ACL Reconstruction with a New Generation of LARS Artificial Ligament

NCT ID: NCT06571955

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-22
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LARS grafted

Patients implanted with grafted ligament (new generation)

Group Type: EXPERIMENTAL

Implantation of LARS artificial grafted ligament to treat ACL injury

Intervention Type: DEVICE

Implantation procedure will be realized by a well-trained orthopaedic surgeon and will consist of ACL repair using LARS artificial grafted ligament.

Control

Patients implanted with non-grafted ligament (current generation)

Group Type: ACTIVE_COMPARATOR

Implantation of LARS artificial non-grafted ligament to treat ACL injury

Intervention Type: DEVICE

Implantation procedure will be realized by a well-trained orthopaedic surgeon and will consist of ACL repair using LARS artificial non-grafted ligaments.

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the grafted ligament
• Subject provides written informed consent approved by the Ethics Committee prior to any clinical investigation related procedure
• Subject must agree to undergo all clinical investigation plan - required clinical follow-up visits
• Subject must agree not to participate in any other clinical investigation for a period of 1 year following the procedure
• Male and female subjects over 40 years old
• MRI positive for full acute ACL injury
• Arthrometric evaluation (KT1000) with a side-to-side difference greater than 3 mm
• Symptomatic subjects with no previous knee injury
• Subjects without concomitant pathologies (fracture, infections, immunodepression, HIV, HCV) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
• I and II degree chondral lesions

Exclusion Criteria

• Subjects under 40 years old
• III and IV degree chondral lesions
• Associated ligament injuries
• Meniscus suture (e.g. hndle bucket meniscal tears) that compromise the rehabilitation program
• History for sepsis
• Subjects with concomitant pathologies (fracture, infections, immunodepression, HIV, HCV,) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
• Previous knee injuries
• Septic arthritis
• Infected tissues
• Pregnancy
• Overweighed, obese subject (>100kg)
• History of metabolic bone disease
• Inflammatory joint disease
• Known neoplastic disease
• Medical treatment (e.g steroid)
• HIV positive subject
• Hepatitis positive subject
• Allergy to Titanium, PET, Ugurol, Gentamicin, Polystyrene Sulfonate, other medication

• Minimum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MOVMEDIX

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guliano Cerulli, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Perugia, , Italy

Countries

Italy

Other Identifiers

CD/PT.03

Identifier Type: -

Identifier Source: org_study_id