Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament

Tissue Regenix Ltd40 enrolled

Overview

The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.

The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented variation of Tissue Regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. The device is used to reconstruct traumatic ACL tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Injuries

Interventions

dCELL® ACL ScaffoldDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with partial or complete tear of the ACL and require reconstruction of the ACL. * Medial Collateral Ligament (MCL) injury grade 2 or less. * Osteoarthritis grade 2 or less on the Kellgren Lawrence scale. * Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol. Exclusion Criteria: * Body Mass Index (BMI) greater than 35 kg/m2. * Treatment with any investigational drug or device within two months prior to screening. * Patients presenting with abnormal degenerative osteoarthritis of the joint. * Previous ACL reconstruction on the target knee. * Current ACL injury on contralateral knee. * Patients using anticoagulants within 2 weeks prior to surgery. * Patients on current immuno-suppressive or radiation therapy within six months of screening. * Patients with diabetes or cardiovascular disease which precludes elective surgery. * Patients with documented renal disease or metabolic bone disease.

Locations (8)

Klinika Chirurgii Endoskopowej Sp. z o.o.

Żory, Ul. Bankowa 2, Poland

Med-Polonia Sp. z o.o.

Poznan, Ul. Obornicka 262, Poland

Hospital Infanta Elena de Madrid-Valdemoro

Madrid, Avd. Reyes Catolicos, 21, Spain

Hospital Clinico San Carlos

Outcomes

Primary Outcomes

Arthrometric measurement of knee joint laxity

Comparison of the magnitude of side-to-side differences in mm between the treated knee and the opposite normal knee using an arthrometric ligament testing device

Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Lachman Test

Clinical assessment of knee stability

Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Pivot Shift Test

Clinical assessment of knee stability

Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Number of Participants With Treatment-Related Adverse Events

The frequency and seriousness of any adverse events or adverse device effects will be assessed

Time frame: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Secondary Outcomes

Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function

Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worst results

Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Evidence of integration of the investigational product by MRI

Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery

Time frame: Baseline, 3 months, 6 months, 12 months, 24 months

Data from ClinicalTrials.gov

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