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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Orthopaedic Trauma Association
Canadian Orthopaedic Foundation
Künzli SwissSchuh
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT01196338
First received: September 1, 2010
Last updated: June 9, 2011
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention
Ankle Injuries
 Behavioral: Early weight-bearing and range of motion exercises
Behavioral: non-weight bearing, no range of motion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Return to work [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Functional outcome and event rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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?

  • Functional outcome and event rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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?


Estimated Enrollment: 110
Study Start Date: September 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 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.
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.

 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196338

Contacts
Contact: Richard Jenkinson, MD, FRCS(C) 416-480-6100 ext 7052 richard.jenkinson@sunnybrook.ca
Contact: Hans Kreder, MD,MPH,FRCSC 416-480-6100 ext 6816 hans.kreder@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Richard Jenkinson, MD, FRCSC     416-480-6100 ext 7052     richard.jenkinson@sunnybrook.ca    
Contact: Hans Kreder, MD,MPH,FRCSC     416-480-6100 ext 6816     hans.kreder@sunnybrook.ca    
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)            
St. Michael's Hopspital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Niloofar Dehghan, BSc, MD     416-997-8735     niloofar.dehghan@utoronto.ca    
Contact: Michael McKee, MD, FRCSC     416-864-5880     mckeem@smh.ca    
Principal Investigator: Michael Mckee, MD, FRCSC            
Sponsors and Collaborators
University of Toronto
Orthopaedic Trauma Association
Canadian Orthopaedic Foundation
Künzli SwissSchuh
Investigators
Principal Investigator: Richard Jenkinson, MD, FRCSC Sunnybrook Health Sciences Centre
Study Chair: Hans Kreder, MD,MPH,FRCSC Sunnybrook Health Sciences Centre
  More Information

Publications:
Siddique Amir, Prasad C.V.R, O'Connor D. Early Active Mobilization Versus Cast Immobilization in Operatively Treated Ankle Fractures. European Journal of Trauma 2005 No4 (31): 398-400

Responsible Party: Dr. Richard Jenkinson, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01196338     History of Changes
Other Study ID Numbers: Ankle
Study First Received: September 1, 2010
Last Updated: June 9, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Ankle fracture
Return to work
Return to function
Rehabilitation
Weight-bearing

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013