Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial
Phase: NA
Conditions: LC Pelvic Fracture
Sponsor: University of Maryland, Baltimore

Pelvis RCT Protocol v4 (2016.06.01) 
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University of Maryland, Shock Trauma Center 
Department of Orthopaedics 
 
 
Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: 
A Prospective Trial (Pelvis RCT) 
 
NCT02605766 
 
University of Maryland IRB Number: HP-00060038 
Principal Investigator: Robert O’Toole, MD 
Safety Monitor: Andrew Pollak, MD 
Version 4 
June 1, 2016 

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TABLE OF CONTENTS 
 
 
Protocol Summary ................................................................................................................. 3 
Key Roles ............................................................................................................................... 4 
Background Information ........................................................................................................ 4 
Rationale ................................................................................................................................ 5 
Potential Risks ....................................................................................................................... 5 
Potential Benefits ................................................................................................................... 6 
Primary Outcome ................................................................................................................... 6 
Secondary Outcomes ............................................................................................................. 6 
Exploratory Outcomes ........................................................................................................... 6 
Description of the Study Design ............................................................................................ 6 
Primary Endpoint ................................................................................................................... 7 
Secondary Endpoints ............................................................................................................. 8 
Study Population .................................................................................................................... 10 
Adjudicating Eligibility ......................................................................................................... 11 
Co-Enrollment Guidelines ..................................................................................................... 11 
Recruitment ............................................................................................................................ 11 
Study Treatments ................................................................................................................... 11 
Clinical Evaluation ................................................................................................................. 12 
Participant Interviews ............................................................................................................ 13 
Study Schedule ....................................................................................................................... 13 
Assessment of Safety ............................................................................................................. 15 
Data Analysis ......................................................................................................................... 16 
Randomization ....................................................................................................................... 17 
Data Management .................................................................................................................. 17 
Missing Data .......................................................................................................................... 18 
Research Ethics Approval ...................................................................................................... 18 
Informed Consent ................................................................................................................... 19 
Vulnerable Populations .......................................................................................................... 20 
Participant Confidentiality ..................................................................................................... 20 
Study Discontinuation ............................................................................................................ 21 
Reports ................................................................................................................................... 21 
Study Records Retention ........................................................................................................ 21 
Supporting Literature ............................................................................................................. 21 
APPENDIX A ........................................................................................................................ 23 
APPENDIX B ........................................................................................................................ 23 
APPENDIX C ................................................................................................ See Attachements 
APPENDIX D ................................................................................................ See Attachements 

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PROTOCOL SUMMARY 
 
Title 
Impact of surgery on pain in lateral compression type pelvic fractures: a 
prospective trial 
Short Title 
Pelvis RCT 
Type of Study 
Prospective randomized control trial OR observational outcomes study 
Primary Objective 
To determine if surgical stabilization of lateral compression type pelvic 
fractures decreases patient reported pain at 2 weeks post injury compared 
to non-operative management. 
Secondary Objective To explore associations between treatment and: 
1. Patient reported pain up to 1 year post injury 
2. Hospital length of stay 
3. Time to first mobilization (bed to chair) 
4. Narcotic use up to 1 year post injury 
5. Work productivity & activity impairment up to 1 year post injury 
6. Health related quality of life up to 1 year post injury 
7. Pelvic specific functional outcome up to 1 year post injury 
8. General function up to 1 year post injury 
Sample Size 
We will recruit a sample size of 130 patients (65 per arm) with a 
minimum of 2 week follow-up for the primary outcome 
Diagnosis and Main 
Inclusion Criteria 
Lateral compression type pelvic fracture amendable to both operative or 
non-operative treatment per surgeon opinion in patients between the ages 
of 18 and 80 years of age, inclusive. 
Length of Follow-up 
1 year 
 
Study duration: We will recruit for a year and a half. Patients will be followed for 1 year. We 
estimate 4 years total. 
 
Primary outcome measure: Pain as measured by using the arithmetic mean of the four pain 
severity items on the patient-reported Brief Pain Inventory assessment (BPI) 2-weeks following 
the patient’s injury. 
 
Secondary outcome measures: Length of stay will be determined by recording the admission 
date versus discharge date for the patient’s index hospitalization. Time to first mobilization (bed 
to chair) will be determined using the physical therapy notes during the patient’s index 
hospitalization and is defined as days post-injury and days post-operative treatment (if 
applicable) to time of first mobilization (bed to chair). Narcotic use will be determined by cross- 
referencing the patient’s medical record during the index hospitalization and follow-up clinic 
appointments with patient-reported usage. Work productivity and impairment will be determined 
using the modified WPAI:SHP questionnaire. Health related quality of life will be measured 
using the VR-12 questionnaire. Pelvic function will be measured using the Majeed Pelvic Score. 
 
Statistical analysis: We are interested in estimating the causal effect of operative treatment 
versus non-operative treatment in lateral compression type pelvic fracture patients. For all our 

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analyses, we will report estimates of the causal effects, standard errors, and confidence 
intervals. We will also report the results of tests of null hypothesis of no causal effect. 
 
 
KEY ROLES 
 
Safety Monitor- Dr. Andrew Pollak will be responsible for overseeing patient safety for the 
study. Dr. Pollak will review the enrollment numbers and medical compliance annually for the 
duration of the study. 
 
Coordinating Center Principle & Sub-Investigators- Dr. Robert O’Toole (PI) and the sub- 
investigators will be responsible for developing a detailed study protocol, providing oversight on 
study progress and act to correct deficiencies in the conduct of the study. The PI and sub- 
investigators will also draft the main publications related to the study, and assist with patient 
consent. 
 
