5 Years' Follow-up Assessment of Surgical Repair for ACL Proximal Rupture (NCT06178497) | Clinical Trial Compass
RecruitingNot Applicable
5 Years' Follow-up Assessment of Surgical Repair for ACL Proximal Rupture
France150 participantsStarted 2023-12-01
Plain-language summary
Isolated ruptures of ACL (anterior cruciate ligament) are ligament injuries that can be proximal, central or distal. Treatment of patients with proximal lesions should be graded. Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and progression risk to a functionally unstable knee less marked. In athletes, the risk of a new sprain must be explained and the patient will choose functional treatment or surgical treatment.
Surgical treatment generally involves ligamentoplasty at the expense of a knee tendon to replace the ruptured ACL. In the context of proximal ACL rupture, the patient can be offered surgical repair of the ACL. There are numerous studies on ACL ligamentoplasties results but literature is poor on modern ACL repair outcomes.
In this context, this study aims to describe the relapse rate at 5 years of patients operated for a proximal ACL tear.
Who can participate
Age range
18 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:
* Patient, male or female, aged ≥ 18 years
* Patient with no history of knee surgery except meniscal surgery
* Patient with an isolated proximal Sherman 1 or 2 ACL tear
* Patient with a proximal Sherman 1 or 2 ACL tear associated to a meniscal lesion
* Patient with a proximal ACL tear associated with an injury to the MCL or LCL grade 1 or 2 but not grade 3
* Patient whose period is less than 3 months between the date of the accident and the surgery
* Patient who received surgical repair between January 2019 and July 2021
Exclusion Criteria:
* Patient with contralateral ACL tear
* Patient with ACL tear Sherman 3 or 4
* Patient with a surgical history on the knee concerned, other than meniscal surgery
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
ACL rupture relapse rate
Timeframe: 1 day
Trial details
NCT IDNCT06178497
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche