Clinical trial NCT06571955: ACL Reconstruction with a New Generation of LARS Artificial Ligament
Official title: Anterior Cruciate Ligament (ACL) Reconstruction with a New Generation of LARS Artificial Ligament
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ACL Injury
Keywords: ACL
Artificial ligament
Lead sponsor: MOVMEDIX
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Serious Adverse Device Effect (SADE)
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of patients' opinion about their knee and associated problems
timeFrame: 12 months
measure: Assessment of patients' pain intensity
timeFrame: 12 months
measure: Assessment of overall knee function
timeFrame: 12 months
measure: Assessment of posterior-anterior knee laxity
timeFrame: 12 months
measure: Assessment of knee flexors-extensors strength
timeFrame: 12 months
measure: Assessment of stabilometry
timeFrame: 12 months
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Instituto di Ricerca Traslazionale Per l'Apparato Locomotore Nicola Cerulli (I.R.T.A.L)
Study officials:
affiliation: Instituto di Ricerca Traslazionale Per l'Apparato Locomotore Nicola Cerulli (I.R.T.A.L)
name: Guliano Cerulli, MD
role: PRINCIPAL_INVESTIGATOR
References: