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Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

Primary Purpose

Ankle Fracture

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Weight bearing + Cam Boot
Non-Weight Bearing + Cam Boot
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fracture focused on measuring Orthopedic, Post-operative, Weight bearing, Range of motion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Weight Bearing + Cam boot

Standard Treatment Cam boot

Arm Description

Outcomes

Primary Outcome Measures

Olerud Molander Ankle Score
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2016
Last Updated
November 7, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02779244
Brief Title
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
Official Title
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture
Keywords
Orthopedic, Post-operative, Weight bearing, Range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Weight Bearing + Cam boot
Arm Type
Experimental
Arm Title
Standard Treatment Cam boot
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Early Weight bearing + Cam Boot
Intervention Description
Patients will be transitioned to weight bearing as tolerated in a cam boot.
Intervention Type
Procedure
Intervention Name(s)
Non-Weight Bearing + Cam Boot
Intervention Description
Subject will be transitioned to non weight bearing cam boot, standard treatment.
Primary Outcome Measure Information:
Title
Olerud Molander Ankle Score
Description
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirmal Tejwan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

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