Comparing recovery outcomes after peroneal tendon surgery with different immobilization methods
Comprehensive Assessment of Peroneal Tendon Injuries - Evaluation and Treatment
This study is testing which recovery method after peroneal tendon surgery helps patients in Gothenburg, Sweden, heal better: a longer time in a cast or a shorter time in a cast followed by a supportive brace.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06593912 on ClinicalTrials.gov |
What this trial studies
This study involves patients undergoing surgery for peroneal tendon injuries in Gothenburg, Sweden, who will be randomly assigned to one of two postoperative immobilization protocols. One group will use a cast for six weeks, while the other will use a cast for three weeks followed by an Air Stirrup for another three weeks, allowing for early range of motion. Patients will undergo biomechanical evaluations and complete patient-reported outcome measures (PROMs) to assess their recovery and quality of life before and after surgery. The goal is to determine which protocol leads to better functional outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who require surgery for peroneal tendon rupture or related injuries.
Not a fit: Patients requiring extensive surgery, those with previous surgeries in the affected area, or individuals with neuromuscular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery protocols for patients undergoing peroneal tendon surgery, leading to better functional outcomes and quality of life.
How similar studies have performed: While similar studies have explored postoperative protocols for tendon injuries, this specific comparison of immobilization methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gothenburg
- Department of Orthopedics — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Katarina Nilsson Helander, Ass prof — Sahlgrenska University Hospital/Gothenburg University
- Study coordinator: Felicia André
- Email: felicia.andre@vgregion.se
- Phone: +463134327416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.