压配型全髋关节置换术陶瓷-陶瓷和陶瓷-聚乙烯关节中使用放射学立体定向分析比较 5 年杯和柄的迁移：一项随机对照试验。
Comparison of 5-year cup and stem migration between ceramic-on-ceramic and ceramic-on-polyethylene bearing in press-fit total hip arthroplasty: a randomised controlled trial using radiostereometric analysis.
机构信息
Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.
Department of Orthopaedic Surgery, LUMC, Leiden, the Netherlands.
出版信息
Hip Int. 2024 Nov;34(6):701-716. doi: 10.1177/11207000241265653. Epub 2024 Aug 19.
INTRODUCTION
The inelasticity of ceramic bearings might affect primary stability and migration of implants in press-fit total hip arthroplasty (THA). This randomised controlled trial compares migration patterns of the uncemented Delta-TT cup and H-MAX S stem between ceramic and polyethylene liners, up to 5 years follow-up.
METHODS
Patients receiving primary press-fit THA were randomly allocated to a ceramic ( 28) or polyethylene ( 25) liner. Migration was measured using model-based radiostereometric analysis (RSA) at baseline and 1.5, 3, 6, 12, 24 and 60 months postoperatively and compared between groups using mixed models statistical analysis. The focus of this study is on the 2- to 5-year migration of the Delta-TT cup and migration during complete follow-up of the H-MAX S stem up to 5-years.
RESULTS
At 5-year follow-up, mean (95% CI) proximal cup translation was 0.56 (0.37-0.74) mm in ceramic and 0.58 (0.25-0.90) mm in polyethylene ( 0.729). The mean change in adduction was 1.05° (0.27-1.82°) in ceramic and 0.78° (-0.16-1.71°) in polyethylene. Mixed modelling showed that all between-group effects were ⩽0.20 mm for translation and ⩽0.22° for rotation at 5 years postoperatively ( ⩾ 0.23). Mean cup migration between 2 and 5 years was limited (all parameters <0.17 mm and <0.30°). At 5-year follow-up, mean stem subsidence was 2.09 mm (0.89-3.29 mm) in ceramic and 2.55 (0.97-4.12) mm in polyethylene. The mean change in internal rotation was 3.69° (1.98-5.40°) in ceramic and 4.01° (2.20-5.81°) in polyethylene. Most stem migration occurred up to 1.5 months, stabilising afterwards. All between-group effects were ⩽0.75 mm for translations and ⩽1.41° for rotations ( ⩾ 0.26).
CONCLUSIONS
5-year migration patterns of press-fit cups and stems were similar between ceramic and polyethylene liners. The Delta-TT cup and H-MAX S stem showed secondary stabilisation and remained stable up to 5 years in both groups, which is promising for long-term survival with both liner types.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov (NCT03093038).
简介
陶瓷轴承的非弹性可能会影响压配合全髋关节置换术（THA）中植入物的初始稳定性和迁移。本随机对照试验比较了陶瓷和聚乙烯衬垫的无水泥 Delta-TT 杯和 H-MAX S 柄之间的迁移模式，随访时间长达 5 年。
方法
接受初次压配合 THA 的患者被随机分配到陶瓷（ 28）或聚乙烯（ 25）衬垫。使用基于模型的放射立体测量分析（RSA）在基线和术后 1.5、3、6、12、24 和 60 个月时测量迁移，并使用混合模型统计分析比较组间差异。本研究的重点是 Delta-TT 杯在 2 至 5 年的迁移以及 H-MAX S 柄在 5 年随访期间的完全迁移。
结果
在 5 年随访时，陶瓷组近端杯的平均（95%CI）平移为 0.56（0.37-0.74）mm，聚乙烯组为 0.58（0.25-0.90）mm（ 0.729）。陶瓷组内收的平均变化为 1.05°（0.27-1.82°），聚乙烯组为 0.78°（-0.16-1.71°）。混合模型显示，所有组间效应在术后 5 年时均为 ⩽0.20 mm（平移）和 ⩽0.22°（旋转）（ ⩾ 0.23）。2 至 5 年间杯的平均迁移量有限（所有参数均 <0.17 mm 和 <0.30°）。在 5 年随访时，陶瓷组的平均柄下沉量为 2.09 mm（0.89-3.29 mm），聚乙烯组为 2.55（0.97-4.12）mm。陶瓷组内旋的平均变化为 3.69°（1.98-5.40°），聚乙烯组为 4.01°（2.20-5.81°）。大多数柄的迁移发生在 1.5 个月内，之后稳定下来。所有组间效应均为 ⩽0.75 mm（平移）和 ⩽1.41°（旋转）（ ⩾ 0.26）。
结论
压配合杯和柄的 5 年迁移模式在陶瓷和聚乙烯衬垫之间相似。Delta-TT 杯和 H-MAX S 柄在两组中均表现出继发性稳定，并在 5 年内保持稳定，这对两种衬垫类型的长期生存是有希望的。
临床试验注册
ClinicalTrials.gov（NCT03093038）。
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