Functional and Patient-reported Outcome After Peroneal Tendon Surgery and Different Immobilization Protocols

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2030-12-31

Brief Summary

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Patients with surgery of a peroneal tendon injury in Gothenburg, Sweden, will be randomized to one of two different postoperative protocols. Before and after surgery the patients will perform biomechanical evaluation and also fill out questionnaires including PROMs. All evaluations will be performed on both limbs.

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Detailed Description

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Patients admitted for surgery because of peroneal tendon injury will be randomized to one of two postoperative immobilization protocols. In group A the patients will use a cast for 6 weeks after surgery. In group B, the patients will use a cast for 3 weeks followed by a Air Stirrup for 3 weeks. The patients in group B will start unloaded range of motion 3 weeks after surgery. Both groups are allowed to weight-bear directly after surgery. The patients will be evaluated before and several times after surgery. Patient-reported outcome measures (PROMs) will be used to evaluate changes in patient quality of life between the two interventions. A biomechanical evaluation of the ankle, knee and hip kinematics and kinetics during walking, running and walking will also be performed before and repeatedly after surgery.

Conditions

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Tendon Tear Tendon Rupture Tendon Injuries Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study comparing two different immobilization protocols.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cast

Postoperative immobilization with cast in 6 weeks.

Group Type ACTIVE_COMPARATOR

Standard protocol

Intervention Type PROCEDURE

Cast 6 weeks after peroneal tendon surgery (standard protocol)

Cast + Air Stirrup

Postoperative immobilization with cast in 3 weeks followed by Air Stirrup in 3 weeks. Early range of motion after 3 weeks postoperative.

Group Type ACTIVE_COMPARATOR

Early Functional Training

Intervention Type PROCEDURE

Early functional training after 3 weeks using Air Stirrup compared to cast (standard protocol) after peroneal tendon surgery.

Interventions

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Early Functional Training

Early functional training after 3 weeks using Air Stirrup compared to cast (standard protocol) after peroneal tendon surgery.

Intervention Type PROCEDURE

Standard protocol

Cast 6 weeks after peroneal tendon surgery (standard protocol)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\* Surgery of peroneal tendon rupture and/or rupture of ligament and/or rupture of retinacle

Exclusion Criteria

* Extensive surgery needed, such as for example heel osteotomy
* Previous surgery in the affected area
* Previous injury in the healthy foot/leg that impairs function
* Neuromuscular disease
* Impaired language comprehension
* Age under 18

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No