ARTHROPLASTY
No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome: a 6.5-year randomized radiostereometric analysis follow-up report
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(22):2 Acta Orthop. 2016 Aug;87(4):363-736 patients who had undergone total hip arthroplasty and completed a 2-year follow-up of a previous randomized controlled trial were invited and included in this follow-up extension. Patients had received a press-fit, all-polyethylene acetabular cup, and had been randomized to placement with or without additional screw fixation. Radiostereometric analysis was performed to assess component migration and wear over 6.5-year follow-up, and the Harris Hip Score and Oxford Hip Score were used to assess clinical outcome. No significant differences were observed between groups in total 3-dimensional translation or rotation of the acetabular component. There were also no significant differences between groups in the total overall and corrected 3-dimensional wear or overall & corrected wear rates.
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
0/4
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？
Press-fit fixation of acetabular cups is often used in total hip arthroplasty. A debate has emerged surrounding the use of additional fixation screws in press-fit acetabular cups. While improved short-term stability may occur, there is concern that long-term stability could be compromised through various mechanisms, such as stress-shielding and wear. However, there is a current lack of evidence from randomized controlled trials to recommend either the use or avoidance of additional screw fixation with press-fit acetabular cups.
主な研究課題は何ですか？
In total hip arthroplasty, is there any significant difference in cup migration, cup wear, and clinical outcome of a cementless all-polyethylene acetabular cup with and without screw fixation, assessed over a 6.5-year follow-up?
重要な知見は？
- There was no significant difference between the screw group and no screw group in either total 3-dimensional translation (p=0.8) or total 3-dimensional rotation (p=0.2).
- Between-group differences in individual planes were non-significant, with the exception of medial-lateral rotation: mean rotation was 0.33deg (+/-0.50) in the screw group and -0.61deg (+/-0.97) in the no screw group (p=0.004).
- There were two cases of clinically relevant rotation of the acetabular component in each group. The same two cases in the no screw group also demonstrated clinically relevant translation of the acetabular component.
- There was no significant difference in total wear over 6-year follow-up between the screw group (0.57+/-0.24mm) and the no screw group (0.53+/-0.20mm) (p=0.6). The only plane which demonstrated a significant difference between groups was medial-lateral wear (Screws: 0.19+/-0.22mm | No screws: -0.04+/-0.12mm | p=0.003).
- Corrected wear analysis, which accounted for the large degree of wear within the first year after surgery, demonstrated similar results to the overall analysis.
- Overall wear rate over 6 years did not significantly differ between the screw group (0.09+/-0.04 mm/year) and the no screw group (0.08+/-0.03 mm/year) (p=0.7). Corrected wear rate also did not significantly differ between groups (0.07+/-0.04 vs. 0.09+/-0.04 mm/year; p=0.3).
- No significant difference between groups was noted either HHS (p=0.6) or OHS (p=0.6).
最も覚えておくべきことは？
In total hip arthroplasty with a press-fit acetabular cup, there were no significant differences in total 3-dimensional translation or rotation of the acetabular cup after 6.5 years, as assessed with RSA, with or without additional screw stabilization. There were also no significant differences in RSA-assessed component wear or clinical outcome after 6 years.
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 additional screw stabilization of cementless, press-fit all-polyethylene acetabular cup in total hip arthroplasty does not confer any significant mid-term advantage in migration, component wear, or clinical outcome over cups placed without additional stabilization.
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