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ACL Reconstruction with a New Generation of LARS Artificial Ligament

NCT06571955 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-21

No results posted yet for this 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.

Conditions

  • ACL Injury

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.

Sponsors & Collaborators

  • MOVMEDIX

    lead INDUSTRY

Principal Investigators

  • Guliano Cerulli, MD · Instituto di Ricerca Traslazionale Per l'Apparato Locomotore Nicola Cerulli (I.R.T.A.L)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2024-03-28
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571955 on ClinicalTrials.gov