Tendon TearNCT06593912
Functional and Patient-reported Outcome After Peroneal Tendon Surgery and Different Immobilization Protocols
A study testing Early Functional Training and Standard protocol in people with Tendon Tear and Tendon Rupture, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Tear, Tendon Rupture, Tendon Injuries
- What is being tested?
- Early Functional Training and Standard protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2024to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery of peroneal tendon rupture and/or rupture of ligament and/or rupture of retinacle
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tendon Tear, Tendon Rupture, Tendon Injuries, Surgery
- Being tested
- Early Functional Training, Standard protocol
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Functional TrainingProcedure or surgery
Early functional training after 3 weeks using Air Stirrup compared to cast (standard protocol) after peroneal tendon surgery.
Standard protocolProcedure or surgery
Cast 6 weeks after peroneal tendon surgery (standard protocol)
| Study group | Role | What they receive |
|---|---|---|
| Cast | Active comparator | Postoperative immobilization with cast in 6 weeks. Receives: 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. Receives: Procedure: Early Functional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
Secondary outcomes (12)
Calf circumference
The widest part of the calf will be measured.
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.
Measured: Preoperative and postoperative at 6 weeks, 3 months, 6 months, 12 months and 24 months.
Balance
The patients balance will be measured with stabilometry.
Measured: 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.
Measured: 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.
Measured: Preoperative and postoperative at 6 months, 12 months and 24 months.
Cutting test
Cutting test will be performed according to standard module.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperative and postoperative at 6 months, 12 months and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon TearStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study comparing two different immobilization protocols.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Capio Group, ATLEVA Fotcenter
- Responsible party
- Sponsor
- Investigators
- Katarina Nilsson Helander, Ass prof, Principal investigator, Sahlgrenska University Hospital/Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593912
- Sponsor's protocol ID
- CAPTI
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Peroneal Tendon Injuries - Evaluation and Treatment
- ClinicalTrials.gov ID
- NCT06593912
- Acronym / sponsor ID
- CAPTI
- Conditions
- Tendon Tear, Tendon Rupture, Tendon Injuries, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Capio Group, ATLEVA Fotcenter
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study comparing two different immobilization protocols.
| Arm | Type | Receives |
|---|---|---|
| Cast | Active comparator | Procedure: Standard protocolPostoperative immobilization with cast in 6 weeks. |
| Cast + Air Stirrup | Active comparator | Procedure: Early Functional TrainingPostoperative immobilization with cast in 3 weeks followed by Air Stirrup in 3 weeks. Early range of motion after 3 weeks postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgery of peroneal tendon rupture and/or rupture of ligament and/or rupture of retinacle
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Functional TrainingEarly functional training after 3 weeks using Air Stirrup compared to cast (standard protocol) after peroneal tendon surgery. | Procedure or surgery | Cast + Air Stirrup |
| Standard protocolCast 6 weeks after peroneal tendon surgery (standard protocol) | Procedure or surgery | Cast |
Primary outcome
NRS
Time frame: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
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.
12 secondary outcomes
Calf circumference
Time frame: Preoperative and 6 months, 12 months and 24 months postoperative.
Range of motion
Time frame: Preoperative and postoperative at 6 weeks, 3 months, 6 months, 12 months and 24 months.
Balance
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Biomechanical evaluation
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Electromyography (EMG)
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Cutting test
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Heel-rise work test
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Background questions
Time frame: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
The Self-Reported Foot and Ankle Score (SEFAS)
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Foot and Ankle Outcome Score (FAOS)
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Physical Activity Scale (PAS)
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
EuroQol- 5 Dimension (EQ-5D)
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katarina Nilsson Helander, Ass prof principal investigator
Sahlgrenska University Hospital/Gothenburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Functional Training and Standard protocol in people with Tendon Tear and Tendon Rupture, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felicia André (+463134327416, felicia.andre@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.