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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Treatments: Botulinum Toxins

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)