Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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: Bone Joint J 2022;104-B(1):76-82.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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: Bone Joint J 2022;104-B(1):76-82.
摘要：
目的：已经开发了无茎肱骨植入物来克服全肩关节置换术（TSA）中干相关的并发症。然而,无茎植入物设计可能会导致初始固定不太稳定，可能影响长期生存。这项研究的目的是研究Simpliciti肩关节系统无茎肱骨组件的早期固定和迁移模式，并评估临床结果。
方法：在这项前瞻性队列研究中，一天对24例患者进行了放射立体测量分析（RSA）X光片，六周,六个月,一年,术后两年。使用基于模型的RSA计算迁移。采用视觉模拟评分法(VAS)评价临床结局,牛津肩评分(OSS)恒定-Murley分数(CMS)，和手臂的残疾，肩和手（DASH）得分。
结果：两年后，沿X-的中值平移，-,z轴为-0.12mm（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（IQR0.02至0.31）。围绕x-的中间旋转，-,z轴为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）。总的来说,20个假体在术后12个月内稳定。四个假体在12至24个月之间显示出连续迁移。在两年的随访中，除了一个修改过的假肢,所有临床评分均显著改善(静息时的中位VAS差异:-3.0(IQR-1.5~-6.0);OSS22.0(IQR15.0~25.0);CMS29.5(IQR15.0~35.75);以及DASH-30.0(IQR-20.6~-41.67)(所有p<0.001)),但一个经修订的假体除外.
结论：结论：我们发现24个植入物中有20个在术后12个月内稳定.四个植入物中连续迁移的重要性尚不清楚，需要进一步研究早期迁移对TSA未来松动的预测价值。临床结果显示临床相关的改善。引用本文：骨关节J2022；104-B（1）：76-82。
方法：在这项前瞻性队列研究中，一天对24例患者进行了放射立体测量分析（RSA）X光片，六周,六个月,一年,术后两年。使用基于模型的RSA计算迁移。采用视觉模拟评分法(VAS)评价临床结局,牛津肩评分(OSS)恒定-Murley分数(CMS)，和手臂的残疾，肩和手（DASH）得分。
结果：两年后，沿X-的中值平移，-,z轴为-0.12mm（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（IQR0.02至0.31）。围绕x-的中间旋转，-,z轴为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）。总的来说,20个假体在术后12个月内稳定。四个假体在12至24个月之间显示出连续迁移。在两年的随访中，除了一个修改过的假肢,所有临床评分均显著改善(静息时的中位VAS差异:-3.0(IQR-1.5~-6.0);OSS22.0(IQR15.0~25.0);CMS29.5(IQR15.0~35.75);以及DASH-30.0(IQR-20.6~-41.67)(所有p<0.001)),但一个经修订的假体除外.
结论：结论：我们发现24个植入物中有20个在术后12个月内稳定.四个植入物中连续迁移的重要性尚不清楚，需要进一步研究早期迁移对TSA未来松动的预测价值。临床结果显示临床相关的改善。引用本文：骨关节J2022；104-B（1）：76-82。
