Clinical Trial: Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
Brief Summary:
The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.
Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.
Detailed Summary:
Sponsor: New York University School of Medicine
Current Primary Outcome: Olerud Molander Ankle Score [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: New York University School of Medicine
Dates:
Date Received: May 16, 2016
Date Started: May 2016
Date Completion: May 2018
Last Updated: November 30, 2016
Last Verified: November 2016