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ACTIVE NOT RECRUITING
NCT06571955
NA

ACL Reconstruction with a New Generation of LARS Artificial Ligament

Sponsor: MOVMEDIX

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

41 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-12-22

Completion Date

2024-12-31

Last Updated

2024-10-21

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Instituto di Ricerca Traslazionale Per l'Apparato Locomotore Nicola Cerulli (I.R.T.A.L)

Perugia, Italy