Matrix-Associated Autologous Chondrocyte Implantation with Spheroid Technology Is Superior to Arthroscopic Microfracture at 36 Months Regarding Activities of Daily Living and Sporting Activities after Treatment

Objective Matrix-associated autologous chondrocyte implantation (ACI) and microfracture (MF) are well-established treatments for cartilage defects of the knee. However, high-level evidence comparing microfracture and spheroid technology ACI is limited. Design Prospective, phase III clinical trial with patients randomized to ACI ( N = 52) or MF ( N = 50). Level of evidence: 1, randomized controlled trial. Both procedures followed standard protocols. For ACI 10 to 70 spheroids/cm2 were administered. Primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS). This report presents results for 36 months after treatment. Results Both ACI and MF showed significant improvement over the entire 3-year observation period. For the overall KOOS, noninferiority of ACI (the intended primary goal of the study) was formally confirmed; additionally, for the subscores “Activities of Daily Living” and “Sport and Recreation,” superiority of ACI over MF was shown at descriptive level. Occurrence of adverse events were not different between both treatments (ACI 77%; MF 74%). Four patients in the MF group required reoperation which was defined as treatment failure. No treatment failure was reported for the ACI group. Conclusions Patients treated with matrix-associated ACI with spheroid technology showed substantial improvement in various clinical outcomes after 36 months. The advantages of ACI compared with microfracture was underlined by demonstrating noninferiority, in overall KOOS and superiority in the KOOS subscores “Activities of Daily Living” and “Sport and Recreation.” In the present study, subgroups comparing different age groups and defect sizes showed comparable clinical outcomes.

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A Prospective, Randomized, Open-Label, Multicenter, Phase III Noninferiority Trial to Compare the Clinical Efficacy of Matrix-Associated Autologous Chondrocyte Implantation With Spheroid Technology Versus Arthroscopic Microfracture for Cartilage Defects of the Knee

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119854442 ◽

2019 ◽

Vol 7 (7) ◽

pp. 232596711985444 ◽

Cited By ~ 10

Author(s):

Philipp Niemeyer ◽

Volker Laute ◽

Wolfgang Zinser ◽

Christoph Becher ◽

Thomas Kolombe ◽

...

Keyword(s):

Activities Of Daily Living ◽

Cartilage Repair ◽

Daily Living ◽

Autologous Chondrocyte Implantation ◽

Statistical Hypothesis ◽

Cartilage Defects ◽

Koos Score ◽

Chondrocyte Implantation ◽

Autologous Chondrocyte

Background:Autologous chondrocyte implantation (ACI) and microfracture are established treatments for large, full-thickness cartilage defects, but there is still a need to expand the clinical and health economic knowledge of these procedures.Purpose:To confirm the noninferiority of ACI compared with microfracture.Study Design:Randomized controlled trial; Level of evidence, 2.Methods:Patients were randomized to be treated with matrix-associated ACI using spheroid technology (n = 52) or microfracture (n = 50). Both procedures followed standard methods. Patients were assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS), MOCART (magnetic resonance observation of cartilage repair tissue) scoring system, Bern score, modified Lysholm score, International Cartilage Repair Society (ICRS) rating (histological and immunochemical scoring after rebiopsy 24 months after implantation), and International Knee Documentation Committee (IKDC) examination form. The main assessments were conducted 24 months after study treatment.Results:In the primary intention-to-treat analysis, the overall KOOS score for both ACI and microfracture yielded a statistically significant improvement relative to baseline. According to the between-group analysis, ACI passed the test of noninferiority compared with microfracture; thus, the primary goal of the study was achieved. The KOOS subscores yielded the same qualitative results as the overall KOOS score (ie, for each of these, noninferiority was demonstrated), and in 1 case (Activities of Daily Living subscore), the threshold for superiority was passed. The subgroup analyses did not yield any clear evidence of an association between treatment effect and any of the categories investigated (age, diagnosis, defect localization, sex). A histological analysis of biopsies from 16 patients (ACI: n = 9; microfracture: n = 7) suggested a better quality of repair in the patients treated with ACI.Conclusion:The efficacy of both ACI and microfracture was demonstrated with respect to both functional outcomes and morphological repair. The primary analysis confirmed the statistical hypothesis of the noninferiority of ACI, even for relatively small cartilage defects (1-4 cm2) treated in this study, the indication for which microfracture is generally accepted as the standard of care. ACI showed significant superiority in the KOOS subscores of Activities of Daily Living at 24 months and Knee-related Quality of Life at 12 months.Registration:NCT01222559 ( ClinicalTrials.gov identifier).

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A 20-Year Follow-up After First-Generation Autologous Chondrocyte Implantation

The American Journal of Sports Medicine ◽

10.1177/0363546517716631 ◽

2017 ◽

Vol 45 (12) ◽

pp. 2751-2761 ◽

Cited By ~ 50

Author(s):

Takahiro Ogura ◽

Brian A. Mosier ◽

Tim Bryant ◽

Tom Minas

Keyword(s):

