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Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

NCT02779244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2023-11-03

No results posted yet for this study

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.

Conditions

  • Ankle Fracture

Interventions

PROCEDURE

Early Weight bearing + Cam Boot

Patients will be transitioned to weight bearing as tolerated in a cam boot.

PROCEDURE

Non-Weight Bearing + Cam Boot

Subject will be transitioned to non weight bearing cam boot, standard treatment.

Sponsors & Collaborators

Principal Investigators

  • Nirmal Tejwan, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2022-06-14
Completion
2023-07-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02779244 on ClinicalTrials.gov