Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis
Phase: NA
Conditions: Foot and Ankle Surgery
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

 
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PROTOCOL COVER SHEET 
 
 
Immediate Weight-bearing Verses Non-Weight-bearing after Foot & Ankle Surgery: A 
Prospective Analysis 
 
04/29/2019 
 
 
 
 
 
PRINCIPAL INVESTIGATOR 
RYAN L. MCMILLEN, DPM, FACFAS  
 
CO-INVESTIGATORS 
CHRISTOPHER J. BETRUS, DPM 
ALAN R. CATANZARITI, DPM, FACFAS 
THE FOOT & ANKLE INSTITUTE 
STEEL VALLEY ORTHOPAEDIC AND SPORTS MEDICINE 
1200 BROOKS LANE, SUITE 240 
CLAIRTON, PA. 15025 
PHONE: 412-469-1660 
 
Email: Kathryn.duffill@ahn.org 
 

 
  
 
 
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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
 
NWB 
WB 
 
 
Non-weight-bearing 
Weight-bearing 
AE 
 
Adverse event 
SAE 
 
Serious adverse event 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ABSTRACT 
In recent years, significant attention has been placed on the safety and efficacy of 
immediate weight-bearing following foot and ankle surgery. Returning patients to their 
previous activities as quickly as possible following surgery is always in the mind of 
providers, but the question of when has been difficult to answer.  
 
Objectives:  
The primary objective is to assess if immediate weight-bearing following foot and ankle 
surgery will yield equivalent, if not superior outcomes to the traditional non-weight-
bearing post-operative course, while avoiding the undesirable effects commonly 
experienced during extended periods of non-weight-bearing.  This will be determined by 
serial radiographs and/or other appropriate imaging modalities, physical exams and using 
patient self-reported pre- and post-operative SF-36 and AOFAS questionnaires.  
 
Study Design:  
Prospective, randomized controlled trial. 
 
Setting/Participants:  
Patients will be consented from 5 sites West Penn Hospital, Jefferson Regional Hospital, 
Forbes Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery Center and 
the level of care will include both inpatient and outpatient. 
The subjects will be identified/recruited during clinic hours as patients requiring an elective 
or traumatic foot and ankle surgery.  During the clinic hours the primary investigator 
and/or the co-investigator will obtain full consent from the patient. We will recruit a 
minimum of 115 participants into each of two study arms, an immediate weight-bearing 
arm and a non-weight-bearing arm, so 230 participants will be included. Patients will be 
eligible if they are undergoing elective or traumatic foot and ankle surgery. Exclusion 
criteria will include any patient less than 18 years of age & over 89, history of foot or ankle 
surgery on the surgical limb, any degree of diagnosed peripheral neuropathy or peripheral 
vascular disease, infection, and/or unwillingness to participate at random in one of the two 
study arms. 
 
Study Interventions and Measures:  
We will be assessing the difference in two groups; immediate protected weight-bearing in 
a CAM walking boot vs strict non-weight-bearing for 6 weeks following foot and ankle 
surgery. Monitoring will be done by way of clinical follow-up, serial radiographs and/or 
other appropriate imaging modalities, and patient reported outcomes by way of AOFAS 
and SF-36 surveys.   
Surgical procedures performed on patients included in the study will vary, as will the 
outcome measures for each procedure. Osseous fusions, including both elective joint 
fusions and bone healing following trauma, will be assessed by both clinical and 
radiographic evaluation. Soft tissue procedures, including elective stabilization and 
traumatic soft tissue repairs, will be assessed clinically and with imaging modalities 

 
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deemed appropriate. Complications during the perioperative and post-operative periods, 
such as non-union, infection, etc. will be included in the outcomes. All participants will also 
complete AOFAS and SF-36 surveys in the pre-operative and post-operative periods. We 
will also include return to work, activity, sport, etc. where appropriate.  
 
 
Table 1: Schedule of Study Procedures 
 
 
 
 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 
Introduction 
There is an ongoing debate within the surgical community as to whether it is best to keep 
patients who have undergone foot and ankle surgery non-weight-bearing (NWB) for an 
extended period of time versus allowing them to bear weight early, or on occasion, 
immediately. The standard for many foot and ankle procedures involving fusion of bone 
and repair of ligaments and tendons has been to keep the patient completely NWB for 6-8 
weeks, or the approximate time it takes for bone and tendon to heal, on average. This 
standard has been challenged in recent years, with more surgeons allowing their patients 
to bear weight earlier than previously considered safe. Our aim is to assess if immediate 
weightbearing following any foot and ankle procedure is equally as safe and effective as an 
extended course of NWB in patients meeting our inclusion criteria.   
 
Study Phase 
Screening 
Surgery 
Post-op   
2-3 w 
Post-op   
6-8 w 
Post-op  
3 m 
Post-op  
6 m 
Post-op   
1 yr 
Post-op 
2 yr 
Unscheduled 
Visits 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
 
  
  
  
  
  
  
  
  
  
Informed 
Consent/Assent 
x 
  
  
  
  
  
  
  
 
Review 
Inclusion/Exclusion 
Criteria 
x 
  
  
  
  
  
  
  
 
Randomization 
x 
 
 
 
 
 
 
 
 
Demographics/PMH 
x 
  
  
  
  
  
  
  
