Actively Recruiting
Comprehensive Assessment of Peroneal Tendon Injuries Evaluating Two Postoperative Immobilization Protocols
Led by Vastra Gotaland Region · Updated on 2025-09-23
50
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
C
Capio Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare two different recovery methods after surgery for peroneal tendon injuries in patients treated in Gothenburg, Sweden. Patients undergoing surgery due to peroneal tendon rupture, ligament rupture, or retinacle rupture will be randomly assigned to one of two postoperative immobilization protocols. The study evaluates the effects of these protocols on patient-reported outcomes and biomechanical function of both legs before and after surgery. Participants in one group will use a cast for 6 weeks following surgery, while those in the other group will have a cast for 3 weeks followed by an Air Stirrup brace for another 3 weeks. The second group will begin gentle, unloaded ankle motion after 3 weeks. Both groups are allowed to bear weight on the affected leg immediately after surgery. Evaluations will be conducted multiple times over a two-year period. Participants will undergo biomechanical assessments of ankle, knee, and hip movements during activities such as walking and running before surgery and at several points post-surgery. They will also complete questionnaires about their foot and ankle function and quality of life. Outcome measures include pain scores at multiple time points, calf circumference, range of motion, balance tests, electromyography, and various functional tests. The study will monitor participant progress for up to 24 months to assess recovery and quality of life changes.
CONDITIONS
Brief Title
Functional and Patient-reported Outcome After Peroneal Tendon Surgery and Different Immobilization Protocols
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Surgery of peroneal tendon rupture and/or rupture of ligament and/or rupture of retinacle
- Age 18 years or older
You will not qualify if you...
- Extensive surgery needed, such as heel osteotomy
- Previous surgery in the affected area
- Previous injury in the healthy foot or leg that impairs function
- Neuromuscular disease
- Impaired language comprehension
- Age under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgery for peroneal tendon injury.
1 visit (in-person)
Duration - 6 weeks
Participants follow one of two postoperative immobilization protocols involving casting and possibly Air Stirrup use, with weight-bearing allowed directly after surgery.
Multiple visits during 6 weeks postoperative period
Duration - Up to 24 months postoperative
Participants complete patient-reported outcome measures and biomechanical evaluations at several timepoints to assess recovery and function.
Visits at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative
Trial Site Locations
Total: 1 location
1
Department of Orthopedics
Gothenburg, Sweden
Actively Recruiting
Research Team
F
Felicia André
K
Katarina Nilsson Helander, Ass prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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