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

Not Applicable

• Conditions: Ankle Injuries

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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

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