Site Principle & Sub-Investigators- The site PI and sub-investigators will be responsible for 
oversight on local study progress. The site PI and sub-investigators will also contribute to the 
main publications related to the study, and assist with patient consent. 
 
Coordinating Center Research Coordinator- Andrea Howe, research specialist, is 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 the research team members and site research coordinators, providing daily 
oversight and management of study implementation, performing data quality control and analysis 
of study results. The coordinating center research coordinator will also conduct monthly reports 
for each site. 
 
Site Research Coordinator- The site research coordinator is responsible for communicating any 
problems or concerns with the coordinating center, maintaining all local study documentation, 
developing and maintaining the site IRB application and consent, and circulating any changes to 
study documents including protocols, case report forms, and IRB materials to the site research 
team members. 
 
Research Team Members- The research team members are responsible for the conduct of the 
clinical study including patient enrollment, performing study procedures, data collection and 
conducting study follow-up visits. 
 
 
BACKGROUND INFORMATION 
 
Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures 
encountered. There is a substantial amount of controversy surrounding the treatment of these 
injuries and there is evidence that both operative and non-operative treatment can be successful. 
The crux of the problem is determining which of these patients would benefit from early surgical 
stabilization and which will heal uneventfully without surgery. Many authors site patient pain 

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and inability to mobilize as indications for surgery, although there is conflicting evidence 
supporting this claim. The presence of chronic pain in the trauma population is a growing area of 
interest, and there is a push towards controlling pain more effectively in the acute setting. It 
remains to be proven that surgical intervention is more effective at decreasing acute and longer 
term pain. 
 
 
RATIONALE 
 
There is evidence in the literature to support both operative and non-operative treatment of 
patients with LC1 or LC2 pelvic fractures. There is conflicting evidence that surgical 
stabilization decreases acute pain and narcotic requirements, although patients are often 
counseled to that effect. We propose to prospectively randomize patients with lateral 
compression type pelvic fractures to non-operative versus operative treatment and track which 
group has less pain, less need for narcotic pain medications, and who mobilizes with physical 
therapy faster. 
 
 
POTENTIAL RISKS 
 
If the patient is randomized to operative treatment, he/she will be exposed to all of the risks 
associated with surgery under a general anesthetic including but not limited to: prolonged 
intubation, heart attack, stroke and death. These risks are extremely rare and will be explained to 
the patient and/or family by the anesthesia team, and a separate anesthesia consent will be 
obtained. The risks of the surgical procedure are rare but include: infection, wound break down, 
failure of hardware, and neurologic injury. A separate surgical consent will be provided to go 
into more detail of the risks of the procedure. 
 
The risk of non-operative treatment is displacement of fracture with possible need for surgical 
intervention or prolonged protected weight-bearing. This is unlikely but will be monitored 
closely, as per our standard of care. 
 
While the intake questionnaire and information gathered is of a sensitive nature (income, 
narcotic use, pain and psychiatric history) and it might cause the patient some discomfort to 
answer truthfully, all information will be kept confidential and no identifiers will be used in 
publication. 
 
While every attempt will be made to keep all information confidential and the master link 
between the patient study number and personal identifiers will be destroyed at the completion of 
the study, there remains a risk of the potential for the loss/breach of confidentiality. This risk will 
be minimized by storing all paper questionnaires in a secure, locked location and all electronic 
data will be password protected. 
 
There may be risks in this study which are not yet known. 

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POTENTIAL BENEFITS 
 
While there are no direct benefits to patients participating in the study (except for those that may 
accrue from closer clinical observation as a study patient), participation may help determine the 
best treatment for lateral compression type pelvic fractures in the future. 
 
 
PRIMARY OBJECTIVE 
 
To compare 2-week post-injury assessments of patient reported pain of participants undergoing 
operative versus non-operative treatment following a lateral compression type pelvic fracture. 
We hypothesize that there will be a decrease in the Visual Analog Scale (VAS) pain scores in the 
operative group as compared to the non-operative group both during their hospital stay and in the 
short-term outpatient follow up. 
 
 
SECONDARY OBJECTIVES 
 
To compare assessments of narcotic use up to 1 year post injury of participants undergoing 
operative versus non-operative treatment following a lateral compression type pelvic fracture. 
We hypothesize that there will be a decrease in the narcotic requirements in the operative group 
as compared to the non-operative group throughout the 1 year follow up. 
 
To compare assessments of time to first mobilization (bed to chair) with physical therapy of 
participants undergoing operative versus non-operative treatment following a lateral compression 
type pelvic fracture. We hypothesize that the operative group will mobilize out of bed to chair 
with physical therapy faster than the non-operative group. 
 
 
EXPLORATORY OBJECTIVES 
 
To explore associations between treatment and: 
1. Hospital length of stay (index hospitalization) 
2. Work productivity and activity impairment up to 1 year post injury 
3. Health related quality of life up to 1 year post injury 
4. Pelvic specific functional outcome up to 1 year post injury. 
 
 
DESCRIPTION OF THE STUDY DESIGN 
 
The Pelvis RCT study is a prospective randomized treatment trial to evaluate outcomes among 
operative versus non-operative lateral compression type fractures.  If the patient does not agree 
to randomization, the patient will be asked to participate in the observational arm of the study. A 
schematic representation of participant enrollment can be found in the figure below. 
A total of 130 patients will be enrolled (65 per arm). University of Maryland, Shock Trauma 
Center will act as the coordinating center for this study and all patient will be recruited from 

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Eligible lateral compression type 
pelvic fractures 
(n=130) 
Operative Treatment 
(n=65) 
Non-operative Treatment 
(n=65) 
University of Maryland, Shock Trauma Center and Indiana University Health Methodist 
Hospital. 
 
