Department of Orthopedic Surgery, William Beaumont Hospital, Beaumont Health, Royal Oak, Michigan.
Holy Cross Orthopedic Research Institute, Fort Lauderdale, Florida.
J Bone Joint Surg Am. 2020 Nov 18;102(22):1974-1984. doi: 10.2106/JBJS.19.01478.
Stemless humeral components for anatomic total shoulder arthroplasty (aTSA) have several reported potential benefits compared with stemmed implants. However, we are aware of no Level-I, randomized controlled trials (RCTs) that have compared stemless implants with stemmed implants in patients managed with aTSA. We sought to directly compare the short-term clinical and radiographic outcomes of stemless and stemmed implants to determine if the stemless implant is noninferior to the stemmed implant.
We performed a prospective, multicenter, single-blinded RCT comparing stemless and short-stemmed implants in patients managed with aTSA. Range-of-motion measurements and American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Constant scores were obtained at multiple time points. Device-related complications were recorded. Radiographic evaluation for evidence of loosening, fractures, dislocation, or other component complications was performed. Statistical analysis for noninferiority was performed at 2 years of follow-up for 3 primary end points: ASES score, absence of device-related complications, and radiographic signs of loosening. All other data were compared between cohorts at all time points as secondary measures.
Two hundred and sixty-five shoulders (including 176 shoulders in male patients and 89 shoulders in female patients) were randomized and received the allocated treatment. The mean age of the patients (and standard deviation) was 62.6 ± 9.3 years, and 99% of the shoulders had a primary diagnosis of osteoarthritis. At 2 years, the mean ASES score was 92.5 ± 14.9 for the stemless cohort and 92.2 ± 13.5 for the stemmed cohort (p value for noninferiority test, <0.0001), the proportion of shoulders without device-related complications was 92% (107 of 116) for the stemless cohort and 93% (114 of 123) for the stemmed cohort (p value for noninferiority test, 0.0063), and no shoulder in either cohort had radiographic signs of loosening. Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up.
At 2 years of follow-up, the safety and effectiveness of the stemless humeral implant were noninferior to those of the stemmed humeral implant in patients managed with aTSA for the treatment of osteoarthritis. These short-term results are promising given the potential benefits of stemless designs over traditional, stemmed humeral components.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
与带柄植入物相比，解剖型全肩关节置换术（aTSA）的无柄肱骨组件具有多项潜在优势。然而，我们尚未发现任何一级、随机对照试验（RCT）比较过无柄植入物与带柄植入物在接受 aTSA 治疗的患者中的情况。我们旨在直接比较无柄和带柄植入物的短期临床和影像学结果，以确定无柄植入物是否不劣于带柄植入物。
我们进行了一项前瞻性、多中心、单盲 RCT，比较了 aTSA 治疗患者中无柄和短柄植入物的情况。在多个时间点测量了活动范围测量值以及美国肩肘外科医生协会（ASES）、单项评估数值评估（SANE）和常数评分。记录与器械相关的并发症。进行影像学评估以确定有无松动、骨折、脱位或其他组件并发症的迹象。在 2 年的随访中，对 3 个主要终点（ASES 评分、无器械相关并发症和影像学松动迹象）进行非劣效性统计分析。所有其他数据均作为次要指标在所有时间点与队列进行比较。
265 个肩部（包括 176 个男性肩部和 89 个女性肩部）被随机分配并接受了分配的治疗。患者的平均年龄（和标准差）为 62.6 ± 9.3 岁，99%的肩部有原发性骨关节炎诊断。在 2 年时，无柄组的 ASES 评分为 92.5 ± 14.9，带柄组为 92.2 ± 13.5（非劣效性检验 p 值，<0.0001），无柄组无器械相关并发症的比例为 92%（116 例中有 107 例），带柄组为 93%（123 例中有 114 例）（非劣效性检验 p 值，0.0063），两个队列中均无肩部出现影像学松动迹象。在 2 年的随访中，在任何时间点，两组的活动范围测量值以及 ASES、SANE 和常数评分均无显著差异。
在 2 年的随访中，无柄肱骨植入物的安全性和有效性不劣于带柄肱骨植入物，用于治疗骨关节炎的 aTSA。鉴于无柄设计相对于传统带柄肱骨组件的潜在优势，这些短期结果很有前景。
治疗水平 I。有关证据水平的完整描述，请参阅作者说明。
