Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

Ankle Fracture Clinical Trial

Official title:

Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779244
• Other study ID #: 16-00720
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 1, 2023
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Intervention

Procedure:
• Early Weight bearing + Cam Boot
Patients will be transitioned to weight bearing as tolerated in a cam boot.
• Non-Weight Bearing + Cam Boot
Subject will be transitioned to non weight bearing cam boot, standard treatment.

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Olerud Molander Ankle Score	The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.	1 year