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

Study Overview
=================
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.

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

Conditions
-----------------
Hamstring Contractures

Intervention / Treatment
-----------------
* Drug: Botulinum toxin
* Other: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>botulinum toxin: 100 units (0.5ml) in 1 injection | Drug: Botulinum toxin<br>* 100 units (0.5ml) in 1 injection<br>|
| Placebo Comparator: Group 2<br>Placebo: 0.5 ml in 1 injection | Other: Placebo<br>* Placebo 0.5 ml in 1 injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Therapeutic success is defined by the absence of extension defect (0 degree of flessum) at 2 months post botulinum toxin injection | Month 2 |