A prospective multicenter study on the outcome of type I collagen hydrogel-based autologous chondrocyte implantation (CaReS) for the repair of articular cartilage defects in the knee

TY - JOUR

T1 - A prospective multicenter study on the outcome of type I collagen hydrogel-based autologous chondrocyte implantation (CaReS) for the repair of articular cartilage defects in the knee

AU - Schneider, Ulrich

AU - Rackwitz, Lars

AU - Andereya, Stefan

AU - Siebenlist, Sebastian

AU - Fensky, Florian

AU - Reichert, Johannes

AU - Löer, Ingo

AU - Barthel, Thomas

AU - Rudert, Maximilian

AU - Nöth, Ulrich

PY - 2011/12/1

Y1 - 2011/12/1

N2 - BACKGROUND: The Cartilage Regeneration System (CaReS) is a novel matrix-associated autologous chondrocyte implantation (ACI) technique for the treatment of chondral and osteochondral lesions (Outerbridge grades III and IV). For this technology, no expansion of the chondrocytes in a monolayer culture is needed, and a homogeneous cell distribution within the gel is guaranteed.PURPOSE: To report a prospective multicenter study of matrix-associated ACI of the knee using a new type I collagen hydrogel (CaReS).STUDY DESIGN: Case series; Level of evidence, 4.METHODS: From 2003 to 2008, 116 patients (49 women and 67 men; mean age, 32.5 ± 8.9 years) had CaReS implantation of the knee in 9 different centers. On the basis of the International Cartilage Repair Society (ICRS) Cartilage Injury Evaluation Package 2000, the International Knee Documentation Committee (IKDC) score, pain score (visual analog scale [VAS]), SF-36 score, overall treatment satisfaction and the IKDC functional status were evaluated. Patient follow-up was performed at 3, 6, and 12 months after surgery and annually thereafter. Mean follow-up was 30.2 ± 17.4 months (range, 12-60 months). There were 67 defects of the medial condyle, 14 of the lateral, 22 of the patella/trochlea, and 3 of the tibial plateau, and 10 patients had 2 lesions. The mean defect size was 5.4 ± 2.4 cm(2). Thirty percent of the defects were <4 cm(2) and 70% were >4 cm(2).RESULTS: The IKDC score improved significantly from 42.4 ± 13.8 preoperatively to 70.5 ± 18.7 (P < .001) at latest follow-up. Global pain level significantly decreased (P < .001) from 6.7 ± 2.2 preoperatively to 3.2 ± 3.1 at latest follow-up. There also was a significant increase of both components of the SF-36 score. The overall treatment satisfaction was judged as very good or good in 88% by the surgeon and 80% by the patient. The IKDC functional knee status was grade I in 23.4%, II in 56.3%, III in 17.2%, and IV in 3.1% of the patients.CONCLUSION: Matrix-associated ACI employing the CaReS technology for the treatment of chondral or osteochondral defects of the knee is a safe and clinically effective treatment that yields significant functional improvement and improvement in pain level. However, further investigation is necessary to determine the long-term viability and clinical outcome of this procedure.

AB - BACKGROUND: The Cartilage Regeneration System (CaReS) is a novel matrix-associated autologous chondrocyte implantation (ACI) technique for the treatment of chondral and osteochondral lesions (Outerbridge grades III and IV). For this technology, no expansion of the chondrocytes in a monolayer culture is needed, and a homogeneous cell distribution within the gel is guaranteed.PURPOSE: To report a prospective multicenter study of matrix-associated ACI of the knee using a new type I collagen hydrogel (CaReS).STUDY DESIGN: Case series; Level of evidence, 4.METHODS: From 2003 to 2008, 116 patients (49 women and 67 men; mean age, 32.5 ± 8.9 years) had CaReS implantation of the knee in 9 different centers. On the basis of the International Cartilage Repair Society (ICRS) Cartilage Injury Evaluation Package 2000, the International Knee Documentation Committee (IKDC) score, pain score (visual analog scale [VAS]), SF-36 score, overall treatment satisfaction and the IKDC functional status were evaluated. Patient follow-up was performed at 3, 6, and 12 months after surgery and annually thereafter. Mean follow-up was 30.2 ± 17.4 months (range, 12-60 months). There were 67 defects of the medial condyle, 14 of the lateral, 22 of the patella/trochlea, and 3 of the tibial plateau, and 10 patients had 2 lesions. The mean defect size was 5.4 ± 2.4 cm(2). Thirty percent of the defects were <4 cm(2) and 70% were >4 cm(2).RESULTS: The IKDC score improved significantly from 42.4 ± 13.8 preoperatively to 70.5 ± 18.7 (P < .001) at latest follow-up. Global pain level significantly decreased (P < .001) from 6.7 ± 2.2 preoperatively to 3.2 ± 3.1 at latest follow-up. There also was a significant increase of both components of the SF-36 score. The overall treatment satisfaction was judged as very good or good in 88% by the surgeon and 80% by the patient. The IKDC functional knee status was grade I in 23.4%, II in 56.3%, III in 17.2%, and IV in 3.1% of the patients.CONCLUSION: Matrix-associated ACI employing the CaReS technology for the treatment of chondral or osteochondral defects of the knee is a safe and clinically effective treatment that yields significant functional improvement and improvement in pain level. However, further investigation is necessary to determine the long-term viability and clinical outcome of this procedure.

KW - Adult

KW - Arthroplasty, Subchondral

KW - Chondrocytes

KW - Collagen

KW - Female

KW - Humans

KW - Hydrogels

KW - Knee Injuries

KW - Knee Joint

KW - Male

KW - Pain, Postoperative

KW - Patient Satisfaction

KW - Prospective Studies

KW - Severity of Illness Index

KW - Transplantation, Autologous

KW - Young Adult

U2 - 10.1177/0363546511423369

DO - 10.1177/0363546511423369

M3 - SCORING: Journal article

C2 - 21984690

VL - 39

SP - 2558

EP - 2565

JO - AM J SPORT MED

JF - AM J SPORT MED

SN - 0363-5465

IS - 12

ER -