Weight Bearing for Fibular Fractures

Study Overview
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Brief Summary
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It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes

Official Title
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Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study

Conditions
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Fibula Fracture

Intervention / Treatment
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* Device: Controlled Ankle Motion (CAM) boot
* Procedure: Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute Exclusion Criteria: Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation Revision ankle fracture cases Pre-existing impaired mobility, Pre-existing cognitive disability, Open fractures, BMI >40, Diabetes mellitus (DM)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early weight bearing<br>Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively | Device: Controlled Ankle Motion (CAM) boot<br>* A CAM boot will be worn on the affected ankle to allow weight bearing<br>Procedure: Physical Therapy<br>* Standard physical therapy protocol will be started at 6 weeks after surgery<br>|
| Active Comparator: Postponed weight bearing<br>Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively. | Device: Controlled Ankle Motion (CAM) boot<br>* A CAM boot will be worn on the affected ankle to allow weight bearing<br>Procedure: Physical Therapy<br>* Standard physical therapy protocol will be started at 6 weeks after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction with treatment #1 | Participant satisfaction will be measured using the Short Form-12 survey (SF-12) | 24 weeks | 
| Participant Satisfaction with treatment #2 | Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores | 24 weeks | 
| Participant Pain after surgery | Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score | 24 weeks |