Ankle Injuries
Conditions
Keywords
Ankle fracture, Return to work, Return to function, Rehabilitation, Weight-bearing
Brief summary
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
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.
Interventions
BEHAVIORALEarly weight-bearing and range of motion exercises
* 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.
BEHAVIORALnon-weight bearing, no range of motion
* 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.
Sponsors
Orthopaedic Trauma Association
Canadian Orthopaedic Foundation
Künzli SwissSchuh
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to work | 3 months | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome and event rate | 2 weeks | 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? |
| Return to work and functional outcome | 9 weeks | 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? |
Countries
Canada
Contacts
Primary ContactRichard Jenkinson, MD, FRCS(C)
Backup ContactHans Kreder, MD,MPH,FRCSC
Outcome results
None listed