military Medical  
 
 
 
 
 
Center 
 
CDR David Dromsky, MC 
 
Naval Medical Center San Diego 
 
Capt Jennifer L. Town, NC 
 
Naval Medical Center San Diego 
 
Kevin Kuhn CDR, MC 
 
Naval Medical Center San Diego 
 
Robert Sheu, LDCR, MC 
 
Naval Medical Center San Diego 
 
LTC Benjamin Kyle Potter, MD 
Walter Reed National Military Medical Center 
 
COL (ret) Charles Scoville, PT 
Walter Reed National Military Medical Center   
 
Daniel Stinner, MD 
 
 
Walter Reed National Military Medical Center  
 
Scott Shawen, MD      
 
Walter Reed National Military Medical Center   
 
Mary Zadnik Newell ScD, OTR/L   Johns Hopkins Bloomberg School of Public Health 
 
Michael Bosse, MD  
 
Carolinas Medical Center 
 
Daniel Scharfstein, PhD  
 
Johns Hopkins Bloomberg School of Public Health  
 
Jennifer DeSanto, RN, MS 
 
Johns Hopkins Bloomberg School of Public Health 
 
Gregory Delissovoy, PhD  
 
Johns Hopkins Bloomberg School of Public Health 
  
 
 

 
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APPENDIX C: DATA COLLECTION SCHEDULE  
 
TIME 0 
T2 
T3 
T4 
Assessment 
Baseline   
 
 
Patient Characteristics  
 
 
 
 
Demographics  
X 
 
 
 
Marital Status &Social Support (MSPS) 
X 
 
 
 
Self Efficacy 
X 
 
 
X 
Income (past year) & Health Insurance 
X 
 
 
X 
Injury Characteristics  
 
 
 
 
Mechanism, Type, Side of Injury  
X 
 
 
 
Classification of Fx (AO/OTA & Gustilo) 
X 
 
 
 
Other limb and non limb injuries  
X 
 
 
 
Medical History and Clinical Assessment  
 
 
 
 
Height and Weight 
X 
 
 
X 
Co-morbidities & Smoking History 
X 
 
 
 
Fracture Healing 
X 
 
 
 
Evidence of PTOA (from x-rays)  
X 
 
 
 
ROM and Strength of Lower limbs  
X 
 
 
X 
VAS Pain and Use of Narcotics   
X 
 
 
X 
Outcomes: Performance Assessments 
 
 
 
 
4 Square Step Test 
X 
X 
 
X 
Illinois Agility Test 
X 
X 
 
X 
Sit to Stand 
X 
X 
 
X 
Timed Stair Ascent 
X 
X 
 
X 
Self Selected Walking Speed 
X 
X 
 
X 
Shuttle Run 
X 
X 
 
X 
Single Leg Stance 
X 
X 
 
X 
Outcomes: Self Reported Measures  
 
 
 
 
Short Musculo Func Assess (SMFA) 
X 
 
X 
X 
Veterans Health Survey (VR-12)   
X 
 
X 
X 
Paffenbarger Activity Scale (PPAQ) 
X 
 
 
X 
Brief Pain Inventory (BPI)  
X 
 
 
X 
Usual Major Activity Status 
X 
 
X 
X 
If working: Work Productivity (WPAI) 
X 
 
X 
X 
Depression Scale of PHQ (PHQ-9)  
X 
 
 
X 
PTSD Checklist (PCL) 
X 
 
 
X 
Use and Satisfaction with IDEO  
 
 
 
 
Satisfaction with Brace (OPUS & CFI)   
X 
X 
X 
X 
Use of Brace, Shoe Wear , Ambulatory Aids     
X 
X 
X 
X 
Use of Services and Aids  
 
 
 
 
Hospitalizations 
X 
 
X 
X 
Orthotic Services  
X 
 
X 
X 
PT/OT Services   
X 
 
X 
X 
Other Services  
X 
 
X 
X 
Treatment  Logs Maintained by CPO & PTs   

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
52 
 
APPENDIX D: CONSENT TEMPLATE 
INFORMED CONSENT DOCUMENT 
 
Participant Consent Form 
Study Title:  Patient Response to an Integrated Orthotic and Rehabilitation Initiative for 
Traumatic Injuries (PRIORITI-MTF) 
Principal Investigator:  Ellen MacKenzie, PhD 
IRB No.:  00005172 
PI Version Date:  Version 6; 12/05/14 
 
You are being asked to volunteer to be a part of a research study.  Please read this form carefully 
before you sign it. This consent form explains the research study and your part in the study.  If you 
decide not to participate in this study there will be no impact on your medical care.  You can 
choose not to take part and if you join, you may quit at any time.  Ask the study doctor or the study 
staff to explain any words or procedures that you do not clearly understand.  Ask as many 
questions as needed.  All of your questions should be answered to your satisfaction before you sign 
this form.  
 
 
1. WHAT IS THE PURPOSE OF THIS RESEARCH STUDY? 
 
This research is being done to help determine whether a new type of custom designed brace along 
with a physical therapy program improves your physical function. Further, the study is a clinical 
investigation to evaluate the effectiveness of an investigational FDA-regulated medical device. 
The device being used in this study is the IDEO brace. Because we are testing this device in the 
study, it will be labeled with the following information: “CAUTION--Investigational device. Limited 
by Federal law to investigational use.”  
 
This brace was developed for wounded warriors who wanted to return to an active lifestyle. Early 
studies showed that wounded warriors who received the brace and participated in the physical 
therapy program had better function than before they had the brace. The purpose of this study is to 
see if the brace along with therapy will improve function and return to usual activities in people 
with lower leg, ankle or foot injuries like yours.  
This PRIORITI study is funded by the Department of Defense (DOD) and is being carried out in 
three Military Treatment Facilities that are taking care of service members who are injured in the 
line of duty.  
 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
53 
 
2. WHY AM I BEING ASKED TO PARTICIPATE? 
 
You are being asked to participate in this study because you had a traumatic injury of the lower leg 
at least 1 year ago and you are still limited in the activities you are able to do. People with injuries 
like yours from around the county are being asked to participate. You are one of 90 patients we are 
asking to join the PRIORITI study. 
 
3. HOW LONG WILL THE STUDY LAST? 
 
Your participation in the study will be expected for one year.  
 
4. HOW DOES THE STUDY WORK? 
After you review this informed consent and agree to be part of the study, the following things will 
happen: 
• You will be asked questions about you and the activities you do now. These questions 
could take up to 15 minutes to answer.  
• Information will be collected about your injury and the care you received for your injury. A 
member of the research team will enter this information into a database. 
• You will receive a clinical assessment to measure in your leg weakness and how well you 
can bend your foot. The assessment could take up to 15 minutes.  
 
If the surgeon feels that you are still eligible based on the clinical assessment you will be 
scheduled to return to the clinic to begin the PRIORITI program that includes up to 8 weeks of 
physical therapy (PT) sessions. Each week for the first 2-4 weeks, you will receive a home 
physical therapy program as prescribed by the study team. The length of the home physical therapy 
program is dependant on the time required to fabricate the IDEO™. In addition, you will be fitted 
for the brace. Before the first PT session, you will be asked to complete several performance tests 
to measure your current physical performance. Performance testing at each interval below could 
take up to 30 minutes of your time. A member of the research team will time you to see how long 
it takes for you to: 
• walk the length of a long hallway 
• repeatedly rise from a chair 
• climb a set of stairs 
• balance on one foot 
• change direction while stepping over a small obstacle 
• run or walk as fast as possible between two cones 
 
During the first 2-4 weeks you may be asked to return to the center for a test fitting, prior to 
receiving the completed IDEO™.  , After you receive the IDEO™ you will be asked to come back 
to the study center for 4 weeks of PT. Each week, you will receive 3 sessions of PT lasting 
approximately 90 minutes. These sessions will teach you how to use your brace and get the most 
out of wearing the brace. At the end of the 4 weeks of therapy, you will be asked to repeat the 
performance tests once again.  
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
54 
 
After you have completed the physical therapy program, you will be given the phone number of 
the orthotist to call if you have any concerns or problems with your brace when you are at home. 
At 6 months after completing the program, you will be called by the Research Coordinator for a 
brief interview. The Research Coordinator will ask about your function and satisfaction with the 
brace and about health care services you have used. 
 
