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非骨水泥型LCS和ATTUNE旋转平台膝关节系统的5年移位及可诱导移位情况:一项随机对照RSA试验的二次报告

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.

作者信息

Puijk Raymond, Koster Lennard A, Pijls Bart G C W, Singh Jiwanjot, Schager Marjolein, Kaptein Bart L, Nolte Peter A

机构信息

Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, the Netherlands.

Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands.

出版信息

Acta Orthop. 2025 Jan 10;96:59-65. doi: 10.2340/17453674.2024.42744.

Abstract

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.

摘要

背景与目的

基于近期特定固定的迁移阈值,非骨水泥型保留交叉韧带旋转平台ATTUNE和低接触应力(LCS)胫骨组件的早期迁移被归类为15年时无菌性松动率超过6.5%的风险因素。在这项随机对照试验(RCT)的二次报告中,我们旨在评估ATTUNE组件的5年迁移、诱导位移和临床结果是否与LCS组件相当。

方法

招募最初2年放射立体测量分析(RSA)RCT的患者进行5年随访。在5年时,参与者接受2次仰卧位和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)、平移和旋转分析迁移情况,重点关注5年迁移、连续迁移(>0.10 mm/年)和诱导位移。还评估了翻修情况以及临床和功能结果。

结果

在5年时,分析了24个ATTUNE和24个LCS植入物。胫骨组件的平均MTPM相似(ATTUNE为1.13mm [置信区间(CI)0.94 - 1.33];LCS为1.24 mm [CI 1.05 - 1.46]),但ATTUNE股骨组件(1.14 mm [CI 0.92 - 1.39])明显低于LCS的1.87 mm [CI 1.57 - 2.21])。2至5年的迁移率相当,但11个ATTUNE和7个LCS超过0.10 mm MTPM/年,表明松动风险更高。诱导位移相似,尽管1例胫骨ATTUNE患者出现过度位移(3.34 mm MTPM)并伴有局灶性骨溶解,但无症状。1例ATTUNE衬垫旋出患者在术后10天进行了翻修,通过单独更换衬垫解决。临床和功能结果相当。

结论

在5年随访时,ATTUNE胫骨组件显示出相似的迁移,而股骨组件的迁移明显少于LCS,主要发生在最初2年。2至5年的迁移率、诱导位移以及临床和功能结果相当。这些发现表明非骨水泥型ATTUNE和LCS膝关节系统之间无菌性松动的长期风险相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbc7/11724477/6acf093182f4/ActaO-96-42744-g001.jpg

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