Arthroscopic Matrix-Assisted Autologous Chondrocyte Transplantation Versus Microfracture: A 6-Year Follow-up of a Prospective Randomized Trial

2021 ◽  
pp. 036354652110104
Author(s):  
Clemente Ibarra ◽  
Enrique Villalobos ◽  
Antonio Madrazo-Ibarra ◽  
Cristina Velasquillo ◽  
Valentin Martinez-Lopez ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
Adverse Events ◽  
Cartilage Repair ◽  
T2 Mapping ◽  
Chondrocyte Transplantation ◽  
Knee Cartilage ◽  
Randomized Controlled ◽  
Preoperative Status ◽  
Autologous Chondrocyte

Background: Few randomized controlled trials with a midterm follow-up have compared matrix-assisted autologous chondrocyte transplantation (MACT) with microfracture (MFx) for knee cartilage lesions. Purpose: To compare the structural, clinical, and safety outcomes at midterm follow-up of MACT versus MFx for treating symptomatic knee cartilage lesions. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 48 patients aged between 18 and 50 years, with 1- to 4-cm2 International Cartilage Repair Society (ICRS) grade III to IV knee chondral lesions, were randomized in a 1:1 ratio to the MACT and MFx treatment groups. A sequential prospective evaluation was performed using magnetic resonance imaging (MRI) T2 mapping, the MOCART (magnetic resonance observation of cartilage repair tissue) score, second-look arthroscopic surgery, patient-reported outcome measures, the responder rate (based on achieving the minimal clinically important difference for the Knee injury and Osteoarthritis Outcome Score [KOOS] pain and KOOS Sport/Recreation), adverse events, and treatment failure (defined as a reoperation because of symptoms caused by the primary defect and the detachment or absence of >50% of the repaired tissue during revision surgery). Results: Overall, 35 patients (18 MACT and 17 MFx) with a mean chondral lesion size of 1.8 ± 0.8 cm2 (range, 1-4 cm2) were followed up to a mean of 6 years postoperatively (range, 4-9 years). MACT demonstrated significantly better structural outcomes than MFx at 1 to 6 years postoperatively. At final follow-up, the MRI T2 mapping values of the repaired tissue were 37.7 ± 8.5 ms for MACT versus 46.4 ± 8.5 ms for MFx ( P = .003), while the MOCART scores were 59.4 ± 17.3 and 42.4 ± 16.3, respectively ( P = .006). More than 50% defect filling was seen in 95% of patients at 2 years and 82% at 6 years in the MACT group and in 67% at 2 years and 53% at 6 years in the MFx group. The second-look ICRS scores at 1 year were 10.7 ± 1.3 for MACT and 9.0 ± 1.8 for MFx ( P = .001). Both groups showed significant clinical improvements at 6 years postoperatively compared with their preoperative status. Significant differences favoring the MACT group were observed at 2 years on the KOOS Activities of Daily Living ( P = .043), at 4 years on all KOOS subscales (except Symptoms; P < .05) and the Tegner scale ( P = .008), and at 6 years on the Tegner scale ( P = .010). The responder rates at 6 years were 53% and 77% for MFx and MACT, respectively. There were no reported treatment failures after MACT; the failure rate was 8.3% in the MFx group. Neither group had serious adverse events related to treatment. Conclusion: Patients who underwent MACT had better structural outcomes than those who underwent MFx at 1 to 6 years postoperatively. Both groups of patients showed significant clinical improvements at final follow-up compared with their preoperative status. MACT showed superiority at 4 years for the majority of the KOOS subscales and for the Tegner scale at 4 to 6 years. The MACT group also had a higher responder rate and lower failure rate at final follow-up. Registration: NCT01947374 ( ClinicalTrials.gov identifier).

