NCT03625154

Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management. Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort. All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
PROCEDURE	ankle open reduction internal fixation	Open Reduction and Internal Fixation with plates and screws
OTHER	non operative management	closed reduction and splinting followed by progressive weight bearing

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-07-18
• Completion: 2020-12-30
• First posted: 2018-08-10
• Last updated: 2018-08-10