Identifying the patient, disease, surgical, and implant positional shift factors that predict outcomes following total shoulder arthroplasty

确定预测全肩关节置换术后结果的患者、疾病、手术和植入物位置变化因素

• 批准号: 10378597
• 负责人: Eric T. Ricchetti
• 金额: $ 24.13万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10378597
• 关键词: Address; Analysis of Covariance; Anatomy; Arthritis; Classification; Clinical; Clinical Trials; Complication; Disease; Evaluation; Future; Health Status; Implant; Institution; Intervention; Investigation; Joints; Lead; Legal patent; Literature; Measures; Medial; Mental Health; Modeling; Modification; Operative Surgical Procedures; Osteolysis; Outcome; Pain; Patient Outcomes Assessments; Patient Selection; Patients; Perioperative; Positioning Attribute; Postoperative Period; Predictive Factor; Procedures; Prospective cohort study; Radiology Specialty; Replacement Arthroplasty; Reporting; Risk Factors; Rotation; Shoulder; Translations; United States; Work; X-Ray Computed Tomography; base; cohort; design; follow-up; improved outcome; opioid use; outcome prediction; patient subsets; prospective; radiological imaging; routine imaging; subscapularis muscle; survivorship

Project Summary—Abstract While total shoulder arthroplasty (TSA) is the preferred surgical treatment for advanced glenohumeral arthritis, a subset of patients does not experience improvement or sustains a complication. Mean TSA complication rates have ranged from 10-17%, with glenoid component loosening reported as the most common long-term complication of anatomic TSA and a common reason for revision surgery. While complications can lead to poor clinical outcomes, multiple studies have also shown associations between baseline demographic, disease- related and surgical factors, and clinical outcomes. Despite these prior studies, the factors associated with poor short- and long-term clinical outcome after anatomic TSA are still not well understood, in part due to the lack of large prospective cohort studies allowing for multivariable analysis. Our proposal’s objective is to identify the factors associated with short- and longer-term clinical and radiographic outcomes following anatomic TSA. Our approach will utilize two unique, prospective TSA cohorts ongoing at our institution to allow for simultaneous investigation of short and longer-term clinical outcomes, as well as the relationship between the two through the assessment of radiographic factors not possible with routine imaging: a larger cohort (over 1,200 projected cases) collecting baseline demographic, disease-related and surgical factors, together with 1 year clinical outcomes (Patient Cohort 1); and a smaller cohort (n=152) collecting CT imaging-based measures, as well as minimum 5 year clinical outcomes (Patient Cohort 2). Specific Aim 1 will use Patent Cohort 1 to identify the risk factors associated with short-term clinical outcomes at 1 year after primary anatomic TSA. Specific Aim 2 will use Patient Cohort 2 to conduct exploratory analyses of the incremental contribution of CT imaging-based radiologic factors to the prediction of longer-term clinical outcomes at minimum 5 years after primary anatomic TSA, beyond that provided by the perioperative risk factors identified in Specific Aim 1. We expect to show that baseline mental health status, pre-operative opioid use, pre-operative Penn Shoulder Score (PSS) or Single Assessment Numeric Evaluation (SANE) score, Walch classification, subscapularis management, and implant position will independently associate with 1-year patient-reported outcomes (PSS, SANE) after controlling for other demographic, disease-related, and surgical factors (Aim 1). We also anticipate that after adjusting for the risk factors investigated in Aim 1, glenoid component shift (translation and/or rotation) and central peg osteolysis at minimum 2 and/or 5 years post-operatively will associate with worse patient-reported outcomes (PSS, SANE) at minimum 5 years, and that the pre-operative Walch classification and joint line medialization and the presence of central peg osteolysis at minimum 2 years will associate with composite glenoid component shift at minimum 5 years (Aim 2). Identifying significant risk factors that are important to clinical outcomes following anatomic TSA would allow for the design of future prospective clinical trial(s) to investigate modification of these factors either directly or indirectly through pre-operative intervention or modification of surgical treatment and/or patient selection based on these factors, with the aim to improve outcomes and survivorship following anatomic TSA.

