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

Comprehensive Assessment of Peroneal Tendon Injuries - Evaluation and Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Tendon Injuries; Surgery; Tendon Rupture; Tendon Tear
• Intervention / Treatment: Procedure: Standard protocol; Procedure: Early Functional Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felicia André; Phone Number: +463134327416; Email: felicia.andre@vgregion.se
• Study Contact Backup: Name: Katarina Nilsson Helander, Ass prof; Phone Number: +46313430778; Email: katarina.nilsson.helander@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Department of Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cast; Postoperative immobilization with cast in 6 weeks.	Procedure: Standard protocol; Cast 6 weeks after peroneal tendon surgery (standard protocol)
Active Comparator: 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.	Procedure: Early Functional Training; Early functional training after 3 weeks using Air Stirrup compared to cast (standard protocol) after peroneal tendon surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calf circumference	The widest part of the calf will be measured.	Preoperative and 6 months, 12 months and 24 months postoperative.
Range of motion	Range of motion (ROM) will be measured with inclinometer. Patients will be barefoot. ROM will be measured preoperative and postoperative after 6 weeks, 3 months, 6 months, 12 months and 24 months. The first two measurements after surgery (6 weeks, 3 months) will be carried out unloaded. The subsequent measurements (6 months, 12 months, 24 months) will be carried out loaded.	Preoperative and postoperative at 6 weeks, 3 months, 6 months, 12 months and 24 months.
Balance	The patients balance will be measured with stabilometry.	Preoperative and postoperative at 6 months, 12 months and 24 months.
Biomechanical evaluation	A biomechanical evaluation of the ankle, knee and hip kinematics and kinetics during walking, running, and jumping will be performed before and after surgery (6 months, 12 months and 24 months). For collection of the data, 16 Qualisys 7+ cameras (Qualisys AB, Gothenburg, Sweden) and 4 force plates will be used. 55 reflectors will be attached on the patient's body to be able to detect segmental movements. Kinetic data will be evaluated in power (watt) in ankle, knee and hip. Comparison will be performed between groups and limbs in power (LSI) - injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.	Preoperative and postoperative at 6 months, 12 months and 24 months.
Electromyography (EMG)	EMG electrodes on the medial and lateral Gastrocnemius, Soleus and Tibialis Anterior, Quadriceps and trunk muscles will be attached on the patient in order to measure how the muscles are recruited during walking, running and jumping. Both healthy and injured sides will be analyzed. The electrical activity in the muscles will be evaluated. Comparison will be performed between groups and limbs in power (LSI) - injured side/healthy side * 100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.	Preoperative and postoperative at 6 months, 12 months and 24 months.
Cutting test	Cutting test will be performed according to standard module.	Preoperative and postoperative at 6 months, 12 months and 24 months.
Heel-rise work test	Ankle plantar flexion endurance and heel-rise height will be evaluated using MuscleLab® during a heel-rise work test.	Preoperative and postoperative at 6 months, 12 months and 24 months.
Background questions	During all follow-ups (including preoperative) the patients will fill out questionnaires. The questionnaires contain questions concerning, for example, fear of physical activity, fear of re-injuring oneself, satisfaction with the treatment, whether they have experienced complications, time on sick leave, etc.	Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
The Self-Reported Foot and Ankle Score (SEFAS)	SEFAS is a questionnaire designed to evaluate disorders of the foot and ankle. The score covers different constructs that are not reported separately in subscales: pain, function including limitations of function, and other symptoms. Each of the 12 multiple-choice questions is scored from 0 to 4; thus, 0 total points represents the most severe disability and 48 represents normal function.	Preoperative and postoperative at 6 months, 12 months and 24 months.
Foot and Ankle Outcome Score (FAOS)	The FAOS is a patient-reported foot- and ankle-specific questionnaire including 42 items in 5 subscales evaluating pain, symptoms, function of daily living (ADL), function in sport and recreation, and quality of life (QOL). Standardized answer options are provided, and each question is rated on a scale from 0 to 4. A score is calculated for each subscale after which raw scores for each subscale are transformed to a scale ranging from 0 to 100 and presented graphically as the FAOS profile. The minimum possible total score for each subscale is 0 points, a condition that represents the most severe disability, whereas the maximum of 100 points represents normal ankle function.	Preoperative and postoperative at 6 months, 12 months and 24 months.
Physical Activity Scale (PAS)	Physical activity questionnaire. A patient reported outcome used fot the purpose to evaluate the patients self estimated physical activity level. The scale is from 1 to 6 and the higher score, the better outcome.	Preoperative and postoperative at 6 months, 12 months and 24 months.
EuroQol- 5 Dimension (EQ-5D)	Descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, and extreme problems. The EQ-5D index is a weighted total value of the score that is calculated after being adjusted for cultural differences. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health.	Preoperative and postoperative at 6 months, 12 months and 24 months.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Capio Group; ATLEVA Fotcenter
• Investigators: Principal Investigator: Katarina Nilsson Helander, Ass prof, Sahlgrenska University Hospital/Gothenburg University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries; AIEOP acute lymphoblastic leukemia protocol
• Other Study ID Numbers: CAPTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No