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

Vastra Gotaland Region

Status: Enrolling

Conditions: Surgery; Tendon Tear; Tendon Rupture; Tendon Injuries

Treatments: Procedure: Standard protocol; Procedure: Early Functional Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06593912

CAPTI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Cast

Active Comparator group

Description:

Postoperative immobilization with cast in 6 weeks.

Treatment:

Procedure: Standard protocol

Cast + Air Stirrup

Active Comparator group

Description:

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

Treatment:

Procedure: Early Functional Training