Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear (NCT06178484) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
France144 participantsStarted 2023-12-01
Plain-language summary
Isolated ruptures of the anterior cruciate ligament (ACL) can be proximal, distal or occur in the middle of the ACL.
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 the risk of progression to a knee functionally unstable less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a surgical treatment.
Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.
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 whose period is less than 3 months between the date of the accident and the 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 stable meniscal lesion or to an MCL or LCL lesion grade 1 or 2 but not grade 3
* Patient practicing a non-contact pivot sport (sliding sports, board sports,racket)
Exclusion Criteria:
* Patient with contralateral ACL tear
* Patient practicing a pivot sport with contacts
* Patient presenting external rotary jumps ++ and +++
* Patient with an ACL tear Sherman 3 or 4
* Patient with meniscal lesions in the shape of a bucket handle or tabs unstable meniscals
* Patient with a surgical history on the knee concerned
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
Subjective IKDC (International Knee Documentation Committee) score
Timeframe: 1 day
Trial details
NCT IDNCT06178484
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche