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自然病程和急性前交叉韧带损伤后的恢复:NACOX 队列研究方案。

Natural corollaries and recovery after acute ACL injury: the NACOX cohort study protocol.

机构信息

Division of Physiotherapy, Department of Medical and Health Sciences, Linköping University, Linkoping, Sweden.

Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.

出版信息

BMJ Open. 2018 Jun 27;8(6):e020543. doi: 10.1136/bmjopen-2017-020543.

Abstract

INTRODUCTION

Anterior cruciate ligament (ACL) injury can result in joint instability, decreased functional performance, reduced physical activity and quality of life and an increased risk for post-traumatic osteoarthritis. Despite the development of new treatment techniques and extensive research, the complex and multifaceted nature of ACL injury and its consequences are yet to be fully understood. The overall aim of the NACOX study is to evaluate the natural corollaries and recovery after an ACL injury.

METHODS AND ANALYSIS

The NACOX study is a multicentre prospective prognostic cohort study of patients with acute ACL injury. At seven sites in Sweden, we will include patients aged 15-40 years, within 6 weeks after primary ACL injury. Patients will complete questionnaires at multiple occasions over the 3 years following injury or the 3 years following ACL reconstruction (for participants who have surgical treatment). In addition, a subgroup of 130 patients will be followed with clinical examinations, several imaging modalities and biological samples. Data analyses will be specific to each aim.

ETHICS AND DISSEMINATION

This study has been approved by the regional Ethical committee in Linköping, Sweden (Dnr 2016/44-31 and 2017/221-32). We plan to present the results at national and international conferences and in peer-reviewed scientific journals. Participants will receive a short summary of the results following completion of the study.

TRIAL REGISTRATION NUMBER

NCT02931084.

摘要

简介

前交叉韧带(ACL)损伤可导致关节不稳定、功能表现下降、身体活动减少和生活质量降低,并增加创伤后骨关节炎的风险。尽管新的治疗技术不断发展,研究也不断深入,但 ACL 损伤及其后果的复杂性和多面性仍未被完全理解。NACOX 研究的总体目标是评估 ACL 损伤后的自然后果和恢复情况。

方法和分析

NACOX 研究是一项多中心前瞻性预后队列研究,纳入瑞典 7 个地点在 ACL 初次损伤后 6 周内的 15-40 岁急性 ACL 损伤患者。患者将在损伤后 3 年内或 ACL 重建后 3 年内(对接受手术治疗的患者)多次完成问卷调查。此外,还将对 130 名患者进行亚组临床检查、多种影像学检查和生物样本检查。数据分析将针对每个目标进行。

伦理和传播

本研究已获得瑞典林雪平地区伦理委员会的批准(Dnr 2016/44-31 和 2017/221-32)。我们计划在国内和国际会议上以及在同行评议的科学期刊上展示研究结果。研究完成后,参与者将收到研究结果的简短总结。

临床试验注册号

NCT02931084。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2458/6020951/65862f47882b/bmjopen-2017-020543f01.jpg

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