Arthroscopic Matrix-Encapsulated Autologous Chondrocyte Implantation: A Pilot Multicenter Investigation in Latin America

Cartilage ◽  
2020 ◽  
pp. 194760352091863
Author(s):  
Enrique Villalobos ◽  
Antonio Madrazo-Ibarra ◽  
Valentín Martínez ◽  
Anell Olivos-Meza ◽  
Cristina Velasquillo ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
Cell Viability ◽  
Cartilage Repair ◽  
Autologous Chondrocyte Implantation ◽  
T2 Mapping ◽  
Second Look ◽  
Arthroscopic Evaluation ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Objective. To evaluate minimum biosecurity parameters (MBP) for arthroscopic matrix-encapsulated autologous chondrocyte implantation (AMECI) based on patients’ clinical outcomes, magnetic resonance imaging (MRI) T2-mapping, Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and International Cartilage Repair Society (ICRS) second-look arthroscopic evaluation, laying the basis for a future multicenter study. Design. Pilot clinical study. We analyzed the logistics to perform AMECI to treat focal chondral lesions in different hospitals following strict biosecurity parameters related to tissue and construct transportation, chondrocyte isolation, and cell expansion. Patient progress was analyzed with patient-reported outcome measures, MRI T2-mapping, MOCART, and ICRS arthroscopic second-look evaluation. Results. Thirty-five lesions in 30 patients treated in 7 different hospitals were evaluated. Cell viability before implantation was >90%. Cell viability in construct remnants was 87% ± 11% at 24 hours, 75% ± 17.1% at 48 hours, and 60% ± 8% at 72 hours after implantation. Mean final follow-up was 37 months (12-72 months). Patients showed statistically significant improvement in all clinical scores and MOCART evaluations. MRI T2-mapping evaluation showed significant decrease in relaxation time from 61.2 ± 14.3 to 42.9 ± 7.2 ms ( P < 0.05). Arthroscopic second-look evaluation showed grade II “near normal” tissue in 83% of patients. Two treatment failures were documented. Conclusions. It was feasible to perform AMECI in 7 different institutions in a large metropolitan area following our biosecurity measures without any implant-related complication. Treated patients showed improvement in clinical, MRI T2-mapping, and MOCART scores, as well as a low failure rate and a favorable ICRS arthroscopic evaluation at a mid-term follow-up. Level of Evidence. 2b.

scholarly journals Allogeneic Umbilical Cord Blood–Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up

2021 ◽  
Vol 9 (1) ◽  
pp. 232596712097305
Author(s):  
Hong-Chul Lim ◽  
Yong-Beom Park ◽  
Chul-Won Ha ◽  
Brian J. Cole ◽  
Beom-Koo Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Cartilage Repair ◽  
Older Patients ◽  
Cartilage Defects ◽  
Full Thickness ◽  
Phase 3 ◽  
Randomized Controlled ◽  
Cartilage Restoration

Background: There is currently no optimal method for cartilage restoration in large, full-thickness cartilage defects in older patients. Purpose: To determine whether implantation of a composite of allogeneic umbilical cord blood–derived mesenchymal stem cells and 4% hyaluronate (UCB-MSC-HA) will result in reliable cartilage restoration in patients with large, full-thickness cartilage defects and whether any clinical improvements can be maintained up to 5 years postoperatively. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A randomized controlled phase 3 clinical trial was conducted for 48 weeks, and the participants then underwent extended 5-year observational follow-up. Enrolled were patients with large, full-thickness cartilage defects (International Cartilage Repair Society [ICRS] grade 4) in a single compartment of the knee joint, as confirmed by arthroscopy. The defect was treated either with UCB-MSC-HA implantation through mini-arthrotomy or with microfracture. The primary outcome was proportion of participants who improved by ≥1 grade on the ICRS Macroscopic Cartilage Repair Assessment (blinded evaluation) at 48-week arthroscopy. Secondary outcomes included histologic assessment; changes in pain visual analog scale (VAS) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and International Knee Documentation Committee (IKDC) score from baseline; and adverse events. Results: Among 114 randomized participants (mean age, 55.9 years; 67% female; body mass index, 26.2 kg/m2), 89 completed the phase 3 clinical trial and 73 were enrolled in the 5-year follow-up study. The mean defect size was 4.9 cm2 in the UCB-MSC-HA group and 4.0 cm2 in the microfracture group ( P = .051). At 48 weeks, improvement by ≥1 ICRS grade was seen in 97.7% of the UCB-MSC-HA group versus 71.7% of the microfracture group ( P = .001); the overall histologic assessment score was also superior in the UCB-MSC-HA group ( P = .036). Improvement in VAS pain, WOMAC, and IKDC scores were not significantly different between the groups at 48 weeks, however the clinical results were significantly better in the UCB-MSC-HA group at 3- to 5-year follow-up ( P < .05). There were no differences between the groups in adverse events. Conclusion: In older patients with symptomatic, large, full-thickness cartilage defects with or without osteoarthritis, UCB-MSC-HA implantation resulted in improved cartilage grade at second-look arthroscopy and provided more improvement in pain and function up to 5 years compared with microfracture. Registration: NCT01041001, NCT01626677 (ClinicalTrials.gov identifier).

