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Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function

NCT ID: NCT04635046

Last Updated: 2023-11-30

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

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-30

Study Completion Date

2024-05-31

Brief Summary

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At the foot and ankle group at the Department of Orthopaedics, Uppsala University Hospital, the routine is to perform a tendon transfer of peroneus longus to brevis in case of a ruptured peroneus brevis tendon in the ankle. The reports of patient outcome from this surgery varies in different studies. The aim of the current study is to analyse how well the patients think their general health has improved after the surgery, and how they perceive that the foot function has changed after the surgery. In an objective way the changes in gait after surgery will be measured with gait analysis.

Detailed Description

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The patients are asked to fill in Short Form 36 (SF 36) and Foot and Ankle Outcome Score (FAOS) before surgery, six months and one year after surgery. At each visit a clinical examination is done by a foot and ankle surgeon, according to a protocol. At the same visit a gait analysis is performed with force plates, registration of speed and gait length and 3D recording. The surgery itself is performed according to the clinic's usual protocol and standardised, so all patients are treated in the same way. The physiotherapy is also done according to a protocol. The surgeon is not involved in the follow- up, this is done by another surgeon, and the gait analysis is done by a physiotherapist.

The patients are chosen from two groups: primary tear of the peroneus brevis tendon, requiring a longus to brevis transfer, and primary tear of the peroneus longus tendon, requiring removal of the tendon.

The first group has a sub-group: patients who are in need of a calcaneal osteotomy because of a severe varus hindfoot. The reason the study group is so heterogenous is that peroneus longus and brevis tears are very rare, and 10 patients are referred to the Orthoaedic deparment each year, that need this type of surgery. The sample size has been calculated to 30 patients (based on changes in force measurements during gate), but more patients need to be involved in the study in order to have 30 patients at one year follow up.

Conditions

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Patient Satisfaction Gait, Rigid

Keywords

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Cavovarus foot Gait analysis Tendon transfer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with tears to their peroneal tendons

Patients with pain over their peroneal tendons clinically, with a verified injury to either of the two tendons on MRI, where we might expect a tendon transfer of the peroneus longus, or extirpation of the peroneus longus, during surgery.

Transfer or extirpation of the peroneus longs tendon

Intervention Type PROCEDURE

Tendon transfer or extirpation of peroneus longus or brevis tendon, ligamental reconstruction +/- calcaneal osteotomy

Interventions

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Transfer or extirpation of the peroneus longs tendon

Tendon transfer or extirpation of peroneus longus or brevis tendon, ligamental reconstruction +/- calcaneal osteotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Tears of the peroneus longus and/or peroneus brevis tendon, verified on MRI.
2. Eligible for surgery of peroneal tendon tears

Exclusion Criteria

1. Other injuries in the affected foot that might affect the gait.
2. Previous surgery in the affected foot that might affect the gait.
3. Neurological conditions in the lower extremities that might affect the gait.
4. Patient can not understand the questionnaires or can not understand Swedish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anna Sprinchorn

OTHER

Sponsor Role lead

Responsible Party

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Anna Sprinchorn

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karl Michaelsson, PhD

Role: STUDY_CHAIR

Professor

Locations

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Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2015/428

Identifier Type: -

Identifier Source: org_study_id