NCT05008731

Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Botulinum toxin	100 units (0.5ml) in 1 injection
OTHER	Placebo	Placebo 0.5 ml in 1 injection

Timeline

• Start date: 2024-07-18
• Primary completion: 2025-11-30
• Completion: 2026-01-01
• First posted: 2021-08-17
• Last updated: 2025-12-04

Locations

1 site across 1 country: France