ARTHROPLASTY
Continued stabilization of trabecular metal tibial monoblock total knee arthroplasty components at 5 years measured with radiostereometric analysis
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(9):16 Acta Orthop. 2012 Feb;83(1):36-40. doi: 10.3109/17453674.2011.645196. Epub 2011 Dec 29This study was conducted to examine the 5-year radiostereometric (RSA) results of the trabecular metal (TM) tibial monoblock component, based on a previous study with a follow-up time of 2 years. 70 patients with osteoarthritis were randomized and received either the trabecular metal tibial implant or the cemented component. Results indicated that stability was observed in the trabecular metal tibial implant up to 5 years despite high levels of initial migration observed in the previous study.
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。
2/4
Randomization
2/4
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？
The potential for improved longevity from the use of uncemented implants have been explored due to recent improvement in biomaterials. In a previous paper by the same authors, the 2-year implant migration results of the trabecular metal tibial monoblock component were presented. However, a longer follow-up was necessary to determine whether the early stability of these implants was sustained. Thus, this study presented the 5-year longitudinal radiostereometric (RSA) results from the original cohort of patients randomized to receive either the uncemented Nexgen LPS TM monoblock tibial component or the cemented NexGen Option Stemmed tibial component.
主な研究課題は何ですか？
Did the trabecular metal tibial implant achieve solid fixation (despite high levels of initial migration) in comparison to the cemented component, assessed at 5 years?
重要な知見は？
- No differences were observed in the WOMAC scores between the groups at any follow-up point (P > 0.006).
- In the cemented group, the proportion of “at risk” components at 5 years was 2 of 18 (0.11, 95% CI: 0.03-0.33) and for the trabecular metal group it was 0 of 27 (95% CI: 0.0-0.13) (P = 0.2).
- There was no difference in maximum total point motion at the 5-year follow-up between both groups (P = 0.9); compared to the cemented group, the trabecular metal group had more subsidence (P = 0.001).
- 9 subjects in the trabecular metal group displayed very high migration in the first 6 months postoperatively (> 1.0 mm) at the 2-year follow-up; at 5 years, stability was still seen in all of these implants with an average change in maximum total point motion of 0.10 mm over the 3 years between follow-ups.
最も覚えておくべきことは？
In the previous 2-year report by the authors, uncertainty was expressed concerning the long-term stability of the trabecular metal tibial implant because of the high initial migration seen in some cases. This study revealed that stability was observed in the trabecular metal tibial implant up to 5 years despite high levels of initial migration.
それが私の患者ケアにどのように影響するか？
The trabecular metal tibial implant appears to achieve solid fixation even though there were high levels of initial migration. However, continued implant surveillance data is required to evaluate the long-term stability of this implant for patients with osteoarthritis.
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