Abstract
BACKGROUND: Microfracture is the first-line treatment for cartilage defects; however, the suboptimal quality of the repaired cartilage remains an issue. PURPOSE/HYPOTHESIS: The aim of this first in-human study was to compare the clinical efficacy and safety of a combination of particulated costal allocartilage and microfracture versus microfracture alone in treating knee cartilage defects. We hypothesized that the particulated costal allocartilage with microfracture would result in superior cartilage repair quality and better clinical outcomes at 48 weeks postoperatively. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients with cartilage defects were allocated randomly to the treatment group (particulated costal allocartilage with microfracture) and control group (microfracture alone). Magnetic resonance imaging (MRI) outcomes of cartilage repair (the primary outcome measure) were evaluated at the 48-week follow-up using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score. Patient-reported clinical outcomes (visual analog scale [VAS] pain score, Knee injury and Osteoarthritis Outcome Score [KOOS], and International Knee Documentation Committee score) and adverse events were evaluated at 12, 24, and 48 weeks postoperatively. RESULTS: Overall, 88 patients were included (44 patients each in the treatment and control groups). The total MOCART score at 48 weeks postoperatively was significantly higher in the treatment group than in the control group (P < .001). Among the 9 MOCART variables, 6 were significantly superior in the treatment versus the control group: degree of repair and defect filling (P < .001), integration to the border zone (P < .001), surface (P = .006), structure (P = .011), signal intensity of the repair tissue (P < .001), and subchondral lamina (P = .005). There were significant between-group differences in KOOS-Pain (P = .014), KOOS-Activities of Daily Living (P = .010), KOOS-Sports (P = .029), and KOOS-Symptoms (P = .039) at 12 weeks postoperatively and in VAS pain (P = .012) and KOOS-Pain (P = .005) at 24 weeks postoperatively. At 48 weeks postoperatively, clinical outcomes were comparable between the groups. CONCLUSION: Microfracture augmented with particulated costal allocartilage resulted in superior cartilage repair quality compared with microfracture alone in terms of MRI evaluation of the knee joint cartilage defect at the 48-week follow-up. Functional outcomes were favorable for both treatments at final follow-up. REGISTRATION: KCT0004936 (Clinical Research Information Service [CRiS] of the Republic of Korea).