SPORTS MEDICINE
Comparison of the collagen meniscus implant with partial meniscectomy: A prospective randomized trial
This report has been verified
by one or more authors of the
original publication.
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最先端の自然言語処理を用いて開発されたOEハイインパクトモデルは、ジャーナルのインパクトファクターのみよりも、研究の将来の引用実績をより正確に予測します。
これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):225 J Bone Joint Surg Am. 2008 Jul;90(7):1413-26.311 patients with an irreparable injury of the medial meniscus or a previous partial medial meniscectomy were divided into 2 study arms: acute arm with no prior surgery on the involved meniscus or the chronic arm with 1, 2 or 3 prior meniscal surgeries. Patients were randomized either to receive the collagen meniscus implant or to be treated with a partial meniscectomy only. Clinical follow-up examinations were performed for 2 years postoperatively, and patients were to complete validated questionnaires 7 years postoperatively. Patients allocated to receive the collagen meniscus implant also underwent 1-year second-look arthroscopy to assess tissue growth and quality. Results indicated that the collagen meniscus implant was found to support new tissue ingrowth, which was stable, safe, and biomechanically competent and improved meniscal function, as evident by the clinical outcomes in patients with a chronic meniscal injury.
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
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
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？
Meniscal injuries lead to increased pain and limitation in clinical function and activity levels. The options in this field are very limited, with cadaver grafts having limited applications. The Biomaterials research evaluates the newer materials for collagen meniscus implant application and it is unclear whether such implant would have a clinical role in future. This study was needed to evaluate the efficacy of the collagen meniscus implant in chronic and acute patients.
主な研究課題は何ですか？
Does the application of collagen meniscus implant have superior clinical outcomes as compared to patients treated with partial medial meniscectomy alone, for irreparable injury of medial meniscus, as evaluated over 7 years?
重要な知見は？
- At 1 year, the 141 repeat arthroscopies that were performed revealed that the collagen meniscus implants had resulted in significantly increased meniscal tissue over that seen after the partial meniscectomy (p=0.001).
- The implant was found to flourish the meniscus-like matrix production and integration, as it was assimilated and resorbed.
- In the chronic study arm, the patients receiving meniscal implant significantly regained much of their lost activity than controls (p=0.02) and also underwent significantly lesser reoperations (p=0.04).
- No differences were observed between the two study groups in the acute arm.
最も覚えておくべきことは？
The collagen meniscus implant was found to support new tissue ingrowth, which was stable, safe, bio-mechanically competent and improved meniscal function, as evident by the improved clinical outcomes in patients with a chronic meniscal injury.
それが私の患者ケアにどのように影響するか？
The collagen meniscus implant has a potential future in replacing the irreparable or lost meniscal tissue and hence improving the quality of life in patients with chronic meniscal injury. Definitive determination of the effect of collagen meniscus implants should be achieved with future research.
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