Revision ACL Reconstructions: A Comparative Effectiveness Treatment Study

修正 ACL 重建：比较疗效治疗研究

• 批准号: 8194594
• 负责人: Rick W Wright
• 金额: $ 66.05万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8194594
• 关键词: Address; Adopted; Affect; Allografting; American; Anterior Cruciate Ligament; Articular Range of Motion; Autologous Transplantation; Braces-Orthopedic appliances; Clinical; Clinical Trials; Cohort Analysis; Cohort Studies; Defect; Degenerative polyarthritis; Development; Enrollment; Evidence based practice; Failure; Future; Goals; Grant; Incidence; Individual; Inferior; Injury; Institution; Knee; Knee Osteoarthritis; Lead; Lesion; Location; Measures; Mind; Operative Surgical Procedures; Orthopedics; Outcome; Outcome Measure; Pain; Pathology; Patients; Physical activity; Physicians; Postoperative Period; Prevalence; Private Practice; Prospective Studies; Quality of life; Recreation; Rehabilitation therapy; Relative (related person); Reliance; Repeat Surgery; Reporting; Research Design; Risk; Risk Factors; Rupture; Sample Size; Societies; Sports; Sports Medicine; Surgeon; Surgical incisions; Swelling; Symptoms; Techniques; Time; Weight-Bearing state; anterior cruciate ligament reconstruction; base; bone; comparative effectiveness; follow-up; graft failure; improved; prospective; reconstruction; success

DESCRIPTION (provided by applicant): Revision anterior cruciate ligament (ACL) reconstruction represents an infrequent but clinically important challenge in orthopaedic practice. Technical issues require specific revision techniques to address complications such as retained hardware, bone tunnel defects, and incorrect tunnel placement. Moreover, it is commonly reported that the results of revision surgery remain inferior to primary reconstructions. These poorer outcomes include worse patient based outcomes, increased knee laxity, higher graft failure rate, meniscal degeneration, and chondral lesions. A number of reasons for the poorer outcome rate have been proposed, including compromised tunnel location, pathology untreated during the primary reconstruction, and greater reliance on allografts for revisions. In order to evaluate the contributions of these and other factors to outcome, large numbers of patients who are undergoing revisions must be identified and followed prospectively. However, due to the relative infrequency of revision ACL reconstructions in any one center, a large multi-center study is necessary to accumulate enough subjects over a reasonable time frame to allow for multivariable analyses. With this in mind, the Multi-center ACL Revision Study (MARS) group was established as an 87 surgeon multi-center group to perform a prospective longitudinal cohort analysis of revision ACL reconstruction. This is a mixed group of academic and private practice physicians and has been supported and endorsed by the American Orthopedic Society for Sports Medicine (AOSSM). The group has been enrolling revision ACL reconstruction patients for over three years and has accumulated greater than 800 patients. This grant uses a prospective cohort study design and focuses on the modifiable predictors for ACL revision outcome at two-year follow-up. The overall goal is to elucidate the factors responsible for success or failure of ACL revision. We hypothesize that modifiable independent variables exist at the time of revision ACL reconstruction that will predict revision ACL reconstruction outcomes. This will be accomplished by focusing on four Specific Aims. Specific Aim 1 will determine if graft choice predicts incidence of graft rerupture, reoperation, return to sports function and activity level 2 years post-surgery. Specific Aim 2 will determine if modifiable surgical factors influence graft rerupture rates and return to sports function. Specific Aim 3 will determine if both prevalence and/or degree of meniscal and chondral damage measured at the time of the revision ACL reconstruction predicts activity level, return to sports function, and pain and swelling symptoms 2 years post-surgery. Specific Aim 4 is an exploratory aim, which determines if various rehabilitation factors influence the incidence of graft rerupture or return to sports activity 2 years following revision ACL surgery. The results of this study will drive the field of Orthopaedics Sports Medicine, in that it will guide practitioners to most appropriately choose the graft for reconstruction, modify surgical approaches and techniques, and manage meniscal and chondral injuries in a way to provide optimal outcome. PUBLIC HEALTH RELEVANCE: Revision ACL reconstruction results in inferior outcome compared with primary reconstructions, thus limiting individuals from returning to their previous activities. This multicenter, prospective study will allow determination of the clinical predictors of success or failure following revision ACL surgery. Once the predictors for outcome are identified, these can be potentially modified to improve patients' results.

描述（由申请人提供）：前交叉韧带（ACL）重建翻修术是骨科实践中罕见但具有临床重要性的挑战。技术问题需要特定的翻修技术来解决并发症，如内固定器械残留、骨隧道缺损和隧道放置不正确。此外，通常报告翻修手术的结果仍劣于初次重建。这些较差的结局包括基于患者的结局较差、膝关节松弛增加、移植物失败率较高、膝关节退行性变和软骨病变。已经提出了结局率较差的一些原因，包括隧道位置受损，初次重建期间未治疗的病理学，以及更依赖同种异体移植物进行翻修。为了评价这些因素和其他因素对结果的影响，必须识别并前瞻性随访大量接受翻修的患者。然而，由于任何一家临床试验机构的ACL重建翻修术相对较少，因此需要进行一项大型多中心研究，以便在合理的时间范围内积累足够的受试者，从而进行多变量分析。考虑到这一点，将多中心ACL翻修研究（MARS）组建立为87名外科医生的多中心组，以进行ACL翻修重建的前瞻性纵向队列分析。这是一个由学术和私人执业医生组成的混合团体，并得到了美国运动医学骨科学会（AOSSM）的支持和认可。该小组已经招募了三年多的ACL重建翻修患者，并积累了超过800例患者。该基金采用前瞻性队列研究设计，重点关注两年随访时ACL翻修结局的可修改预测因素。总体目标是阐明ACL翻修术成功或失败的因素。我们假设在ACL重建翻修术时存在可修改的自变量，这些自变量将预测ACL重建翻修术的结局。这将通过专注于四个具体目标来实现。具体目标1将确定移植物选择是否预测移植物再破裂、再手术、术后2年恢复运动功能和活动水平的发生率。具体目标2将确定是否可修改的手术因素影响移植物再破裂率和恢复运动功能。具体目标3将确定ACL重建翻修时测量的踝关节和软骨损伤的患病率和/或程度是否可预测术后2年的活动水平、恢复运动功能以及疼痛和肿胀症状。具体目标4是一个探索性目标，确定各种康复因素是否影响ACL翻修手术后2年移植物再断裂或恢复体育活动的发生率。这项研究的结果将推动骨科运动医学领域的发展，因为它将指导从业者最适当地选择移植物进行重建，修改手术方法和技术，并以提供最佳结果的方式管理骨骼和软骨损伤。 公共卫生相关性：与初次重建相比，翻修ACL重建的结果较差，因此限制了患者恢复之前的活动。这项多中心前瞻性研究将确定ACL翻修手术后成功或失败的临床预测因素。一旦确定了结果的预测因素，就可以潜在地修改这些预测因素以改善患者的结果。