During the final study visit at 12 months following completion of the PRIORITI program, you will 
be asked to return to the study center and complete the performance tests one more time and 
answer questions about your function and satisfaction with the brace. This could take up to 45 
minutes of your time.  
 
5. WHAT ARE THE POTENTIAL RISKS OR DISCOMFORTS? 
 
There is a small possibility that you may injure yourself during the PT sessions. These sessions 
will be performed under close supervision by a trained physical therapist and will be geared toward 
your ability level.  
 
There also may be a small risk of falling during the performance tests. The tests are given in order 
of difficulty. If you can’t perform the tests of lower difficulty, you will not be asked to perform 
more difficult tests. If you don’t feel comfortable doing any of the tests, you can stop at any time.   
 
There is also a chance that your function and quality of life may not improve. This may be 
disappointing to you. 
 
Any time information is collected for a study there is a small risk of breach of confidentiality. As 
described below, your research data will be identified by a unique study number rather than your 
name and all measures allowed by law to protect your confidentiality will be taken by the research 
staff. 
 
 In this study, you will be exposed to a small amount of radiation called "ionizing radiation," which 
is like x-rays. Studies have shown that getting a lot of radiation at one time or getting many small 
doses over time may cause cancer. The risk of getting cancer from the one small radiation dose in 
this study is very small.  
 
Tell us now if you have been in other research studies where you had ionizing radiation. Also tell 
us if you have been exposed to radiation in other ways, like on your job or in radiation therapy.  
 
What if you are pregnant? If you are pregnant or nursing, you cannot be in this research study 
because the radiation may harm your baby. 
 
 
6. WHAT ARE THE POTENTIAL BENEFITS? 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
55 
 
 
As a result of participating in this study, your physical function, quality of life and performance of 
daily activities may improve. Furthermore, your participation in the study could help us determine 
the best treatment for injuries like yours. This information could be very helpful to other people 
who have this same injury in the future.  
 
 
 
7. DO I GET ANY PAYMENT FOR BEING IN THE STUDY? 
 
Active duty military personnel will not be paid to participate in the study. 
 
If you are not on active military duty you will receive a total of $300 for your participation in the 
study.  The $300 will be provided to you according to the following schedule: 
 
• $50 at the time you enroll in the study and complete the baseline assessments.  
• $75 when you complete the home physical therapy (prior to receiving the IDEO™) 
• $75 when you complete the 4 weeks of physical therapy (after receiving the IDEO™)  
• $100 when you complete the final assessment at 12 months  
 
 
8. ARE THERE ANY COSTS INVOLVED IN BEING IN THE STUDY? 
 
There is no cost to you to participate in this study. You will not be charged for the brace or the 
physical therapy. You will not be charged for additional visits to the orthotist during the study 
period if you have problems with the brace.  
 
9. WILL MY INFORMATION BE KEPT PRIVATE? 
 
The information we collect from you will be kept private to the best of our ability. Your name, 
birth date, medical record number and any other information that could identify you as an 
individual will be removed from all study forms. Instead, we will label your forms with a unique 
study number. The link between your name and your study number will be kept confidential to the 
greatest extent provided by law. The information collected for the study will be stored in a 
password protected, HIPAA verified computer database that only authorized members of our 
research team can use. When we report the results of the study, we will combine the information 
about you with similar information about hundreds of other people so your individual information 
will not be identifiable.  
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
56 
 
All study records will be considered confidential, and your name will not be used in reports or 
publications.   
 
10. WILL YOU SHARE MY INFORMATION WITH OTHERS? 
 
We will use your information only for the purposes of this study. The data from the study may be 
published. However, you will not be identified by name. People designated from the institutions 
where the study is being conducted will be allowed to inspect sections of your medical and 
research records related to the study. This includes people designated by The Johns Hopkins 
Bloomberg School of Public Health who are overseeing this study.  Everyone using study 
information will work to keep your personal information confidential. Your personal information 
will not be given out unless required by law. 
 
The Department of Defense is providing funding to conduct this study. Representatives from 
the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research 
Protections (ORP) Human Research Protections Office (HRPO) and your local IRB may have 
access to research records in their role to protect human subjects engaged in research.  
11. WHAT ARE MY ALTERNATIVES TO PARTICIPATION? 
 
Your alternative is to not take part in the study. If you choose not to take part, your healthcare will 
not be affected. 
 
12. WHAT HAPPENS IF I LEAVE THE STUDY EARLY? 
 
Your participation in this study is completely voluntary. You have the right to withdraw from the 
research study at any time without penalty. Your decision will not affect the medical care you 
receive. If you decide to stop participating, you should notify the study doctor or the research 
coordinator at your center.  
 
Your participation in this research study could be ended without your consent. Possible reasons 
could include our decision to end the study early or other reasons.  
 
13. WHAT HAPPENS IF I AM INJURED OR BECOME ILL BECAUSE I TOOK PART IN 
THIS STUDY? 
 
If you are injured or become ill because of your participation in this study, you will receive 
emergency medical care if needed and you will receive assistance in getting other medical care as 
needed.  You or your insurance carrier will be billed for the cost of care, just as you would be 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
57 
 
billed for any other medical care.  If you have any costs that are not covered by insurance, they are 
your responsibility.   
 
You do not give up any of your legal rights by signing this form. You can seek legal compensation 
for any injury that may occur to you during the study as a result of an error by a member of the 
research staff or others.  
 
 
14. WHO DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
 
• <<insert name>>, the study coordinator at your hospital has discussed this information with 
you and offered to answer any questions you may have.   If you have further questions or 
get sick or injured as a result of being in this study, you can contact << insert him/her>> at 
<<telephone number>>.  You may also call the Director of the Study at your hospital, 
<<insert name>>, at <<telephone number>>.   
 
• 
If you have further questions about your rights as a study participant you can call or contact 
your local IRB office or the Johns Hopkins Bloomberg School of Public Health IRB 
Office. The Johns Hopkins Bloomberg School of Public Health is serving as the overall 
coordinating center for this study that is being conducted in hospitals around the country. 
Contact the Johns Hopkins IRB if you feel you have not been treated fairly or if you have 
other concerns.  The IRB contact information is:   
 
 
You will receive a copy of this signed consent form. 
 
 
 
What does your signature (or thumbprint/mark) on this consent form mean? 
 
Your signature (or thumbprint/mark) on this form means: 
 
• You have been informed about this study’s purpose, procedures, possible benefits and risks. 
• You have been given the chance to ask questions before you sign. 
• You have voluntarily agreed to be in this study.  
 
________________________              _____________________________   ________  ___:___ 
Print name of Adult Participant              Signature of Adult Participant           Date          Time                               

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
58 
 
                            
 
 
Ask the participant to mark a “left thumb impression” in this box if the participant (or participant’s 
parent) is unable to provide a signature above.  
 
 
________________________        _____________________________       __________ ___:__ 
Print name of Person Obtaining     Signature of Person Obtaining Consent   Date          Time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
59 
 
APPENDIX E: EVALUTION TO GIVE CONSENT 
 
EVALUATION TO GIVE CONSENT 
 
Procedure: Make a subjective judgment regarding item 1 below.  Ask questions 2 through 4. You 
may select the language to use in asking the questions in order to help the respondent understand 
them.  
 
 
1. 
Is the respondent alert and able to communicate with you? 
 
Yes ___ 
No ____   (if condition not likely to change, seek proxy 
consent)  
 
2. 
Ask the respondent to name at least one thing that s/he will be asked to do as part of the 
study. 
 
Describe__________________________________________________________________
______________________________________________________________________ 
 
3. 
Ask the respondent to explain what s/he could do if s/he decided s/he did not want to 
participate in the study. 
 
Describe__________________________________________________________________
______________________________________________________________________ 
 
4. 
Ask the respondent to explain what s/he would do if s/he were experiencing distress or 
discomfort at any time during the study. 
 
