ACL Reconstruction with a New Generation of LARS Artificial Ligament
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of Serious Adverse Device Effect (SADE) — 6 months
Primary outcome will evaluate the safety of the grafted ligament by reporting the number of SADE(s) in the Experimental Arm.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Instituto di Ricerca Traslazionale Per l'Apparato Locomotore Nicola Cerulli (I.R.T.A.L) | Perugia | Italy |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06571955 on ClinicalTrials.gov ↗ ← All trials in Italy