Patients and/or the patient’s legally authorized representative (LAR) will be approached for 
informed consent as soon as is feasible following determination of eligibility. 
 
During the index hospitalization, participants will be asked to provide basic demographic 
information, health status and function prior to injury. Study injury characteristics will be 
obtained from the surgeon and the participant’s medical record. 
 
Participants will be prospectively followed at 2 weeks, 6 weeks, 3 months and 1 year post-injury. 
All follow-ups will occur in person at the hospital clinic follow-ups or over the phone and will 
consist of both a clinical examination (when applicable) and interview. 
 
 
 
 
Figure: Participant Enrollment 
 
 
 
PRIMARY ENDPOINT 
 
The primary endpoint is patient reported pain severity as measured by the Brief Pain Inventory 
assessment (BPI). The BPI is a 15-item questionnaire that assesses the severity of pain, the 
impact of pain on daily function, the location of pain, pain medications and the amount of pain 
relief. There is no scoring algorithm but the arithmetic mean of the four severity items can be 
used as a measure of pain severity and the arithmetic mean of the seven interference items can be 
used as a measure of pain interference. This assessment has been chosen because it is a short, 
reliable, patient reported assessment of pain that has been specifically designed for and validated 
in patients with pain from acute conditions such as postoperative pain. 
“Late” operative treatment 
(by 1 year post injury) 
Non-operative at 1 year post 
injury 

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SECONDARY ENDPOINTS 
 
The secondary endpoints include: 
1. Length of stay. This will be found in the patient’s medical record using the admission 
date and time versus the discharge date and time during his/her index hospitalization. 
2. Time to first mobilization (bed to chair). This will be found in the patient’s medical 
record during his/her index hospitalization. Data will be found in the physical therapy 
notes and will be recorded as days post-injury and days post-operative treatment if 
applicable. 
3. Patient reported narcotic use. This is will recorded by cross-referencing the patient’s 
medical record and patient-reported questionnaire about pain medication use. The total 
narcotic use will be converted to the morphine equivalent for statistical analysis. 
4. Patient reported work productivity and activity impairment. This will be measured using 
the modified Work Productivity and Activity Impairment (WPAI: SHP) assessment. The 
WPAI: SHP is a 6-item questionnaire that yields four types of scores: 1 – Absenteeism 
(work time missed); 2 – Presenteeism (impairment at work / reduced on-the-job 
effectiveness); 3 – Work productivity loss (overall work impairment / absenteeism plus 
presenteeism); and 4 – Activity impairment. WPAI outcomes are expressed as 
impairment percentages with higher numbers indicating greater impairment and less 
productivity, i.e., worse outcomes, as follows: 
Questions: 
a. currently employed 
b. hours missed due to pelvic injury 
c. hours missed due to other reasons 
d. hours actually worked 
e. degree pelvic injury affected productivity while working 
f. degree pelvic injury affected regular activities 
Scores: 
1. Percent work time missed due to pelvic injury: 
[b ÷ (b + d)] × 100 
2. Percent impairment while working due to pelvic injury: 
(e ÷ 10) × 100 
3. Percent overall work impairment due to pelvic injury: 
(b ÷ (b + d) + [1 + (b ÷ (b + d)) × (e ÷ 10)]) × 100 
4. Percent activity impairment due to pelvic injury: 
(f ÷ 10) × 100 
5. Patient reported health related quality of life. This will be measured using the VR-12…. 
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the 
scores of the twelve questions and range from 0 to 100, where a zero indicated the lowest 
level of health measured by the scales and 100 indicates the highest level of health. Both 
Physical and Mental Health Composite Scales combine the 12 items in such a way that 
they compare to the national norm with a mean score of 50.0 and a standard deviation of 
10.0. 
6. Patient reported pelvic function. This will be measured using the Majeed Pelvic Score. 
The Majeed Pelvic Score uses five criteria chosen for functional assessment after major 
pelvic fractures: pain, standing, sitting, sexual intercourse and performance at work. Each 

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of these clinical parameters is scored, the total being a maximum of 100 points for 
patients who were working before the injury and 80 points for those who were not. The 
five sections of the assessment are scored as shown in Table I and discussed below. 
Pain. Pain is an important sequel of major pelvic injury, and is given a score of 30 points, 
allocated according to the six grades listed in Table I. Standing. Weight-bearing in the 
erect position is given 36 points, in three main categories (aids, gait and walking ability), 
each of which has six grades. Sitting. Sitting is an important function in relation to the 
pelvis, but less so than gait or walking ability. A total score of 10 points is given in four 
grades. Sexual intercourse. For both men and women, four points are allocated for 
comfort during sexual intercourse. This does not take account of neurological or 
psychological impotence and is recorded in four grades. If, for any reason, sexual 
intercourse has not been attempted, a score of four points is given. Work. Work 
performance is allocated 20 points in five grades, ranging from no regular work to return 
to the same job as before injury with no loss of performance. A patient who was not 
working at the time of his injury is not scored; his overall assessment is then out of 80 
points. 
The accumulative grading system is shown in Table II. This gives a breakdown into 
excellent, good, fair and poor for both working and non-working patients. 

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STUDY POPULATION 
 
The study population will be patients aged 18-80 with a lateral compression type pelvic fracture 
that go on to receive operative or non-operative treatment of the injury. 
 