项目摘要-摘要 虽然全肩关节置换术（TSA）是晚期盂肱关节炎的首选手术治疗， 一部分患者没有经历改善或维持并发症。平均TSA并发症 发生率范围为10 - 17%，关节盂组件松动是最常见的长期 解剖TSA的并发症和翻修手术的常见原因。虽然并发症可能导致穷人 临床结果，多项研究也显示了基线人口统计学，疾病， 相关因素和手术因素以及临床结果。尽管有这些先前的研究， 解剖TSA后的短期和长期临床结果不佳仍然没有得到很好的理解，部分原因是 缺乏允许多变量分析的大型前瞻性队列研究。我们提案的目的是 确定与短期和长期临床和影像学结局相关的因素， 解剖TSA。我们的方法将利用我们机构正在进行的两个独特的前瞻性TSA队列， 同时研究短期和长期临床结局，以及 通过对常规影像学检查不可能的放射学因素进行评估， 1 200个预测病例），收集基线人口统计学、疾病相关和手术因素，以及1 年临床结局（患者队列1）;以及一个较小的队列（n = 152），收集基于CT成像的 指标以及至少5年临床结局（患者队列2）。具体目标1将使用专利 队列1，以确定与初次治疗后1年的短期临床结局相关的风险因素 解剖TSA。特定目标2将使用患者队列2对增量进行探索性分析 基于CT成像的放射学因素对预测长期临床结局的贡献 初次解剖型TSA后至少5年，超出所确定的围手术期风险因素所提供的时间 具体目标1。 我们希望表明，基线心理健康状况，术前阿片类药物使用，术前宾州肩关节 评分（PSS）或单一评估数字评价（SANE）评分，Walch分级，肩胛下肌 管理和植入物位置将与1年患者报告的结局独立相关（PSS， 在控制了其他人口统计学因素、疾病相关因素和手术因素（目的1）后，我们还预计 在调整目标1中研究的风险因素后，关节盂组件移位（平移和/或 旋转）和中央立柱骨质溶解，将导致术后至少2年和/或5年的 至少5年时患者报告的结局（PSS，SANE），术前Walch分级 关节线内侧化和至少2年时存在中央立柱骨质溶解将与 至少5年时复合关节盂组件移位（目标2）。确定重要的风险因素， 对解剖TSA后的临床结局很重要，这将允许设计未来的前瞻性临床 研究通过术前干预直接或间接改变这些因素的试验 或基于这些因素修改手术治疗和/或患者选择， 解剖TSA后的结局和生存率。

项目成果

Effectiveness of a Web-Based Electronic Prospective Data Collection Tool for Surgical Data in Shoulder Arthroplasty.

• DOI: 10.1053/j.sart.2020.12.011
• 发表时间: 2021-09
• 期刊: Seminars in arthroplasty
• 作者: Sahoo S;Rodríguez JA;Serna M;“Cleveland Clinic Shoulder Group”;Spindler KP;Derwin KA;Iannotti JP;Ricchetti ET
• 通讯作者: Ricchetti ET

Relationship Between Glenoid Component Shift and Osteolysis After Anatomic Total Shoulder Arthroplasty: Three-Dimensional Computed Tomography Analysis.

• DOI: 10.2106/jbjs.20.00833
• 发表时间: 2021-08-04
• 期刊: The Journal of bone and joint surgery. American volume
• 作者: Ricchetti ET;Jun BJ;Jin Y;Ho JC;Patterson TE;Dalton JE;Derwin KA;Iannotti JP
• 通讯作者: Iannotti JP

Associations of preoperative patient mental health status and sociodemographic and clinical characteristics with baseline pain, function, and satisfaction in patients undergoing primary shoulder arthroplasty.

• DOI: 10.1016/j.jse.2020.08.003
• 发表时间: 2021-05
• 期刊: Journal of shoulder and elbow surgery
• 影响因子: 3
• 作者: Sahoo S;Derwin KA;Zajichek A;Cleveland Clinic Shoulder Group;Entezari V;Imrey PB;Iannotti JP;Ricchetti ET
• 通讯作者: Ricchetti ET

Stepped Augmented Glenoid Component in Anatomic Total Shoulder Arthroplasty for B2 and B3 Glenoid Pathology: A Study of Early Outcomes.

• DOI: 10.2106/jbjs.20.01420
• 发表时间: 2021-10-06
• 期刊: The Journal of bone and joint surgery. American volume
• 作者: Iannotti JP;Jun BJ;Derwin KA;Ricchetti ET
• 通讯作者: Ricchetti ET