drugset / Trial / NCT05008731

Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

NCT05008731 ↗

Phase 3 Terminated 13 enrolled Ramsay Santé
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2024-07-18
Primary completion
2026-02-20
Completion
2026-02-20

Outcome

Outcome not reported

Stopped (Enrollment): “The site had difficulties to recruit. Some associated investigators can not be involved in the study anymore and others centers contacted don't have enough ressources to conduct the study. Premature end of inclusions on 07/10/2025 \& LPLV on11/27/2025”

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin Protein / enzyme biologic 100 iu Other