 
Physical Examination 
x 
  
x 
x 
x 
x 
x 
x 
x 
Adverse Event 
Assessment 
  
  
x 
x 
x 
x 
x 
x 
x 
Radiographs/Imagining 
x 
  
x 
x 
x 
x 
x 
x 
x 
Complete AOFAS/SF-
36 survey 
x 
  
  
x 
x 
  
x 
x 
 

 
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1.2 
Relevant Literature and Data 
The available literature has included a number of different procedures where 
immediate or early weight-bearing has been allowed. In regards to 1st metatarsal-
phalangeal joint fusions, Dayton and McCall reported immediate weight-bearing 
postoperatively in 42 patients with 47 fusions fixated with 2 crossed screws (n=30), 1 screw 
and 1 k-wire (n=12), and 2 or more k-wires (n=5). Postoperative evaluation was performed 
at weeks 1, 2, 4, 6, 9, and 12.  The overall union rate was 100%, with an average return to 
athletic shoes at 6.24 weeks. (1) Mah and Banks described a fixation method a 3 crossing k-
wires with immediate weight-bearing in a modified post-op shoe with hallux cutout to 
restrict loading of the hallux. Twenty-two consecutive cases in 20 patients were 
retrospectively reviewed. Standard AP and lateral radiographs were used to monitor bone 
healing, with the pins being removed at 6 weeks and the post-op shoe employed for 8 
weeks. Solid fusion was observed in 19 patients (86.36%) between 6-8 weeks 
postoperative. Two feet (9.1%) had nonunion and 1 foot (4.55%) had a delayed union. (2) 
 
There is also extensive evidence that midfoot fusions such as the Lapidus procedure have 
had good results following immediate or early weight-bearing. Blitz et al. were able to 
challenge the traditional postoperative non-weight-bearing period by using a 2 or 3 crossed 
screw fixation technique and allowing the patient to protected weight bear after 
approximately two weeks. Using both a curettage joint prep technique by one surgeon and 
planar resection by another surgeon, the joints were prepped to bleeding bone and then 
fixated with two crossing screws using lag technique. A third screw was used across the 1st 
and 2nd cuneiforms depending on surgeon judgment for adequate fixation. The results of 
these procedures were reviewed retrospectively. Of the 80 feet in which the results were 
reviewed, protected weight-bearing began at a mean of 14.8 days postop, with 100% going 
on to successful union at a mean time of 44.5 days. (3)  Basile et al. investigated the 
outcomes of patients undergoing Lapidus who were allowed immediate weight-bearing in 
a removable boot with those made non-weight-bearing in a short leg cast for 6 weeks. 
They assessed first intermetatarsal angle and first ray elevation measurement 
radiographically immediately postoperative and then at the 6-month postoperative visit. In 
a total of 41 feet, there were no significant radiographic changes between the two groups 
in regards to radiographic evaluation and no non-unions or mal-unions were observed in 
either group. (4)  Using a plantar oriented plate for Lapidus fixation, Gutteck et al. analyzed 
results between restricted weight-bearing with floor contact (NWB) and immediate full 
weight-bearing (FWB), both in short arthrodesis shoes. They reviewed 17 cases in each 
group and found there was no statistically significant difference in radiographic results, 
AOFAS scores or visual analog scale scores. They did, however, show there was a significant 
difference in time to return to work, as the FWB group was fit to return to work at a mean 
of 30.8 days postoperatively, while the NWB group averaged 57 days. (5)  
There is also substantial evidence early or immediate weight-bearing is an alternative 
following trauma. Maffulli et al. performed a comparative longitudinal study placing 
patients undergoing open repair of midsubstance Achilles tendon tears into two groups, an 

 
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early weight-bearing and ankle mobilization group versus an immobilization group. The 
immobilization group was non-weight-bearing and underwent cast changes every 2 weeks 
for 6 weeks until a plantigrade ankle position was achieved, at which point they were 
advised to bear weight. The early weight-bearing group was placed in a weight-bearing cast 
for two weeks and encouraged to bear weight as tolerated. A single cast change was 
performed at 2 weeks and an anterior splint was applied to control dorsiflexion for the next 
4 weeks. Both groups attended physiotherapy postoperatively. Results showed the early 
weight-bearing group had fewer outpatient visits, discarded their crutches after an average 
of 2.5 weeks and were more satisfied with their surgery. The non-weight-bearing group 
discarded their crutches at an average of 5.5 weeks. And while the early weight-bearing 
group attended an average of 6.1 therapy sessions over 2.1 months, the non-weight-
bearing group needed an average of 13.6 sessions over an average of 4.6 months. (6)  
Costa et al performed an additional early study looking at the difference in postoperative 
outcomes between early weight-bearing and traditional non-weight-bearing. Their 
randomized controlled trial on operatively treated patients placed patient in one of two 
groups: one which could immediately weight bear in a carbon-fiber orthosis with three 1.5 
cm heel raises (n=23), known as the treatment group, or one which was non-weight-
bearing in a traditional plaster cast postoperatively (n=25), the control group. Subjects 
were evaluated every two weeks for eight weeks; with each visit allowing both the plaster 
group and the heel raise group to progressively return to a plantigrade position from 
equinus. Results showed significant differences in time to return to walking and return to 
stair climbing, in favor of the treatment group, though no difference was observed in time 
to return to sport or work. (7)  Suchak et al. evaluated 98 patients divided into two groups, 
an early-weight-bearing group or a non-weight-bearing group. Weight-bearing status was 
validated using a pressure sensor in a fixed-hinge ankle-foot orthosis and assessment was 
performed at six weeks, three months, and six months. Using the RAND 36-Item Health 
Survey, health-related quality of life was assessed. Results were significantly better for the 
weight-bearing group in the domains of physical functioning, social functioning, role-
emotional, and vitality scores at six weeks. Patients in the weight-bearing group also 
reported fewer limitations of daily activities. No re-rupture occurred in either group. (8)  
Huang et al. performed a systematic review with Meta-analysis of the literature between 
1990-2013, and found that postoperative early weight-bearing combined with early ankle 
motion exercises achieves superior and more rapid functional recovery versus conventional 
immobilization after surgical treatment of Achilles tendon repair.  Of note, they found few 
advantages when only early ankle motion exercises were applied. (9)  Valkering and 
Aufwerber, with their colleagues, looked at the healing process of Achilles tendon ruptures 
after surgery in a novel way, when they used in vivo microdialysis to examine healing 
metabolites. In their prospective randomized (controlled trial, they divided patients into 
two groups, a post-operative functional weight-bearing mobilization group (n=27) and a 
non-weight-bearing group placed in a plaster cast (n=29). Both groups underwent direct 
repair of the Achilles tendon rupture, and were then divided into their postoperative 
groups. The weight-bearing group was allowed to be weight-bearing in a controlled 
orthosis, allowing 15-30 degrees of plantarflexion. The non-weight-bearing group went into 

