SPORTS MEDICINE
Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage defects of the knee in a randomized controlled trial versus microfracture
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):194 Am J Sports Med. 2008 Feb;36(2):235-46118 patients presenting with symptomatic cartilage defects were included in the randomized control trial to determine the safety and efficacy of characterized chondrocyte implantation (CCI) treatment. Patients received either CCI or a microfracture procedure. Results from 18 month follow-up indicated that the CCI procedure demonstrated superior structural regeneration, while providing non-inferior functional outcomes.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
3/4
Randomização
4/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
The healing capacity of articular cartilage is poor. A number of regenerative techniques have been developed, in hopes of promoting natural regeneration and the restoration of natural pain free motion. Autologous CCI was one of the first regenerative techniques developed, and though a number of case studies have demonstrated positive results, there is still a lack of high level evidence. This study aimed to evaluate the safety and efficacy of CCI in a high quality RCT.
主な研究課題は何ですか？
Is structural regeneration, using characterized chondrocyte implantation superior in terms of safety and efficacy to repair of symptomatic cartilage damage using microfracture?
重要な知見は？
- Structural regeneration was significantly greater in the CCI group than in the microfracture (p=0.003) and was also accompanied by a greater histology assessment score (p=0.012).
- CCI was found to be non-inferior in comparison to the microfracture technique in terms of average KOOS scores, which increased in both groups (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)
- 88% of patients in the CCI group and 82% of patients in the microfracture group reported one or more adverse events; however, the majority of these events were mild, and difference between groups regarding the occurrence of adverse events not significant (p>0.05).
最も覚えておくべきことは？
Characterized chondrocyte implantation provided superior structural regeneration, non-inferior functional outcomes, and similar short term clinical outcomes, when compared to the microfracture technique for patients suffering from symptomatic cartilage defects.
それが私の患者ケアにどのように影響するか？
This study suggests that characterized chondrocyte implantation is a safe and effective treatment for symptomatic cartilage defects. However, longer term follow ups are needed to confirm the findings.
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