scholarly journals Minimum 10-Year Clinical and Radiological Outcomes of a Randomized Controlled Trial Evaluating 2 Different Approaches to Full Weightbearing After Matrix-Induced Autologous Chondrocyte Implantation

2019 ◽  
Vol 48 (1) ◽  
pp. 133-142 ◽  
Author(s):  
Jay R. Ebert ◽  
Michael Fallon ◽  
Timothy R. Ackland ◽  
Gregory C. Janes ◽  
David J. Wood
Keyword(s):  
Randomized Controlled Trial ◽  
Magnetic Resonance ◽  
Study Design ◽  
Autologous Chondrocyte Implantation ◽  
Controlled Trial ◽  
Repair Tissue ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Background: Longer term outcomes after matrix-induced autologous chondrocyte implantation (MACI) are lacking, while early postoperative weightbearing (WB) management has traditionally been conservative. Purpose: To investigate the longer term clinical and radiological outcomes after an 8-week (vs 12-week) WB protocol after MACI. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A randomized study design allocated 70 patients to an 8- (n = 34) or 12-week (n = 36) approach to full WB after MACI of the medial or lateral femoral condyle. Patients were evaluated preoperatively; at 3, 12, and 24 months after surgery; and at 5 and 10 years after surgery. At 10 years (range, 10.5-11.5 years), 60 patients (85.7%; 8 weeks: n = 29; 12 weeks: n = 31) were available for review. Clinical outcomes included patient-reported outcomes, maximal isokinetic knee extensor and flexor strength, and functional hop capacity. High-resolution magnetic resonance imaging (MRI) was undertaken to assess the quality and quantity of repair tissue per the MOCART (magnetic resonance observation of cartilage repair tissue) system. A combined MRI composite score was also evaluated. Results: Clinical and MRI-based scores for the full cohort significantly improved ( P < .05) over the 10-year period. Apart from the Tegner activity score, which improved ( P = .041), as well as tissue structure ( P = .030), which deteriorated, there were no further statistically significant changes ( P > .05) from 5 to 10 years. There were no 10-year differences between the 2 WB rehabilitation groups. At 10 years, 81.5% and 82.8% of patients in the 8- and 12-week groups, respectively, demonstrated good-excellent tissue infill. Graft failure was observed on MRI at 10 years in 7 patients overall, which included 4 located on 10-year MRI (8 weeks: n = 1; 12 weeks: n = 3) and a further 3 patients (8 weeks: n = 1; 12 weeks: n = 2) not included in the current analysis who proceeded to total knee arthroplasty. At 10 years, 93.3% of patients were satisfied with MACI for relieving their pain, with 83.3% satisfied with their ability to participate in sport. Conclusion: MACI provided high satisfaction levels and tissue durability beyond 10 years. The outcomes of this randomized trial demonstrate a safe 8-week WB rehabilitation protocol without jeopardizing longer term outcomes.

scholarly journals Collagen-Covered Autologous Chondrocyte Implantation Versus Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee

2019 ◽  
Vol 7 (9) ◽  
pp. 232596711986821 ◽  
Author(s):  
Vegard Fossum ◽  
Ann Kristin Hansen ◽  
Tom Wilsgaard ◽  
Gunnar Knutsen
Keyword(s):  
Randomized Controlled Trial ◽  
Autologous Chondrocyte Implantation ◽  
Controlled Trial ◽  
Long Term Results ◽  
Cartilage Defects ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Background:Autologous matrix-induced chondrogenesis (AMIC) is a single-stage alternative to autologous chondrocyte implantation for treatment of localized cartilage defects of the knee. To our knowledge, no randomized controlled trial exists comparing the 2 methods.Purpose:To evaluate any difference in the outcome of AMIC as compared with collagen-covered autologous chondrocyte implantation (ACI-C).Study Design:Randomized controlled trial; Level of evidence, 2.Methods:A prospective randomized controlled clinical trial was designed to assess any differences in the outcomes between ACI-C and AMIC for the treatment of ≥1 chondral or osteochondral defects of the distal femur and/or patella. The inclusion period was set to 3 years, and the aim was to include 80 patients (40 in each group). Patient inclusion was broad, with few exclusion criteria. The primary outcome was change in Knee injury and Osteoarthritis Outcome Score (KOOS) at 2 years as compared with baseline. The secondary outcomes were the number of failures in each group at 2 years and the change in KOOS subscale, Lysholm, and pain visual analog scale (VAS) scores at 2 years as compared with baseline. A 2-sample t test with a significance level of P < .05 was used to compare the change in score from baseline between groups.Results:A total of 41 patients over 3 years were included in the study: 21 in the ACI-C group and 20 in the AMIC group. All the patients had prior surgery to the index knee. At 2-year follow-up, the clinical scores for both groups improved significantly from baseline. No significant differences between groups were seen in the change from baseline for KOOS (AMIC, 18.1; ACI-C, 10.3), any of the KOOS subscales, the Lysholm score (AMIC, 19.7; ACI-C, 17.0), or the VAS pain score (AMIC, 30.6; ACI-C, 19.6). Two patients in the AMIC group had progressed to a total knee replacement by the 2-year follow-up as compared with none in the ACI-C group.Conclusion:At 2-year follow-up, no significant differences were found regarding outcomes between ACI-C and AMIC. Mid- and long-term results will be important.Registration:NCT01458782 ( ClinicalTrials.gov identifier).

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.

scholarly journals Autologous Chondrocyte Implantation to Isolated Patella Cartilage Defects

Cartilage ◽  
2016 ◽  
Vol 8 (2) ◽  
pp. 146-154 ◽  
Author(s):  
Arvind von Keudell ◽  
Roger Han ◽  
Tim Bryant ◽  
Tom Minas
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Outcome Measures ◽  
Autologous Chondrocyte Implantation ◽  
Tibial Tubercle ◽  
Resonance Imaging ◽  
Patient Reported ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Background Autologous chondrocyte implantation (ACI) is a durable treatment for patients with chondral defects. This study presents the comprehensive evaluation of patients with patella defects treated with ACI at medium- to long-term follow-up. Methods Thirty consecutive patients with isolated chondral lesions of the patella were enrolled prospectively. Primary outcome measures were validated patient reported outcome measures and objective magnetic resonance imaging. Results Nineteen of 30 patients underwent tibial tubercle osteotomy (TTO) to correct lateral maltracking in combination with soft tissue balancing. The defect sizes were large, averaging 4.7 ± 2.1 cm2 (range 2.2-30.0 cm2). Pidoriano/Fulkerson classification revealed that 3 defects were type II (lateral), 9 were type III (medial), and 18 were type IV (central/panpatella). Age at the time of surgery was 32 ± 10 years. At follow-up of 2 to 14 years, knee function was rated good to excellent in 25 (83%) patients, fair in 4 (13%) patients, and poor in 1 (3%) patient. Three patients failed treatment after a mean of 75 months (6.25 years). All 3 failures were Workers Compensation (WC) cases. They were older than the non-WC patients, 42 ± 6 years compared with the non-WC 28 ± 9 years ( P = 0.0019). Significant increases in all clinical and health utility outcome scores were seen. Magnetic resonance imaging demonstrated that the fill grade, surface and integrity of the repair tissue correlated with clinical scores. Conclusion ACI to isolated patella defects results in significant functional improvement at a minimum of 24 months, with the results remaining durable at latest follow-up of 15 years. Level of evidence Level 4.

Sporting Activity Is Reduced 11 Years After First-Generation Autologous Chondrocyte Implantation in the Knee Joint

2017 ◽  
Vol 45 (12) ◽  
pp. 2762-2773 ◽  
Author(s):  
Benjamin Erdle ◽  
Simon Herrmann ◽  
Stella Porichis ◽  
Markus Uhl ◽  
Nadir Ghanem ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
Knee Joint ◽  
Autologous Chondrocyte Implantation ◽  
Repair Tissue ◽  
Sporting Activity ◽  
Chondrocyte Implantation ◽  
Sporting Activities ◽  
Autologous Chondrocyte

Background: Little is known about long-term sporting activity after periosteal autologous chondrocyte implantation (ACI-P) and its correlation to clinical, morphological, and ultrastructural cartilage characteristics on magnetic resonance imaging (MRI). Purpose: To evaluate long-term sporting activity after ACI-P and to correlate with clinical and MRI findings. Study Design: Case series; Level of evidence, 4. Methods: Patients who underwent ACI-P for isolated cartilage defects of the knee joint between 1997 and 2001 were analyzed for sporting ability for 3 different time points: lifetime until the onset of pain, the year before ACI-P, and 11 years (range, 9.0-13.4 years) postoperatively. Sporting activity was assessed and patients’ level of activity scaled using standardized questionnaires. MRI scans of the affected knee joint at follow-up were analyzed using the MOCART (magnetic resonance observation of cartilage repair tissue) score and T2 mapping. Results: Seventy of 86 patients (81% follow-up rate) consisting of 25 female and 45 male patients, with a mean age of 33.3 ± 10.2 years at the time of surgery, mean defect size of 6.5 ± 4.0 cm2, and 1.17 treated defects per patient, agreed to participate in the study at a mean 10.9 ± 1.1 years after ACI-P. Fifty-nine patients (69% of total; 84% of follow-up) agreed to MRI, allowing the complete evaluation of 71 transplant sites. Before the onset of symptoms (lifetime), 95.7% of patients played a mean 6.0 sporting activities at a competitive level. In the year before ACI-P, 81.4% of patients played a mean 3.4 sporting activities in 2.4 sessions during 5.4 hours per week at a recreational level. At follow-up, 82.9% of the patients played a mean 3.0 sporting activities in 1.8 sessions during 3.0 hours per week at a recreational level. In contrast to objective factors, 65.6% of the patients felt that their subjective sporting ability had improved or strongly improved after ACI-P, whereas 12.9% felt that their situation had declined or strongly declined, and 21.4% stated that their sporting ability had undergone no change because of surgery. Factors of sporting activity correlated significantly with clinical long-term outcomes. MRI analysis with a mean repair tissue T2 relaxation time of 35.2 milliseconds and mean MOCART score of 44.9 showed no conclusive significant correlation to sporting activity. Level of performance was the only sporting activity factor to show a weak correlation with subgroups of the MOCART score. Conclusion: The premorbid level of sporting and recreational activities cannot be achieved 11 years after ACI-P. The MRI results determined at this time point did not conclusively correlate with long-term sporting activity.

scholarly journals Prospective Long-term Follow-up of Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation: A Randomized Clinical Trial

2020 ◽  
Vol 48 (9) ◽  
pp. 2230-2241
Author(s):  
Alexander Barié ◽  
Patrizia Kruck ◽  
Reza Sorbi ◽  
Christoph Rehnitz ◽  
Doris Oberle ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
Autologous Chondrocyte Implantation ◽  
Cartilage Defects ◽  
Repair Tissue ◽  
Sf 36 ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte ◽  
Time Point

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%.

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