Describe__________________________________________________________________
______________________________________________________________________ 
 
I hereby certify that the above-named respondent is alert, able to communicate, and able to give 
acceptable answers to items 2, 3, and 4, above. 
 
____________________________________         ____________________________________ 
Research Coordinator                                                            Date 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
60 
 
APPENDIX F: BROCHURE INSERT 
 
Be part of the PRIORITI -MTF Team! 
Help advance limb trauma care through research. 
 
What is the PRIORITI-MTF Study? 
The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed 
brace, called the IDEO ™ along with a physical therapy program, called Return to Run, improves 
your physical function.  
 
Why me? 
The PRIORITI-MTF study is funded by the Department of Defense (DoD) and is being carried out 
in three Military Treatment Facilities across the United States that are taking care of service 
members who were injured in the line of duty.  
 
You are being asked to participate in this study because you had a traumatic injury of the lower leg 
at least 1 year ago and you are still limited in the activities you are able to do. Service members 
with injuries like yours from around the country are being asked to participate.  
 
How does the study work?  
If you are eligible for the study and agree to participate, the following things will happen: 
• You will be asked questions about you and the activities you do now. 
• Information will be collected about your injury and the care you received for your injury. 
This information will be entered into a database by a member of the research team. 
• You will receive a clinical assessment to measure your leg weakness and how well you can 
bend your foot. 
• You will be measured for the IDEOTMbrace and begin a home physical therapy (PT) 
program while the IDEO™  is being made. 
• You will be fitted for the IDEO™ and will participate in 4 weeks of physical therapy with 
the brace. 
• You will be asked to participate in performance testing at several intervals: at baseline, 
after the 4 week Return to Run PT program and at one year following completion of the 
program.  At these times we will also ask you questions about your functioning and 
satisfaction with the device.  
• After the end of the program, the IDEO™ is yours to keep.   
 
We hope you will consider taking part in the PRIORITI-MTF Study.  It is a way to be part of a 
nationwide effort to help advance limb trauma care for others in the future.  Please talk to your 
doctor about participating, or email us at prioriti-mtf@metrc.org.  You can also visit 
www.prioriti-mtf.org or www.METRC.org to learn more. 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
61 
 
APPENDIX G: Draft Radio Script 
 
Have you sustained an injury to your lower leg while in the military 1 or more years 
ago? Does this injury prevent you from performing your day to day activities and 
engaging in sports and other recreational activities? If so, you may be eligible to 
participate in a research study to evaluate a new brace for lower leg 
injuries.  Qualified participants will receive study related orthopedic evaluations, 
receive a new orthotic brace and participate in a four week physical therapy program 
at no charge. If you are interested please visit www.prioriti-mtf.org for more 
information or call 410-614-3723.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
62 
 
 
Appendix H: Sample Letter from Physicians to potential participants: 
 
Dear (Colleague) 
 
I am reaching out to you to give you some information about a study that is being done locally that 
could impact some of your patients. The research is being done to help determine whether a new 
type of custom designed brace called the IDEO along with an intense physical therapy program 
called the Return to Run Program improves your patient’s physical function. The IDEO was 
developed for wounded warriors who want to return to an active lifestyle, including active duty.  
The study is for patients who have had an injury to their lower leg and are one or more years out 
from their injury. We are looking for patients with unilateral injuries who are healed (will not 
require further surgeries within the next 6 months) and able to fully bear weight. They must also 
meet the following criteria:  
Evidence of either: 
• Weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury 
(defined as less than 4 out of 5 on manual muscle test)  
• Limited ankle dorsiflexion (< 10 degrees) and /or limited ankle plantarflexion (< 20 
degrees) resulting from leg injury 
• Mechanical pain with loading to hindfoot/midfoot (>= 50 mm on a 0-100 mm visual 
analogue scale assessing average daily pain)  
• Ankle or hindfoot fusion or candidate for ankle or hindfoot fusion 
• Candidate for amputation secondary to ankle/foot impairment  
 
If you feel that you have patients who meet the above criteria, please provide them with the 
enclosed brochure and contact information. You may also refer them to our website: www.prioriti-
mtf.org. If you have questions please feel free to reach out to me (Site PI name) or (Site PI 
Coordinator name) using the following contact information (phone number, email).  You can also 
visit www.prioriti-mtf.org to learn more. We appreciate your consideration in referring your 
patients to this study.  
 