 
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a plaster cast for 2 weeks, followed by a boot with traditional wedge progression until they 
reached a plantigrade orientation after 4 additional weeks. In their microdialysis analysis, 
they found that the healing tendons in both groups exhibited increased levels of 
metabolites glutamate, lactate, and pyruvate, compared to the subject’s contralateral 
tendon, but the functional weight-bearing group had a significantly higher concentration of 
glutamate compared to the non-weight-bearing cast group. This correlated to improved 
functional outcomes at 6 months, and supported their conclusion that functional weight-
bearing enhances early healing response after Achilles tendon repair. (10) 
 
In the review of the literature, two separate systemic reviews were identified, which 
support early weight-bearing after ankle fracture repair when compared to late weight-
bearing or non-weight-bearing for six weeks following surgery. These reviews found no 
significant adverse results in the early weight-bearing groups, while finding earlier return to 
previous activities and earlier return to work. (11,12).  Additionally, Assal et al. was able to 
show that, with augmented fixation, early weight-bearing in older patients (greater than 
70) with Weber B ankle fractures was a safe and satisfactory method of postoperative care. 
(13) Starkweather et al. found no malunions or nonunions, and a 9.5% complication rate in 
patients allowed to be protective weight-bearing following ankle fracture ORIF, while 
Firoozabadi et al. saw a complication rate of 8% and a loss of correction in only 1 of 26 (4%) 
patients allowed to immediately bear weight following ankle ORIF . (14, 15)  In a 
randomized control trial, Dehghan et al. divided 110 patients into an early WB group (2 
weeks) and a late WB group (6 weeks) and assessed time to return to work, SF-36 scores, 
and rates of complications. They found no difference in return to work between the two 
groups, but the early WB group showed significantly improved SF-36 scores on both 
physical and mental components. Early WB was also found to have similar wound 
complication rates, with no cases of fixation failure or loss of reduction. The late WB group 
additionally showed higher rates of hardware removal due to irritation. (19% vs 2%) (16) 
 
In regards to calcaneal fractures, it is commonly understood that three months of non-
weight-bearing has been the traditional standard of care following open reduction internal 
fixation. Both Hyer et al. and Kayali et al. performed retrospective reviews of early weight-
bearing following open reduction and internal fixation of calcaneal fractures using locking 
plate fixation, and their results were significant for no unfavorable effects of early weight-
bearing. (17, 18)  Park et al. retrospectively reviewed 86 patients with acute fifth 
metatarsal base fractures, divided into conservatively treated versus operatively treated 
and then further grouped into early weight-bearing or late. They analyzed bone resorption, 
clinical union, and AOFAS and VAS scores, with results showing no differences in AOFAS or 
VAS scores, fewer cases of bone resorption in the early weight-bearing groups and earlier 
bony unions in the early weight-bearing groups. Their conclusion was early weight-bearing 
may help this population, regardless of surgical or conservative treatment. (19)  Wagner et 
al. retrospectively reviewed 22 patients who suffered low-energy Lisfranc injuries who 
were then subsequently treated with percutaneous screw fixation and early weight-bearing 

 
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during the third postoperative week. Findings were significant for a complete satisfaction 
rate of 90.9%, an average AOFAS score of 94, and an average return to work of 7 weeks 
with return to symptom-free sport activities at 12.4 weeks. (20) 
 
1.3 
Compliance Statement 
This study will be conducted in full accordance all applicable Allegheny Health Network 
Research Policies and Procedures and all applicable Federal and state laws and regulations 
including 45 CFR 46. All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and will report unanticipated problems involving risks to subjects or others in 
accordance with The ASRI-WPAHS IRB Policies and Procedures and all federal 
requirements. Collection, recording, and reporting of data will be accurate and will ensure 
the privacy, health, and welfare of research subjects during and after the study. 
 
2 
STUDY OBJECTIVES 
The purpose of the study is to determine the safety and efficacy of immediate weight-
bearing following foot and ankle surgery compared to the traditional non-weight-bearing 
post-operative course.  
 
2.1 
Primary Objective (or Aim) 
The primary objective of this study is to determine whether immediate weight-bearing 
following foot and ankle surgery provides similar or superior results to the traditional non-
weight-bearing post-operative course, while reducing the disuse atrophy and length of 
rehabilitation necessary to recover during the transition to weight-bearing following an 
extended course of non-weight-bearing.  This will be done by way of clinical follow-up, 
serial radiographs and/or other appropriate imaging modalities, and patient reported 
outcomes by way of AOFAS and SF-36 surveys.   
 
