Failure with Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes

连续性失败及其与肩袖修复临床结果的关系

• 批准号: 9234474
• 负责人: Kathleen Anne Derwin
• 金额: $ 61.76万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9234474
• 关键词: Accounting; Age; Area; Atrophic; Attenuated; Biomedical Engineering; Classification; Clinical; Clinical Research; Defect; Enrollment; Failure; Human; Image; Implant; Individual; Infiltration; Intervention; Location; Magnetic Resonance Imaging; Measures; Medial; Medical; Monitor; Muscle; Operative Surgical Procedures; Outcome; Pain; Patient Outcomes Assessments; Patients; Pattern; Postoperative Period; Prospective cohort study; Questionnaires; Radio-Opaque; Recurrence; Reporting; Rotator Cuff; Shoulder; Signal Transduction; Surgeon; Tantalum; Tendon structure; Testing; Thick; Time; Tissues; Translations; Ultrasonography; United States; X-Ray Computed Tomography; base; bone; clinical predictors; cohort; cost; healing; imaging modality; improved; multidisciplinary; predictive modeling; prospective; public health relevance; radiologist; rehabilitation strategy; repaired; rotator cuff tear; scaffold; tissue repair; treatment strategy

 DESCRIPTION (provided by applicant): Healing following rotator cuff repair remains a significant clinical challenge, and repair failure rates of 20-70% continue to be reported. We postulate that the weak relationships between current measures of structural integrity and such clinical outcomes are due to an imprecise understanding of tendon healing, which limits advances in treatment and rehabilitation strategies aimed to improve healing and outcomes. Structural outcomes currently evaluated with MRI or ultrasound indicate only if the repair is intact, attenuated, or failed, but are inadequate to discern the extent to which the tendon has "failed with continuity", i.e., undergone significant tendon retraction in the absence of a discernible defect (gap) in repair continuity. This proposal's objective is to challenge and expand our current definition of rotator cuff healing by investigating tendon retraction - broadly defined as medial translation of the repaired tendon away from the bone with or without a defect - as a common and clinically predictive structural outcome following rotator cuff repair. The approach is to characterize tendon retraction using an array of implanted markers, and investigate its relationships to pre- operative tissue quality (MRI), post-operative repair integrity (MRI) and clinical outcomes in a prospectively enrolled cohort of 125 patients. Pre- and post-operatively, patients will complete validated outcome questionnaires at 6 weeks and repeat these, as well as undergo MRI (repair continuity), CT imaging (tendon retraction) and strength testing, at 3, 6, 12 and 24 months. Specific Aim 1 will characterize the magnitude, patterns, and timing of tendon retraction for 2 years after rotator cuff repair, and assess its relationship to pre- operative tisue quality and post-operative repair integrity (both by traditional MRI). Specific Aim 2 will assess the extent to which tendon retraction after rotator cuff repair is associated with and can improve prediction of 1- and 2-year strength and patient reported outcomes (PROs). We expect to show that tendon retraction is common, occurs early post-operatively, with or without repair continuity as assessed by traditional imaging, and significantly correlates with clinical outcomes. The immediate and highly significant consequence of this finding would be a paradigm shift in our understanding of tendon repair healing, now incorporating the magnitude, timing and location of tendon retraction as well as the continuity of the repaired tissue. This information would yield a more precise understanding of rotator cuff tendon healing, allowing for advances in treatment strategies that improve surgical healing and clinical outcomes and result in more durable rotator cuff repairs over time.

 描述（由申请人提供）：肩袖修复后的愈合仍然是一个重大的临床挑战，并且继续报告20-70%的修复失败率。我们假设，目前的结构完整性和临床结果之间的关系薄弱，是由于肌腱愈合的不准确的理解，这限制了进步的治疗和康复策略，旨在改善愈合和结果。目前用MRI或超声评估的结构结果仅指示修复是否完整、衰减或失败，但不足以辨别肌腱“连续性失败”的程度，即，在修复连续性中没有明显缺陷（间隙）的情况下，发生了显著的肌腱收缩。这项提案的目的是挑战和扩大 我们目前通过研究肌腱牵拉对肩袖愈合的定义-广义定义 作为修复的肌腱远离骨的内侧平移，有或没有缺陷-作为肩袖修复后的常见和临床预测结构结果。该方法旨在使用一系列植入标记物表征肌腱牵拉，并在前瞻性入组的125例患者队列中研究其与术前组织质量（MRI）、术后修复完整性（MRI）和临床结局的关系。术前和术后，患者将在6周时完成经验证的结局问卷，并在3、6、12和24个月时重复这些问卷，以及接受MRI（修复连续性）、CT成像（肌腱牵开）和强度测试。具体目标1将描述肩袖修复术后2年肌腱回缩的幅度、模式和时间，并评估其与术前组织质量和术后修复完整性的关系（均通过传统MRI）。特定目标2将评估肩袖修复后肌腱牵拉的程度，并可改善1年和2年强度预测和患者报告结局（PRO）。我们希望表明肌腱回缩是常见的，发生在术后早期，有或没有修复的连续性，通过传统的成像评估，并与临床结果显着相关。这一发现的直接和非常重要的后果将是我们对肌腱修复愈合的理解的范式转变，现在将肌腱收缩的幅度，时间和位置以及修复组织的连续性纳入其中。这些信息将使我们更准确地了解肩袖肌腱愈合，从而促进治疗策略的进步，改善手术愈合和临床结局，并随着时间的推移实现更持久的肩袖修复。