Inclusion Criteria: 
1. Patients that have one of the following pelvic fractures (includes bilateral sacral 
fractures): lateral compression type 1, lateral compression type 2, lateral compression 
type 3. 
2. Patients between 18 and 80 years of age, inclusive. 
3. Patient has reached skeletal maturity. 
4. The patient’s pelvic fracture is a result of trauma (includes polytraumatized patients). 
5. The patient/family/guardian is English-speaking. 
6. The patient’s surgeon agrees to randomization (the patient is amendable to either 
operative or non-operative treatment). 
7. Patient enrollment and, if applicable, patient randomization, can occur within 96 hours 
post injury. 
 
Exclusion Criteria: 
Patients who satisfy any of the following exclusion criteria will be ineligible for enrollment in 
the study: 
1. The patient has prior surgical hardware in place that precludes intervention. 
2. If the patient’s pelvic fracture is classified as LC1 and the associated sacral fracture is 
incomplete as indicated by failure to violate both the anterior and posterior cortex. 
3. The patient received prior surgical intervention for his/her current pelvic injury. 
4. The patient has sacral morphology that precludes percutaneous fixation. 
5. The patient is non-ambulatory due to an associated spinal cord injury. 
6. The patient was non-ambulatory pre-injury. 
7. The patient is currently pregnant. 
8. The patient is enrolled in another study that does not allow co-enrollment. 
9. The patient is likely to have severe problems maintaining follow up. 

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ADJUDICATING ELIGIBILITY 
 
To ensure consistency in the application of inclusion criteria and in the classification of injuries, 
all fractures will be re-evaluated by a surgeon in Shock Trauma who is not treating the patient. 
These evaluations will be based on slides of AP and lateral x-rays. Each case will be 
independently reviewed. The non-treating surgeon will convene to discuss the case if there is 
disagreement regarding eligibility or classification of the injury to resolve differences of opinion. 
 
 
CO-ENROLLMENT GUIDELINES 
 
If allowed by the local IRB, participants in the Pelvis RCT study may be co-enrolled in other 
research studies based on the following guidelines: 
A. Regardless of whether the participant is enrolled in the randomization arm or the 
observational arm of the Pelvis RCT study, the participant may be co-enrolled in any 
other observational study. 
B. If the participant is enrolled in the randomization arm, he or she may only be co-enrolled 
in up to two additional randomized control trials prior to the completion of the 
intervention. 
C. If the participant is enrolled in the randomization arm, he or she may co-enrolled in any 
other randomized control trial after the intervention is complete. 
D. If the participant is enrolled in the observational arm, he or she may be co-enrolled in any 
other randomized control trial at any time. 
 
 
RECRUITMENT 
 
Approximately 130 participants will be enrolled in the Pelvis RCT study. Participants will be 
recruited during the index hospitalization for the treatment of a qualifying lateral compression 
type pelvic injury. Consenting procedures are described in detail in the Study Schedule and 
Informed Consent Sections of this protocol. 
 
 
STUDY TREATMENTS 
 
Both treatment options used in the study are current standard of care practices and the same 
resources (pain management, social work, physical therapy, etc.) will be available to study 
patients as to all trauma patients. 
 
Non-operative Treatment Group 
Patients enrolled in the non-operative treatment group will not undergo surgical intervention for 
their pelvic fracture. They will mobilize as per the surgeon’s instructions according to standard 
of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if 
the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. 
If complications arise and/or surgery is required, crossover will be allowed and recorded within 
study follow-up forms. 

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Operative Treatment Group 
Patients enrolled in the operative treatment group will undergo surgical intervention for their 
pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for 
the patient’s injury. The patient will mobilize as per the surgeon’s instructions and x-rays will be 
taken at follow-up clinic appointments to determine if the injury is healing properly.  If 
additional surgery is required or other complications arise, this will be recorded within the study 
follow-up forms. 
 
 
CLINICAL EVALUATION 
 
A summary of the clinical evaluations is outlined below and can also be found in Appendix B. 
 
Medical Record Review 
During the index hospitalization, information about the participant (medical history, height and 
weight, etc.) and the participant’s injuries and hospital stay will be collected, including 
mechanism, presence of and severity of other orthopaedic and non-orthopaedic injuries, 
procedures done in the hospital, overall (and ICU) length of stay, time to mobilization (bed to 
chair) in physical therapy, pain medication administration, and discharge disposition. 
 
Assessment of Study Injuries 
The extent and severity of the pelvic injury will be prospectively assessed by the treating surgeon 
after initial x-rays are taken. The following injury characteristics will be collected: 
• Lateral compression type classification of the pelvic fracture 
• Skin defect associated with the pelvic injury 
• Muscle and tendon injury associated with the pelvic injury 
• Deep vein injury associated with the pelvic injury 
• Nerve injury associated with the pelvic injury 
 
Assessment of Study Injury Treatment 
For participants undergoing operative treatment, the following information will be obtained: 
• Type of fracture stabilization 
• Type and timing of fixation revisions 
• Limb Complications (type, severity, treatment) 
 
Assessments at 2 weeks, 6 weeks, 3 months, and 1 year post injury 
• Complications since last follow-up (type, severity, treatment) 
• Assessment of fracture healing 
• Weight bearing status and ambulation 
• Use of ambulatory devices 
• Pain assessment 
• Narcotic use assessment 

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X- rays 
AP and lateral x-rays at admission, post-operative treatment (when applicable), and at the 2 
week, 6 week, 3 month and 1 year follow-ups will be obtained. These x-rays are obtained per 
standard of care. 
 
 
PARTICIPANT INTERVIEWS 
 
A summary of the participant interviews performed are outlined below and can also be found in 
Appendix D. 
 