2.2 
Secondary Objectives (or Aim) 
The secondary objectives are to: 
• Determine if there are specific procedures better suited to immediate weight-bearing. 
• Determine if patient satisfaction is higher in an immediate weight-bearing group 
compared to NWB. 
• Determine if immediate weight-bearing allows earlier return to work and/or sport. 
 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
The study will be a randomized 1:1, controlled trial, prospective in nature, where 
participants undergoing foot and ankle surgery will be randomly placed into one of two 

 
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groups; an immediate weight-bearing group or a non-weight-bearing group. The patients 
will be randomly placed into the study group and control group if they meet all eligibility 
criteria.  The first patient recruited will be assigned a unique study identifier (i.e., FAI001) 
and a coin flip will randomize the patient into either the study group (Heads) or control 
group (Tails).  From that point, all patients will be placed into their groups by alternating 
between the control group and the study group.  No bias will be placed on the subject or 
the procedure in regard to inclusion into a certain research group. Patients will be recruited 
and should they agree will be consented to the study with two year follow up results. 
 
3.2 
Study Duration, Enrollment and Number of Sites 
 
This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes 
Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville 
Surgery.  Recruitment will stop when a minimum of 230 subjects are consented. The 
duration of the study for an individual patient will be two years from the surgery date. This 
will include the pre-operative assessment, surgery, regular post-operative appointments 
and a final two year follow-up, as noted in the table in the schedule of study section. 
 
3.2.1 Duration of Study Participation 
The study duration will require 7 visits to the clinic plus a surgery day therefore will require 
a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative 
visits to the clinics.  The entire follow up period will occur over 2 years. 
 
3.2.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at 5 AHN investigative sites in the United States; West Penn 
Hospital, Jefferson Regional Hospital, Forbes Regional Hospital, Bethel Park Surgery Center, 
and Monroeville Surgery Center.  Recruitment will stop when at least 115 subjects are 
randomly included in each of the two study arms. It is expected that approximately 230 
subjects will be enrolled.  
 
3.3 
Study Population 
3.3.1 Inclusion Criteria 
1) Males or females age 18 to 89 years  
2) Undergoing foot and ankle surgery 
3) Must be able to read and understand English and consent for themselves 
 
3.3.2 Exclusion Criteria 
1) Diagnosed peripheral neuropathy 
2) Diagnosed peripheral vascular disease 
3) Documented infection to the surgical extremity  
4) Previous surgery to the surgical limb 

 
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5) Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, 
or renal disease which would predispose patients to poor healing and/or non-union 
6) Subjects who, in the opinion of the Investigator, may be non-compliant with study 
schedules or procedures. 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
 
4 
STUDY PROCEDURES 
4.1 
Screening Visit 
Below is a list of all of the procedures to be performed at each visit.  
• Informed Consent 
• Physical Exam 
• Radiographic/Advanced Imaging 
• Medical Record Review 
• Review of the medical record will include reviewing the past medical and 
surgical history, laboratory values, and most recent visits to other health care 
providers in the standard fashion of any office or inpatient encounter 
• Surgical procedure discussed and operative consent 
• Pre-operative AOFAS and SF-36 surveys completed 
 
4.2 
Surgical Visit  
4.2.1 Surgery 
• Physical Exam 
• Medical Record Review Necessary surgical procedure performed  
 
4.3 
Follow-up Phase 
Follow-up Visit 1 (2-3 weeks post-op) 
• Physical Exam 
• Radiographic/Advanced Imagining  
• Sutures removed 
• Medical Record Review  
Follow-up Visit 2 (6-8 weeks post-op) 
• Physical Exam 
• Radiographic/Advanced Imagining  
• Post-op AOFAS and SF-36 survey 
• Medical Record Review  
Follow-up Visit 3 (3 months post-op) 
• Physical Exam 
• Radiographic/Advanced Imagining 
• Post-op AOFAS and SF-36 survey  
• Medical Record Review  
Follow-up Visit 3 (6 months post-op) 

 
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• Physical Exam 
• Radiographic/Advanced Imagining  
• Medical Record Review  
Follow-up Visit 4 (12 months post-op) 
• Physical Exam 
• Radiographic/Advanced Imagining  
• Post-op AOFAS and SF-36 survey 
• Medical Record Review  
Follow-up Visit 5 (24 months post-op) 
• Physical Exam 
• Radiographic/Advanced Imagining  
• Post-op AOFAS and SF-36 survey 
• Medical Record Review  
 
 
4.4 
Unscheduled Visits 
Unscheduled visits necessary to address any post-operative complications will be included 
in the patients study record. At no time will the welfare of the patient be compromised for 
the execution of the study. If at any time it is decided that a patient should be withdrawn 
from one of the two study arms, it will be recorded in the study results.  
 
4.5 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to study treatment or visit schedules, or AEs.  The Investigator may also 
withdraw subjects who violate the study plan, or to protect the subject for reasons of 
safety or for administrative reasons.  It will be documented whether or not each subject 
completes the clinical study 
 
4.5.1 Early Termination Study Visit 
Subjects who withdraw from the study before the 12 month follow-up visit will not be 
included in the final analysis of the study. 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 
Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical Record Review 
The following will be abstracted from the medical chart: 
• Patient age 
• Past Medical history –  
• Diabetic vs non-diabetic 
• Height/Weight (BMI) 

 
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• Smoker vs past-smoker vs non-smoker.  
• Past surgical history  
• Occupation and activities 
 
5.1.2 Physical Examination 
Physical examination will include evaluation of the dermatologic neurologic, vascular, and 
musculoskeletal systems of the lower extremities. 
  
5.1.3 Radiographic/Advanced Imaging 
X-rays, CT, MRI, and/or ultrasound will be obtained, when indicated, at certain visits 
determined by the physician. These imaging modalities will evaluate bone healing, joint 
fusion, and soft tissue repair integrity.  
 
5.1.4 AOFAS and SF-36 survey 
Standardized and validated surveys to assess patient function and satisfaction.  The SF36 
has proven useful in surveys of general and specific populations, comparing relative burden 
of diseases, and in differentiating the health benefits produced by a wide range of different 
treatments.  In this study we will use the SF36 to assess patient’s perceptions of their 
health. 
  
6 
STATISTICAL CONSIDERATIONS 
The purpose of the study is to compare the results of immediate weight-bearing versus 
non-weight-bearing after foot and ankle surgery. 
It is hypothesized that immediate weight-bearing following foot and ankle surgery would 
provide better patient satisfaction with functional outcomes compared to non-weight-
bearing after foot and ankle surgery. 
 
6.1 
Primary Endpoint 
The primary outcome measures are the American Orthopaedic Foot and Ankle Society 
(AOFAS) Ankle-Hindfoot Scale score and the SF-36 Health Survey Score as it pertains to the 
patient’s ankle/foot. These assessments will be given to the patient in the pre-operative 
and post-operative periods. 
  
6.2 
Secondary Endpoints 
The secondary outcome measures are the frequency of complications during the 
perioperative and post-operative periods, osseous healing as assessed by both clinical and 
radiographic evaluation, and healing outcomes of soft tissue procedures. These results will 
be analyzed at the end of the follow-up period. 

 
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6.3 
Control of Bias and Confounding 
There will be no predilection towards race, ethnicity, sex or sexual orientation.  Individuals 
included in this study will have limited recruit/selection biased.  Because the study is 
focused on physical functionality of patients it will be isolating those patients having a 
hindfoot fusion procedure and will be recruited from the Foot & Ankle Institute at Western 
Pennsylvania Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park 
Surgery Center, and Monroeville Surgery.   
6.4 
Statistical Methods 
6.4.1 Analysis of Primary Outcome of Interest 
 
All analysis will begin with assessment of the normality of continuous variables using the 
Kolmogorov-Smirnov test. Normally distributed continuous variables will be reported as 
means and standard deviations; non-normally distributed data as median and interquartile 
range. Categorical data will be reported as counts and percentages. The Student’s t-test 
will be used to compare continuous demographic and clinical data between the immediate 
weight-bearing and non-weight-bearing groups. The chi-square test or Fisher’s exact test 
will be used to compare categorical data between groups. Cronbach’s alpha will be used to 
measure reliability, or internal consistency, of both the Medical Outcomes Study 36-Item 
Short Form Health Survey (SF-36) and the AOFAS Ankle-Hindfoot Scale survey (AOFAS). 
Spearman’s rank correlation coefficient will be used to assess the relationship between the 
physical and mental component scores and the eight subdomain scores from the SF-36 and 
the pain, function and alignment scores of the AOFAS. SF-36 scores and AOFAS scores will 
be adjusted for patient age, gender, BMI and presence of diabetes mellitus. Nonparametric 
tests will be used when data breaks the normality assumption. A value of p<.05 on two-
tailed testing will be considered statistically significant. Statistical analysis will be 
performed using IBM-SPSS Statistics, version 24.0 (IBM-SPSS Inc., Armonk, NY).  
 Using one-way repeated measures analysis of variance (ANOVA), differences over time in 
radiographic and advanced imaging parameters will be assessed separately for the 
immediate weight-bearing and non-weight-bearing groups. Two-way repeated measures 
ANOVA will be used to assess differences over time in these parameters between the two 
groups. Tukey’s test or Dunn’s procedure will be used for post-hoc pairwise comparisons, 
as indicated. 
 
Descriptive statistics on the physical and mental component scores and the eight 
subdomain scores from the SF-36 will be reported for the immediate weight-bearing and 
non-weight bearing groups. In order to examine differences in SF-36 scores within each 
group over time, a one-way repeated measures ANOVA will be conducted to determine if 
the SF-36 scores are significantly different between visits (e.g., screening, post-operative at 
6 – 8 weeks, post-operative at 12 months, and post- operative at 24 months). A two-way 
repeated measures ANOVA will be conducted to determine if the SF-36 scores are 
significantly different between the two groups for these same visits. Post-hoc pairwise 
comparisons using Tukey’s test or Dunn’s procedure will be performed, as indicated. 

 
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Descriptive statistics on the pain, function and alignment component scores from the 
AOFAS will be reported for the immediate weight-bearing and non-weight bearing groups. 
In order to examine differences in AOFAS scores within each group over time, a one-way 
repeated measures ANOVA will be conducted to determine if the AOFAS scores are 
significantly different between visits (e.g., screening, post-operative at 6 – 8 weeks, post-
operative at 12 months, and post-operative at 24 months). A two-way repeated measures 
ANOVA will be conducted to determine if the AOFAS scores are significantly different 
between the two groups for these same visits. Post-hoc pairwise comparisons using 
Tukey’s test or Dunn’s procedure will be performed, as indicated. 
 
The chi-square test will be used to examine the frequency of complications during the 
perioperative and post-operative periods, osseous healing as assessed by both clinical and 
radiographic evaluation and frequency of soft tissue procedures between the immediate 
weight-bearing and non-weight bearing groups.  
 
Logistic regression analysis will be performed to assess which patient characteristics and 
surgical characteristics are associated with higher SF-36 scores and AOFAS scores.  
 