Articular Cartilage ◽

Clinical Outcomes ◽

Autologous Chondrocyte Implantation ◽

First Generation ◽

Short Form ◽

Cartilage Defects ◽

Sf 36 ◽

Chondrocyte Implantation ◽

Autologous Chondrocyte

Background: Treating articular cartilage defects is a demanding problem. Although several studies have reported durable and improved clinical outcomes after autologous chondrocyte implantation (ACI) over a long-term period, there is no report with over 20 years’ follow-up. Purpose: To evaluate clinical outcomes after first-generation ACI for the treatment of knees with disabling, large single and multiple cartilage defects for which patients wished to avoid prosthetic arthroplasty, with a minimum of 20 years’ follow-up. Study Design: Case series; Level of evidence, 4. Methods: The authors reviewed prospectively collected data from 23 patients (24 knees; mean age, 35.4 years [range, 13-52 years]) undergoing ACI for the treatment of symptomatic, full-thickness articular cartilage lesions. A mean of 2.1 lesions per knee were treated over a mean total surface area of 11.8 cm2 (range, 2.4-30.5 cm2) per knee. Kaplan-Meier survival analysis and functional outcome scores, including the modified Cincinnati Knee Rating System, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Short Form–36 (SF-36), were used. Patients also self-reported an improvement in pain with a visual analog scale and a satisfaction survey. Results: The 20-year survival rate was 63% (95% CI, 40%-78%). The evaluation of the 15 knees with retained grafts demonstrated that all clinical scores except the WOMAC subscore for stiffness and SF-36 mental component summary score improved significantly and were sustained to 20 years postoperatively. Ninety-three percent of these patients rated knee-specific outcomes as good or excellent. The outcomes for 9 of 24 knees were considered failures, including 5 undergoing revision ACI and 4 being converted to arthroplasty at a mean of 1.7 and 5.9 years, respectively. Only 1 of 5 knees that underwent revision ACI was converted to arthroplasty at 1.9 years after the index surgery, and the other 4 patients were able to maintain their biological knee. Overall, 20 years later, 79% of patients maintained their native knee, for which they initially sought treatment, and were satisfied when evaluated. Conclusion: First-generation ACI provided satisfactory survival rates and significant clinical improvements over a 20-year follow-up, which offers an important standard for comparison with newer-generation ACI technologies of the future.

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Do meta-analyses reveal time-dependent differences between the clinical outcomes achieved by microfracture and autologous chondrocyte implantation in the treatment of cartilage defects of the knee?

Journal of Orthopaedic Science ◽

10.1007/s00776-013-0449-3 ◽

2013 ◽

Vol 18 (6) ◽

pp. 940-948 ◽

Cited By ~ 24

Author(s):

Lukas Leopold Negrin ◽

Vilmos Vécsei

Keyword(s):

Clinical Outcomes ◽

Autologous Chondrocyte Implantation ◽

Time Dependent ◽

Cartilage Defects ◽

Chondrocyte Implantation ◽

Meta Analyses ◽

Autologous Chondrocyte

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Prone-positioned knee arthroscopy for isolated retropatellar cartilage defects with gel-type autologous chondrocyte implantation

Operative Orthopädie und Traumatologie ◽

10.1007/s00064-021-00710-1 ◽

2021 ◽

Author(s):

Mahmut Enes Kayaalp ◽

Yigit Umur Cirdi ◽

Sebastian Kopf ◽

Roland Becker

Keyword(s):

Autologous Chondrocyte Implantation ◽

Knee Arthroscopy ◽

Cartilage Defects ◽

Chondrocyte Implantation ◽

Autologous Chondrocyte

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Etiology of Cartilage Lesions Does Not Affect Clinical Outcomes of Patellofemoral Autologous Chondrocyte Implantation

Cartilage ◽

10.1177/19476035211030991 ◽

2021 ◽

pp. 194760352110309

Author(s):

Alexandre Barbieri Mestriner ◽

Jakob Ackermann ◽

Gergo Merkely ◽

Pedro Henrique Schmidt Alves Ferreira Galvão ◽

Luiz Felipe Morlin Ambra ◽

...

Keyword(s):

Clinical Outcomes ◽

Autologous Chondrocyte Implantation ◽

Second Generation ◽

Cartilage Lesion ◽

Chondrocyte Implantation ◽

Group 3 ◽

Group 2 ◽

Autologous Chondrocyte ◽

Group 1

Objective To determine the relationship between cartilage lesion etiology and clinical outcomes after second-generation autologous chondrocyte implantation (ACI) in the patellofemoral joint (PFJ) with a minimum of 2 years’ follow-up. Methods A retrospective review of all patients that underwent ACI in the PFJ by a single surgeon was performed. Seventy-two patients with a mean follow-up of 4.2 ± 2.0 years were enrolled in this study and were stratified into 3 groups based on the etiology of PFJ cartilage lesions: patellar dislocation (group 1; n = 23); nontraumatic lesions, including chondromalacia, osteochondritis dissecans, and degenerative defects (group 2; n = 28); and other posttraumatic lesions besides patellar dislocations (group 3; n = 21). Patient’s mean age was 29.6 ± 8.7 years. Patients in group 1 were significantly younger (25.4 ± 7.9 years) than group 2 (31.7 ± 9.6 years; P = 0.025) and group 3 (31.5 ± 6.6 years; P = 0.05). Body mass index averaged 26.2 ± 4.3 kg/m2, with a significant difference between group 1 (24.4 ± 3.2 kg/m2) and group 3 (28.7 ± 4.5 kg/m2; P = 0.005). A clinical comparison was established between groups based on patient-reported outcome measures (PROMs) and failure rates. Results Neither pre- nor postoperative PROMs differed between groups ( P > 0.05). No difference was seen in survivorship between groups (95.7% vs. 82.2% vs. 90.5%, P > 0.05). Conclusion Cartilage lesion etiology did not influence clinical outcome in this retrospective study after second generation ACI in the PFJ. Level of Evidence Level III, retrospective comparative study.

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