New surgical method for repairing ruptured Achilles tendon
Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
This study is testing a new two-layer surgery for fixing a ruptured Achilles tendon to see if it helps people recover better than the usual non-surgical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 67 Years |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 3 sites (Copenhagen, Capital and 2 other locations) |
| Trial ID | NCT06723639 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel two-layer surgical technique aimed at restoring the anatomy of a ruptured Achilles tendon. Participants will be randomly assigned to either the new surgical approach followed by rehabilitation or a standard non-surgical treatment followed by rehabilitation. The study will assess clinical outcomes, muscle and tendon structure, and function one year post-injury. The goal is to determine if the new surgical method leads to better patient-reported outcomes compared to traditional treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with a complete mid-substance Achilles tendon rupture within 14 days of injury.
Not a fit: Patients with conditions such as diabetes, smoking habits, or other lower limb injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with Achilles tendon ruptures.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving surgical outcomes for tendon repairs.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with a complete mid-substance Achilles tendon rupture based on clinical exam, including Thompson/Matles test, by an experienced physician. * Presented within 14 days from injury. * Understands and reads Danish. * No contraindications for MRI. Exclusion Criteria: * Smoking * Diabetes * Other injuries affecting their lower limb function. * Contralateral Achilles tendon rupture. * Re-rupture. * Anticoagulation treatment. * Inability to follow rehabilitation or complete follow-up tests. * Immunosuppressive treatment, including systemic corticosteroid treatment. * Pregnant
Where this trial is running
Copenhagen, Capital and 2 other locations
- , Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark. — Copenhagen, Capital, Denmark (Recruiting)
- Copenhagen University Hospital, Amager-Hvidovre — Copenhagen, Capital, Denmark (Not_yet_recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
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.