NCT01196338

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Injuries

Interventions

Type	Name	Description
BEHAVIORAL	Early 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.
BEHAVIORAL	non-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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2010-09-08
• Last updated: 2011-06-13

Locations

2 sites across 1 country: Canada