Abstract：
BACKGROUND: Acute unreconstructible 3- or 4-part proximal humerus fractures can be treated with hemiarthroplasty or reverse polarity shoulder arthroplasty. Randomized trials using implants from multiple different companies or uncemented implants have found superior results with reverse polarity arthroplasty.
OBJECTIVE: This study aims to determine whether cemented reverse polarity arthroplasty produces a superior outcome compared to cemented hemiarthroplasty using one implant system in patients aged 65 years and over at 12 months follow-up as measured with the Constant score.
METHODS: A prospective patient and assessor blinded multicenter randomized controlled trial was conducted of shoulder hemiarthroplasty or reverse polarity arthroplasty in patients aged 65 years and older with acute 3- and 4-part proximal humerus fracture not amenable to osteosynthesis. The primary outcome was the Constant score at 12 months with total follow-up to 24 months. Block randomization by site was undertaken using random number generation and sealed envelopes. Power analysis indicated that 17 patients were required in each arm to achieve 80% power with an alpha-value of 5%. Secondary outcome measures were the difference in the mean Constant Score, Quick Disabilities of the Arm Shoulder and Hand Questionnaire (QuickDASH), Oxford Shoulder Score (OSS), American Shoulder and Elbow Surgeons (ASES) Score and EQ5D-5L up to two years; differences in complication rate at one and two years; differences in revision and implant failure at one and two years.
RESULTS: 18 patients were randomized to hemiarthroplasty and 18 to reverse polarity arthroplasty across 4 sites. The primary outcome as measured by the Constant score at 12 months was better in the reverse polarity shoulder arthroplasty (RSA) group (Mean 51.1, s.d. 14.9) compared to the hemiarthroplasty (HA) group (mean 35.0, s.d. 13.5) (p=0.004). No significant difference was reported at 24 months but this may be due to high rates of attrition (22%). The mean EQ-5D-5L patient rated health status score was significantly higher in the RSA group compared to the HA group at 12 months. One hemiarthroplasty was revised due to implant uncoupling and one reverse polarity shoulder replacement was revised due to instability. No other complications were recorded.
CONCLUSIONS: Treatment of unreconstructible 3- or 4-part proximal humerus fractures with reverse polarity shoulder arthroplasty results in a superior outcome compared to shoulder hemiarthroplasty at 12 months measured with the Constant score with no increased risk of failure up to 24 months in patients age 65 years and over. High attrition rates are observed in this older population due to cognitive decline and death from other causes.
OBJECTIVE: This study aims to determine whether cemented reverse polarity arthroplasty produces a superior outcome compared to cemented hemiarthroplasty using one implant system in patients aged 65 years and over at 12 months follow-up as measured with the Constant score.
METHODS: A prospective patient and assessor blinded multicenter randomized controlled trial was conducted of shoulder hemiarthroplasty or reverse polarity arthroplasty in patients aged 65 years and older with acute 3- and 4-part proximal humerus fracture not amenable to osteosynthesis. The primary outcome was the Constant score at 12 months with total follow-up to 24 months. Block randomization by site was undertaken using random number generation and sealed envelopes. Power analysis indicated that 17 patients were required in each arm to achieve 80% power with an alpha-value of 5%. Secondary outcome measures were the difference in the mean Constant Score, Quick Disabilities of the Arm Shoulder and Hand Questionnaire (QuickDASH), Oxford Shoulder Score (OSS), American Shoulder and Elbow Surgeons (ASES) Score and EQ5D-5L up to two years; differences in complication rate at one and two years; differences in revision and implant failure at one and two years.
RESULTS: 18 patients were randomized to hemiarthroplasty and 18 to reverse polarity arthroplasty across 4 sites. The primary outcome as measured by the Constant score at 12 months was better in the reverse polarity shoulder arthroplasty (RSA) group (Mean 51.1, s.d. 14.9) compared to the hemiarthroplasty (HA) group (mean 35.0, s.d. 13.5) (p=0.004). No significant difference was reported at 24 months but this may be due to high rates of attrition (22%). The mean EQ-5D-5L patient rated health status score was significantly higher in the RSA group compared to the HA group at 12 months. One hemiarthroplasty was revised due to implant uncoupling and one reverse polarity shoulder replacement was revised due to instability. No other complications were recorded.