Baseline Hospital Interview 
During the index hospitalization, participants will be asked about the following: 
• Age, gender, race and ethnicity, and education 
• Smoking history 
• Previous injuries (specifically pelvis or back) 
• Pain medication usage prior to this injury 
• Work and health status prior to this injury 
• General and pelvic function prior to this injury 
. 
Follow-up Interviews 
At 2 weeks, 6 weeks, 3 months, and 1 year following their injury, participants will be asked 
about the following: 
• Any re-hospitalization or outpatient surgery since the last visit for any reason related to 
his/her pelvic injury 
• Rehabilitation received 
• Pain medication usage 
• Work Status – Work Productivity and Activity Impairment 
• Pain – Brief Pain Inventory 
• Health Status – VR-12 
• Pelvic Function – Majeed Pelvic Score 
 
STUDY SCHEDULE 
 
Screening and Consent 
All patients between the ages of 18 and 80 (inclusive) with a lateral compression type pelvic 
fracture will be screened for eligibility by the research coordinator or research team members in 
close coordination with the surgeon investigators. Screening will typically occur within the first 
day after hospital admission. An eligibility checklist form will be completed on every potentially 
eligible participant and entered onto the electronic data capture system. The treating surgeon will 
be available via pager to answer questions regarding study eligibility. When the treating surgeon 
is not available, the study PI will be available to page. Contact information for the PI and 
alternate contact is available in Appendix A. In most cases, questions should be resolved at this 
level. 

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Once eligibility has been confirmed, the informed consent process will be completed by the 
research coordinator or research team member and attending surgeon. Patients will be 
approached about potential participation in the study as soon as is feasible following 
determination of eligibility. It will be important to enroll these participants as soon as possible to 
prospectively collect information about their injury and its treatment. 
 
Following completion of informed consent, the participant’s study injury characteristics will be 
further adjudicated by a non-treating surgeon as described in the Adjudicating Eligibility Section 
of this protocol. Participants with injuries that are not judged eligible for inclusion will be 
withdrawn from the study. 
 
Enrollment/Baseline 
Once consented into the study, baseline data regarding participant characteristics, injury 
characteristics, fracture classification and medical history/co-morbidities will be collected. 
Characteristics about the hospital course and treatment received will also be collected. A brief 
interview will be conducted with the participant. All data will be recorded on the paper Case 
Report Form (CRF) and entered into the electronic data capture system. 
 
Follow-up 
Participants will return for follow-up visits at 2 weeks, 6 weeks, 3 months, and 1 year post 
injury. Participants will undergo a clinical evaluation by the treating surgeon and be interviewed 
by the research coordinator or research team member. These visits tend to mirror clinic visits per 
standard of care, however there may be some circumstances where patients are unwilling to 
return to the clinic. In these situations the research coordinator or research team member may 
obtain as much visit data as possible by phone and/or medical record review to prevent loss of 
important study information. All data will be recorded on the paper Case Report Form (CRF) and 
entered into the electronic data capture system. 
 
Retention 
Every effort will be made to retain participants in the study. We will keep participants engaged 
through use of study updates during non-study clinic appointments, and reminder calls/letters for 
upcoming appointment visit window timeframes. 
 
Visit Windows 
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 week before or after the ideal date for the 2 week and 6 week follow-up appointments, and 2 
weeks before or after the ideal date for a visit for the 3 month and 1 year follow-up 
appointments. Study data will still to be collected even if the visit falls out of the ideal window 
of time. 

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ASSESSMENT OF SAFETY 
 
The study will monitor and report adverse events to ensure participant safety. Each participating 
site is responsible for ensuring that all local IRB requirements for reporting adverse events (both 
internal and external) are met. 
The safety monitor (SM) is responsible for providing medical guidance and overseeing 
participant safety for the study. The SM 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 the Principal and Sub- 
Investigators at each site. 
 
Reportable New Information (RNI) 
The following information must be reported to the coordinating center IRB within FIVE (5) 
business days of the investigator becoming aware of the information (please note that a separate 
RNI must be completed and submitted for each problem/event/report): 
• Information that indicates a new or increased risk. For example: 
• New information (e.g., an interim analysis, safety monitoring report, publication 
in the literature, sponsor report, or investigator finding) indicates an increase in 
the frequency or magnitude of a previously known risk, or uncovers a new risk 
• An investigator brochure, package insert, or device labeling is revised to indicate 
an increase in the frequency or magnitude of a previously known risk, or describe 
a new risk 
• Withdrawal, restriction, or modification of a marketed approval of a drug, device, 
or biologic used in the research protocol 
• Protocol violation that harmed subjects or others or that indicates subjects or 
others might be at increased risk of harm 
• Complaint of a subject that indicates subjects or others might be at increased risk 
of harm or at risk of a new harm 
• Any changes significantly affecting the conduct of the research 
• Any harm experienced by a subject or other individual which in the opinion of the local 
investigator is unexpected and at least probably related to the Human Research 
procedures and suggests that the research places subjects or others at a greater risk of 
harm than was previously known or recognized 
• A harm is “unexpected” when its specificity or severity are inconsistent with risk 
information previously reviewed and approved by the IRB in terms of nature, 
severity, frequency, and characteristics of the study population 
• A harm is “at least probably related to the Human Research procedures” if in the 
opinion of the local investigator, the research procedures more likely than not 
caused the harm (greater than 50% probability) 
• Non-compliance with the federal regulations governing human research or with the 
requirements or determinations of the IRB, or an allegation of such non-compliance 
• Failure to follow the protocol due to the action or inaction of the investigator or research 
staff 
• Breach of confidentiality 
• Change to the protocol taken without prior IRB review to eliminate an apparent 
immediate hazard to a subject 

