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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
100 units (0.5ml) in 1 injection
Placebo 0.5 ml in 1 injection
Clinique du Sport
Paris, France
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
Time frame: Month 2
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