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

Not Applicable

• Conditions: Ankle Injuries
• Interventions: Behavioral: non-weight bearing, no range of motion; Behavioral: Early weight-bearing and range of motion exercises

• Registration Number: NCT01196338
• Lead Sponsor: University of Toronto

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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-08
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-13
• Primary Completion: 2012-01
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-weightbearing no ROM	non-weight bearing, no range of motion	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.
Early weight-bearing and ROM	Early weight-bearing and range of motion exercises	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functional outcome and event rate	6 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	12 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, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?

Trial Locations

Locations (2)

St. Michael's Hopspital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada