Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

NCT05008731 | Active Not Recruiting Phase 3

• 1 other identifier: 2020-005742-42
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Hamstring Contractures

Outcome Measures

Primary Outcomes (1)

• 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

  Month 2

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Botulinum toxin

Group 2

PLACEBO COMPARATOR

Placebo: 0.5 ml in 1 injection

Other: Placebo

Interventions

Botulinum toxin DRUG

100 units (0.5ml) in 1 injection

Group 1

Placebo OTHER

Placebo 0.5 ml in 1 injection

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique du Sport

Paris, 75005, France

Location

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Alexandre Hardy, MD

  Clinique du sport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A placebo is used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 17, 2021
• Study Start: July 18, 2024
• Primary Completion: November 30, 2025
• Study Completion: January 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)