Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon a… (NCT03308760) | Clinical Trial Compass
CompletedNot Applicable
Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
France20 participantsStarted 2012-12
Plain-language summary
Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Studies investigating the evolution of ankle muscle strength following surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to determine the possibility of returning to the sport. This project thus proposes to study, in comparison with the healthy ankle:(1) the evolution of muscle strength in the flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12 months, following surgery for acute unilateral rupture of the Achilles tendon, operated on using the conventional technique in young sportsmen and women and in comparison with the healthy side.
Who can participate
Age range
18 Years – 45 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:
* persons informed about the research
* sportsmen and women (competition or leisure, practiced \> 3h/week)
* Between 18 and 45 years old
* First episode of acute traumatic unilateral rupture of the Achilles tendon
* Open surgery in the Orthopaedic and Traumatology Department of Dijon University Hospital
* Identical post-operative immobilisation programme for 6 weeks
* Absence of major post-operative complications delaying the rehabilitation
Exclusion Criteria:
* persons without national health insurance cover
* concomitant joint disease that could be aggravated by the tests
* heart disease/contra-indication to effort required during the isokinetic test
* management other than open surgery (orthopaedic, functional, percutaneous surgery, …)
* Rupture of the contralateral tendon
* Contra-indication for the use of the Biodex S4 pro
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
Muscle strength
Timeframe: 6 months
2
Postural parameters measured using a stabilometry platform