NCT06571955

ACL Reconstruction with a New Generation of LARS Artificial Ligament

Anterior Cruciate Ligament (ACL) Reconstruction with a New Generation of LARS Artificial Ligament

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: MOVMEDIX · Industry
• Sex: All
• Age: 41 Years
• Healthy volunteers: Not accepted

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 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.

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 analysis and biomechanical measurements.

Conditions

• ACL Injury

Interventions

Type	Name	Description
DEVICE	Implantation of LARS artificial grafted ligament to treat ACL injury	Implantation procedure will be realized by a well-trained orthopaedic surgeon and will consist of ACL repair using LARS artificial grafted ligament.
DEVICE	Implantation of LARS artificial non-grafted ligament to treat ACL injury	Implantation procedure will be realized by a well-trained orthopaedic surgeon and will consist of ACL repair using LARS artificial non-grafted ligaments.

Timeline

• Start date: 2021-12-22
• Primary completion: 2024-03-28
• Completion: 2024-12-31
• First posted: 2024-08-26
• Last updated: 2024-10-21

Locations

1 site across 1 country: Italy