NCT02779244

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?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2022-06-14
• Completion: 2023-07-01
• First posted: 2016-05-20
• Last updated: 2023-11-03

Locations

1 site across 1 country: United States