Weight Bearing for Fibular Fractures

May 3, 2021 updated by: Rothman Institute Orthopaedics

Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study

It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (age>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute

Exclusion Criteria:

  • Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation
  • Revision ankle fracture cases
  • Pre-existing impaired mobility,
  • Pre-existing cognitive disability,
  • Open fractures,
  • BMI >40,
  • Diabetes mellitus (DM)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early weight bearing
Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively
Device: Controlled Ankle Motion (CAM) boot
A CAM boot will be worn on the affected ankle to allow weight bearing
Procedure: Physical Therapy
Standard physical therapy protocol will be started at 6 weeks after surgery
Active Comparator: Postponed weight bearing
Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively.
Device: Controlled Ankle Motion (CAM) boot
A CAM boot will be worn on the affected ankle to allow weight bearing
Procedure: Physical Therapy
Standard physical therapy protocol will be started at 6 weeks after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction with treatment #1
Time Frame: 24 weeks
Participant satisfaction will be measured using the Short Form-12 survey (SF-12)
24 weeks
Participant Satisfaction with treatment #2
Time Frame: 24 weeks
Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores
24 weeks
Participant Pain after surgery
Time Frame: 24 weeks
Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2018

Primary Completion (Anticipated)

December 20, 2021

Study Completion (Anticipated)

December 20, 2021

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSHA18D.798

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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