Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

2020-005742-42

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

2024-07-02

2026-01-01

2026-01-01

Not yet recruiting

Early phase I

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)

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2024-07-01