TY - JOUR
T1 - Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial
AU - Saris, D.
AU - Price, A.
AU - Widuchowski, W.
AU - Bertrand-Marchand, M.
AU - Caron, J.
AU - Drogset, J.O.
AU - Emans, P.
AU - Podskubka, A.
AU - Tsuchida, A.
AU - Kili, S.
AU - Levine, D.
AU - Brittberg, M.
AU - SUMMIT study group, the
PY - 2014/6
Y1 - 2014/6
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 valueResults: 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.
AB - 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 valueResults: 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.
KW - cartilage repair
KW - clinical outcomes
KW - knee
KW - matrix-applied characterized autologous cultured chondrocytes (MACI) implant
KW - microfracture
KW - ARTICULAR-CARTILAGE REPAIR
KW - TRAUMATIC CHONDRAL DEFECTS
KW - KNEE
KW - IMPLANTATION
KW - OUTCOMES
KW - JOINT
U2 - 10.1177/0363546514528093
DO - 10.1177/0363546514528093
M3 - Article
C2 - 24714783
SN - 0363-5465
VL - 42
SP - 1384
EP - 1394
JO - The American Journal of Sports Medicine
JF - The American Journal of Sports Medicine
IS - 6
ER -