Eingartner C, Heigele T, Dieter J, Winter E, Weise K
BG Trauma Center, University of Tübingen, Schnarrenbergstr. 95, 72076 Tübingen, Germany.
Int Orthop. 2003;27 Suppl 1:S11-5.
The BiCONTACT femoral stem for cementless fixation is being used without any technical modification after 15 years. The long-term results should be evaluated in this study. A consecutive series was continuously monitored in a prospective follow-up study. A survival analysis was performed, clinical results were rated according to the Harris score. There were 236 patients with 250 total hip replacements (THR); mean age at time of implantation was 58.2 years. Indications for THR included osteoarthritis (62.4%), dysplasia (16.8%), trauma (8.4%) and femoral-head necrosis (16.8%). Average time of follow-up evaluation was 8.9 years (range 7.4-10.7 years). At follow-up, 27 patients had died and two could not be located. Seven patients were revised--two for infection, one for recurrent dislocation, two for component undersizing with rapid subsidence, and one for aseptic loosening of a varus-malaligned stem; one radiologically well-fixed stem had been revised during acetabular revision. Survival estimate showed an overall survival rate of 97.1% after 11 years (confidence limits: 98.7% upper and 93.6% lower). Radiologically, tiny reactive lines (< 2 mm) were present in the distal zones of the femoral shaft, but no radiolucencies could be found in the proximal anchoring zone. Migration analysis with Ein-Bild-Röntgen-analyse/femoral component analysis (EBRA/FCA) demonstrated a very small amount of migration: in 31.0%, the overall migration was between 0.5 and 1 mm after 120 months; 8.5% had an absolute amount of subsidence exceeding 2 mm after 120 months (one case more than 3 mm). Mean subsidence was 0.2 mm after 3 months and 6 months, 0.3 mm after 12 months, and reached 0.5 mm after 10 years. An initial small amount of subsidence could be detected in 45.1%, and 15.5% had a late onset of subsidence. Continuous sinking could be found in 12.7%, while 26.8% had irregular patterns of migration. Clinical results were somewhat compromised by a higher-than-average rate of cup loosening (uncoated threaded cup). The average Harris hip score at follow-up was 84.3 points. Interestingly, no femoral osteolysis could be detected, even in cases with severe acetabular osteolyses, indicating sealing of the stem interface by tight osseointegration of the proximally-coated stem.
用于非骨水泥固定的BiCONTACT股骨柄在15年后仍在使用，未作任何技术改进。本研究应对其长期结果进行评估。在一项前瞻性随访研究中对连续系列病例进行持续监测。进行了生存分析，临床结果根据Harris评分进行评定。共有236例患者接受了250次全髋关节置换（THR）；植入时的平均年龄为58.2岁。THR的适应证包括骨关节炎（62.4%）、发育不良（16.8%）、创伤（8.4%）和股骨头坏死（16.8%）。平均随访评估时间为8.9年（范围7.4 - 10.7年）。随访时，27例患者死亡，2例失访。7例患者进行了翻修——2例因感染，1例因复发性脱位，2例因假体尺寸过小伴快速下沉，1例因内翻畸形柄的无菌性松动；1例在髋臼翻修时对放射学上固定良好的柄进行了翻修。生存估计显示11年后总体生存率为97.1%（置信限：上限98.7%，下限93.6%）。放射学检查显示，股骨干远端区域存在微小的反应性线（<2 mm），但近端锚固区域未发现透光线。采用电子图像X线分析/股骨部件分析（EBRA/FCA）进行的移位分析显示移位量非常小：31.0%的患者在120个月后总体移位在0.5至1 mm之间；8.5%的患者在120个月后绝对下沉量超过2 mm（1例超过3 mm）。3个月和6个月时平均下沉量为0.2 mm，12个月时为0.3 mm，10年后达到0.5 mm。45.1%的患者可检测到初始少量下沉，15.5%的患者下沉出现较晚。12.7%的患者出现持续下沉，26.8%的患者移位模式不规则。临床结果因髋臼杯松动率高于平均水平（未涂层螺纹杯）而受到一定影响。随访时平均Harris髋关节评分为84.3分。有趣的是，即使在严重髋臼骨溶解的病例中也未检测到股骨骨溶解，这表明近端涂层柄通过紧密的骨整合密封了柄界面。
