NCT03032653

Immediate Weight-Bearing Ankle Study

Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Fraser Orthopaedic Research Society · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-centre historical control group comparative study will compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.

Detailed description

Ankle fractures are among the most common injuries, making up 9% of all fractures. Rotational ankle fractures are among the most common of all fractures, with an incidence averaging 4.2 per 1,000 individuals annually. These fractures range from minimal injuries amenable to non-surgical management to complex injuries with potential of long-term sequelae. Known risk factors for ankle fractures are age, body mass index and previous ankle fracture, with the highest incidence in elderly women. Most ankle fractures are low-energy injuries which occur when the body rotates about a planted foot, whether it be during sports, normal gait, or otherwise. Stable ankle fractures are generally treated non-surgically, while unstable fractures are usually treated with surgical reduction and fixation, with indications previously well-described and published. However, the post-operative management of such injuries is still controversial, with large variability between care providers. Protocols range from complete immobilization of the affected ankle and non-weightbearing to early range-of-motion (ROM) and weightbearing (WB). Studies have compared immobilization and non-WB to early ROM and WB but results have been mixed, with the most recent study demonstrating safety and advantages to protected WB and ROM at two weeks post-operatively versus non-WB and immobilization for six weeks. The Investigators intend to expand on the studies above and propose a single-centre historical control group comparative study to compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.

Conditions

• Ankle Fractures
• Surgery

Interventions

Type	Name	Description
OTHER	Late Rehabilitation	Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot. 6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:
OTHER	Early Rehabilitation	Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted

Timeline

• Start date: 2017-02-09
• Primary completion: 2021-01-18
• Completion: 2021-01-18
• First posted: 2017-01-26
• Last updated: 2021-04-23

Locations

1 site across 1 country: Canada