Costal Chondrocyte–Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect

2020 ◽  
Vol 48 (5) ◽  
pp. 1236-1245 ◽  
Author(s):  
Kyoung-Ho Yoon ◽  
Jae-Young Park ◽  
Jin-Yeon Lee ◽  
EunAh Lee ◽  
Jungsun Lee ◽  
...  
Keyword(s):  
Articular Cartilage ◽  
Magnetic Resonance ◽  
Cartilage Repair ◽  
Therapeutic Option ◽  
Cartilage Defects ◽  
Resonance Imaging ◽  
Defect Filling ◽  
Costal Chondrocyte ◽  
Autologous Chondrocyte

Background: Because articular chondrocyte-based autologous chondrocyte implantations (ACIs) have restrictively restored articular cartilage defects, alternative cell sources as a new therapeutic option for cartilage repair have been introduced. Purpose: To assess whether implantation of a costal chondrocyte–derived pellet-type (CCP) ACI allows safe, functional, and structural restoration of full-thickness cartilage defects in the knee. Study Design: Case series; Level of evidence, 4. Methods: In this first-in-human study, 7 patients with symptomatic, full-thickness cartilage lesions were enrolled. The chondrocytes isolated from the patients’ costal cartilage were expanded, followed by 3-dimensional pellet culture to prepare the CCP-ACI. Implantation of the pellets was performed via minimal arthrotomy and secured with a fibrin sealant. Clinical scores, including the International Knee Documentation Committee (IKDC) subjective, Lysholm, and Tegner activity scores, were estimated preoperatively and at 1, 2, and 5 years postoperatively. High-resolution magnetic resonance imaging was also performed to evaluate cartilage repair as well as to calculate the MOCART (magnetic resonance observation of cartilage repair tissue) score. Results: The costal chondrocytes of all patients formed homogeneous-sized pellets, which showed the characteristics of the hyaline cartilaginous tissue with lacunae-occupied chondrocytes surrounded by glycosaminoglycan and type II collagen-rich extracellular matrix. There were no treatment-related serious adverse events during the 5-year follow-up period. Significant improvements were seen in all clinical scores from preoperative baseline to the 5-year follow-up (IKDC subjective score, 34.67 to 75.86; Lysholm score, 34.00 to 85.33; Tegner activity score, 1.17 to 4.67; and MOCART score, 28.33 to 83.33). Two patients had complete defect filling on magnetic resonance imaging evaluation at 1 year. Moreover, at 5 years postoperatively, complete defect filling was observed in 4 patients, and hypertrophy or incomplete defect filling (50%-100%) was observed in 2 patients. Conclusion: The overall results of this clinical study suggest that CCP-ACI can emerge as a promising therapeutic option for articular cartilage repair with good clinical outcomes and structural regeneration and with stable results at midterm follow-up. Registration: NCT03517046 ( ClinicalTrials.gov identifier)

scholarly journals Mosaicplasty versus Matrix-Assisted Autologous Chondrocyte Transplantation for Knee Cartilage Defects: A Long-Term Clinical and Imaging Evaluation

2020 ◽  
Vol 10 (13) ◽  
pp. 4615
Author(s):  
Stefano Zaffagnini ◽  
Angelo Boffa ◽  
Luca Andriolo ◽  
Davide Reale ◽  
Maurizio Busacca ◽  
...  
Keyword(s):  
Activity Level ◽  
Autologous Chondrocyte Transplantation ◽  
Cartilage Defects ◽  
Chondrocyte Transplantation ◽  
Knee Cartilage ◽  
Cartilage Lesions ◽  
Long Term Follow Up ◽  
Autologous Chondrocyte

