Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

Not Applicable

Completed

• Conditions: Ankle Fracture
• Interventions: Procedure: Early Weight bearing + Cam Boot; Procedure: Non-Weight Bearing + Cam Boot

• Registration Number: NCT02779244
• Lead Sponsor: NYU Langone Health

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Study Start: 2017-09-01
• Primary Completion: 2022-06-14
• Study Completion: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Operative unstable ankle fractures

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Weight Bearing + Cam boot	Early Weight bearing + Cam Boot	-
Standard Treatment Cam boot	Non-Weight Bearing + Cam Boot	-

Primary Outcome Measures

Name	Time	Method
Olerud Molander Ankle Score	1 year	The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States