To assess performance of a polyurethane scaffold designed to facilitate regrowth of tissue after irreparable partial meniscus tissue loss. Fifty-two subjects with irreparable medial or lateral meniscus tissue lesions with intact rim, presence of both horns and stable, well aligned knees, were treated with the scaffold. Tissue ingrowth was assessed using dynamic contrast enhanced MRI (DCE-MRI) at 3 months (n=43), and by histological examination of biopsies (n=44) at 12 months relook arthroscopy. Cartilage status on MRI at 1week, 3, 12 and 24 months, and clinical outcomes were assessed from baseline to 24 months using Visual Analogue Scale (VAS), Knee and Osteoarthritis Outcome Score (KOOS), Lysholm and International Knee Documentation Committee (IKDC).Purpose
Methods
To assess the performance of an acellular synthetic scaffold in the treatment of painful partial meniscal tissue loss. Subjects recruited (n=52) had irreparable medial or lateral meniscus partial meniscus loss, intact rim, presence of both horns and a stable well aligned knee. Diagnostic imaging was used to assess tissue ingrowth at 3 months post-implantation by evidence of vascularisation in the scaffold using DCE-MRI with intravenous gadolinium contrast material (n=42). All DCE-MRI scans were assessed centrally for neovascularisation in the peripheral half of the scaffold meniscus and integration of the implanted device. Stability of tissue ingrowth and cartilage scores in the index compartment were assessed at 12 and 24 months post-implantation using anatomic MRI scans.Purposes of the study
Methods