Due to the potential small sample sizes associated with the various orthopaedic procedures 
included in this study, the primary analysis will focus on the comparison of the immediate 
weight-bearing and non-weight bearing groups. Any analyses associated with an individual 
orthopaedic procedure will be considered exploratory. Finally, the data will not be adjusted 
for the center where the procedure was performed. 
 
6.5 
Sample Size and Power 
The study power calculation is based on the primary endpoints. 
Assuming the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale 
score and the SF-36 Health Survey Score (as it pertains to the patient’s foot/ankle) are 
normally distributed in the immediate weight-bearing and non-weight-bearing groups and 
using an independent-samples t-test with a .05 two-sided significance level, and (absent 
any prior study results) assuming a “medium” effect size of Cohen’s d = 0.40, 200 evaluable 
patients (100 patients in each group) would give you a power of 80% to detect a true 
difference in means on the questionnaires, if present. Fifteen patients will be added to 
each group for the potential of loss to follow-up. Final sample size is 230 patients (115 
patients in each group). Sample size was calculated using an a-priori sample size calculator 
for Student t-tests (2017) available from http://www.danielsoper.com.  
1 “Effect size” is a statistical expression of the magnitude of the difference between two 
groups (Portney and Watkins, 2000). The standardized mean effect, one type of effect size, 
expresses the mean difference between two groups in standard deviation units. This is 

 
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typically reported as Cohen’s “d.”  Interpretation of effect size depends on the research 
question.  Cohen (1988) defines his effect sizes as: 8 = large (8/10 of a standard deviation 
unit) .5 = moderate (1/2 of a standard deviation) .2 = small (1/5 of a standard deviation). I 
would recommend using the “medium” effect size for your project. A medium effect size 
can range from 0.3 to 0.5. 
SAFETY MANAGEMENT 
6.6 
Clinical Adverse Events 
During the course of this study the team will follow the protocol laid out in the IRB.  If for 
any reason the protocol needs changed, appropriate modifications will be submitted to the 
IRB for permission/approval. Compliance meetings will occur annually to assure that data 
and confidentiality are being maintained. Clinical adverse events (AEs) will be monitored 
throughout the study.  
 
6.7 
Adverse Event Reporting 
All on-site SAEs (AHN or related sites) will be reported to the IRB in accordance with IRB 
policies. AEs that are not serious will be summarized in narrative or other format and 
submitted to the IRB at the time of continuing review. 
 
6.8 
Definition of an Adverse Event 
An adverse event is any untoward medical occurrence in a subject who has received an 
intervention (drug, biologic, or other intervention).  The occurrence does not necessarily 
have to have a causal relationship with the treatment.  An AE can therefore be any 
unfavorable or unintended sign (including an abnormal laboratory finding, for example), 
symptom, or disease temporally associated with the use of a medicinal product, whether 
or not considered related to the medicinal product. 
All AEs (including serious AEs) will be noted in the study records and on the case report 
form with a full description including the nature, date and time of onset, determination of 
non-serious versus serious, intensity (mild, moderate, severe), duration, causality, and 
outcome of the event. 
The risks associated with the study arm, which is immediate weightbearing following foot 
and ankle surgery include the potential for the following: 
• 
Excessive Pain with weightbearing on the surgical extremity 
• 
Potential wound complications associated with surgical incision sites 
• 
Possible hardware failure 
• 
Possible non-union, mal-union, or delayed union during osseous healing 
• 
Possible non-healing or delayed healing of soft tissue structures 
 
6.9 
Definition of a Serious Adverse Event (SAE) 
An SAE is any adverse drug experience occurring at any dose that results in any of the 
following outcomes:  
• Death, 

 
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• A life-threatening event (at risk of death at the time of the event),  
• Requires inpatient hospitalization or prolongation of existing hospitalization, a 
persistent or significant disability/incapacity, or a congenital anomaly/birth defect in 
the offspring. 
 
6.9.1 Relationship of SAE to study drug or other intervention 
The relationship of each SAE to the study intervention should be characterized using one of 
the following terms in accordance with ASRI-WPAHS IRB Guidelines: definitely, probably, 
possibly, unlikely or unrelated.  
 
6.10 IRB/IEC Notification of SAEs and Other Unanticipated Problems 
The Investigator will promptly notify the IRB of all on-site unanticipated, serious Adverse 
Events that are related to the research activity. Other unanticipated problems related to 
the research involving risk to subjects or others will also be reported promptly. Written 
reports will be filed using the IRB system and in accordance with the IRB SOP#11. External 
SAEs that are both unexpected and related to the study intervention will be reported 
promptly after the investigator receives the report.  
 
6.10.1 Follow-up report 
If an SAE has not resolved at the time of the initial report and new information arises that 
changes the investigator’s assessment of the event, a follow-up report including all 
relevant new or reassessed information (e.g., concomitant medication, medical history) 
should be submitted to the IRB. The investigator is responsible for ensuring that all SAE are 
followed until either resolved or stable.  
 
 
7 
STUDY ADMINISTRATION 
7.1 
Data Collection and Management 
Data Sources 
 
7.1.1 Initial recruitment of study participants will be at the discretion of the participating 
surgeons, as they will be involved in the decision to proceed with surgery, along 
with the patient.  
7.1.2 Study participation will in no way affect the surgical decision making of the surgical 
provider. Once the patient has agreed/consented to participate in the study, the 
Epic Electronic Medical Record System will be used to record variables such as 
physical examination, imaging, surgery type, etc. The office visits and operative 
reports will be used to record the surgeon’s observations and interventions.  
7.1.3 Paper versions of the AOFAS and SF-36 surveys will be uploaded into the patient 
charts in Epic on password protected AHN computers. The paper version of these 

 
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forms will be kept in a locked file cabinet which is locked in the research 
coordinators office.  
7.1.4 A backup of the data will also be stored on a pass key protected external hard-drive 
provided by the West Penn Hospital Foot and Ankle Residency Program.  
7.1.5 All subjects in each arm of the study will be given a unique study number, linking 
them to the patient MRN number in the Epic system.  
7.1.6 All data will be retained and destroyed after publication in accordance with 
institutional policy, SOP 072, IRB Record Retention, which is 10 years. 
 