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• Incarceration of a subject in a study not approved by the IRB to involve prisoners 
• Complaint of a subject that cannot be resolved by the research team 
• Premature suspension or termination of the research by the sponsor or the investigator 
• Unanticipated adverse device effect (any serious adverse effect on health or safety or any 
life-threatening problem or death caused incidence in the investigational plan or 
application – including a supplementary plan or application – or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects) 
• Audit, inspection, or inquiry by a federal agency 
• Written reports of study monitors 
 
Serious Adverse Event (SAE) 
Serious Adverse Events may be discovered during regularly scheduled visits or though 
unscheduled participant contacts between visits. SAEs will be managed according to the medical 
judgment of the treating physician and source documentation will be maintained (e.g. laboratory 
and/or radiology reports, clinical notes, discharge summaries). The following are the categories 
considered for a serious adverse event and must be reported to the IRB during the continuing 
review process: 
• Serious, unexpected, not related 
• 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 participants eligible for the study 
• e.g. Death not due to study participation 
• Serious, expected, related 
• 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 
• Serious, expected, not related 
 
Study patients who experience an SAE will be followed until resolution of the event and a final 
report will be submitted to the safety monitor and IRB. Please note that SAE’s and RNI’s may 
overlap and a single event may be classified under both conditions. 
 
 
DATA ANALYSIS 
 
Our primary hypothesis is that the operative treatment group will have lower VAS pain scores 
compared to the non-operative treatment group both during their hospital stay and in the short- 
term outpatient follow-up. 
 
Based on the results of a pilot study, we expect pain scores in the non-operative group to have a 
mean of 5.7 and a standard deviation of 2.3. Assuming a 20% reduction in pain scores, 130 
patients (65 per arm) are required to have an 80% chance of detecting, as significant at the 5% 
level, a decrease in the primary outcome measure from 5.7 in the control group to 4.56 in the 
experimental group. This is our primary outcome and the study will be powered for this variable. 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 17 of 24 
 
Primary data analysis will involve direct comparison of the change in value of the reported pain 
scores at the time points listed below. We will be powered to detect a 20% reduction in pain. 
Secondary analysis will compare the value of narcotics administered at the distinct time periods. 
Tertiary analysis will be comparing the time (in days) to mobilization with physical therapy. The 
previous retrospective pilot study incorporated a propensity factor, generated from well 
documented sources of pain. As this is a prospectively randomized trial, we do not anticipate 
needing to accommodate for matching. 
 
 
RANDOMIZATION 
 
Eligible patients will be randomized in equal proportions to one of the two treatment groups: 1) 
operative treatment of the lateral compression type fracture, 2) non-operative treatment of the 
lateral compression type fracture. Allocation will be concealed using a centralized 24-hour 
computerized randomization system, www.randomize.net, that will allow Internet based 
allocation. The treatment allocation will be stratified on the following prognostic factors to 
ensure balance between the intervention groups: 1) patient intubation status at time of 
enrollment, 2) patient prescription pain medication usage during the month prior to injury. 
 
 
DATA MANAGEMENT 
 
Data will be collected in real time by the study site investigator, research coordinator, or research 
team member, directly on paper Administrative Forms (AFs) or Case Report Forms (CRFs) 
which will serve as source documents for the study. The study personnel 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. All data requested on the AF or 
CRF must be completed. Source documents will be signed by the study team member that has 
reviewed the AF or CRF. An electronic data capture system, REDCap, will be used to submit 
data to the coordinating center located at University of Maryland, Shock Trauma. Upon receipt 
of the data, the coordinating center will make a visual check of the data and will query all 
missing data, implausible data, and inconsistencies. 
 
The REDCap data entry screens will be similar to the paper AFs and CRFs. Data integrity will 
be enhanced by using the electronic data capture system through a variety of mechanisms for 
checking data at the time of entry including referential data rules, valid values, range checks, and 
consistency checks against data already stored in the database. Clinical site personnel will be 
able to view and modify data for participants recruited from their clinical site only. Each time 
data is submitted or modified, it will be validated by the coordinating center. 
 
All AFs and CRFs must be kept secure in locked cabinets or other enclosures that are accessible 
only to study personnel. All electronic data must be password-protected and accessible only to 
study personnel. The coordinating center will be responsible for backing up all electronically 
submitted data. Hard copy documents containing subject data and patient identifiers (and contact 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 18 of 24 
 
information) will be stored in secure document containers (file cabinets, lockers, drawers, etc.) in 
accordance with standard document management practices. Paper forms and the files containing 
personally identifiable data at each site will be destroyed within 5 years of study completion. 
 
Quality control quality assurance procedures will be in place for the duration of the study. 
Ongoing data edits and internal audits will be performed to ensure collection of quality data. The 
continuous and timely flow of data from the AFs and CRFs to the REDCap electronic data 
capture system is an essential prerequisite for maintaining data quality. 
 
Monthly performance reports will be completed by the coordinating center research coordinator 
summarizing among other things: recruitment, status of follow up, data completion, and 
timelines of data entry. 
 
Missing data queries will be reported on the monthly basis by the research coordinator. The 
research team will be asked to answer these queries as soon as possible. Any unresolved queries 
will continue to be reported on the monthly basis. 
 
 
MISSING DATA 
 
As with most prospective studies, missing data will be unavoidable, even with excellent follow 
up. Since the informative nature of missing data cannot be verified from the observed data, we 
will adopt a sensitivity analysis framework for reporting results. We will analyze data under a 
variety of modeling assumptions regarding how strongly the missingness mechanism is related to 
outcomes. Regarding study conduct, we will: 
1. Limit participant burden and inconvenience in data collection 
2. Select high quality research team members 
3. Monitor and report missing data rates during the study 
4. Emphasize the importance of full participation in the study during the consent process 
5. Collect information on the reasons for missing data 
6. Actively engage participants in the study and educate them about the importance of their 
engagement 
7. Collect surrogate information on participants who miss clinic visits 
8. Hold regular meetings to discuss strategies for enrollment and engagement of 
participation 
 
While these efforts will help to minimize missing data, we recognize that missing data is 
inevitable. 
 
