Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
Stopped: The site had difficulties to recruit. Some associated investigators can not be involved in the study anymore and others centers contacted don't have enough ressources to conduct the study. Premature end of inclusions on 07/10/2025 \& LPLV on11/27/2025
France13 participantsStarted 2024-07-18
Plain-language summary
Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring
* Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection
* Group 2: placebo: 0.5 ml in 1 injection
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 over 18 years of age
* Patient who has read and signed the consent form for participation in the study
* Patient operated on for primary ACL ligamentoplasty with or without meniscal repair
* Patient with reducible flatus \>10° at 1 month post ligamentoplasty
Exclusion Criteria:
* Revision ligamentoplasty
* Multi-ligament knee
* Patient under court protection, guardianship or trusteeship
* Patient not affiliated to the French social security system
* Patient participating in another therapeutic protocol
* Pregnant woman or woman of childbearing age without effective contraception
* Patient unable to understand the informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
* Patient with known hypersensitivity to botulinum toxin
* Patient with peripheral neuromuscular dysfunction or pronounced atrophy of the semitendinosus muscle
* Patient treated with anticoagulants, chloroquine (or hydroxychloroquine)
* Patient treated in the previous seven days with antibiotics or muscle relaxants (such as tubocurarine)
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
The percentage of therapeutic success, defined by the absence of extension defect at M3 post ligamentoplasty, will be compared between the groups by a Chi-2 test.
Timeframe: Month 2
Trial details
NCT IDNCT05008731
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche