Recruiting

Weightbearing vs. Non-Weightbearing

Sponsor:

University of Toronto

Code:

NCT01196338

Conditions

Ankle Injuries

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Early weight-bearing and range of motion exercises

non-weight bearing, no range of motion

Study Details

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.

Conditions

Ankle Injuries

Study ID

NCT01196338

Start date

Sep, 2010

Status verified date

Sep, 2010

Completion date

Jun, 2012

Anticipated

Primary completion date

Jan, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Return to work [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Richard Jenkinson, MD, FRCS(C)

416-480-6100richard.jenkinson@sunnybrook.ca

Hans Kreder, MD,MPH,FRCSC

416-480-6100hans.kreder@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Richard Jenkinson, MD, FRCSC

416-480-6100richard.jenkinson@sunnybrook.ca

Hans Kreder, MD,MPH,FRCSC

416-480-6100hans.kreder@sunnybrook.ca

Principal Investigator:

Richard Jenkinson, MD, FRCS(C)

St. Michael's Hopspital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Niloofar Dehghan, BSc, MD

416-997-8735niloofar.dehghan@utoronto.ca

Michael McKee, MD, FRCSC

416-864-5880mckeem@smh.ca

Principal Investigator:

Michael Mckee, MD, FRCSC

More Information

Sponsor

University of Toronto

Last update posted

Jun 13, 2011

Last verified

Sep, 2010

Keywords

  • Ankle fracture
  • Return to work
  • Return to function
  • Rehabilitation
  • Weight-bearing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2011-06-13.