Status:
ACTIVE_NOT_RECRUITING
ACL Reconstruction with a New Generation of LARS Artificial Ligament
Lead Sponsor:
MOVMEDIX
Conditions:
ACL Injury
Eligibility:
All Genders
41+ years
Phase:
NA
Brief Summary
This clinical investigation is intended to demonstrate the safety of the new generation of LARS ligaments and compare this new generation (grafted ligament) of artificial ligament to the LARS current ...
Detailed Description
Forty subjects over 40 years old with acute ACL injury will be included. A follow-up program is planned over 1 year per subject (days 7, 15, 30, 60, 90, 180, 365) based on physical therapy, biological...
Eligibility Criteria
Inclusion
- Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the grafted ligament
- Subject provides written informed consent approved by the Ethics Committee prior to any clinical investigation related procedure
- Subject must agree to undergo all clinical investigation plan - required clinical follow-up visits
- Subject must agree not to participate in any other clinical investigation for a period of 1 year following the procedure
- Male and female subjects over 40 years old
- MRI positive for full acute ACL injury
- Arthrometric evaluation (KT1000) with a side-to-side difference greater than 3 mm
- Symptomatic subjects with no previous knee injury
- Subjects without concomitant pathologies (fracture, infections, immunodepression, HIV, HCV) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
- I and II degree chondral lesions
Exclusion
- Subjects under 40 years old
- III and IV degree chondral lesions
- Associated ligament injuries
- Meniscus suture (e.g. hndle bucket meniscal tears) that compromise the rehabilitation program
- History for sepsis
- Subjects with concomitant pathologies (fracture, infections, immunodepression, HIV, HCV,) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
- Previous knee injuries
- Septic arthritis
- Infected tissues
- Pregnancy
- Overweighed, obese subject (\>100kg)
- History of metabolic bone disease
- Inflammatory joint disease
- Known neoplastic disease
- Medical treatment (e.g steroid)
- HIV positive subject
- Hepatitis positive subject
- Allergy to Titanium, PET, Ugurol, Gentamicin, Polystyrene Sulfonate, other medication
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06571955
Start Date
December 22 2021
End Date
December 31 2024
Last Update
October 21 2024
Active Locations (1)
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1
Instituto di Ricerca Traslazionale Per l'Apparato Locomotore Nicola Cerulli (I.R.T.A.L)
Perugia, Italy, 06100