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OpenTrials
Completed

NCT Number: NCT02779244

Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Weight bearing + Cam Boot

Procedure

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

Non-Weight Bearing + Cam Boot

Procedure

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

Primary outcomes

  1. Olerud Molander Ankle Score

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
May 20, 2016
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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