Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures

Study Overview
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Brief Summary
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The primary objective of the investigators randomized controlled trial is to determine if early protected weightbearing and ankle range of motion after surgical treatment (open reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.

Detailed Description
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This is a randomized controlled trial comparing early weightbearing and mobilization VS immobilization and non-weightbearing after initial treatment of unstable ankle fractures. The primary objective of our randomized control trial is to determine if early protected weightbearing and ankle range of motion post open reduction internal fixation (ORIF) for unstable ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast. Our secondary objective is to determine the rate of adverse events (wound healing, infection, hardware failure) with early weightbearing and ROM comparable to rates with traditional post-op ankle immobilization.

Official Title
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Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial

Conditions
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Ankle Injuries

Intervention / Treatment
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* Behavioral: Early weight-bearing and range of motion exercises
* Behavioral: non-weight bearing, no range of motion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral unstable ankle fracture requiring surgical stabilization Treatment within two weeks of injury Closed or low grade open ankle fracture (grade 1 and/or 2) Skeletally mature Exclusion Criteria: Skeletally immature Previous ipsilateral ankle surgery Bilateral ankle fractures or other major injuries that would affect recovery time Grade 3 open fractures Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient) Non-ambulatory pre injury Tibial plafond fractures including articular impaction requiring elevation Syndesmosis injury requiring fixation Posterior Malleolus fracture - more than 25% of articular surface
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-weightbearing no ROM<br>Patients will be placed in a back slab post-op and will remain non-weight bearing with crutches with no range of motion for a total of 6 weeks. After 6 weeks post-op, they will be placed in a boot orthosis and permitted to weight-bear as tolerated. | Behavioral: non-weight bearing, no range of motion<br>* 0 weeks to 2 weeks: Posterior plaster slab or cast, non-weightbearing, crutches; At 2 week visit to clinic: Posterior plaster slab or cast removed, staples/stitches removed, BK fibreglass cast or other orthosis applied, with instructions to continue non-weightbearing; At 2 weeks to 6 weeks: Ankle remains immobile and non-weightbearing; After 6 weeks: Begin weightbearing as tolerated. Instructions for limited range of motion to be given, and wean from orthosis.<br>|
| Experimental: Early weight-bearing and ROM<br>Patients will be placed in a back slab post-operatively. At 2 weeks post op they will have the back slab removed and placed in a boot orthosis. At this time they will be permitted to weight-bear as tolerated and perform limited ankle range of motion exercises. After 6 weeks post op they will start to wean from the boot orthosis. | Behavioral: Early weight-bearing and range of motion exercises<br>* 0 weeks to 2 weeks: Posterior plaster slab or cast, non-weightbearing, crutches; At 2 week visit to clinic: Posterior plaster slab or cast removed, staples/stitches removed placed in orthosis, with instructions to be weightbearing as tolerated. Instructions for limited range of motion to be given; At 2 weeks to 6 weeks: Weightbearing as tolerated in orthosis, follow range of motion instructions; After 6 weeks: Instructions to continue weightbearing as tolerated, wean from orthosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work compared to traditional post-op ankle immobilization in a non-weightbearing cast? | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome and event rate | Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast? | 2 weeks | 
| Functional outcome and event rate | Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast? | 6 weeks | 
| Return to work and functional outcome | Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast? | 9 weeks | 
| Return to work and functional outcome | Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast? | 6 months | 
| Return to work and functional outcome | Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast? | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle fracture, Return to work, Return to function, Rehabilitation, Weight-bearing