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

NCT06593912 | Recruiting

• 1 other identifier: CAPTI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tendon Tear; Tendon Rupture; Tendon Injuries; Surgery

Outcome Measures

Primary Outcomes (1)

• NRS

  Pain will be graded using Numeric Rating Scale (NRS) ranging from 0 to 10, whereas 0 is corresponding to no pain and 10 is corresponding to the worst pain imaginable. Patients will be asked to select a corresponding number (0 - 10) to indicate the pain intensity they are experiencing during an average day, before taking the functional tests, during the tests and after taking the functional tests. In follow-ups that does not include any functional tests, the patients will only grade pain during an average day.

  Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.

Secondary Outcomes (12)

• Calf circumference

  Preoperative and 6 months, 12 months and 24 months postoperative.

• Range of motion

  Preoperative and postoperative at 6 weeks, 3 months, 6 months, 12 months and 24 months.

• Balance

  Preoperative and postoperative at 6 months, 12 months and 24 months.

• Biomechanical evaluation

  Preoperative and postoperative at 6 months, 12 months and 24 months.

• Electromyography (EMG)

  Preoperative and postoperative at 6 months, 12 months and 24 months.

Study Arms (2)

Cast

ACTIVE COMPARATOR

Postoperative immobilization with cast in 6 weeks.

Procedure: Standard protocol

Cast + Air Stirrup

ACTIVE COMPARATOR

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

Procedure: Early Functional Training

Interventions

Early Functional Training PROCEDURE

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

Cast + Air Stirrup

Standard protocol PROCEDURE

Cast 6 weeks after peroneal tendon surgery (standard protocol)

Cast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Capio Group: collaborator
• ATLEVA Fotcenter: collaborator

Study Sites (1)

Department of Orthopedics

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Tendon Injuries

Interventions

AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Katarina Nilsson Helander, Ass prof

  Sahlgrenska University Hospital/Gothenburg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felicia André

CONTACT

+463134327416; felicia.andre@vgregion.se

Katarina Nilsson Helander, Ass prof

CONTACT

+46313430778; katarina.nilsson.helander@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled study comparing two different immobilization protocols.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)