Department of Shoulder and Elbow Surgery, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Department of Orthopaedics, New Royal Infirmary of Edinburgh, Edinburgh, UK.
J Shoulder Elbow Surg. 2018 Aug;27(8):1483-1490. doi: 10.1016/j.jse.2018.02.057. Epub 2018 Apr 3.
The aim of this prospective multicenter study was to evaluate clinical and radiologic results of a new metaphyseal anchored system. This system features a different anchor geometry that potentially leads to better bony integration and less loosening.
From November 2012 until December 2015, 148 patients (151 shoulders) were treated with the Sidus Stem-Free Shoulder System at 9 centers in Europe. The main indication was primary osteoarthritis (80.1%). This analysis only includes patients diagnosed with primary osteoarthritis (n = 121). A clinical evaluation was performed using the Constant-Murley score, Subjective Shoulder Value, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, and range of motion. Radiologic assessment was based on the occurrence of radiolucent lines and signs of implant migration, osteolysis, loosening, and heterotopic ossification.
We evaluated 105 patients after a follow-up period of 2 years. There were 53 women and 52 men. The average age was 64 years. Total shoulder arthroplasty was performed in 73 cases and hemiarthroplasty in 32. The Constant-Murley score improved from 26 points preoperatively to 70 points at 2 years' follow-up (P < .001). The Subjective Shoulder Value increased from 34% to 84% (P < .001), and the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form increased from 34 points to 86 points (P < .001). Radiologically, neither migration nor loosening was found. However, radiolucent lines of 2 mm or greater could be detected around the glenoid in 2 cases, but none of them have had clinical relevance yet. The overall complication rate was 6.7%, and the revision rate was 0%.
Patients with the Sidus Stem-Free Shoulder System achieve good clinical and radiologic short-term results that are comparable with the results of other stem-free shoulder implants.
本前瞻性多中心研究旨在评估一种新型干骺端锚定系统的临床和影像学结果。该系统具有不同的锚定几何形状，有可能导致更好的骨整合和减少松动。
2012 年 11 月至 2015 年 12 月，在欧洲的 9 个中心，148 名患者（151 个肩部）接受了 Sidus Stem-Free 肩系统治疗。主要适应证为原发性骨关节炎（80.1%）。本分析仅包括诊断为原发性骨关节炎的患者（n=121）。使用 Constant-Murley 评分、主观肩部值、美国肩肘外科医生标准化肩部评估表和活动范围进行临床评估。影像学评估基于是否存在透光线和植入物迁移、骨溶解、松动和异位骨化的迹象。
我们对 105 例患者进行了 2 年的随访，其中 53 例为女性，52 例为男性，平均年龄 64 岁。73 例患者行全肩关节置换术，32 例患者行半肩关节置换术。术前 Constant-Murley 评分为 26 分，术后 2 年随访时为 70 分（P<.001）。主观肩部值从 34%增加到 84%（P<.001），美国肩肘外科医生标准化肩部评估表从 34 分增加到 86 分（P<.001）。影像学上，未发现迁移或松动。然而，在 2 例患者的肩胛盂周围可以检测到 2mm 或更大的透光线，但目前均无临床意义。总的并发症发生率为 6.7%，翻修率为 0%。
Sidus Stem-Free 肩系统的患者获得了良好的临床和影像学短期结果，与其他无柄肩植入物的结果相当。
