Cyclops syndrome MedDRA version: 20.0 Level: PT Classification code 10058029 Term: Arthrofibrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: XEOMIN
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A
Other descriptive name: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (
Sponsors
Groupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient over 18 years of age - Patient who has read and signed the informed 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 118 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 118
Exclusion criteria
Exclusion criteria: - Revision of 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the benefit of an injection of botulinum toxin into the muscle body of the semitendinosus on the reduction of contracture of the hamstrings after ACL ligamentoplasty;Secondary Objective: To assess the benefit of botulinum toxin injection on the incidence of post ligamentoplasty cyclops syndrome. To assess the impact of the treatment on muscle recovery of the hamstring. To evaluate the tolerance of the treatment.;Primary end point(s): Evaluation of the effectiveness of the treatment is based on the assessment of knee mobility at Month 2 post-botulinum toxin injection (i.e. 3 months after the ligamentoplasty). Therapeutic success is defined by the absence of extension defects at this assessment.;Timepoint(s) of evaluation of this end point: Total number of evaluations: 3 Inclusion D0; month 2; month 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cyclops syndrome should be systematically investigated in patients with a six-month extension defect. Its diagnosis is based on MRI data (nodular lesion, anterior to the graft, hypointense or intermediate signal on T1 and T2 weighted sequences). Iso-kinetics is a technique that allows an objective, reliable and reproducible assessment of muscle strength. The speed of movement of the joint is constant throughout the movement and the resistance exerted by the machine is self-adapted to the force that the patient is capable of developing in order to avoid muscle injuries. Using this data, the machine calculates the peak torque, i.e. the maximum power of the muscle group tested according to the relationship Power = Force*Speed; and the total work corresponding to all the force put into play over the entire iso kinetic session. The tolerance of the test treatment will be assessed by collecting the adverse events that occurred during the study.;Timepoint(s) of evaluation of this end point: Total number of evaluations: 3 Inclusion D0; month 2; month 5 | — |
Countries
France
Contacts
Public ContactSAHBANE
VIVACTIS M2RESEARCH
Outcome results
None listed