Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University Langone Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Operative unstable ankle fractures
Exclusion Criteria:
- Requirement of syndesmotic fixation
- Pilon fractures
- Open fractures
- Patients with diabetic neuropathy
- BMI>40
- Polytrauma patients
- Patients who are unable to comply with non-weight bearing
- Patients who are unable to follow up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early Weight Bearing + Cam boot
|
Patients will be transitioned to weight bearing as tolerated in a cam boot.
|
|
Active Comparator: Standard Treatment Cam boot
|
Subject will be transitioned to non weight bearing cam boot, standard treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Olerud Molander Ankle Score
Time Frame: 1 year
|
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nirmal Tejwan, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-00720
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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