Knee Injuries
Conditions
Keywords
meniscus, meniscectomy, decellularised, xenograft
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.
Interventions
DEVICEdCELL® Meniscus
decellularised porcine xenograft
Sponsors
Tissue Regenix Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief as assessed by Visual Analog Scale (VAS) | 24 months | Change in VAS Pain score from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee functional improvement as assessed by patient questionnaires | 24 months | IKDC, Lysholm and KOOS score change over time |
Countries
Poland, United Kingdom
Outcome results
None listed