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

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.

Conditions

• Ankle Injuries

Interventions

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.

Sponsors & Collaborators

• Orthopaedic Trauma Association

  collaborator OTHER

• Canadian Orthopaedic Foundation

  collaborator OTHER

• Künzli SwissSchuh

  collaborator UNKNOWN

• University of Toronto

  lead OTHER

Principal Investigators

• Richard Jenkinson, MD, FRCSC · Sunnybrook Health Sciences Centre

• Hans Kreder, MD,MPH,FRCSC · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2012-01-31

Completion

2012-06-30

Countries

• Canada

Study Locations