ACL Reconstruction with a New Generation of LARS Artificial Ligament

MOVMEDIX

Status

Active, not recruiting

Conditions

ACL Injury

Treatments

Device: Implantation of LARS artificial non-grafted ligament to treat ACL injury

Device: Implantation of LARS artificial grafted ligament to treat ACL injury

Study type

Interventional

Funder types

Industry

Identifiers

NCT06571955

CD/PT.03

Details and patient eligibility

About

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 artificial ligament (non-grafted ligament) which is CE marked since 1997, in case of ACL injury. The new generation of LARS artificial ligament is expected to improve physiological response by enhancing fibroblast proliferation, fibroblast organization and collagen type I & III secretion. This physiological response leads to a better osseo-integration of the ligaments. Therefore, the study is expected to demonstrate the investigational device safety and biomechanical improvements.

Full 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 analysis and biomechanical measurements.

Enrollment

40 patients

Sex

All

Ages

41+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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