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

University of Toronto

Status: Unknown

Conditions: Ankle Injuries

Treatments: Behavioral: Early weight-bearing and range of motion exercises; Behavioral: non-weight bearing, no range of motion

Study type: Interventional

Funder types: Other

Identifiers

NCT01196338

Ankle

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Non-weightbearing no ROM

Active Comparator group

Description:

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.

Treatment:

Behavioral: non-weight bearing, no range of motion

Early weight-bearing and ROM

Experimental group

Description:

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.

Treatment:

Behavioral: Early weight-bearing and range of motion exercises