Effect of Sliding-Taper Compared with Composite-Beam Cemented Femoral Prosthesis Loading Regime on Proximal Femoral Bone Remodeling A Randomized Clinical Trial
Effect of Sliding-Taper Compared with Composite-Beam Cemented Femoral Prosthesis Loading Regime on Proximal Femoral Bone Remodeling A Randomized Clinical Trial
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DOI：
10.2106/jbjs.k.00657
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发表时间：
2013-01-02
影响因子：
5.3
通讯作者：
Wilkinson, Jeremy Mark
中科院分区：
文献类型：
--
作者：
Jayasuriya, Raveen L.;Buckley, Simon C.;Wilkinson, Jeremy Mark
背景资料：这项为期两年的随机临床试验是为了研究骨水泥股骨假体的几何形状是否影响在股骨近端方面的应变适应性骨重建的模式后，主要全髋关节arthroplasty.Methods：一百二十例患者随机接受Charnley（复合梁），埃克塞特（双锥形），或C-柄（三锥形）假体。通过双能X线骨密度仪（DXA）测量两年内股骨近端骨密度的变化。在术前基线和术后第一年收集尿液和血清样本，测量骨转换标志物。在尿中测量I型胶原的N-端肽作为破骨细胞活性的标记，在血清中测量骨钙素作为成骨细胞活性的标记。结果：两组受试者的基线特征相似（p > 0.05），术后2年内使用Harris和Oxford髋关节评分测量临床结果，使用数字化X线片测量假体移位。所有假体设计的股骨骨矿物质密度在第一年都有所下降，第二年没有进一步的损失。复合梁和滑动锥设计之间的降低在区域分布和幅度上相似（p > 0.05）。股骨近端内侧（Gruen区7）的骨丢失最大（14%）。在第一年，I型胶原的N端肽和骨钙素活性也出现了短暂的增加，这些增加在三个假体组中的模式相似（p > 0.05）。所有假体均显示出与其设计类型一致的移位模式，并且在两年的研究过程中观察到临床髋关节评分的类似改善。在复合梁或滑动锥形骨水泥股骨假体设计中，假体与宿主骨之间载荷转移机制的差异不是全髋关节置换术后股骨近端骨丢失的主要决定因素，包括第三锥形的设计表现出与双锥形设计相似的重塑轮廓。
Background: This two-year randomized clinical trial was performed to examine whether the geometry of the cemented femoral prosthesis affects the pattern of strain-adaptive bone remodeling in the proximal aspect of the femur after primary total hip arthroplasty.Methods: One hundred and twenty patients were randomized to receive a Charnley (composite-beam), Exeter (double-tapered), or C-Stem (triple-tapered) prosthesis. The change in proximal femoral bone mineral density over two years was measured by dual x-ray absorptiometry (DXA). Bone turnover markers were measured in urine and serum samples collected at the preoperative baseline and during the first postoperative year. N-telopeptide of type-I collagen was measured in urine as a marker of osteoclast activity, and osteocalcin was measured in serum as a marker of osteoblast activity. Clinical outcome was measured with use of the Harris and Oxford hip scores and prosthesis migration was measured with use of digitized radiographs during the first two postoperative years.Results: The baseline characteristics of the subjects in each group were similar (p > 0.05). Decreases in femoral bone mineral density were observed over the first year for all prosthesis designs, with no further loss during the second year. The decreases were similar in regional distribution and magnitude between the composite-beam and sliding-taper designs (p > 0.05). Bone loss was greatest (14%) in the proximal medial aspect of the femur (Gruen zone 7). Transient increases in both N-telopeptide of type-I collagen and osteocalcin activity also occurred over the first year, and these increases were similar in pattern among the three prosthesis groups (p > 0.05). All prostheses showed migration patterns that were consistent with their design type, and similar improvements in clinical hip scores were observed over the two-year course of the study.Conclusions: Differences in the mechanism of load transfer between the prosthesis and host bone in composite-beam or sliding-taper cemented femoral prosthesis designs were not a major determinant of proximal femoral bone loss after total hip arthroplasty, and the design that included a third taper exhibited a remodeling profile that was similar to those of the double-tapered design.