Zan Renato Aroca Aroca, Lazarini Rafael Fuchs, Matsunaga Fabio Teruo, Netto Nicola Archetti, Belloti João Carlos, Tamaoki Marcel Jun Sugawara
Orthopedics and Traumatology-Division of Hand surgery and Upper Limb, Universidade Federal de São Paulo, São Paulo, São Paulo, Brazil
Department of Orthopaedics and Traumatology, Hospital Felicio Rocho, Belo Horizonte, Minas Gerais, Brazil.
BMJ Open. 2020 Dec 24;10(12):e043449. doi: 10.1136/bmjopen-2020-043449.
Anatomical total shoulder arthroplasty (TSA) is an effective treatment adopted for patients with glenohumeral osteoarthritis (OA). The glenoid component failure is the main risk that occurs in this therapeutic choice; however, doubts remain regarding the selection of the best implant for avoiding complication. This systematic review aims to evaluate the glenoid component in TSA by comparing the complications of different types of implants.
A systematic review of randomised clinical trials or quasi-randomised trials will be performed by applying the Preferred Reporting Items for Systematic Review and Meta-Analysis protocols and comparing polyethylene (keeled and pegged) versus metal-backed implants in adult patients with glenohumeral OA. Our search strategy will be performed using MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE and Web of Science. Data management and extraction will be performed using a data withdrawal form and by analysing study method characteristics, participant characteristics, intervention characteristics, results and methodological domains. The database search will be performed by February 2021. The Grading of Recommendations Assessment, Development and Evaluation will be used for assessing the quality of evidence of each study selected; however, some critical and important outcomes were determined such as the shoulder function through functional scores (Constant-Murley and American Shoulder and Elbow Surgeons), complications represented by pain (Visual Analogue Scale), surgical revision, radiograph radiolucency and loosening. The confidence in estimated effects for these outcomes will be applied as the overall confidence. The outcomes will be defined as early or late, according to the postoperative follow-up of less than or greater than 1 year, respectively, for complications and radiographs. For the shoulder function, follow-ups will be divided into 6, 12 and 24 months. Heterogeneity is expected in systematic reviews; therefore, the selection of outcomes, as well as the sample size, and specific statistical analysis can lead to meta-analysis; however, if it fails, narrative evidence synthesis will be conducted. Other analyses such as descriptive, subgroup and sensitivity analyses will be performed whenever possible. This systematic review will, therefore, provide evidence concerning the best clinical practice for avoiding complications.
This study has been approved by the Institutional Review Board of Universidade Federal de São Paulo (protocols 0725/2017, 2.157.415 and 70473017.5.0000.5505), and the findings will be disseminated through peer-reviewed publication and conference presentations.
CRD42018079537.
解剖型全肩关节置换术（TSA）是治疗盂肱关节骨关节炎（OA）患者的一种有效方法。盂肱关节假体失败是这种治疗选择中出现的主要风险；然而，对于选择最佳植入物以避免并发症仍存在疑问。本系统评价旨在通过比较不同类型植入物的并发症来评估TSA中的盂肱关节假体。
将应用系统评价和Meta分析的首选报告项目协议，对随机临床试验或半随机试验进行系统评价，比较成年盂肱关节OA患者中聚乙烯（带龙骨和带钉）与金属背衬植入物。我们将使用MEDLINE、PubMed、Cochrane对照试验中央注册库、EMBASE和科学网进行检索策略。将使用数据提取表并通过分析研究方法特征、参与者特征、干预特征、结果和方法学领域来进行数据管理和提取。数据库检索将于2021年2月进行。将使用推荐评估、制定和评价分级来评估所选每项研究的证据质量；然而，确定了一些关键和重要的结果，如通过功能评分（Constant-Murley和美国肩肘外科医师学会评分）评估肩部功能、以疼痛（视觉模拟评分）表示的并发症、手术翻修、X线片透射线和松动情况。对这些结果估计效应的置信度将用作总体置信度。根据并发症和X线片术后随访时间分别少于或大于1年，将结果定义为早期或晚期。对于肩部功能，随访将分为6、12和24个月。系统评价中预计会存在异质性；因此，结果的选择、样本量以及特定的统计分析可能会导致Meta分析；然而，如果失败，则将进行叙述性证据综合。只要有可能，将进行其他分析，如描述性分析、亚组分析和敏感性分析。因此，本系统评价将提供有关避免并发症的最佳临床实践的证据。
本研究已获得圣保罗联邦大学机构审查委员会的批准（协议号0725/2017、2.157.415和70473017.5.0000.5505），研究结果将通过同行评审出版物和会议报告进行传播。
PROSPERO注册号：CRD42018079537。
