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

Hamstring Contractures Clinical Trial

— SCALA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05008731
• Other study ID #: 2020-005742-42
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2021
• Est. completion date: April 2024

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Alexandre Hardy, MD
• Phone: 189164500
• Email: alexandre.hardy[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Contracture
• Hamstring Contractures

Intervention

Drug:
• Botulinum toxin
100 units (0.5ml) in 1 injection

Other:
• Placebo
Placebo 0.5 ml in 1 injection

Locations

Country	Name	City	State
France	Clinique du Sport	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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