Raymond Puijk, Lennard A Koster, Bart G C W Pijls, Jiwanjot Singh, Marjolein Schager, Bart L Kaptein, Peter A Nolte
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引用次数: 0
摘要
背景和目的:根据最近的固定特异性迁移阈值,非骨水泥十字韧带损伤旋转平台ATTUNE和低接触应力(LCS)胫骨组件的早期迁移被归类为15年无菌性松动率超过6.5%的高风险。在这份随机对照试验(RCT)的二次报告中,我们旨在评估ATTUNE组件的5年移位、可诱发移位和临床结果是否与LCS组件相当: 方法:从最初的为期两年的放射性立体计量分析(RSA)RCT中招募患者进行为期5年的随访。5年后,参与者接受了2次仰卧和1次负重RSA检查、临床评估和问卷调查。使用最大总点运动(MTPM)、平移和旋转分析移位情况,重点关注5年移位、持续移位(> 0.10 mm/年)和诱导性移位。此外,还对翻修情况以及临床和功能结果进行了评估: 结果:分析了24个ATTUNE和24个LCS种植体的5年移位情况。胫骨组件的平均MTPM相似(ATTUNE为1.13毫米[置信区间(CI)0.94-1.33];LCS为1.24毫米[CI 1.05-1.46]),但ATTUNE股骨组件的平均MTPM(1.14毫米[CI 0.92-1.39])明显低于LCS的1.87毫米[CI 1.57-2.21])。2-5年的移位率相当,但11个ATTUNE和7个LCS的移位率超过0.10 mm MTPM/年,表明松动风险较高。诱发移位的情况相似,但有一名胫骨ATTUNE患者出现了过度移位(3.34 mm MTPM),并伴有局灶性骨溶解,但没有症状。一名患者在术后10天因ATTUNE植入物脱出而进行了翻修,通过单独更换植入物解决了问题。临床和功能结果相当: 结论:在5年的随访中,ATTUNE胫骨组件的移位情况相似,而股骨组件的移位明显少于LCS,移位主要发生在前两年。2至5年的移位率、可诱发的移位以及临床和功能结果相当。这些研究结果表明,非骨水泥ATTUNE和LCS膝关节系统的长期无菌性松动风险相当。
5-year migration and inducible displacement of the uncemented LCS and ATTUNE rotating platform knee systems: a secondary report of a randomized controlled RSA trial.
Background and purpose: Early migration of the uncemented cruciate-sacrificing rotating platform ATTUNE and Low Contact Stress (LCS) tibial components was classified as at-risk for aseptic loosening rates exceeding 6.5% at 15 years based on recent fixation-specific migration thresholds. In this secondary report of a randomized controlled trial (RCT) we aimed to evaluate whether the 5-year migration, inducible displacement, and the clinical outcome of the ATTUNE components were comparable to those of the LCS.
Methods: Patients from the initial 2-year radiostereometric analysis (RSA) RCT were recruited for a 5-year follow-up. At 5 years, participants underwent 2 supine and 1 loaded RSA examination, clinical assessments, and questionnaires. Migration was analyzed using maximum total point motion (MTPM), translations, and rotations, focusing on 5-year migration, continuous migration (> 0.10 mm/year), and inducible displacement. Revisions, along with clinical and functional outcomes, were also evaluated.
Results: At 5 years, 24 ATTUNE and 24 LCS implants were analyzed. The mean MTPM was similar for tibial components (ATTUNE 1.13mm [confidence interval (CI) 0.94-1.33]; LCS 1.24 mm [CI 1.05-1.46]) but significantly lower for the ATTUNE femoral component (1.14 mm [CI 0.92-1.39]) than LCS 1.87 mm [CI 1.57-2.21]). 2-to-5-year migration rates were comparable, but 11 ATTUNE and 7 LCS exceeded 0.10 mm MTPM/year, indicating a higher risk of loosening. Inducible displacement was similar, although 1 patient with a tibial ATTUNE showed excessive displacement (3.34 mm MTPM) with focal osteolysis but no symptoms. 1 revision 10 days post-surgery was performed for an ATTUNE insert spinout, resolved with an isolated insert exchange. Clinical and functional outcomes were comparable.
Conclusion: At the 5-year follow-up, ATTUNE tibial components showed similar migration, while the femoral component migrated significantly less than the LCS, which mainly occurred during the first 2 years. 2-to-5-year migration rates, inducible displacement, and clinical and functional outcomes were comparable. These findings suggest a comparable long-term risk of aseptic loosening between the uncemented ATTUNE and LCS knee systems.
期刊介绍:
Acta Orthopaedica (previously Acta Orthopaedica Scandinavica) presents original articles of basic research interest, as well as clinical studies in the field of orthopedics and related sub disciplines. Ever since the journal was founded in 1930, by a group of Scandinavian orthopedic surgeons, the journal has been published for an international audience. Acta Orthopaedica is owned by the Nordic Orthopaedic Federation and is the official publication of this federation.