Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

Study Overview
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Brief Summary
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The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

Detailed Description
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This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.

Official Title
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Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study

Conditions
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Post Operative Treatment After Unstable Malleolar Fractures

Intervention / Treatment
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* Other: Full weight bearing
* Other: Partial weight bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with surgically stabilized unstable ankle fractures signed informed consent closed tibial and fibular epiphysis age 18 or older Exclusion Criteria: dementia and other known cognitive impairment or incapacity of judgement polytrauma bilateral injury of the lower extremities additional injury of the ipsilateral lower extremity which prevents full weight bearing associated injury of one or both upper extremities open fractures grade II° and III° chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy open epiphysis pregnancy

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full weight bearing<br>After 2 weeks after surgery the arm will begin full weight bearing | Other: Full weight bearing<br>* Full weight bearing monitored with a bio-feedback insole<br>|
| Active Comparator: Partial weight bearing<br>The arm will perform partial weight bearing for 6 weeks after surgery | Other: Partial weight bearing<br>* Partial weight bearing monitored with a bio-feedback insole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manchester Oxford Foot and Ankle Questionnaire | Patient reported Outcome measure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other PROMs (patient reported outcome measures) |  | 1 year | 
| Range of Motion |  | 1 year | 
| Secondary dislocation of fracture |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malleolar fractures, postoperative treatment protocol, full weight bearing, partial weight bearing, bio-feedback insoles