ARTHROPLASTY
Small and similar amounts of micromotion in an anatomical stem and a customized cementless femoral stem in regular-shaped femurs. A 5-year follow-up randomized RSA study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(13):9 Acta Orthop. 2014 Apr;85(2):152-8100 patients with primary or secondary osteoarthritis were randomized to investigate any additional benefits associated with the use of the Unique customized stem compared with the conventional ABG-I stem. Patients were evaluated over 5 years using radiostereometric (RSA). The evidence presented in this study revealed no improvement in long-term mechanical stability associated with the Unique stem. It is important to note that no included patients presented with abnormal geometry of the upper femur for which the custom stems are developed.
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。
3/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
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？
Micromovements along the implant-bone interface are associated with loosening of uncemented femoral stem implants. Generally speaking, a 40 micrometer interfacial motion contributes to partial bone ingrowth, and those exceeding 150 micrometers completely disrupts ingrowth. Mechanical stability of the implant is influenced by patient- and implant-specific factors, and uncemented customized femoral stems are hypothesized to promote superior mechanical fixation compared to standard implants. This study was needed to conduct radiostereometric (RSA) follow-up on a 5 year RCT that evaluated the Unique customized stem (Scandinavian Customized Prosthesis [SCP]), against a conventional ABG-I stem.
主な研究課題は何ですか？
What is the comparative migration between the use of the Unique customized stem, and the conventional ABG-I stem, as evaluated using radiostereometric (RSA) over 5 years?
重要な知見は？
- Motion between the 2 types of stems were comparable (all p>0.05): The median subsidence was -0.03mm for the ABG-I stem compared to -0.13mm for the Unique stem (p=0.15). Mean retroversion was 0.15 degrees compared to -0.08 degrees in the ABG-I and Unique stems respectively (p=0.41).
- Time was noted as a factor that was significantly related to: translation along the y (p=0.02) and z (p<0.01) axes and rotation around the x (p=0.03) and z (p=0.01) axes.
- A single Unique stem subsided 5.3mm within the first year and then stabilized. Further analysis revealed no loosening.
- Mean preoperative Merle d’Aubigne score was 11 in the ABG-I group compared to 10 in the Unique groups. At final follow-up of 5 years, mean scores in both groups was 17.
- Preoperative pain decreased from 6.5 to 1.1 in the ABG-I group and from 6.5 to 1.0 in the Unique group. Satisfaction was 1.1 and 0.7 respectively at 5 years.
- No hips were revised over the 5 years; there were, however, 5 complications: ABG –I group had 2 instances of DVT and 2 early dislocations. The Unique group had 1 common peroneal nerve dysfunction.
最も覚えておくべきことは？
Radiostereometric analysis (RSA) between the use of the Unique customized stem ((Scandinavian Customized Prosthesis (SCP)), and the conventional ABG-I stem revealed no improvement in long-term mechanical stability associated with the Unique stem.
それが私の患者ケアにどのように影響するか？
The evidence presented in this study indicated no additional benefits associated with the use of the Unique customized stem ((Scandinavian Customized Prosthesis (SCP)). It is important to note that none of the included patients presented with abnormal geometry of the upper femur for which the custom stems were developed.
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