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

 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，修复失败率仍有20%-70%的报道。我们推测，目前的结构完整性测量与临床结果之间的弱关系是由于对肌腱愈合的不精确理解，这限制了旨在改善愈合和结果的治疗和康复策略的进展。目前用核磁共振或超声波评估的结构结果仅显示修复完好、减弱或失败，但不足以辨别肌腱“连续失败”的程度，即在修复连续性中没有明显缺陷(间隙)的情况下发生显著的肌腱回缩。这项提议的目的是挑战和扩大 我们目前通过研究肌腱收缩对肩袖愈合的定义--广义定义 修复后的肌腱向内侧平移，脱离骨骼，有或没有缺陷--这是肩袖修复后常见的临床预测结构结果。该方法是使用一系列植入的标记物来表征肌腱收缩，并在125名患者的前瞻性队列中调查其与术前组织质量(MRI)、术后修复完整性(MRI)和临床结果的关系。在手术前和术后，患者将在6周完成有效的结果问卷并重复这些结果，并在3、6、12和24个月接受MRI(修复连续性)、CT成像(肌腱回缩)和力量测试。具体目标1将描述肩袖修复术后2年肌腱收缩的幅度、模式和时机，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)。具体目标2将评估肩袖修复后肌腱回缩的程度，并可改善对1年和2年强度和患者报告结果(PRO)的预测。我们期望显示肌腱回缩是常见的，发生在术后早期，有或没有修复连续性通过传统的影像评估，并且与临床结果显著相关。这一发现的直接和非常重要的结果将是我们对肌腱修复愈合的理解的范式转变，现在纳入了肌腱回缩的幅度、时间和位置以及修复组织的连续性。这些信息将产生对肩袖肌腱愈合的更准确的了解，从而允许在治疗策略方面的进步，从而改善手术愈合和临床结果，并随着时间的推移导致更持久的肩袖修复。

 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.