Autologous chondrocyte implantation using the original periosteum-cover technique versus matrix-associated autologous chondrocyte implantation: a randomized clinical trial.
Zeifang Felix,Oberle Doris,Nierhoff Corinna,Richter Wiltrud,Moradi Babak,Schmitt Holger
The American journal of sports medicine
BACKGROUND:Autologous chondrocyte implantation (ACI) is frequently used to treat symptomatic defects of the articular cartilage. PURPOSE:To test whether matrix-associated autologous chondrocyte implantation or the original periosteal flap technique provides superior outcomes in terms of clinical efficacy and safety. STUDY DESIGN:Randomized controlled trial; Level of evidence, 2. METHODS:Twenty-one patients (mean age, 29.3 +/- 9.1 years) with symptomatic isolated full-thickness cartilage defects (mean 4.1 +/- 09 cm2) at the femoral condyle were randomized to matrix-associated autologous chondrocyte implantation or the original periosteal flap technique. The primary outcome parameter was the postoperative change in knee function as assessed by the International Knee Documentation Committee (IKDC) score at 12 months after ACI. In addition, the IKDC score was assessed at 3, 6, 12, and 24 months after surgery. Secondary outcome parameters were postoperative changes in health related quality of life (Short Form-36 Health Survey), knee functionality (Lysholm and Gillquist score), and physical activity (Tegner Activity Score) at 3, 6, 12, and 24 months after ACI. Magnetic resonance imaging was performed to evaluate the cartilage 6, 12, and 24 months after ACI and rated using the Magnetic Resonance Observation of Cartilage Repair Tissue score. Adverse events were recorded to assess safety. RESULTS:The primary outcome parameter showed improvement of patients 1 year after autologous chondrocyte implantation, but there was no difference between the periosteal flap technique and matrix-associated ACI (P = .5573); 2 years after ACI, a similar result was found (P = .4994). The study groups did not show differences in the Short Form-36 categories and in knee functionality as assessed by Tegner Activity Score 12 months (P = .4063) and 24 months (P = .1043) after ACI. There was a significant difference in the Lysholm and Gillquist score at 12 months (P = .0449) and 24 months (P = .0487) favoring the periosteal flap technique group. At 6 months after surgery, a significantly lower Magnetic Resonance Observation of Cartilage Repair score was obtained in the matrix-associated ACI group (P = .0123), corresponding to more normal magnetic resonance imaging diagnostic findings. Twelve and 24 months after ACI, the differences between the 2 groups were not significant (12 months, P = .2065; 24 months, P = .6926). Adverse events were related to knee problems such as transplant delamination, development of an osseous spur, osteochondral dissection, and transplant hypertrophy. Systemic (allergic, toxic, or autoimmune) reactions did not occur. CONCLUSION:There was no difference in the efficacy between the original and the advanced ACI technique 12 and 24 months after surgery regarding International Knee Documentation Committee, Tegner Activity Score, and Short Form-36; however, with respect to the Lysholm and Gillquist score, better efficacy was observed in the periosteal flap technique group.
Prospective Long-term Follow-up of Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation: A Randomized Clinical Trial.
Barié Alexander,Kruck Patrizia,Sorbi Reza,Rehnitz Christoph,Oberle Doris,Walker Tilman,Zeifang Felix,Moradi Babak
The American journal of sports medicine
BACKGROUND:Matrix-associated autologous chondrocyte implantation (MACI) is a further development of the original autologous chondrocyte implantation periosteal flap technique (ACI-P) for the treatment of articular cartilage defects. PURPOSE:We aimed to establish whether MACI or ACI-P provides superior long-term outcomes in terms of patient satisfaction, clinical assessment, and magnetic resonance imaging (MRI) evaluation. STUDY DESIGN:Randomized controlled trial; Level of evidence, 2. METHODS:A total of 21 patients with cartilage defects at the femoral condyle were randomized to MACI (n = 11) or ACI-P (n = 10) between the years 2004 and 2006. Patients were assessed for subjective International Knee Documentation Committee (IKDC) score, Lysholm and Gillquist score, Tegner Activity Score, and 36-Item Short Form Health Survey (SF-36) preoperatively (T0), at 1 and 2 years postoperatively (T1, T2), and at the final follow-up 8 to 11 years after surgery (T3). Onset of osteoarthritis was determined using the Kellgren-Lawrence score and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and delayed gadolinium-enhanced MRI of cartilage was used to evaluate the cartilage. Adverse events were recorded to assess safety. RESULTS:There were 16 patients (MACI, n = 9; ACI-P, n = 7) who were reassessed on average 9.6 years after surgery (76% follow-up rate). The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2. IKDC scores increased significantly at all postoperative evaluation time points in ACI-P. In MACI, IKDC scores showed a significant increase at T1 and T3 when compared with T0. In the majority of the patients (10/16; MACI, 5/9; ACI-P, 5/7) a complete defect filling was present at the final follow-up as shown by the MOCART score, and 1 patient in the ACI-P group displayed hypertrophy of the repair tissue, which represents 6% of the whole study group and 14.3% of the ACI-P group. Besides higher SF-36 vitality scores in ACI-P at T3, no significant differences were seen in clinical scores and MRI scores between the 2 methods at any time point. Revision rate was 33.3% in MACI and 28.6% in ACI-P at the last follow-up. CONCLUSION:Our long-term results suggest that first- and third-generation ACI methods are equally effective treatments for isolated full-thickness cartilage defects of the knee. With the number of participants available, no significant difference was noted between MACI and ACI-P at any time point. Interpretation of our data has to be performed with caution due to the small sample size, which was further limited by a loss to follow-up of 24%.