Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-10-31

Brief Summary

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The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

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Detailed Description

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This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.

Conditions

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Post Operative Treatment After Unstable Malleolar Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Full weight bearing

After 2 weeks after surgery the arm will begin full weight bearing

Group Type EXPERIMENTAL

Full weight bearing

Intervention Type OTHER

Full weight bearing monitored with a bio-feedback insole

Partial weight bearing

The arm will perform partial weight bearing for 6 weeks after surgery

Group Type ACTIVE_COMPARATOR

Partial weight bearing

Intervention Type OTHER

Partial weight bearing monitored with a bio-feedback insole

Interventions

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Full weight bearing

Full weight bearing monitored with a bio-feedback insole

Intervention Type OTHER

Partial weight bearing

Partial weight bearing monitored with a bio-feedback insole

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with surgically stabilized unstable ankle fractures
* signed informed consent
* closed tibial and fibular epiphysis
* age 18 or older

Exclusion Criteria

* dementia and other known cognitive impairment or incapacity of judgement
* polytrauma
* bilateral injury of the lower extremities
* additional injury of the ipsilateral lower extremity which prevents full weight bearing
* associated injury of one or both upper extremities
* open fractures grade II° and III°
* chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
* open epiphysis
* pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes