Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
Phase 3
Not yet recruiting
- Conditions
- Hamstring Contractures
- Interventions
- Other: Placebo
- Registration Number
- NCT05008731
- Lead Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Brief 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
- Detailed Description
The study includes three assessments: one month after ligamentoplasty (inclusion visit) and then at M2 and M5. The therapeutic benefit of the study treatments is based on the evolution of the extension defect at M2.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 132
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Botulinum toxin botulinum toxin: 100 units (0.5ml) in 1 injection Group 2 Placebo Placebo: 0.5 ml in 1 injection
- Primary Outcome Measures
Name Time Method 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. Month 2 Therapeutic success is defined by the absence of extension defect (0 degree of flessum) at 2 months post botulinum toxin injection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinique du Sport
🇫🇷Paris, France