scholarly journals Focal cartilage defects in the knee –a randomized controlled trial comparing autologous chondrocyte implantation with arthroscopic debridement

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Per-Henrik Randsborg ◽  
Jan Brinchmann ◽  
Sverre Løken ◽  
Heidi Andreassen Hanvold ◽  
Tommy Frøseth Aae ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Autologous Chondrocyte Implantation ◽  
Controlled Trial ◽  
Cartilage Defects ◽  
Arthroscopic Debridement ◽  
Randomized Controlled ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

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 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 Characterized Chondrocyte Implantation Results in Better Structural Repair when Treating Symptomatic Cartilage Defects of the Knee in a Randomized Controlled Trial versus Microfracture

2008 ◽  
Vol 36 (2) ◽  
pp. 235-246 ◽  
Author(s):  
Daniel B. F. Saris ◽  
Johan Vanlauwe ◽  
Jan Victor ◽  
Miroslav Haspl ◽  
Michael Bohnsack ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcome ◽  
Knee Injury ◽  
Controlled Trial ◽  
Cartilage Defects ◽  
Structural Repair ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Chondrocyte Implantation

Background As the natural healing capacity of damaged articular cartilage is poor, joint surface injuries are a prime target for regenerative medicine. Characterized chondrocyte implantation uses an autologous cartilage cell therapy product that has been optimized for its biological potency to form stable cartilage tissue in vivo. Purpose To determine whether, in symptomatic cartilage defects of the femoral condyle, structural regeneration with characterized chondrocyte implantation is superior to repair with microfracture. Study Design Randomized controlled trial; Level of evidence, 1. Methods Characterized chondrocyte implantation was compared with microfracture in patients with single grade III to IV symptomatic cartilage defects of the femoral condyles in a multicenter trial. Patients aged 18 to 50 years were randomized to characterized chondrocyte implantation (n = 57) or microfracture (n = 61). Structural repair was blindly assessed in biopsy specimens taken at 1 year using (1) computerized histomorphometry and (2) evaluation of overall histological components of structural repair. Clinical outcome was measured using the self administered Knee injury and Osteoarthritis Outcome Score. Adverse events were recorded throughout the study. Results Characterized chondrocyte implantation resulted in better structural repair, as assessed by histomorphometry ( P = .003) and overall histologic evaluation ( P = .012). Aspects of structural repair relating to chondrocyte phenotype and tissue structure were superior with characterized chondrocyte implantation. Clinical outcome as measured by the Knee injury and Osteoarthritis Outcome Score at 12 to 18 months after characterized chondrocyte implantation was comparable with microfracture at this stage. Both treatment groups had a similar mean baseline overall Knee injury and Osteoarthritis Outcome Score (56.30 ± 13.61 and 59.53 ± 14.95 for microfracture and characterized chondrocyte implantation, respectively), which increased in both groups to 70.56 ± 12.39 and 72.63 ± 15.55 at 6 months, 73.26 ± 14.66 and 73.10 ± 16.01 at 12 months, and 74.73 ± 17.01 and 75.04 ± 14.50 at 18 months, respectively. Both techniques were generally well tolerated; the incidence of adverse events after characterized chondrocyte implantation was not markedly increased compared with that for microfracture. Conclusion One year after treatment, characterized chondrocyte implantation was associated with a tissue regenerate that was superior to that after microfracture. Short-term clinical outcome was similar for both treatments. The superior structural outcome may result in improved long-term clinical benefit with characterized chondrocyte implantation. Long-term follow-up is needed to confirm these findings.

scholarly journals A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC®) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers

2013 ◽  
Vol 7 (1) ◽  
pp. 133-143 ◽  
Author(s):  
Sven Anders ◽  
Martin Volz ◽  
Hubert Frick ◽  
Jörg Gellissen
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Collagen Type I ◽  
Cartilage Defects ◽  
Type I ◽  
Randomized Controlled ◽  
First Results ◽  
Post Operation

Microfracture (MFx) is currently the recommended option for the treatment of small cartilage defects but is not regarded as suitable for the treatment of defects larger than 2.5 cm2. To extent its applicability to medium-sized defects MFx has been combined with a collagen type I/III matrix (Chondro-Gide®). This technique is called Autologous Matrix-Induced Chondrogenesis (AMIC®) and meanwhile a clinically established treatment option for localized full-thickness small- to medium-sized cartilage defects. Despite its more spreading clinical use, clinical data published so far are limited to mainly case report series.In this study, we report the first results of a randomized, controlled trial assessing the efficacy and safety of AMIC®versus MFx. Patients enrolled in 2 centers were included in this analysis. 38 patients (aged 21-50 years, mean defect size 3.4 cm2) were randomized and treated either with MFx, with sutured AMIC®or glued AMIC®. Clinical outcomes (modified Cincinnati and ICRS score) could be assessed in 30 patients at 1-year and 27 patients at 2-years post-operation. Improvements in both scores were seen at 1-and 2-years post-operation, irrespective of the technique used. MRI assessment revealed a satisfactory and homogenous defect filling in the majority of patients. No treatment-related adverse events were reported.This interim analysis confirms the mid-term results for AMIC®reported in literature. It demonstrates clearly that clinical outcomes at 1-year post-operation are maintained at 2-years. Therefore we consider enhancing MFx with Chondro-Gide®is a valid and safe cartilage repair option for small- to medium-sized cartilage defects of the knee.

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