ARTHROPLASTY
A prospective randomized study comparing electrochemically deposited hydroxyapatite and plasma-sprayed hydroxyapatite on titanium stems
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(12):47 Acta Orthop. 2011 Feb;82(1):13-950 patients undergoing total hip arthroplasty were randomized to receive either plasma-sprayed hydroxyapatite (HA) or electrochemically deposited hydroxyapatite (Bonemaster, BM),as a coating for the fixation of uncemented femoral stems, in order to compare the safety and efficacy of the two coatings. At a follow-up of two years, the two groups were similar in regards to their clinical outcomes.
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
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？
Alternative bone coatings, such as Bonemaster (BM), provide potential advantages in terms of remodelling and transporting of bone-active substances. The trial was necessary to investigate whether the use of this alternative is safe for conventional clinical use.
主な研究課題は何ですか？
In patients undergoing total hip arthroplasty for non-inflammatory osteoarthritis, does electrochemically deposited Bonemaster provide non-inferior results in terms of safety, as compared with a conventional femoral implant utilizing plasma-sprayed hydroxyapatite?
重要な知見は？
- The null hypothesis was rejected for BMD in Gruen zone 1 (p = .01); bone loss was less in the BM group. The null hypothesis was accepted for all other regions (p > .05)
- No statistically significant results were obtained with respect to femoral migration or rotation following implantation (p > .05)
- There were no significant differences in the Harris Hip Scores at two year follow-up between the groups (p > .05)
- There were no significant differences in the oxford hip score between the two groups (p > .05)
最も覚えておくべきことは？
Functional scores, migration, and rotation of the femoral head following total hip arthroplasty were not significantly different. Potential benefits in terms of bone mineral density were identified in favor of the Bonemaster group.
それが私の患者ケアにどのように影響するか？
The results suggest that Bonemaster is clinically non-inferior to conventional plasma-sprayed hydroxyapatite and is a viable alternative. Long term follow-up is necessary to investigate other potential benefits of electrochemical deposition and whether or not long-term fixation is achieved. The small sample size of the study should be taken into account.
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