ARTHROPLASTY
Decreased migration with locally administered bisphosphonate in cemented cup revisions using impaction bone grafting technique
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2019;7(3):6 Acta Orthop. 2018 Feb;89(1):17-2220 patients who were scheduled for isolated acetabular cup revision with impaction allografting following primary total hip arthroplasty were included and randomized to local intraoperative administration of clodronate or saline. The purpose of this study was to compare cup migration over a 24-month follow-up. Results demonstrated significantly lower cup subsidence (proximodistal translation; y-axis) in the clodronate group compared to the saline group, but no significant difference in x-axis and z-axis translation between groups. No significant difference in cup rotation in any plane was observed between groups.
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
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/5
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？
Early studies have demonstrated promising results in association with bisphosphonate treatment to reduce implant migration in cases of total joint arthroplasty. In addition, there has been increasing interest in the use of local bisphosphonate to improve implant stability in cases of revision performed with adjunct allograft.
主な研究課題は何ですか？
In acetabular revision with a cemented cup and allograft, does the local application of clodronate result in significantly lower acetabular cup migration over the first 2 years of follow-up, as compared to control saline?
重要な知見は？
- Translation of the cup in the mediolateral direction (x-axis) did not significantly differ between the clodronate group and the control group at 6 weeks (p=0.2), 3 months (p=0.3), 12 months (p=0.6), or 24 months (p=0.3).
- Translation of the cup in the proximodistal direction (y-axis) was significantly lower in the clodronate group compared to the control group at 6 weeks (0.10mm [95%CI 0.00, 0.19] vs. 0.35mm [95%CI 0.16, 0.54]; p=0.01), 12 months (0.21mm [95%CI 0.06, 0.37] vs. 0.59mm [95%CI 0.23-0.94]; p=0.03), and 24 months (0.22mm [95%CI 0.07, 0.36] vs. 0.59mm [95%CI 0.27-0.91]; p=0.02).
- Translation of the cup in the anteroposterior direction (z-axis) did not significantly differ between the clodronate group and the control group at 6 weeks (p=0.2), 3 months (p=0.3), 12 months (p=0.6), or 24 months (p=0.3).
- Rotation of the cup in the x-, y, and z-axis did not significantly differ between the clodronate group and the control group at 6 weeks, 3 months, 12 months, and 24 months (all p>0.05).
- Periprosthetic areal BMD around the acetabular cup did not significantly differ between the clodronate group and the control group after 3 or 12 months.
最も覚えておくべきことは？
In revision arthroplasty for an acetabular cup with impaction allografting, intraoperative treatment of the allograft with clodronate 60mg/mL demonstrated significantly reduced acetabular cup subsidence over 24-months when compared to the treatment of the allograft with control saline.
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 cup stability, particularly when considering proximodistal cup migration, may be improved with the treatment of allografts with clodronate in acetabular cup revision with impaction bone grafting. Given the small sample, further studies should be considered. Larger trials should look to continue to investigate cup stability associated with local bisphosphonate application, as well as thoroughly assess any potential adverse events with its use.
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