Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, 107 Yan Jiang Road West, Guangzhou, 510120, Guangdong, China.
BMC Musculoskelet Disord. 2020 Dec 7;21(1):819. doi: 10.1186/s12891-020-03818-w.
The critical shoulder angle (CSA), which helps to predict patients who are at risk of rotator cuff tears (RCTs) with large degree and who are susceptible to osteoarthritis with low angle, has been identified as one of the most vital acromial parameters; anterolateral and lateral acromioplasties have been proven to be valid ways to reduce CSA. However, no study has compared the effect of different acromioplasties on the reduction of the large CSA (≥33°) clinically. Additionally, either anterolateral or lateral acromioplasty could not precisely correct large CSAs to a favorable range (30-33°) in each patient. Thus, we will propose a novel precise acromioplasty technique for the purpose of reducing CSA accurately and effectively, and compare the effectiveness of different acromioplasties on the reduction of the CSA.
A total of 60 RCT patients who have indications for arthroscopic rotator cuff repair and with pre-operative CSA ≥33° will be recruited in outpatient center of Sun Yat-sen Memorial Hospital. Eligible participants will be randomly allocated to Group A (anterolateral acromioplasty), Group B (lateral acromioplasty) or Group C (precise acromioplasty) via a random, computer-generated number system. Three surgical plans will be made for each participant respectively by one professional surgeon according to the results of randomization allocation. The post-operative CSA will be measured 2 days post-operation. Follow-up will be maintained at 3, 6, and 12 months after surgery including the visual analog scale score, the University of California at Los Angeles score, the Constant Shoulder Score and the American Shoulder and Elbow Surgeon Shoulder Assessment Form. Finally, all outcomes will be assessed by two researchers who are blinded to the recruitment and allocation.
This is the first clinical trial to evaluate the impact of different acromioplasties on the reduction of the CSA. Additionally, this study will provide a new precise acromioplasty technique, which is a novel precision and individualized treatment to prevent degenerative RCTs by reducing the CSA.
ChiCTR2000032343 . Registered on April 26th, 2020.
临界肩角（CSA）有助于预测肩袖撕裂（RCT）程度较大且易患小角度骨关节炎的患者，已被确定为最重要的肩峰参数之一；前外侧和外侧肩峰成形术已被证明是降低 CSA 的有效方法。然而，尚无研究比较不同肩峰成形术对大 CSA（≥33°）的临床降低效果。此外，前外侧或外侧肩峰成形术都无法在每个患者中将大 CSA 精确地矫正到有利范围（30-33°）。因此，我们将提出一种新的精确肩峰成形术技术，以准确有效地降低 CSA，并比较不同肩峰成形术对 CSA 降低的效果。
本研究将在中山大学孙逸仙纪念医院门诊中心招募 60 例具有关节镜肩袖修复指征且术前 CSA≥33°的 RCT 患者。合格的参与者将通过随机、计算机生成的数字系统随机分配至 A 组（前外侧肩峰成形术）、B 组（外侧肩峰成形术）或 C 组（精确肩峰成形术）。每位专业外科医生将根据随机分组分配的结果分别为每位参与者制定三种手术方案。术后 2 天测量术后 CSA。术后 3、6 和 12 个月随访时，包括视觉模拟评分、加利福尼亚大学洛杉矶分校评分、Constant 肩部评分和美国肩肘外科医生肩部评估表，评估所有结果。最后，两名对招募和分组均不知情的研究人员评估所有结果。
这是第一项评估不同肩峰成形术对 CSA 降低影响的临床试验。此外，本研究将提供一种新的精确肩峰成形术技术，通过降低 CSA 为预防退行性 RCT 提供一种新的精确和个体化治疗方法。
ChiCTR2000032343，于 2020 年 4 月 26 日注册。
