Puijk Raymond, Koster Lennard A, Pijls Bart G C W, Singh Jiwanjot, Schager Marjolein, Kaptein Bart L, Nolte Peter A
Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, the Netherlands.
Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands.
Acta Orthop. 2025 Jan 10;96:59-65. doi: 10.2340/17453674.2024.42744.
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.
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.
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.
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.
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。
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。
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。
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。
