Matrix-applied characterized autologous cultured chondrocytes versus microfracture: Two-year follow-up of a prospective randomized trial

Daniel Saris, Andrew Price, Wojciech Widuchowski, Marion Bertrand-Marchand, Jacob Caron, Jon Olav Drogset, Pieter Emans, Ales Podskubka, Anika I. Tsuchida, Sven Kili, David Levine, Mats Brittberg

Research output: Contribution to journalArticleAcademicpeer-review

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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 cm2) 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 cm2. 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 cm2 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.

Original languageEnglish
Pages (from-to)1384-1394
Number of pages11
JournalAmerican journal of sports medicine
Volume42
Issue number6
DOIs
Publication statusPublished - 2014

Fingerprint

Stress Fractures
Knee Injuries
Chondrocytes
Knee Osteoarthritis
Safety
Cartilage
Knee
Pain
Treatment Failure
Randomized Controlled Trials
Magnetic Resonance Imaging
Therapeutics
Articular Cartilage
Activities of Daily Living
Thigh
Histology
Quality of Life
Bone and Bones
Population

Keywords

  • Cartilage repair
  • Clinical outcomes
  • Knee
  • Matrix-applied characterized autologous cultured chondrocytes (MACI) implant
  • Microfracture

Cite this

Saris, Daniel ; Price, Andrew ; Widuchowski, Wojciech ; Bertrand-Marchand, Marion ; Caron, Jacob ; Drogset, Jon Olav ; Emans, Pieter ; Podskubka, Ales ; Tsuchida, Anika I. ; Kili, Sven ; Levine, David ; Brittberg, Mats. / Matrix-applied characterized autologous cultured chondrocytes versus microfracture : Two-year follow-up of a prospective randomized trial. In: American journal of sports medicine. 2014 ; Vol. 42, No. 6. pp. 1384-1394.
@article{d2f5d4a6372d4756a4f6f78227b70d98,
title = "Matrix-applied characterized autologous cultured chondrocytes versus microfracture: Two-year follow-up of a prospective randomized trial",
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 cm2) 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 cm2. 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 cm2 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.",
keywords = "Cartilage repair, Clinical outcomes, Knee, Matrix-applied characterized autologous cultured chondrocytes (MACI) implant, Microfracture",
author = "Daniel Saris and Andrew Price and Wojciech Widuchowski and Marion Bertrand-Marchand and Jacob Caron and Drogset, {Jon Olav} and Pieter Emans and Ales Podskubka and Tsuchida, {Anika I.} and Sven Kili and David Levine and Mats Brittberg",
year = "2014",
doi = "10.1177/0363546514528093",
language = "English",
volume = "42",
pages = "1384--1394",
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Saris, D, Price, A, Widuchowski, W, Bertrand-Marchand, M, Caron, J, Drogset, JO, Emans, P, Podskubka, A, Tsuchida, AI, Kili, S, Levine, D & Brittberg, M 2014, 'Matrix-applied characterized autologous cultured chondrocytes versus microfracture: Two-year follow-up of a prospective randomized trial' American journal of sports medicine, vol. 42, no. 6, pp. 1384-1394. https://doi.org/10.1177/0363546514528093

Matrix-applied characterized autologous cultured chondrocytes versus microfracture : Two-year follow-up of a prospective randomized trial. / Saris, Daniel; Price, Andrew; Widuchowski, Wojciech; Bertrand-Marchand, Marion; Caron, Jacob; Drogset, Jon Olav; Emans, Pieter; Podskubka, Ales; Tsuchida, Anika I.; Kili, Sven; Levine, David; Brittberg, Mats.

In: American journal of sports medicine, Vol. 42, No. 6, 2014, p. 1384-1394.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Matrix-applied characterized autologous cultured chondrocytes versus microfracture

T2 - Two-year follow-up of a prospective randomized trial

AU - Saris, Daniel

AU - Price, Andrew

AU - Widuchowski, Wojciech

AU - Bertrand-Marchand, Marion

AU - Caron, Jacob

AU - Drogset, Jon Olav

AU - Emans, Pieter

AU - Podskubka, Ales

AU - Tsuchida, Anika I.

AU - Kili, Sven

AU - Levine, David

AU - Brittberg, Mats

PY - 2014

Y1 - 2014

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 cm2) 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 cm2. 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 cm2 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 cm2) 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 cm2. 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 cm2 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

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DO - 10.1177/0363546514528093

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JO - American journal of sports medicine

JF - American journal of sports medicine

SN - 0363-5465

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