An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Injuries
- Sponsor
- Tissue Regenix Ltd
- Enrollment
- 32
- Locations
- 4
- Primary Endpoint
- Pain relief as assessed by Visual Analog Scale (VAS)
- Status
- Suspended
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pain relief as assessed by Visual Analog Scale (VAS)
Time Frame: 24 months
Change in VAS Pain score from baseline
Secondary Outcomes
- Knee functional improvement as assessed by patient questionnaires(24 months)