Back to resultsEffect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction (SCALA)
Primary Purpose
Hamstring Contractures
Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Botulinum toxin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hamstring Contractures
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)
Sites / Locations
- Clinique du Sport
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
botulinum toxin: 100 units (0.5ml) in 1 injection
Placebo: 0.5 ml in 1 injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05008731
First Posted
August 16, 2021
Last Updated
August 16, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05008731
Brief Title
Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
Acronym
SCALA
Official Title
Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hamstring Contractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Masking Description
A placebo is used
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
botulinum toxin: 100 units (0.5ml) in 1 injection
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo: 0.5 ml in 1 injection
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Intervention Description
100 units (0.5ml) in 1 injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo 0.5 ml in 1 injection
Primary Outcome Measure Information:
Title
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.
Description
Therapeutic success is defined by the absence of extension defect (0 degree of flessum) at 2 months post botulinum toxin injection
Time Frame
Month 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Hardy, MD
Phone
189164500
Ext
33
Email
alexandre.hardy@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Hardy, MD
Organizational Affiliation
Clinique du sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique du Sport
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
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