Different surgical procedures have been proposed over the past few years to treat cartilage lesions. The aim of this study was to compare mosaicplasty and matrix-assisted autologous chondrocyte transplantation (MACT) at long-term follow-up. Forty-three patients were included: 20 mosaicplasty and 23 MACT. Patients were evaluated before and 12 years after surgery with the International Knee Documentation Committee (IKDC) subjective and objective scores for symptoms and function, and with the Tegner score for activity level. Magnetic Resonance Imaging (MRI) was used to evaluate repair tissue with the MOCART 2.0 score. Mosaicplasty and MACT showed good clinical and MRI results (IKDC subjective score 75.3 ± 21.8 and 81.8 ± 13.0, both p < 0.0005). Mosaicplasty presented a 10% reoperation rate and a 25% overall failure rate, while no failures were documented in MACT (p = 0.016). While size did not influence the results in the MACT group, mosaicplasty presented lower IKDC objective and Tegner scores in lesions bigger than 2 cm2 (p = 0.031 and p = 0.014, respectively). Mosaicplasty and MACT presented both satisfactory clinical and MRI results at long-term follow-up. However, for larger lesions, MACT presented better subjective and objective outcomes, as well as less failures, which should be considered when choosing the most suitable treatment for patients affected by knee cartilage lesions.

scholarly journals Minimum 10 Year Clinical and Radiological Outcomes of a Randomized Controlled Trial Evaluating Accelerated Weight Bearing After Matrix-Induced Autologous Chondrocyte Implantation

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0026
Author(s):  
Jay R. Ebert ◽  
Michael Fallon ◽  
Greg Janes ◽  
David Wood
Keyword(s):  
Magnetic Resonance ◽  
Clinical Outcomes ◽  
Autologous Chondrocyte Implantation ◽  
Weight Bearing ◽  
Repair Tissue ◽  
Randomized Controlled ◽  
Post Surgery ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Objectives: Matrix-induced autologous chondrocyte implantation (MACI) has demonstrated encouraging clinical outcomes in the treatment of symptomatic knee chondral defects. However, longer term results are still lacking and post-operative management has traditionally been conservative, with little available evidence on how best to progressively increase weight bearing (WB) and rehabilitation post-surgery. This study sought to investigate the longer term clinical and radiological outcomes following an accelerated (versus conservative) WB protocol after MACI. Methods: A randomized controlled study design was used to investigate outcomes in 70 patients who underwent MACI to the medial or lateral femoral condyle between November 2005 and November 2007, in conjunction with either an accelerated (AR, n=34, 8 weeks to full WB) or conservative (CR, n=36, 12 weeks to full WB) approach to post-operative WB rehabilitation. Patients were evaluated pre-surgery and at 3, 6, 12 and 24 months, as well as 5 years post-surgery. At minimum 10 year follow up (range 10.5-11.5 years), 60 patients (86%, AR=31, CR=29) were available for review. Clinical outcomes included the IKDC, KOOS, Lysholm, Cincinnati, Tegner, SF-36, Satisfaction, maximal isokinetic knee extensor and flexor strength and functional hop capacity. Limb Symmetry Indicies (LSIs) comparing the operated and non-operated limbs were calculated for strength and functional measures. High resolution magnetic resonance imaging (MRI) was undertaken to assess the quality and quantity of repair tissue as per the magnetic resonance observation of cartilage repair tissue (MOCART) scoring system. A combined MRI composite score was also evalauted. ANOVA investigated group differecnes over time. Results: While the AR group reported significantly less knee pain in the earlier post-operative timeline, no significant differences (p>0.05) were observed in patient demographics or injury/surgery characteristics between groups, nor clinical and MRI-based scores, at minimum 10 year post-operative follow up. All clinical scores across both groups significantly improved (p<0.001) to 5 years, maintained to 10 years. At minimum 10 years, no differences were observed in mean LSIs for maximal isokinetic knee extension strength (AR=96.8%, CR=97.9%), or the single (AR=95.5%, CR=98.9%) and triple hop (AR=96.7%, CR=99.6%) tests for distance. At a minimum 10 years 82.4% and 83.3% of patients in the AR and CR groups, respectively, demonstrated a good-excellent MRI composite score, while 79.4% and 83.3% demonstrated good-excellent tissue infill, as per the MOCART score. Graft failure was observed on MRI in 5 patients (8.3%, AR=2, CR=3) at 10 years post-surgery. At 10 years, 93.3% of patients were satisfied with MACI for relieving their pain, with 83.4% satisfied with their ability to participate in sport. Conclusion: MACI provided high levels of patient satisfaction and tissue durability beyond 10 years. The outcomes of this randomized trial demonstrate a safe and effective accelerated WB rehabilitation protocol, with improved early patient outcomes albeit comparable longer term results.

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