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

Ankle Fractures Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03625154
Study type Interventional
Source Cedars-Sinai Medical Center
Contact
Status Not yet recruiting
Phase N/A
Start date September 1, 2018
Completion date December 30, 2020
View Details
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