ACL Reconstruction with a New Generation of LARS Artificial Ligament

NCT06571955 | Active Not Recruiting

• 1 other identifier: CD/PT.03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury

Keywords

ACL; Artificial ligament

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Device Effect (SADE)

  Primary outcome will evaluate the safety of the grafted ligament by reporting the number of SADE(s) in the Experimental Arm.

  6 months

Secondary Outcomes (6)

• Assessment of patients' opinion about their knee and associated problems

  12 months

• Assessment of patients' pain intensity

  12 months

• Assessment of overall knee function

  12 months

• Assessment of posterior-anterior knee laxity

  12 months

• Assessment of knee flexors-extensors strength

  12 months

Study Arms (2)

LARS grafted

EXPERIMENTAL

Patients implanted with grafted ligament (new generation)

Device: Implantation of LARS artificial grafted ligament to treat ACL injury

Control

ACTIVE COMPARATOR

Patients implanted with non-grafted ligament (current generation)

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

Interventions

Implantation of LARS artificial grafted ligament to treat ACL injury DEVICE

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

LARS grafted

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

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

Control

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MOVMEDIX: lead

Study Sites (1)

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

Perugia, 06100, Italy

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Guliano Cerulli, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 26, 2024
• Study Start: December 22, 2021
• Primary Completion: March 28, 2024
• Study Completion: December 31, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)