7.2 
Confidentiality 
All data and records generated during this study will be kept confidential in accordance 
with Institutional policies and HIPAA on subject privacy and that the Investigator and other 
site personnel will not use such data and records for any purpose other than conducting 
the study.  
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between provider (the PI) and any recipient 
researchers (including others at AHN) before sharing a limited dataset (dates and zip 
codes). No personal subject identifiers will be used in any presentation or publication. 
All data and records generated during this study will be kept confidential in accordance 
with Institutional policies and HIPAA on password protected institutional computers only 
accessed by the research team. The investigators and other site personnel will not use such 
data and records for any purpose other than conducting this study. All participants will be 
given random unique study identification numbers corresponding, but not matching, their 
MRN in the Epic system.  The study team will have access to the subject’s medical records 
until the records can be transferred to data sheets containing the appropriate patient study 
identification number.   
The data will be destroyed 10 years after publication in accordance with SOP072.  Any 
breaches in confidentiality or other problems will be identified by the study team and 
reported to the IRB.  
 
7.3 
 Regulatory and Ethical Considerations 
7.3.1 Data and Safety Monitoring Plan 
The principal Investigator (P.I.) will be responsible for the ongoing data safety monitoring 
and oversight for the study sites.  Study progress will be reviewed and submitted to the 
Institutional Review Board (IRB) annually. 
 
The study would be discontinued if there is clear evidence that subjects in the early weight 
bearing study arm are encountering higher rates of complications compared to the control 
arm, non-weight bearing (NWB).  This would be determined by an outside statistician 
(Diane Thompson, LLC) that will review the data and adverse events after the first 10 

 
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patients have been enrolled in each study arm. Complications would include evidence of 
higher than expected non-unions, mal-union, uncontrolled pain, or wound complications, 
as evaluated for which specific surgical procedures were performed, any potential risk 
factors the patient carried, and patient compliance within the study protocol, and then 
treated appropriately for their risk of altered or inferior post-operative care. 
7.3.2 Risk Assessment 
7.3.2.1 There is a potential risk for loss of confidentiality in this study which will be 
minimalized by only the research team accessing the research data and the PHI. 
7.3.2.2 Unique patient study specific identifiers will be used during data collection.  
7.3.2.3 All data forms will be maintained in a locked cabinet in the research coordinator’s 
office. 
7.3.2.4 No PHI will be transferred, shared or stored on personal computers. 
7.3.2.5 Risk of exposure for X-rays; but the dose involved in general x-rays is minimal. 
7.3.2.6  There are no increased risks associated with the control arm of the study, which is 
a traditional non-weight-bearing period of 6 weeks following foot and ankle 
surgery. The risks associated with the study arm, which is immediate 
weightbearing following foot and ankle surgery, include potential pain with 
weightbearing on the surgical extremity; potential wound complications 
associated with the surgical incision sites; possible hardware failure; possible non-
union, mal-union, or delayed union during osseous healing; and/or possible non-
healing or delayed healing of soft tissue structures. 
7.3.2.7   Currently, the post-operative course following foot and ankle surgery is subjective, 
based on the previous experiences of the surgeon performing the surgery. We do 
not believe that there is any additional risk associated with the control arm of the 
study, which is to maintain non-weightbearing for 6 weeks following foot and 
ankle surgery. All of the potential risks, including pain, non-union, non-healing, 
infection, wound complications, and others are possible regardless of the post-
operative course. Additionally, we believe that the risks associated with 
immediate weightbearing following foot and ankle surgery are minimal, as there 
is ample evidence of previous success with immediate weightbearing following 
certain procedures.  
7.3.2.8 We will minimize the risk of harm by close follow-up during the post-operative 
course, utilizing appropriate protective devices during weightbearing following 
foot and ankle surgery, and thoroughly educating our participants on the warning 
signs of potential complications, regardless of the study group into which the 
participant falls. 
 
 

 
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7.3.3 Potential Benefits of Study Participation 
The potential benefits of study participation, namely for those participant randomly placed 
in the immediate weightbearing group of the study, would be those similar to benefits 
found in previous immediate or early weightbearing studies performed and mentioned in 
the literature review. These potential benefits would include: 
 
1. The ability to bear weight on the surgical extremity in a protective boot.  
2. Reduced  muscle atrophy of the surgical extremity 
3. Reduced stress on the non-surgical extremity 
4. Reduced necessity of rehabilitation following healing of the surgical extremity 
5. Increased quality of life during healing following foot and/or ankle surgery 
6. Earlier return to work following foot and/or ankle surgery  
7.3.4 Risk-Benefit Assessment 
The risks of immediate weightbearing following foot and ankle surgery are not unlike the 
risks faced with a traditional post-operative course of non-weightbearing. While there may 
be a minimal increase in risk for complications in the study group, given the potential 
increase of stress on the fixation constructs, potential tension to the surgical incision, and 
potential pain associated with weightbearing immediately after surgery, we believe that 
the benefits outweigh the risks. Increasing quality of life during the post-operative period, 
while decreasing debility and returning patients to their pre-injury or pre-surgical state 
sooner than previously expected is a substantial benefit. 
 
