Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankle Injuries
- Sponsor
- University of Toronto
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Return to work
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Return to work
Time Frame: 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 Outcomes
- Functional outcome and event rate(6 weeks)
- Return to work and functional outcome(12 months)