Hamstring Contractures
Conditions
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.
Interventions
DRUGBotulinum toxin
100 units (0.5ml) in 1 injection
OTHERPlacebo
Placebo 0.5 ml in 1 injection
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
A placebo is used
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAlexandre Hardy, MD
Clinique du sport
Outcome results
None listed