Botulinum toxin treatment for hamstring contractures after ACL surgery
Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
PHASE3 · GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT05008731
This study is testing if botulinum toxin injections can help people who have tight hamstrings after ACL surgery improve their knee movement.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05008731 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of botulinum toxin injections in treating hamstring contractures that may occur after anterior cruciate ligament (ACL) reconstruction. It is a monocentric, prospective, randomized, double-blind study involving two groups of 66 patients, where one group receives botulinum toxin and the other a placebo. The patients will be assessed at one month, two months, and five months post-surgery to evaluate the improvement in knee extension. The primary outcome measure is the change in extension defect at two months after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have undergone primary ACL ligamentoplasty and have a reducible extension deficit greater than 10 degrees one month post-surgery.
Not a fit: Patients who have had revision ligamentoplasty, multi-ligament knee injuries, or those with contraindications to botulinum toxin will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve knee function and reduce complications associated with hamstring contractures after ACL reconstruction.
How similar studies have performed: While the use of botulinum toxin for muscle contractures is established, this specific application in post-ACL reconstruction is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Paris
- Clinique du Sport — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Alexandre Hardy, MD — Clinique du sport
- Study coordinator: Alexandre Hardy, MD
- Email: alexandre.hardy@me.com
- Phone: 189164500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hamstring Contractures