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?

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.

Study Overview

• Status: Completed
• Conditions: Ankle Fracture
• Intervention / Treatment: Procedure: Early Weight bearing + Cam Boot; Procedure: Non-Weight Bearing + Cam Boot

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Weight Bearing + Cam boot	Procedure: Early Weight bearing + Cam Boot; Patients will be transitioned to weight bearing as tolerated in a cam boot.
Active Comparator: Standard Treatment Cam boot	Procedure: Non-Weight Bearing + Cam Boot; Subject will be transitioned to non weight bearing cam boot, standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olerud Molander Ankle Score	The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.	1 year

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nirmal Tejwan, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimated): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Post-operative; Range of motion; Orthopedic; Weight bearing
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 16-00720

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No