New surgical method for repairing ruptured Achilles tendon
Official title: Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
Run by Bispebjerg Hospital · NCT06723639 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 67 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 3 sites (Copenhagen, Capital and 2 other locations) |
| Status | Recruiting |
| Started | February 28, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | April 15, 2025 |
| Trial ID | NCT06723639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with a complete mid-substance Achilles tendon rupture within 14 days of injury.
✕Probably not a fit
Patients with conditions such as diabetes, smoking habits, or other lower limb injuries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with Achilles tendon ruptures.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving surgical outcomes for tendon repairs.
Who can join: the full rules
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 it's running
-
, 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Immediate neuromuscular electrical stimulation for Achilles tendon pain and function
Researchers will try two types of neuromuscular electrical stimulation to see if they immediately reduce pain and improve heel-rise performance in people with Achilles tendinopathy or a past Achilles tendon rupture.
-
Achilles Tendon Rupture: 12-Month Outcomes After Non-Surgical Rehab
This study tests how well people recover 12–15 months after non-surgical treatment for an Achilles tendon rupture using a structured rehab protocol in an NHS setting.
-
Blood flow restriction training to improve recovery after Achilles tendon repair
This trial will test whether adding blood flow restriction training to standard rehabilitation helps adults recover muscle strength and tendon function after surgical repair of an Achilles tendon rupture.
-
Collagen scaffold augmentation to support Achilles tendon repair
This trial will test whether adding a collagen scaffold during surgical repair helps adults with acute Achilles tendon ruptures recover better than standard repair.
-
Strength training effects on recovery after Achilles tendon rupture
This study is testing how different levels of strength training can help men recover better after an Achilles tendon rupture.
-
Blood Flow Restriction Exercise for Achilles Tendon Rupture
This study is testing if adding Blood Flow Restriction Exercise to regular treatment can help people recover better from an Achilles tendon rupture, depending on when they start the exercise.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.