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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
decellularised porcine xenograft
"Ortotrauma" Spółka Z Ograniczoną
Bialystok, Poland
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
Oswestry, Shropshire, United Kingdom
The Hillingdon Hospitals NHS FOUNDATION TRUST
Uxbridge, United Kingdom
Clifton Park Hospital
York, United Kingdom
Pain relief as assessed by Visual Analog Scale (VAS)
Change in VAS Pain score from baseline
Time frame: 24 months
Knee functional improvement as assessed by patient questionnaires
IKDC, Lysholm and KOOS score change over time
Time frame: 24 months
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