Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus

Study Overview
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Brief Summary
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The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.

Detailed Description
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The dCELL® Meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of Tissue Regenix's platform dCELL® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. It is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy.

Official Title
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An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus

Conditions
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Knee Injuries

Intervention / Treatment
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* Device: dCELL® Meniscus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy Must be a stable, well aligned knee with ligament laxity of Grade II or less Osteoarthritis <grade 3 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 Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months Patients using anticoagulants Patients on current immuno-suppressive or radiation therapy or having received such therapies within six months of screening Patients with diabetes or cardiovascular disease which precludes elective surgery Patients with documented renal disease or metabolic bone disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dCELL® Meniscus<br> | Device: dCELL® Meniscus<br>* decellularised porcine xenograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief as assessed by Visual Analog Scale (VAS) | Change in VAS Pain score from baseline | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee functional improvement as assessed by patient questionnaires | IKDC, Lysholm and KOOS score change over time | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meniscus, meniscectomy, decellularised, xenograft