Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, Netherlands.
Department of Orthopaedic Surgery, Erasmus Medical Center, Delft, Netherlands.
Bone Joint J. 2022 Jan;104-B(1):76-82. doi: 10.1302/0301-620X.104B1.BJJ-2021-0945.R1.
Stemless humeral implants have been developed to overcome stem-related complications in total shoulder arthroplasty (TSA). However, stemless implant designs may hypothetically result in less stable initial fixation, potentially affecting long-term survival. The aim of this study is to investigate early fixation and migration patterns of the stemless humeral component of the Simpliciti Shoulder System and to evaluate clinical outcomes.
In this prospective cohort study, radiostereometric analysis (RSA) radiographs were obtained in 24 patients at one day, six weeks, six months, one year, and two years postoperatively. Migration was calculated using model-based RSA. Clinical outcomes were evaluated using the visual analogue scale (VAS), the Oxford Shoulder Score (OSS), the Constant-Murley Score (CMS), and the Disabilities of the Arm, Shoulder and Hand (DASH) score.
At two years, median translation along the x-, y-, and z-axis was -0.12 mm (interquartile range (IQR) -0.18 to 0.02), -0.17 mm (IQR -0.27 to -0.09), and 0.09 mm (IQR 0.02 to 0.31). Median rotation around the x-, y-, and z-axis was 0.12° (IQR -0.50 to 0.57), -0.98° (IQR -1.83 to 1.23), and 0.09° (IQR -0.76 to 0.30). Overall, 20 prostheses stabilized within 12 months postoperatively. Four prostheses showed continuous migration between 12 and 24 months. At two-year follow-up, with the exception of one revised prosthesis, all clinical scores improved significantly (median VAS difference at rest: -3.0 (IQR -1.5 to -6.0); OSS 22.0 (IQR 15.0 to 25.0); CMS 29.5 (IQR 15.0 to 35.75); and DASH -30.0 (IQR -20.6 to -41.67) (all p < 0.001)) with the exception of one revised prosthesis.
In conclusion, we found that 20 out of 24 implants stabilized within 12 months postoperatively. The significance of continuous migration in four implants is unclear and future research on the predictive value of early migration for future loosening in TSA is required. Clinical results revealed a clinically relevant improvement. Cite this article: 2022;104-B(1):76-82.
为了克服全肩关节置换术(TSA)中与柄相关的并发症,已经开发出无柄肱骨干假体。然而,无柄植入物的设计理论上可能导致初始固定稳定性降低,这可能会影响长期存活率。本研究的目的是研究 Simpliciti 肩关节系统无柄肱骨干的早期固定和迁移模式,并评估临床结果。
在这项前瞻性队列研究中,在术后第 1 天、第 6 周、第 6 个月、第 1 年和第 2 年对 24 例患者进行放射立体测量分析(RSA)射线照相。使用基于模型的 RSA 计算迁移。使用视觉模拟量表(VAS)、牛津肩评分(OSS)、常数-穆雷评分(CMS)和手臂残疾问卷(DASH)评分评估临床结果。
在两年时,沿 x、y 和 z 轴的中位数平移分别为-0.12 毫米(四分位距(IQR)-0.18 至 0.02)、-0.17 毫米(IQR-0.27 至-0.09)和 0.09 毫米(IQR-0.02 至 0.31)。绕 x、y 和 z 轴的中位数旋转分别为 0.12°(IQR-0.50 至 0.57)、-0.98°(IQR-1.83 至 1.23)和 0.09°(IQR-0.76 至 0.30)。总体而言,20 个假体在术后 12 个月内稳定。4 个假体在 12 至 24 个月之间出现持续迁移。在两年随访时,除 1 例翻修假体外,所有临床评分均显著改善(休息时 VAS 差值中位数:-3.0(IQR-1.5 至-6.0);OSS22.0(IQR15.0 至 25.0);CMS29.5(IQR15.0 至 35.75);和 DASH-30.0(IQR-20.6 至-41.67)(均 p<0.001),除 1 例翻修假体外。
总之,我们发现 24 个植入物中有 20 个在术后 12 个月内稳定。4 个植入物持续迁移的意义尚不清楚,需要进一步研究早期迁移对 TSA 未来松动的预测价值。临床结果显示出具有临床意义的改善。