ARTHROPLASTY
Comparison of trabecular metal cups and titanium fiber-mesh cups in primary hip arthroplasty: A randomized RSA and bone mineral densitometry study of 50 hips
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):18 Acta Orthop. 2011 Apr;82(2):155-60. Epub 2011 Mar 2560 patients with noninflammatory hip arthritis were randomized to receive either a tantalum trabecular metal acetabular cup or titanium fiber-mesh cup, as part of the primary hip arthroplasty surgical procedure. The primary endpoint was cup migration. Bone mineral density and the Harris hip score were also evaluated. Results indicated positive early results with the tantalum trabecular metal cup on fixation outcomes, as well as comparable results on the secondary endpoint outcomes. A longer observation period is recommended to examine the effects over a longer time period.
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。
4/4
Randomização
3/4
Medidas de resultado
3/4
Inclusão/Exclusão
2/4
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?
Initial stability is critical for an implant to achieve bone ingrowth. A number of clinical studies have shown good outcomes in bone ingrowth with trabecular metal. However, no published studies have examined this relationship with radiostereometric analysis (RSA). This study compares tantalum trabecular metal acetabular cups and titanium fiber-mesh cups in primary hip arthroplasty.
主な研究課題は何ですか?
What are the outcomes in cup migration, bone mineral density, and Harris hip scores with tantalum trabecular metal acetabular cups compared to titanium fibermesh cups, in patients with noninflammatory hip arthritis undergoing primary hip arthroplasty at 2 years?
重要な知見は?
- Radiostereometric analysis (RSA) indicated minimal rotation and translation at the 2-year follow-up. No statistically significant difference was seen between the two groups on translation. The trabecular tantalum surface cups (Monoblock) had less rotation on the transverse axis compared to the titanium fiber-mesh cup (Trilogy) (Monoblock: Mean -0.01 degrees [95%CI: -0.11 to 0.12]; Trilogy: Mean -0.60 degrees [95%CI: -0.72 to -0.48]) (p=0.04)
- Both groups reported a similar increase in Harris hip score at 3 months postoperatively from a score of 50 (28-70) to 92 (76-100) in the tantalum group and from 48 (34-64) to 95 (77-100) in the Trilogy group
- Both groups had similar degrees of reduction in bone mineral density
最も覚えておくべきことは?
Positive early results were seen for both implant cups in terms of fixation onto the acetabular host bone. RSA revealed both groups had minimal rotation and translation (with less rotation on the transverse axis for the tantalum group). Results also indicated similar reduction in bone mineral density and similar increase in Harris hip score.
それが私の患者ケアにどのように影響するか?
A study with a longer observation period is recommended to determine the long-term outcomes of the tantalum trabecular metal acetabular cups.
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