ARTHROPLASTY
10-year results of a new low-monomer cement follow-up of a randomized RSA study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(6):15 Acta Orthop. 2012 Dec;83(6):604-8. doi: 10.3109/17453674.2012.742392. Epub 2012 Nov 1.44 patients undergoing total hip replacement were randomized to receive a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with Palacos R bone cement. The 10 year results of the study indicated that Cemex bone cement performs just as well as Palacos R bone cement.
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
1/4
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？
Enhancements in cementing techniques during cemented total hip arthroplasty have reduced the incidence of early loosening and delayed revision time. However, the curing temperature during the cementing process is believed to cause bone and cell necrosis, which leads to membrane formation and aseptic loosening, a cause for revision. Cemex was designed to reduce the curing temperature by removing the smallest sizes of particles in the polymer powder, which would lead to a smaller surface area reacting with monomers. But, laboratory tests have shown that the curing temperature of Cemex is no different that the curing temperature of conventional Palacos R. This study aimed to determine aimed to examine the clinical properties of Cemex and compare the results with those of Palacos R.
主な研究課題は何ですか？
Does Cemex Rx bone cement reduce femoral stem migration and rotation while improving hip pain and function when compared to Palacos R bone cement among total hip replacement patients, 10 years after surgery?
重要な知見は？
- The magnitudes of rotation into flexion/extension and retroversion were significantly larger among the patients that received Palacos bone cement (p=0.005 and 0.01, respectively) but there was no significant difference in rotation around the sagittal axis as most implants were tilted into varus (p=0.7).
- The magnitude of subsidence was similar among the patients that received Palacos bone cement and the patients that received Cemex bone cement (p=0.7).
- There was no significant differences in migration of the femoral component in relation to the cement mantle between the treatment groups. Most migration occurred between the stem and cement mantle in both groups.
- Radiolucent lines along the stem were found in Gruen zones 2 and 6 in 22 cases. The proportion of radiolucent lines in the total interface was 40% for the patients that received Palacos and 50% for the patients that received Cemex.
- There was no significant difference in Harris hip scores and pain scores between the patients that received Cemex bone cement and Palacos bone cement.
最も覚えておくべきことは？
There was no significant difference in rotation around the sagital axis, the magnitude of subsidence, migration of the femoral component, radiolucent lines, hip function, and pain between the two treatment groups.
それが私の患者ケアにどのように影響するか？
The study suggests that Cemex Rx bone cement will preform similarly to Palacos R bone cement when used for total hip replacements. Further research trials are needed to confirm these findings.
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