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

Autor:	Saris D; University Medical Center Utrecht, Utrecht, the Netherlands Reconstructive Medicine, Tissue Regeneration, MIRA Institute, University of Twente, Enschede, the Netherlands d.saris@umcutrecht.nl., Price A; NIHR Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Widuchowski W; District Hospital of Orthopedics and Trauma Surgery, Department of Knee Surgery, Arthroscopy and Sports Traumatology, Piekary Slaskie, Poland., Bertrand-Marchand M; Chirurgie Arthrose, Sport et Arthroscopie, Polyclinique Saint Roch, Montpellier, France., Caron J; St Elisabeth Ziekenhuis, Afdeling Orthopedie, Tilburg, the Netherlands., Drogset JO; Department of Orthopaedics, Trondheim University Hospital, Trondheim, Norway., Emans P; Academisch Ziekenhuis Maastricht, Afdeling Orthopedie, Maastricht, the Netherlands., Podskubka A; First Faculty of Medicine, Charles University in Prague, Hospital Bulovka, Prague, Czech Republic., Tsuchida A; University Medical Center Utrecht, Utrecht, the Netherlands., Kili S; Genzyme Biosurgery (now Sanofi Biosurgery), Oxford, UK., Levine D; Genzyme Biosurgery (now Sanofi Biosurgery), Cambridge, Massachusetts, USA., Brittberg M; Region Halland Orthopedics, Kungsbacka Hospital, Kungsbacka, Sweden.
Jazyk:	angličtina
Zdroj:	The American journal of sports medicine [Am J Sports Med] 2014 Jun; Vol. 42 (6), pp. 1384-94. Date of Electronic Publication: 2014 Apr 08.
DOI:	10.1177/0363546514528093
Abstrakt:	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. (© 2014 The Author(s).)
Databáze:	MEDLINE
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