(Signed by Treating Physician) 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
63 
 
 
 
Appendix I: Study Video [DRAFT] 
Narrative 
 
 
 
 
Suggestions for Visuals 
You are watching this video because you had a bad 
injury to your lower leg one or more years ago. 
Although this type of injury is rare in everyday life, 
it is quite common among members of the military. 
For this reason, the United States Department of 
Defense is funding research to help us determine 
the best way to treat these injuries. The goal of this 
research is to help wounded service members and 
veterans like you recover from severe leg injuries 
and return to the activities they enjoy doing. We are 
asking you to consider participating in this research 
today to help others like you in the future.  
The name of this research study is the PRIORITI 
study. This video will give you more information to 
help you decide if you would like to participate in 
the study. 
The goal of the PRIORITI study is to evaluate the 
benefits of a new brace for the lower leg. This 
brace is called the Intrepid Dynamic Exoskeletal 
Orthosis or the IDEO brace.  
 
PRIORITI study logo 
Image of service members  
Image of severe open fracture of the tibia 
 
 
 
 
 
 
 
 
 
Image of IDEO 
 
Right now there are braces called ankle foot 
orththoses, or AFO’s, that have been made for 
people with different needs. They provide support 
to the ankle where there might be weakness.  Most 
of these braces, however, are static or have no 
moving parts.  
Other braces, like the IDEO brace, have been made 
to provide support but also incorporate a strut that 
acts as a spring. The strut is intended to act as an 
energy storing device, which is meant to help 
provide a balance of power in the muscles of the 
Images of braces 
 
 
 
 
Image of IDEO 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
64 
 
lower leg and ankle. The brace is intended to assist 
in increasing the speed and quality with which you 
can walk and return to vigorous activities like 
running.  
 
 
This brace was developed by a team at the Center 
for the Intrepid in San Antonio, TX 
Some research has been done using the brace along 
with a physical therapy program called the Return 
to Run or RTR program. The multidisciplinary 
Return to Run (RTR) clinical pathway focuses on 
strength, agility and speed with the goal of enabling 
patients to return to running, sports and military 
deployment.  
For the purpose of this study, we would like to re-
create this program and test it closer to where you 
live. This is why we need people like you to 
participate. We would like to further evaluate the 
IDEO brace along with the RTR program outside 
the place where it was created.  
ENTER DR X.   
You are being asked to participate in the PRIORITI 
study because your doctor has determined that you  
could potentially benefit from wearing the IDEO. 
The type of injury you sustained is fairly 
uncommon, so the study’s success depends on 
people with injuries like yours from major trauma 
centers across the country joining together to take 
part in this effort.  
If you choose to participate in this study you will 
be asked to do the following:  
Step 1: To determine if you can be in the study 
• 
You will be asked questions about you and 
the activities you do now 
• 
Information will be collected about your 
injury and the care you received for your 
injury. This information will be entered 
into a database by a member of the 
research team. 
Images of CTI, Ryan, Etc? 
 
 
Images of PT, Running w brace, RTR Group 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
65 
 
• 
You will receive a clinical assessment to 
measure in your leg weakness and how 
well you can bend your ankle. 
 
Step 2: The Study Itself 
If the surgeon feels that you are eligible based on 
the clinical assessment you will be scheduled to 
return to the clinic to begin the PRIORITI program. 
The program includes 8 weeks of physical therapy 
(PT) sessions …. 4 weeks before you get the brace 
and 4 weeks after you have been fitted and are 
wearing the brace.  
 
