Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two 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. 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 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.

Official Title
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Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis

Conditions
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Foot and Ankle Surgery

Intervention / Treatment
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* Other: Weight Bearing
* Other: Strict non-weight bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 18 to 89 years Undergoing foot and ankle surgery Must be able to read and understand English and consent for themselves Exclusion Criteria: Diagnosed peripheral neuropathy Diagnosed peripheral vascular disease Documented infection to the surgical extremity Previous surgery to the surgical limb Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Immediate protected weight-bearing<br>Immediate protected weight-bearing | Other: Weight Bearing<br>* Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery<br>* Other names: Early Weight Bearing;|
| Other: Traditional non weight bearing<br>Strict non-weight-bearing | Other: Strict non-weight bearing<br>* Strict non weight bearing for 6 weeks following foot & ankle surgery<br>* Other names: Non-weight bearing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale | American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy | Both Arms: Screening | 
| Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale | American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy | Both Arms: Post-operative 6-8 weeks | 
| Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale | American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy | Both Arms: Post-operative 3 month | 
| Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale | American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy | Both Arms: Post-operative 12 month | 
| Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale | American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy | Both Arms: Post-operative 24 month | 
| Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND | 36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy | Both Arms: Screening | 
| Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND | 36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy | Both Arms: Post-operative 6-8 weeks | 
| Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND | 36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy | Both Arms: Post-operative 3 month | 
| Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND | 36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy | Both Arms: Post-operative 12 month | 
| Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND | 36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy | Both Arms: Post-operative 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. | Both arms: Screening | 
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. | Both arms: Post-operative 2-3 weeks | 
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. | Both arms: Post-operative 6-8 weeks | 
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. | Both arms: Post-operative 3 month | 
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. | Both arms: Post-operative 6 month | 
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. | Both arms: Post-operative 12 month | 
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. | Both arms: Post-operative 24 month | 
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. | Both arms: Screening | 
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. | Both arms: Post-operative 2-3 weeks | 
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. | Both arms: Post-operative 6-8 weeks | 
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. | Both arms: Post-operative 3 month | 
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. | Both arms: Post-operative 6 month | 
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. | Both arms: Post-operative 12 month | 
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. | Both arms: Post-operative 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle surgery, Foot surgery