Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. (June 2014)

• Record Type: Journal Article
• Authors: Saris, Daniel; Price, Andrew; Widuchowski, Wojciech; Bertrand-Marchand, Marion; Caron, Jacob; Drogset, Jon Olav; Emans, Pieter; Podskubka, Ales; Tsuchida, Anika; Kili, Sven; Levine, David; Brittberg, Mats
• Other Names: Paša Libor non-byline-author.; Trc Tomas non-byline-author.; Slynarski Konrad non-byline-author.; Sanson Bernd-Jan non-byline-author.; Bezuidenhoudt Mauritz non-byline-author.
• Is Part Of: American journal of sports medicine. Volume 42:Number 6(2014:Jun.)
• Page Start: 1384
• Page End: 1394
• Publication Date: 2014-06
• Subjects: cartilage repair -- clinical outcomes -- knee -- matrix-applied characterized autologous cultured chondrocytes (MACI) implant -- microfracture; Sports medicine -- Periodicals; Sports injuries -- Periodicals; Orthopedic surgery -- Periodicals; 617.102705
• DOI: 10.1177/0363546514528093
• Languages: English
• ISSNs: 0363-5465

Abstract

Background: Randomized controlled trials studying the efficacy and safety of matrix-applied characterized autologous cultured chondrocytes (MACI) versus microfracture (MFX) for treating cartilage defects are limited. Purpose: To compare the clinical efficacy and safety of MACI versus MFX in the treatment of patients with symptomatic cartilage defects of the knee. Study Design: Randomized controlled clinical trial; Level of evidence, 1. Methods: Patients enrolled in the SUMMIT (Demonstrate the Superiority of MACI implant to Microfracture Treatment) trial had ≥1 symptomatic focal cartilage defect (Outerbridge grade III or IV; ≥3 cm 2 ) of the femoral condyles or trochlea, with a baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) pain value <55. The co–primary efficacy endpoint was the change in the KOOS pain and function subscores from baseline to 2 years. Histological evaluation and magnetic resonance imaging (MRI) assessments of structural repair tissue, treatment failure, the remaining 3 KOOS subscales, and safety were also assessed. Results: Of the 144 patients treated, 137 (95%) completed the 2-year assessment. Patients had a mean age of 33.8 years and a mean lesion size of 4.8 cm 2 . The mean KOOS pain and function subscores from baseline to 2 years were significantly more improved with MACI than with MFX (pain: MACI, 37.0 to 82.5 vs MFX, 35.5 to 70.9; function: MACI, 14.9 to 60.9 vs MFX, 12.6 to 48.7; P = .001). A significant improvement in scores was also observed on the KOOS subscales of activities of daily living (MACI, 43.5 to 87.2 vs MFX, 42.6 to 75.8; P < .001), knee-related quality of life (MACI, 18.8 to 56.2 vs MFX, 17.2 to 47.3; P = .029), and other symptoms (MACI, 48.3 to 83.7 vs MFX, 44.4 to 72.2; P < .001) for patients treated with MACI compared with MFX. Repair tissue quality was good as assessed by histology/MRI, but no difference was shown between treatments. A low number of treatment failures (nonresponders: MACI, 12.5% vs MFX, 31.9%; P = .016) and no unexpected safety findings were reported. Conclusion: The treatment of symptomatic cartilage knee defects ≥3 cm 2 in size using MACI was clinically and statistically significantly better than with MFX, with similar structural repair tissue and safety, in this heterogeneous patient population. Moreover, MACI offers a more efficacious alternative than MFX with a similar safety profile for the treatment of symptomatic articular cartilage defects of the knee.