ARTHROPLASTY
No effect of risedronate on femoral periprosthetic bone loss following total hip arthroplasty
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(2):4 Acta Orthop. 2015 Oct;86(5):569-7474 patients scheduled for uncemented total hip arthroplasty were randomized to postoperative administration of either risedronate or placebo for 6 months. The purpose of this study was to compare changes in periprosthetic bone mineral density between groups at 4 year follow-up. Additionally, component migration, the incidence of heterotopic ossification, and clinical outcomes were assessed during follow-up. Results demonstrated no significant difference in periprosthetic BMD changes between groups after 4 years.
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
4/4
Outcome Measurements
0/4
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？
Periprosthetic bone mass loss following total hip arthroplasty remains an important concern, given its implications in possible periprosthetic fracture and component loosening. Much research has been conducted on the efficacy of risedronate, a bisphosphonate, in the attenuation of bone loss in patients with osteoporosis, and research has started to be conducted in its possible role as a postoperative therapy following total joint arthroplasty. Nevertheless, the body of evidence is still too small to establish the role of risedronate therapy following total hip arthroplasty.
主な研究課題は何ですか？
Following total hip arthroplasty, what effect does risedronate therapy have on periprosthetic bone resorption, as compared to placebo over 4 year follow-up?
重要な知見は？
- Mean decrease in BMD of Gruen zones 1 and 7 after 4 years did not significantly differ between groups. In Gruen zone 1, the mean decrease in BMD was -19% (+/-14) in the risedronate group and -21% (+/-13) in the placebo group (p=1.0). In Gruen zone 7, decreases were -23% (+/-16) and -22% (+/-15%), respectively (p=1.0).
- There were also no significant between-group differences in percent change in BMD of Gruen zones 2-6 after 4 years (all p>0.05).
- Groups demonstrated a similar degree of subsidence of the femoral stem after 4 years; -1.7mm (+/-1.2) in the risedronate group and -1.7mm (+/-1.5) in the placebo group.
- Incidence of heterotopic ossification was similar between groups; 10 patients of the risedronate group (8 Class I-II; 2 Class III-IV) and 8 patients in the placebo group (7 Class I-II; 1 Class III-IV).
- Clinical outcome measures of the Harris Hip Score and EQ-5D were similar between groups at 4-year follow-up.
最も覚えておくべきことは？
Postoperative administration of risedronate for 6 months after total hip arthroplasty was not met with a significant effect on perioprosthetic bone mineral density at 4-year follow-up, as compared to placebo.
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 risedronate is not effective for long-term attenuation of periprosthetic bone mineral density following total hip arthroplasty. Additional, high-quality randomized controlled trials are needed to confirm the current findings, and evaluate if there is role of risedronate in the postoperative management of patients following total hip arthroplasty.
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