Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
1 other identifier
interventional
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedNovember 3, 2023
November 1, 2023
4.8 years
May 16, 2016
November 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Olerud Molander Ankle Score
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.
1 year
Study Arms (2)
Early Weight Bearing + Cam boot
EXPERIMENTALStandard Treatment Cam boot
ACTIVE COMPARATORInterventions
Patients will be transitioned to weight bearing as tolerated in a cam boot.
Subject will be transitioned to non weight bearing cam boot, standard treatment.
Eligibility Criteria
You may qualify if:
- Operative unstable ankle fractures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University Langone Medical Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nirmal Tejwan, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2016
First Posted
May 20, 2016
Study Start
September 1, 2017
Primary Completion
June 14, 2022
Study Completion
July 1, 2023
Last Updated
November 3, 2023
Record last verified: 2023-11