 
RESEARCH ETHICS APPROVAL 
 
This protocol, the consent form template, the AFs, and the CRFs have been reviewed and 
approved by University of Maryland Institutional Review Board (IRB). The protocol, clinical 
site-specific informed consent forms, and any participant recruitment material will need to be 
reviewed and approved by each clinical site’s local ethics board. Prior to commencement of the 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 19 of 24 
 
study the clinical site must provide the coordinating center with a copy of the ethics board 
approval. 
 
 
INFORMED CONSENT 
 
Both a Randomized Control Trial (RCT) consent and Observational (OBS) consent has been 
prepared for the Pelvis RCT study and is attached in Appendix C. The consent form describes 
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. 
 
Eligible patients will be approached for their consent to participate. Informed consent will be 
obtained prior to treatment group assignment. 
 
To encourage a high level of participation from eligible patients, the attending surgeon will be 
involved in the consent conversation. The conversation will be initiated by the research 
coordinator or research team member and the surgeon together. Patients and their families will 
be informed of the risks and benefits of participation and what will be expected of them if they 
choose to participate. Consent will be obtained in accordance with principles of GCP and ICH 
guidelines. 
 
The study should be presented as a randomized control trial upon initial consent conversation. If 
the patient or LAR declines to participate after full understanding of the trial, only then should 
the observational arm be presented. 
 
Whenever possible, the patient him or herself (as opposed to a proxy) should be consented. Prior 
to initiating the consent process, a research team member will determine if the patient has the 
ability to understand the relevant study information and communicate and maintain a choice. If 
it is determined that the patient lacks the capacity to consent, the legally authorized 
representative (LAR) will be contacted. 
 
The research staff will endeavor to answer all questions posed by the participant and his/her 
family to ensure their understanding of the protocol. A limited number of questions will be asked 
of all patients after they are introduced to the study and have reviewed the consent form. These 
questions assess the person’s understanding of the study and what it means to participate, their 
appreciation of the consequences of participation, and their ability to consider alternatives to 
participation. A formal comprehension test may be utilized, or comprehension will be assessed 
by the person(s) obtaining the consent. A template for a comprehension test is provided in 
Appendix D. 
 
The research team member will ask the questions and determine the appropriateness of the 
responses. If the research team member is at all unsure about the patient’s ability to consent s/he 
will consult with the PI. 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 20 of 24 
 
A legally authorized representative (LAR) with reasonable knowledge of the potential participant 
will be approached to consent on the patient’s behalf if one of the following is true: 
• The patient is unresponsive or intubated (and likely to remain unresponsive or 
intubated before surgery or 96 hours post-injury) 
• The patient cannot adequately answer the questions and it is determined that the 
patient’s level of cognition is not likely to change before surgery or 96 hours post- 
injury 
 
The choice of LAR will follow standard procedures. In order of priority the following will be 
approached: 
• Health care agent (identified under a written advance directive) 
• Court appointed guardian 
• Spouse 
• Adult child 
• Parent 
• Adult brother or sister 
• Close friend or other relative 
 
Guidance will be provided to assist the LAR in making the consent decision. They will be 
advised to base the decision on the patient’s expressed wishes, or, if these are not known, what 
they believe the patient would have desired under the circumstances of the injury, his or her 
beliefs and values. If the LAR does not know what the patient would have wanted, the LAR will 
be advised to base the decision with the patient’s best interest in mind. They will be asked to 
carefully consider how much leeway the patient would likely give the LAR in making the choice 
about participation in the study. When the participant regains capacity to consent during the 
study period, the participant will be re-consented using standard consenting procedures described 
above. 
 
Recognizing that consent is an ongoing process, the study team will encourage the participants to 
ask additional questions that may arise during the course of their participation in the study. 
 
 
VULNERABLE POPULATIONS 
 
The study will not include children, pregnant women, or prisoners. 
 
 
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. 
 
Participants will be identified only by an identification code but not by their name, SSN, or 
hospital medical record number. The Research Coordinator will maintain a separate confidential 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 21 of 24 
 
enrollment log which matches identifying codes with patient names and addresses available only 
to research staff. 
 
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 IRB or Safety Monitor. Consent procedures and forms, and the 
communication, transmission and storage of patient data will comply with the IRB and 
requirements for compliance with the Health Insurance Portability and Accountability Act 
(HIPAA). 
 
 
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. 
 
 
REPORTS 
 
The site research coordinator will respond to all site queries and progress reports monthly to 
ensure quality data collection and address missing data or visits at regular intervals. 
 
 
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, paper forms will be shredded and the file containing personally identifiable data will be 
permanently deleted from local site computers. 
 
 
SUPPORTING LITERATURE 
 
Young JW, Burgess AR, Brumback RJ, Poka A. Lateral compression fractures of the pelvis: the 
importance of plain radiographs in the diagnosis and surgical management. Skeletal Radiol. 
1986;15:103–109. 
 
Manson T, O’Toole RV, Whitney A, Duggan B, Sciadini M, Nascone J.Young-Burgess 
classification of pelvic ring fractures. Does it predict mortality, transfusion requirements, and 
non-orthopaedic injuries?J Orthop Trauma. 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 22 of 24 
 
Burgess AR, Eastridge BJ, Young JW, Ellison TS, Ellison PS Jr, Poka A, Bathon GH, Brumback 
RJ. Pelvic ring disruptions: effective classification system and treatment protocols. J Trauma 
1990;30:848–856. 
 
Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta 
Orthop. 2005;76:667–678. 
 
Oransky M, Tortora M. Nonunions and malunions after pelvic fractures: why they occur and 
what can be done? Injury. 2007;38: 489–496 
 
Routt ML Jr, Kregor PJ, Simonian PT, Mayo KA. Early results of percutaneous iliosacral screws 
placed with the patient in the supine position. J Orthop Trauma. 1995;9:207–214. 
 
Bruce B, Reilly M, Sims S. Predicting future displacement on nonoperatively managed lateral 
compression sacral fractures: Can it be done? JOT 2011; 25(9):523-528. 
Sagi HC, Coniglinoe FM, Stanford JH. Examination under anesthetic for occult pelvic ring 
instability. JOT 2011;25:529-537. 
 
Gaski G, Manson T, Castillo R, Slobogean G, O’Toole R. Nonoperative treatment of lateral 
compression type 1 pelvic ring injuries with complete sacral fracture. JOT5407R1. 
 
Kanakaris NK, Angoules AG, Nikolaou VS, Kontakis G, Giannoudis PV. Treatment and 
outcomes of pelvic malunion and nonunions. CORR 2009;467:2112-2124. 
 
Khoury A, Kreder H, Skrinskas T, et al. Lateral compression fracture of the pelvis represents a 
heterogeneous group of complex 3D patterns of displacement. Injury. 2008;39:893–902. 
 
Barei D, Shafer B, Beingessner D, Gardner M, Nork S, Routt C. The impact of open reduction 
internal fixation on acute pain management in unstable pelvic ring injuries. J Trauma 
2010;68(4):949-953. 
 
Tosounidis T, Kanakaris N, Nikolaou V, Ta B, Giannoudis P. Assessment of lateral compression 
type I pelvic ring injuries by intraoperative manipulation: which fracture pattern is unstable? 
International Orthopedics 2012;36:2553-2558. 
 
Castillo R, Mackenzie E, Wegener S, Bosse M, The LEAP study group. Prevalence of chronic 
pain seven years following limb threatening lower extremity trauma. Pain 2006;124:321-329. 
 
Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring 
instability. JOT 2011; 25(9) 529-536. 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 23 of 24 
 
APPENDIX A: STUDY CONTACT ROSTER 
 
Principal Investigator 
Robert O’Toole, MD 
Phone: (410) 328-2981 
E mail: rotoole@umoa.umm.edu 
Safety Monitor 
Andrew Pollak, MD 
Phone: (410) 328-1421 
Email: apollak@umoa.umn.edu 
Research Coordinator 
Andrea Howe 
Phone: (410) 706-6823 
Email: ahowe@umoa.umn.edu 
 
 
 
APPENDIX B: DATA COLLECTION SCHEDULE 
 
 
Assessment 
Screen 
/    
Enroll 
Pre- 
Rand. 
Base 
Post- 
Rand. 
Base 
96- 
hour 
2 
week 
6 
week 
3 
month 
1 year 
Pelvic x-rays 
X 
Informed Consent 
X 
HIPAA 
X 
Stratification Levels (AF03) 
Intubation Status (at time of consent) 
X 
Prescription Pain Medication Usage 
(during month prior to pelvic injury) 
X 
Patient Intake (CRF01) 
Demographics (age, gender, 
race/ethnicity, education) 
X 
Smoking History 
X 
Previous Injuries 
X 
Pre-injury Pain Medication Usage 
X 
Pre-injury Work Status (WPAI:SHP) 
X 
Pre-Injury Health Status (VR-12) 
X 
Pre-Injury Pelvic Function (Majeed 
Pelvic) 
X 
Index Hospitalization - Clinical 
Intake (CRF02) 
Length of Stay & Discharge Disposition 
X 

Pelvis RCT Protocol v4 (2016.06.01) 
Page 24 of 24 
 
 
Assessment 
Screen 
/    
Enroll 
Pre- 
Rand. 
Base 
Post- 
Rand. 
Base 
96- 
hour 
2 
week 
6 
week 
3 
month 
1 year 
ICU Length of Stay 
X 
Date/Time & Mechanism of Injury 
X 
Height & Weight 
X 
Medical History 
X 
Time to Mobilization (Bed to Chair) 
X 
Narcotic Use 
X 
OR Trip(s) Identification 
X 
Classification of All Injuries 
X 
Study Injury Characteristics 
X 
Study Treatment Characteristics 
X 
Patient Follow-Up (CRF03 & CRF04) 
Brief Pain Inventory (BPI) 
X 
X 
X 
X 
X 
Re-hospitalizations or Surgeries 
X 
X 
X 
X 
Physical Therapy Tracking 
X 
X 
X 
X 
Post-Injury Pain Medication Usage 
X 
X 
X 
X 
Post-Injury Work Status (WPAI: SHP) 
X 
X 
X 
X 
Post-Injury Health Status (VR-12) 
X 
X 
X 
X 
Post-Injury Pelvic Function (Majeed 
Pelvic) 
X 
X 
X 
X 
Clinical Follow-Up (CRF05) 
Ambulation & Weight Bearing Status 
X 
X 
X 
X 
Pain Medication Usage 
X 
X 
X 
X 
Fracture Healing Status 
X 
X 
X 
X 
Complications (type, severity, 
treatment) 
X 
X 
X 
X 
 
 
APPENDIX C: CONSENT TEMPLATES 
 
See attachment. 
 
 
APPENDIX D: AFs and CRFs 
 
See attachment.