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@article{1205305,
author = {Saris, Daniel and Price, Andrew and Widuchowski, Wojciech and BertrandandMarchand, Marion and Caron, Jacob and Drogset, Jon Olav and Emans, Pieter and Podskubka, Ales and Tsuchida, Anika and Kili, Sven and Levine, David and Brittberg, Mats and Paša, Libor and Trc, Tomas and Slynarski, Konrad and Sanson, BerndandJan and Bezuidenhoudt, Mauritz},
article_location = {Chicago},
article_number = {6},
doi = {http://dx.doi.org/10.1177/0363546514528093},
keywords = {cartilage repair; clinical outcomes; knee; matrix-applied characterized autologous cultured chondrocytes (MACI) implant; microfracture},
language = {eng},
issn = {0363-5465},
journal = {The American Journal of Sports Medicine},
title = {Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture Two-Year Follow-up of a Prospective Randomized Trial},
url = {http://www.ncbi.nlm.nih.gov/pubmed/24714783},
volume = {42},
year = {2014}
}
TY - JOUR
ID - 1205305
AU - 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 - Paša, Libor - Trc, Tomas - Slynarski, Konrad - Sanson, Bernd-Jan - Bezuidenhoudt, Mauritz
PY - 2014
TI - Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture Two-Year Follow-up of a Prospective Randomized Trial
JF - The American Journal of Sports Medicine
VL - 42
IS - 6
SP - 1384-1394
EP - 1384-1394
PB - Thomson Reuters
SN - 03635465
KW - cartilage repair
KW - clinical outcomes
KW - knee
KW - matrix-applied characterized autologous cultured chondrocytes (MACI) implant
KW - microfracture
UR - http://www.ncbi.nlm.nih.gov/pubmed/24714783
N2 - 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.
ER -
SARIS, Daniel, Andrew PRICE, Wojciech WIDUCHOWSKI, Marion BERTRAND-MARCHAND, Jacob CARON, Jon Olav DROGSET, Pieter EMANS, Ales PODSKUBKA, Anika TSUCHIDA, Sven KILI, David LEVINE, Mats BRITTBERG, Libor PAŠA, Tomas TRC, Konrad SLYNARSKI, Bernd-Jan SANSON and Mauritz BEZUIDENHOUDT. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture Two-Year Follow-up of a Prospective Randomized Trial (Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial.). \textit{The American Journal of Sports Medicine}. Chicago: Thomson Reuters, 2014, vol.~42, No~6, p.~1384-1394. ISSN~0363-5465. Available from: https://dx.doi.org/10.1177/0363546514528093.
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