Clinical trial NCT05008731: Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
Official title: Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hamstring Contractures
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique du Sport
Study officials:
affiliation: Clinique du sport
name: Alexandre Hardy, MD
role: PRINCIPAL_INVESTIGATOR
References: