Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT05008731

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2026-01-31

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.

Conditions

Hamstring Contractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Botulinum toxin

Intervention Type: DRUG

100 units (0.5ml) in 1 injection

Group 2

Placebo: 0.5 ml in 1 injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo 0.5 ml in 1 injection

Interventions

Botulinum toxin

100 units (0.5ml) in 1 injection

Intervention Type: DRUG

Placebo

Placebo 0.5 ml in 1 injection

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Hardy, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique du sport

Locations

Clinique du Sport

Paris, , France

Countries

France

Other Identifiers

2020-005742-42

Identifier Type: -

Identifier Source: org_study_id