ACL Reconstruction With a New Generation of LARS Artificial Ligament
- Conditions
- ACL Injury
- Registration Number
- NCT06571955
- Lead Sponsor
- MOVMEDIX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Subject is able to verbally confirm understanding of risks, benefits and treatment<br> alternatives of receiving the grafted ligaments<br><br> - Subject provides written informed consent approved by the EC prior to any clinical<br> investigation related procedure<br><br> - Subject must agree to undergo all clinical investigation plan - required clinical<br> follow-up visits<br><br> - Subject must agree not to participate in any other clinical investigation for a<br> period of 1 year following the procedure<br><br> - Male and female subjects over 40 years old.<br><br> - MRI positive for full acute ACL injury<br><br> - Arthrometric evaluation (KT1000) with a side-to-side difference greater than 3 mm<br><br> - Symptomatic subjects with no previous knee injury<br><br> - Subjects without concomitant pathologies (fracture, infections, immunodepression,<br> HIV, HCV) that could influence the outcome of the study or prevent the subject from<br> following the post-operative follow-up program as per protocol<br><br> - I and II degree chondral lesions<br><br>Exclusion Criteria:<br><br> - Subjects under 40 years old<br><br> - III and IV degree chondral lesions<br><br> - Associated ligament injuries<br><br> - Meniscus suture (e.g Handle bucket meniscal tears) that compromise the<br> rehabilitation program<br><br> - History for sepsis<br><br> - Subjects with concomitant pathologies (fracture, infections, immunodepression, HIV,<br> HCV,) that could influence the outcome of the study or prevent the subject from<br> following the post-operative follow-up program as per protocol<br><br> - Previous knee injuries<br><br> - Septic arthritis<br><br> - Infected tissues<br><br> - Pregnancy<br><br> - Overweighed, Obese subject (>100kg)<br><br> - History of metabolic bone disease<br><br> - Inflammatory joint disease<br><br> - Known neoplastic disease<br><br> - Medical treatment (e.g steroid)<br><br> - HIV positive subject<br><br> - Hepatitis positive subject<br><br> - Allergy to Titanium, PET, Ugurol, Gentamicin, Polystyrene Sulfonate, other<br> medication
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Serious Adverse Device Effect (SADE)
- Secondary Outcome Measures
Name Time Method Assessment of patients' opinion about their knee and associated problems;Assessment of patients' pain intensity;Assessment of overall knee function;Assessment of posterior-anterior knee laxity;Assessment of knee flexors-extensors strength;Assessment of stabilometry