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

June 9, 2011 updated by: University of Toronto

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard Jenkinson, MD, FRCS(C)
        • Sub-Investigator:
          • Hans Kreder, MD,MPH,FRCSC
        • Sub-Investigator:
          • Niloofar Dehghan, MD
        • Sub-Investigator:
          • Venessa Stas, MD, FRCS(C)
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hopspital
        • Contact:
        • Contact:
          • Michael McKee, MD, FRCSC
          • Phone Number: 416-864-5880
          • Email: mckeem@smh.ca
        • Principal Investigator:
          • Michael Mckee, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-weightbearing no ROM

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.

  • 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.
Experimental: Early weight-bearing and ROM

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.

  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome and event rate
Time Frame: 2 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?
2 weeks
Functional outcome and event rate
Time Frame: 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?
6 weeks
Return to work and functional outcome
Time Frame: 9 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?
9 weeks
Return to work and functional outcome
Time Frame: 6 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?
6 months
Return to work and functional outcome
Time Frame: 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?
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Jenkinson, MD, FRCSC, Sunnybrook Health Sciences Centre
  • Study Chair: Hans Kreder, MD,MPH,FRCSC, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

June 13, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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