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Abstract：
OBJECTIVE: To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component.
METHODS: Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed.
RESULTS: A total of 93 patients were randomized (46 TM; 47 POLY). No significant or clinically important differences were found with patient-reported outcomes at 24-month follow-up. Regarding the glenoid components, there were no complications or revision surgeries in either group. Grade 1 metal debris was observed in three (6.5%) patients with TM glenoids at 24 months but outcomes were not negatively impacted.
CONCLUSIONS: Early results from this RCT showed no differences in disease-specific QOL, radiographs, complication rates, or shoulder function between uncemented second-generation TM and cemented POLY glenoids at 24 months postoperatively. Revision surgeries and reoperations were reported in both groups, but none attributed to glenoid implant failure. At 24 months postoperatively, Grade 1 metal debris was found in 6.5% of patients with a TM glenoid but did not negatively influence patient-reported outcomes. Longer-term follow-up is needed and is underway. Cite this article: Bone Jt Open 2021;2(9):728-736.
METHODS: Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed.
RESULTS: A total of 93 patients were randomized (46 TM; 47 POLY). No significant or clinically important differences were found with patient-reported outcomes at 24-month follow-up. Regarding the glenoid components, there were no complications or revision surgeries in either group. Grade 1 metal debris was observed in three (6.5%) patients with TM glenoids at 24 months but outcomes were not negatively impacted.
CONCLUSIONS: Early results from this RCT showed no differences in disease-specific QOL, radiographs, complication rates, or shoulder function between uncemented second-generation TM and cemented POLY glenoids at 24 months postoperatively. Revision surgeries and reoperations were reported in both groups, but none attributed to glenoid implant failure. At 24 months postoperatively, Grade 1 metal debris was found in 6.5% of patients with a TM glenoid but did not negatively influence patient-reported outcomes. Longer-term follow-up is needed and is underway. Cite this article: Bone Jt Open 2021;2(9):728-736.
摘要：
目的：报告一项研究疾病特异性生活质量（QOL）的随机对照试验（RCT）术后早期（两年）发现，临床,患者报告，使用第二代非骨水泥小梁金属（TM）关节盂与胶结聚乙烯关节盂（POLY）组件进行全肩关节置换术（TSA）的患者的放射学结果。
方法：来自三个中心的5名受过研究金培训的外科医生参加了研究。筛选年龄在18至79岁之间，主要诊断为肱骨关节炎的患者的资格。患者在术中被随机分配到TM或POLY关节盂组件。研究间隔为：基线，六周,six-,12-，术后24个月。主要结果是西部安大略省骨关节炎肩关节QOL评分。审查了金属碎片的放射学图像。进行了组内和组间比较的混合效应重复测量方差分析。
结果：共有93名患者被随机分组（46TM；47POLY）。在24个月的随访中，患者报告的结果没有发现显着或临床上重要的差异。关于关节盂部件，两组均无并发症或翻修手术.在24个月时，在三名（6.5％）患有TM腺体的患者中观察到1级金属碎片，但对结果没有负面影响。
结论：该RCT的早期结果显示疾病特异性生活质量无差异，射线照片,并发症发生率,术后24个月，非骨水泥第二代TM和骨水泥POLY腺体之间的肩关节功能。两组均报告了修正手术和再次手术，但没有归因于关节盂植入失败。术后24个月，在6.5％的TM关节盂患者中发现了1级金属碎片，但对患者报告的结果没有负面影响。需要长期随访，并且正在进行中。引用这篇文章：BoneJtOpen2021；2（9）：728-736。
方法：来自三个中心的5名受过研究金培训的外科医生参加了研究。筛选年龄在18至79岁之间，主要诊断为肱骨关节炎的患者的资格。患者在术中被随机分配到TM或POLY关节盂组件。研究间隔为：基线，六周,six-,12-，术后24个月。主要结果是西部安大略省骨关节炎肩关节QOL评分。审查了金属碎片的放射学图像。进行了组内和组间比较的混合效应重复测量方差分析。
结果：共有93名患者被随机分组（46TM；47POLY）。在24个月的随访中，患者报告的结果没有发现显着或临床上重要的差异。关于关节盂部件，两组均无并发症或翻修手术.在24个月时，在三名（6.5％）患有TM腺体的患者中观察到1级金属碎片，但对结果没有负面影响。
结论：该RCT的早期结果显示疾病特异性生活质量无差异，射线照片,并发症发生率,术后24个月，非骨水泥第二代TM和骨水泥POLY腺体之间的肩关节功能。两组均报告了修正手术和再次手术，但没有归因于关节盂植入失败。术后24个月，在6.5％的TM关节盂患者中发现了1级金属碎片，但对患者报告的结果没有负面影响。需要长期随访，并且正在进行中。引用这篇文章：BoneJtOpen2021；2（9）：728-736。