CONCLUSIONS: Treatment of unreconstructible 3- or 4-part proximal humerus fractures with reverse polarity shoulder arthroplasty results in a superior outcome compared to shoulder hemiarthroplasty at 12 months measured with the Constant score with no increased risk of failure up to 24 months in patients age 65 years and over. High attrition rates are observed in this older population due to cognitive decline and death from other causes.
摘要：
背景：急性不可重建的肱骨近端3-或4-部分骨折可采用半髋关节置换术或反极性肩关节置换术治疗。使用来自多个不同公司的植入物或非骨水泥植入物的随机试验发现，反极性关节成形术的效果更好。
目的：本研究旨在确定在65岁及以上患者12个月随访时，使用一种植入物系统的骨水泥性反极性关节置换术是否比骨水泥性半关节置换术产生更好的结果。
方法：一项前瞻性患者和评估者盲法多中心随机对照试验，对年龄在65岁及以上的急性肱骨近端三部分和四部分骨折患者进行肩关节置换术或反极性关节置换术。主要结果是12个月时的Constant评分，总随访至24个月。使用随机数生成和密封信封进行按部位分组随机化。功率分析表明，每个手臂需要17名患者才能达到80％的功率，α值为5％。次要结果指标是平均恒定评分的差异，手臂和手的快速残疾问卷（QuickDASH），牛津肩评分（OSS），美国肩肘外科医生（ASES）评分和EQ5D-5L长达两年；一年和两年的并发症发生率差异；一年和两年的翻修和植入物失败差异。
结果：18例患者在4个部位随机接受半髋关节置换术，18例患者接受反向极性关节置换术。通过12个月时的Constant评分测量的主要结果在反极性肩关节置换术（RSA）组（平均值51.1，s.d.14.9）优于半髋关节置换术（HA）组（平均值35.0，s.d.13.5）（p=0.004）。在24个月时没有显着差异，但这可能是由于高流失率（22％）。在12个月时，RSA组的平均EQ-5D-5L患者评估健康状况评分明显高于HA组。由于植入物解耦，对一次半髋关节置换术进行了修正，由于不稳定，对一次反向极性肩关节置换术进行了修正。无其他并发症记录。
结论：在使用Constant评分测量的12个月时，使用反极性肩关节置换术治疗不可重建的肱骨近端3-或4-部分骨折的效果优于肩关节置换术，在65岁及以上的患者中，直到24个月的失败风险没有增加。由于认知能力下降和其他原因导致的死亡，在该老年人群中观察到高流失率。
目的：本研究旨在确定在65岁及以上患者12个月随访时，使用一种植入物系统的骨水泥性反极性关节置换术是否比骨水泥性半关节置换术产生更好的结果。
方法：一项前瞻性患者和评估者盲法多中心随机对照试验，对年龄在65岁及以上的急性肱骨近端三部分和四部分骨折患者进行肩关节置换术或反极性关节置换术。主要结果是12个月时的Constant评分，总随访至24个月。使用随机数生成和密封信封进行按部位分组随机化。功率分析表明，每个手臂需要17名患者才能达到80％的功率，α值为5％。次要结果指标是平均恒定评分的差异，手臂和手的快速残疾问卷（QuickDASH），牛津肩评分（OSS），美国肩肘外科医生（ASES）评分和EQ5D-5L长达两年；一年和两年的并发症发生率差异；一年和两年的翻修和植入物失败差异。
结果：18例患者在4个部位随机接受半髋关节置换术，18例患者接受反向极性关节置换术。通过12个月时的Constant评分测量的主要结果在反极性肩关节置换术（RSA）组（平均值51.1，s.d.14.9）优于半髋关节置换术（HA）组（平均值35.0，s.d.13.5）（p=0.004）。在24个月时没有显着差异，但这可能是由于高流失率（22％）。在12个月时，RSA组的平均EQ-5D-5L患者评估健康状况评分明显高于HA组。由于植入物解耦，对一次半髋关节置换术进行了修正，由于不稳定，对一次反向极性肩关节置换术进行了修正。无其他并发症记录。
结论：在使用Constant评分测量的12个月时，使用反极性肩关节置换术治疗不可重建的肱骨近端3-或4-部分骨折的效果优于肩关节置换术，在65岁及以上的患者中，直到24个月的失败风险没有增加。由于认知能力下降和其他原因导致的死亡，在该老年人群中观察到高流失率。
