Weight Bearing for Fibular Fractures

NCT ID: NCT04872296

Last Updated: 2021-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2021-12-20

Brief Summary

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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

Detailed Description

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Conditions

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Fibula Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early weight bearing

Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively

Group Type ACTIVE_COMPARATOR

Controlled Ankle Motion (CAM) boot

Intervention Type DEVICE

A CAM boot will be worn on the affected ankle to allow weight bearing

Physical Therapy

Intervention Type PROCEDURE

Standard physical therapy protocol will be started at 6 weeks after surgery

Postponed weight bearing

Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively.

Group Type ACTIVE_COMPARATOR

Controlled Ankle Motion (CAM) boot

Intervention Type DEVICE

A CAM boot will be worn on the affected ankle to allow weight bearing

Physical Therapy

Intervention Type PROCEDURE

Standard physical therapy protocol will be started at 6 weeks after surgery

Interventions

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Controlled Ankle Motion (CAM) boot

A CAM boot will be worn on the affected ankle to allow weight bearing

Intervention Type DEVICE

Physical Therapy

Standard physical therapy protocol will be started at 6 weeks after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RSHA18D.798

Identifier Type: -

Identifier Source: org_study_id

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