7.4 
Recruitment Strategy 
Patient recruitment will be generated from the clinic sites listed in section 3.2 of the 
protocol.  Initial recruitment of study participants will be at the discretion of the 
participating surgeons, as they will be involved in the decision to proceed with surgery, 
along with the patient. Study participation will in no way affect the surgical decision making 
of the surgical provider. Informed Consent/Assent and HIPAA Authorization 
  
7.5 
Payment to Subjects/Families 
Subjects will not be paid for participation in the study.  All treatments, exams, radiographs 
and visits are considered standard of care with the exception of the questionnaires which 
will be distributed at five of their visits. 
 
7.5.1 Reimbursement for travel, parking and meals 
Discounted parking will be provided to those subjects/patients that come to the West Penn 
Hospital clinical site.  All other sites provide free parking. 
 

 
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8 
PUBLICATION 
Principal Investigator and Co-Investigators are part of the AHN and will have complete 
access to all data for the purpose of publication at study completion.  No other outside 
entities are involved in this research study. 
 
9 
REFERENCES 
References: 
 
1. Dayton P, McCall A. Early Weightbearing After First Metatarsophalangeal Joint 
Arthrodesis: A Retrospective Observational Case Analysis. J Foot Ankle Surg. 43(3): 
156-159, 2004. 
2. Mah CD, Banks AS. Immediate Weightbearing Following First Metatarsophalangeal 
Joint Fusion with Kirschner Wire Fixation. J Foot Ankle Surg. 48(1): 3-8, 2009. 
3. Blitz NM, et al. Early Weight Bearing After Modified Lapidus Arthrodesis: A 
Multicenter Review of 80 Cases. J Foot Ankle Surg. 49: 357-362, 2010. 
4. Basile P et al. Immediate Weight Bearing Following Modified Lapidus Arthrodesis. J 
Foot Ankle Surg. 49: 459-464, 2010. 
5. Gutteck N et al. Immediate full weightbearing after tarsometatarsal arthrodesis for 
hallux valgus correction-Does it increase the complication rate? Foot Ankle Surg. 21: 
198-201, 2015. 
6. Maffulli N et al. Early Weightbearing and Ankle Mobilization after Open Repair of 
Acute Midsubstance Tears of the Achilles Tendon. Am J Sports Med. 31(5): 692-700, 
2003. 
7. Costa ML, et al. Randomised controlled trials of immediate weight-bearing 
mobilization for rupture of the tendo Achillis. J Bone Joint Surg [Br]. 88-B: 69-77, 
2006. 
8. Suchak AA et al. The Influence of Early Weight-Bearing Compared with Non-Weight-
Bearing After Surgical Repair of the Achilles Tendon. J Bone Joint Surg Am. 90: 1876-
83, 2008. 
9. Huang J et al. Rehabilitation Regimen After Surgical Treatment of Acute Achilles 
Tendon Ruptures: A Systematic Review With Meta-analysis. Am J Sports Med. 43(4): 
1008-16, 2015. 
10. Valkering KP et al. Functional weight-bearing mobilization after Achilles tendon 
rupture enhances early healing response: a single-blinded randomized controlled 
trial. Knee Surg Sports Traumatol Arthrosc. 25: 1807-1816, 2017. 
11. Smeeing DPJ et al. Weight-Bearing and Mobilization in the Postoperative Care of 
Ankle Fractures: A Systematic Review and Meta-Analysis of Randomized Controlled 
Trials and Cohort Studies. PLos One. 10(2): e0118320, 2015. 
12. Black JDJ et al. Early weight-bearing in operatively fixed ankle fractures: A 
systematic review. The Foot. 23: 78-85, 2013. 
13. Assal M et al. Augmented Osteosynthesis of OTA 44-B Fractures in Older Patients: A 
Technique Allowing Early Weightbearing. J Orth op Trauma. 25(12): 742-747, 2011. 

 
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14. Starkweather et al. Early Protected Weightbearing after Open Reduction Internal 
Fixation of Ankle Fractures. J Foot Ankle Surg. 51: 575-578, 2012. 
15. Firoozabadi R et al. Immediate Weight-Bearing after Ankle Fracture Fixation. 
Advances in Orthopedics. 2015. 
16. Dehghan N et al. Early Weightbearing and Range of Motion Versus Non-
Weightbearing and Immobilization After Open Reduction and Internal Fixation of 
Unstable Ankle Fractures: A Randomized Controlled Trial. J Orthop Trauma. 30(7): 
345-352, 2016. 
17. Hyer CF, Atway S, et al. Early Weight Bearing of Calcaneal Fractures Fixated With 
Locked Plates. Foot Ankle Spec. 3(6): 320-323, 2010. 
18. Kayali C, Altay T, et al. The effect of early weight-bearing on comminuted calcaneal 
fractures treated with locking plates. Eklem Hastalik Cerrahisi. 25(2): 85-90, 2014. 
19. Park J-Y, Kim H-N, et al. Effect of Weight-Bearing in Conservative and Operative 
Management of Fractures of the Base of the Fifth Metatarsal Bone. Biomed Res Int. 
2017: 1397252. 
20. Wagner E, Ortiz C, et al. Early Weight-Bearing After Percutaneous Reduction and 
Screw Fixation for Low-Energy Lisfranc Injury. Foot Ankle Int. 34(7): 978-983, 2013. 
 
 
 
 
 
 
APPENDIX 
Append relevant information. 
I. 
DATA COLLECTION FORMS  
a. See attached 
 
II. 
APPENDIX  
a. Questionnaires 

 
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