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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status and phase: Enrolling; Phase 3

Conditions: Hamstring Contractures

Treatments: Drug: Botulinum toxin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05008731

2020-005742-42

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

botulinum toxin: 100 units (0.5ml) in 1 injection

Treatment:

Drug: Botulinum toxin

Group 2

Placebo Comparator group

Description:

Placebo: 0.5 ml in 1 injection

Treatment:

Other: Placebo