Background: A novel, biodegradable, aliphatic polyurethane scaffold was designed to fulfill an unmet clinical need in the treatment of patients with irreparable partial meniscal lesions.
Hypothesis: Treatment of irreparable partial meniscal lesions with an acellular polyurethane scaffold supports new tissue ingrowth.
Study Design: Case series; Level of evidence, 4.
Methods: Fifty-two patients (with 34 medial and 18 lateral lesions) were recruited into a prospective, single-arm, multicenter, proof-of-principle study and treated with the polyurethane scaffold. The scaffold was implanted after partial meniscectomy using standard surgeon-preferred techniques for suturing. Tissue ingrowth was assessed at 3 months by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and at 12 months by gross examination during second-look arthroscopy, in the course of which a biopsy sample from the inner free edge of the scaffold meniscus was taken for qualitative histologic analysis.
Results: Tissue ingrowth at 3 months was demonstrated on DCE-MRI in 35 of 43 (81.4%) patients. All but one 12-month second-look (43 of 44 [97.7%]) showed integration of the scaffold with the native meniscus and all biopsy specimens (44) showed fully vital material, with no signs of cell death or necrosis. Three distinct layers were observed based on morphologic structure, vessel structure presence or absence, and extracellular matrix composition.
Conclusion: The DCE-MRI demonstrated successful early tissue ingrowth into the scaffold. The biopsy findings demonstrated the biocompatibility of the scaffold and ingrowth of tissue with particular histologic characteristics suggestive of meniscus-like tissue. In conclusion, these data show for the first time consistent regeneration of tissue when using an acellular polyurethane scaffold to treat irreparable partial meniscus tissue lesions.