Physical Therapy 
You will recieve a home physical therapy program 
from your study team.  You will perform the 
exercises as directed for each of the first 4 weeks. 
Before the first PT session, you will be asked to 
complete several performance tests to measure your 
current physical performance. A member of the 
research team will also time you to see how long it 
takes for you to: 
• 
walk the length of a long hallway 
• 
repeatedly rise from a chair 
• 
climb a set of stairs 
• 
balance on one foot 
• 
change direction while stepping over a 
small obstacle 
• 
run or walk as fast as possible between 
two cones 
These tests will be repeated at different times over 
the course of the study.  
IDEO Brace 
The brace will be custom made for you by a 
Certified Prothestist/Orthotist or CPO in the 
prosthetics lab at your base hospital.  
Video of brace measuring, fitting etc. 
 
Physical Therapy Again… 
After the first 4 weeks of physical therapy, you will 
be asked to repeat the physical performance tests. 
At this time you will receive the brace and will be 
asked to come back to the study center for another 
4 weeks of PT. Each week, you will receive 3 
sessions of PT lasting approximately 90 minutes. 
More images of PT 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
66 
 
These sessions will teach you how to use your 
brace and get the most out of wearing the brace. At 
the end of the 4 weeks of therapy, you will be 
asked to repeat the performance tests once again.  
 
Finally, during the final study visit at 12 months 
following completion of the PRIORITI program, 
you will be asked to return to the study center and 
complete the performance tests and answer 
questions about your function and satisfaction with 
the brace.  
 
Performance test pics 
We hope that the description of the IDEO brace 
and the RTR program has helped you better 
understand the study. We hope to show if this brace 
is beneficial in improving function following a 
severe injury like yours.  Our goal is to help people 
with these severe injuries recover and get back to 
doing what they enjoy most in life.  
If you have questions about these treatments or the 
study, please ask your surgeon or study coordinator 
at the end of the video.  
Thank you for considering taking part in the 
PRIORITI study. Previous research volunteers have 
provided us with tremendous knowledge that will 
directly benefit you in the care we give you today. 
We are asking you to consider participating to help 
civilians and injured service members in the future. 
If you decide to join PRIORITI, know that you will 
be helping to shape the future of trauma care.     
Thanks again for learning more about the 
PRIORITI study, and we wish you the best in your 
recovery. 
Images of patients 
More images of service members 
Thank you! 
 
 
 
 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
67 
 
 
Appendix J: Draft Study Announcement  
RESEARCH STUDY FOR ADULTS WITH DECREASED LOWER 
LEG FUNCTION 
We are looking for volunteers to take part in a study to evaluate a 
new brace for military personnel who have had an injury to their 
lower leg 1 or more years ago, resulting in a loss of function. 
You may qualify if you are 18 years or older, are at least 1 YEAR past 
your injury and can answer yes to one or more of the following questions: 
o Are you limited in what or how much you are able to do at 
home, at work or at school because of your leg injury? 
o Are you limited in the types or frequency of sports and 
recreational activities you would like to do because of your 
leg injury? 
o Are you dissatisfied with the recovery you have made from 
your leg injury? 
 
Qualified participants will receive study related orthopaedic evaluations, will 
be fitted for and receive the new orthotic brace, and participate in 8 weeks of 
physical therapy at no charge to you.  Military personnel who are not on active 
duty will receive compensation for time and travel. Assistance with 
transportation is available.  
For more information please call: 
(XXX) XXX-XXXX 
Contact Site PI 
 
 
 
 
Contact Site Coordinator 
Principal Investigator  
 
 
 
Research Coordinator 
This study has been reviewed by, and received ethics clearance through, (your institutional 
research office name, location). 

 
PRIORITI-MTF Protocol v 8.0   August 31, 2015 
68 
 
Appendix K: Research Coordinator Script for 6 Month Visit 
The following will be read to the participant during the 6 month follow up phone call: 
The study is able to cover the expense of your transportation to and from the center for the 12 
month follow up visit. Accommodations for one night will be covered if you are unable to travel to 
and from the center in one day.  We will cover up to 50/day for meals for a maximum of 2 days.  
After mentioning the reimbursement plan, the coordinator will make arrangements per institutional 
policy and inform the coordinating center.