HAND & WRIST
Equally good fixation of cemented and uncemented cups in total trapeziometacarpal joint prostheses
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(3):33 Acta Orthop. 2013 Feb;84(1):98-105. doi: 10.3109/17453674.2013.765625. Epub 2013 Jan 2328 patients (32 hands) were randomized to evaluate the effectiveness of cemented versus uncemented trapezium cups in total arthroplasty of the trapeziometacarpal joint. Patients were allocated to receive either uncemented Elektra screwed trapezium cups or cemented DLC all-polythelene trapezium cups, and underwent radiostereometric analysis and clinical evaluation for 2 years. Results at 2 years indicated that there were no significant differences between groups for trapezium component migration, and clinical outcomes were similar.
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
3/4
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？
High rates of component loosening - both cemented and uncemented - have been reported in total arthroplasty for trapeziometacarpal joint osteoarthritis, primarily with the trapezium cup. The gold standard implants are considered to be cemented all-polyethylene trapezium cups, yet some studies have found comparable outcomes with the uncemented Elektra hydroxyapatite(HA)-coated trapezium screw cup, with clinical importance of the results undetermined. Therefore, this study was designed to compare the clinical fixation of the two implants.
主な研究課題は何ですか？
Did uncemented Elektra screw cups (inserted without threading of the bone) provide similar clinical fixation to cemented DLC trapezium cups when measured after 2 years?
重要な知見は？
- 2 year migration (total translation) of uncemented Elektra cups was 0.80mm (95%CI -0.56 to 2.2) and 0.36mm (95%CI 0.07-0.64) in DLC all-poly cups, resulting in a statistically insignificant difference of -0.44mm (95%CI -1.7 to 0.86, p=0.3).
- 2 uncemented Elektra cups and 1 cemented DLC cup were classified as loose (total translation > 1.0mm).
- Analysis was also conducted excluding 2 outliers (1 from each group), and found 2-year total translation of 0.19mm (95%CI 0.07-0.31) in uncemented cups and 0.24mm (95%CI 0.16-0.31) in cemented cups.
- No significant differences were observed between groups in grip strength, VAS scores at rest or during activity, or DASH scores at any time throughout the duration of study (P > 0.05).
最も覚えておくべきことは？
Component migration and clinical outcome were similar between uncemented Elektra HA-coated screwed trapezium cup or cemented DLC all-polyethylene trapezium cup 2 years following total arthroplasty of the trapeziometacarpal joint.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that either cemented or uncemented cups in trapeziometacarpal arthroplasty provide comparably good fixation properties. However, investigation into the long-term survival and outcomes of uncemented cups should be considered, as well as the implications of metal-on-metal articulation in total trapeziometacarpal arthroplasty.
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