Clinical trial NCT01196338: Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures
Official title: Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Injuries
Keywords: Ankle fracture
Return to work
Return to function
Rehabilitation
Weight-bearing
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: Canadian Orthopaedic Foundation
name: Künzli SwissSchuh
First posted: 2010-09-08
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Return to work
timeFrame: 3 months
Secondary outcomes:
measure: Functional outcome and event rate
timeFrame: 2 weeks
measure: Functional outcome and event rate
timeFrame: 6 weeks
measure: Return to work and functional outcome
timeFrame: 9 weeks
measure: Return to work and functional outcome
timeFrame: 6 months
measure: Return to work and functional outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hopspital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Richard Jenkinson, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Hans Kreder, MD,MPH,FRCSC
role: STUDY_CHAIR
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citation: Kreder, Hans What is the Role of