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ACL Reconstruction with a New Generation of LARS Artificial Ligament
Sponsor: MOVMEDIX
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
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.
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