GENERAL ORTHOPAEDICS
A Randomized Trial Comparing Autologous Chondrocyte Implantation with Microfracture: Findings at Five Years
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):142 J Bone Joint Surg Am. 2007 Oct;89(10):2105-12This study was based on previous work completed by the same authors in 2004 which looked at the outcomes of autologous chondrocyte implantation and microfracture surgery at 2-year follow-up. This current study looks at outcomes at 5-year follow-up. 80 patients with a single chronic symptomatic cartilage defect on the femoral condyle were randomized to undergo one of two treatments. One group underwent an autologous chondrocyte implantation procedure while the other group underwent microfracture surgery. Results showed that clinical outcomes were comparable between the two groups. One-third of the patients showed radiographic signs of early osteoarthritis at the 5-year follow-up.
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。
1/4
Randomization
3/4
Outcome Measurements
1/4
Inclusion / Exclusion
2/4
Therapy Description
4/4
Statistics
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？
Autologous chondrocyte implantation and microfracture surgery are two procedures used in the treatment of cartilage lesions, but there is uncertainty on what is the best method for treatment. In 2004, the authors of this current study presented the results of these two methods of treatment at the 2-year follow-up. This study examines autologous chondrocyte implantation compared to microfracture surgery in the treatment of cartilage lesions at the 5-year follow-up.
主な研究課題は何ですか？
What are the clinical outcomes of performing autologous chondrocyte implantation compared to microfracture procedure on patients with a single chronic symptomatic cartilage defect on the femoral condyle at the 5-year follow-up?
重要な知見は？
- There were no significant differences seen between the two groups on the Lysholm score (p=0.227) and the VAS scores (p=0.278) at the 5-year follow-up.
- Both the implantation and microfracture group saw clinically significant improvements from preoperative measures at the 2 and 5-year follow-up.
- 72% of the patients in both groups saw an improvement in pain and 80% of the patients had better Lysholm scores from baseline at the 5-year follow-up. (p<0.05)
- At the 5-year follow-up, both groups saw 9 failures (23%) compared to the 2-year follow-up where the implantation group saw 2 failures and the microfracture group saw 1.
- Patients with the best-quality cartilage (mainly hyaline) examined at the 2-year follow up did not have any subsequent failures.
- No correlation was seen with histological quality and clinical outcomes.
- At the 5-year follow-up, 1/3 of the patients in each group showed radiographic evidence of early osteoarthritis.
最も覚えておくべきことは？
No significant differences were seen in clinical and radiographic outcomes between the autologous chondrocyte implantation group and the microfracture group at follow-up. 77% of patients in both groups saw satisfactory results. At the 5-year follow-up, 1/3 of the patients saw early radiographic signs of osteoarthritis. The study also proposed that microfracture surgery should be the first option for treatment due to it's minimally invasive and low-cost factors.
それが私の患者ケアにどのように影響するか？
Patients may not find any significant differences when undergoing autologous chondrocyte implantation or microfracture procedure in the treatment of cartilage lesions. Further studies are required to determine the long-term effects of both treatments as well as the progression of osteoarthritis.
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