Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon … (NCT06114368) | Clinical Trial Compass
By InvitationNot Applicable
Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture
Greece40 participantsStarted 2023-03-05
Plain-language summary
The goal of this observational study is to compare the outcomes of two different surgical techniques (Endoscopic Flexor Hallucis Longus transfer - Group 1 vs Minimally Invasive primary repair - Group 2) for patients with acute Achilles tendon rupture. The main questions to be answered are:
1. Which group's patients are more satisfied?
2. Which group's patients appear to have a greater complication rate?
3. Which group's patients have greater calf and ankle circumference compared to the unaffected limb?
4. Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb?
5. Are group 1 patients characterized by strength deficit in hallux flexion power?
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed Consent Form
* Age between 18-75 years
* Acute Achilles Tendon Rupture (\<3 weeks)
* Surgical Management with Endoscopic Flexor Hallucis Longus transfer or Minimally Invasive primary tendon repair
* More than 12 months postoperative follow-up
* Patients operated after 2015
Exclusion Criteria:
* Inability or Unwillingness to cooperate
* Medically unfit for examination (e.g. due to terminal illness)
* Age less than 18 or more than 75 years
* Non-operative Management as definitive treatment
* Surgical Management other than the ones described in the inclusion criteria
* Neglected Achilles Tendon Rupture (\>3 weeks)
* Bilateral Achilles Tendon Rupture
* Patients operated before 2015
* Comorbidities interfering with the secondary outcomes (e.g. Venous insufficiency resulting in lower limb excessive edema interferes with ankle and calf circumference, rheumatoid arthritis and/or previous foot and ankle surgery interferes with active and passive range of motion of the ankle, etc)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score