ARTHROPLASTY
Reverse hybrid and cemented hip replacement compared using radiostereometry and dual-energy X-ray absorptiometry: 43 hips followed for 2 years in a prospective trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(6):26 Acta Orthop. 2012 Dec;83(6):592-8. doi: 10.3109/17453674.2012.742393. Epub 2012 Nov 151 patients, including 52 hips, undergoing treatment for osteoarthritis were randomized to receive either reverse hybrid (cemented polyethylene cup with cementless femoral stem) or conventional cemented total hip replacement (both components cemented) to determine if there was a difference in outcome between the techniques. Clinical outcome, wear, component migration and bone remodeling were recorded over 2 years postoperatively. The results showed that there were no major differences between the two procedures. This study indicated that the reverse hybrid procedure does not provide improved outcomes when compared to the conventional cemented method in total hip replacement.
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
Aleatorización
3/4
Medidas de resultado
2/4
Inclusión/Exclusión
4/4
Descripción del tratamiento
4/4
Estadística
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？
The Swedish Hip Arthroplasty and Norwegian Arthroplasty Registers have shown increased use of reverse hybrid technique (cemented polyethylene cup with cementless femoral stem) in total hip replacement. This is in part is due to the observed improvement in survivability of the cementless stems with respect to component loosening. However, there has been concern regarding polyethylene wear induced by hydroxyapatite (HA) in HA-coated implants, commonly seen in reverse hybrid total hip replacements. Also, there has not been a study conducted that has shown that the reverse hybrid technique is superior to conventional cemented total hip replacement, indicating the need for this study.
主な研究課題は何ですか？
Does the reverse hybrid total hip replacement technique provide superiority to conventional cemented total hip replacement with respect to clinical results, wear, remodeling of the bone, component migration, or component loosening after 2 years?
重要な知見は？
- Similar improvements in Harris hip and Oxford hip scores were observed in both groups.
- There were no significant differences observed between groups in the amount of wear in the x- (p=0.9), y- (p=0.9), and z-axes (p=0.08), and the vectorial resultant 3D wear (p=0.7).
- Cup and stem component migration in any direction (x-, y-, or z-axes) were observed to not significantly differ between groups.
- Rotation of stem component did not significantly differ between groups. Rotation of cup component in the y- and z-axes was not significantly different between groups. Rotation of the cup component in the x-axis was -0.24 degrees (95%CI -0.55 to 0.07) in the RH group and 0.13 degrees (95%CI -0.08 to 0.34) and in the cemented group, resulting in significant difference (p=0.03).
- Bone remodeling around the cup was found to be similar between groups.
- Significant bone loss in Gruen Zone 1 of the femur was observed in the RH group (18%, 95%CI 11-24%) when compared to the cemented group (1.4%, 95%CI -3.2-5.9%) (p<0.001). Bone loss in remaining Gruen zones (2-7) was not significant between groups.
- There were no significant differences between groups for incidence of component loosening (p>0.05).
最も覚えておくべきことは？
The use of a cementless stem in total hip replacement provided similar results to a cemented stem with regards to Harris hip and Oxford hip scores, wear, component migration/rotation, bone remodelling, and bone loss after 2 years. Although significantly higher bone loss in Gruen Zone 1 was associated with the cementless stems, it is unlikely that it is an important clinical finding due to the long-term survivability of the cementless stems.
それが私の患者ケアにどのように影響するか？
There are no major differences between a cementless and a cemented femoral stem in total hip arthroplasty after 2 years. An extended study with a longer follow-up period is necessary to investigate any differences that may exist between the two techniques.
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