在五年内,在凝固的十字形保持ATTUNE和PFC-Sigma膝关节假肢之间没有组件迁移的差异:随机临床放射立体测量试验的更新
Yasin Yüksel1, Lennard A Koster1, Bart L Kaptein1
1Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands.
The bone & joint journal
|October 31, 2023
概括
这项研究发现,ATTUNE全膝关节整形术 (TKA) 在5年内显示出稳定的固定和与PFC-Sigma TKA可比的结果. 没有证据表明部部件迁移增加,这支持人们对ATTUNE TKA.的无菌松动的担忧.
科学领域:
- 整形外科手术 整形外科手术
- 生物医学工程 生物医学工程
- 放射学 放射学是指放射学
背景情况:
- 对于ATTUNE全膝关节整形术 (TKA) 存在相互矛盾的临床结果.
- 这项研究比较了凝固的ATTUNE和PFC-Sigma交叉式维护TKA.
研究的目的:
- 评估ATTUNE与PFC-Sigma TKAs的五年随访结果.
- 使用射频立体分析 (RSA) 分析组件迁移.
- 评估临床结果,患者报告的结果措施 (PROM) 和放射性结果.
主要方法:
- 一个单盲随机受控试验 (RCT) 包括74个初级TKA.
- 放射立体分析 (RSA) 和PROM在多个时间点收集到60个月.
- 放射性线条 (RLLs) 被测量在6周,12个月和60个月.
主要成果:
- 五年后,ATTUNE (0.96毫米) 的大腿部部部件迁移 (MTPM) 比PFC-Sigma (1.37毫米) 低 (p < 0.001).
- 在ATTUNE (1.12毫米) 和PFC-Sigma (1.25毫米) (p = 0.438) 之间,部成分MTPM是可比的.
- 在5年后,ATTUNE (20%) 与PFC-Sigma (3%) 的中部部RLL更为普遍,但没有进展.
结论:
- ATTUNE TKA表现出稳定的固定,部和部部件的迁移相当于PFC-Sigma在5年.
- 没有证据表明小腿骨部部件迁移增加,这表明ATTUNE无菌松的风险没有增加.
- 预计ATTUNE TKA的长期性能将与已建立的PFC-Sigma系统相提并论.
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