The safety and short-term efficacy of a novel polyurethane meniscal scaffold for the treatment of segmental medial meniscus deficiency

Meniscal loss is associated with an increased risk of developing osteoarthritis. Tissue engineering solutions, which include the development of novel material scaffolds, are being utilised to aid the regeneration of meniscal tissue. The purpose of this study was to monitor the safety profile and the short-term efficacy of a novel polyurethane meniscal scaffold in the treatment of patients with painful knees following partial medial meniscectomy. Ten consecutive patients with segmental tissue loss from the medial meniscus were treated with the arthroscopic implantation of an Actifit(A (R)) (Orteq Sports Medicine) polyurethane meniscal scaffold. Patients were followed up at 2 and 6 weeks, then again at 6 and 12 months. Primary outcome measures included reporting of complications and patient-reported outcome scores (KOOS, KSS, UCLA Activity scale, VAS pain). Secondary outcome was MRI assessment at 6 and 12 months looking at scaffold morphology, integration and associated joint injury/inflammation. Eight male and 2 female patients were included in the study with a mean age of 29 (range 18-45). No complications were reported. All patients were happy with their surgery. At 6 months, a statistically significant improvement (P < 0.05) in all PROMS except the UCLA activity scale and VAS pain scale were noted. The improvement remained at 12 months. MRI analysis revealed the presence of scaffolds at 6 months, with evidence of some tissue integration in many improvements in scaffold morphology and ICRS classification of cartilage in the medial compartment were noted at 12 months. No synovitis was noted in the joint or adverse reactions in the other compartments. The new Actifit(A (R)) polyurethane scaffold has been shown to be a safe, effective implant, for the treatment of patients with pain as a result of segmental medial meniscus loss at 1 year. IV.