Department of Orthopaedics and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.
BMC Musculoskelet Disord. 2022 Feb 5;23(1):117. doi: 10.1186/s12891-021-04867-5.
Anterior cruciate ligament (ACL) rupture is a very common knee injury in the sport active population. There is much debate on which treatment (operative or non-operative) is best for the individual patient. In order to give a more personalized recommendation we aim to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture.
The ROTATE-trial is a multicenter, open-labeled cluster randomized controlled trial with superiority design. Randomization will take place on hospital level (n = 10). Patients must meet all the following criteria: aged 18 year or older, with a complete primary ACL rupture (confirmed by MRI and physical examination) and maximum of 6 weeks of non-operative treatment. Exclusion criteria consists of multi ligament trauma indicated for surgical intervention, presence of another disorder that affects the activity level of the lower limb, pregnancy, and insufficient command of the Dutch language. The intervention to be investigated will be an adjusted treatment decision strategy, including an advice from our treatment algorithm. Patient reported outcomes will be conducted at baseline, 3, 6, 12 and 24 months. Physical examination of the knee at baseline, 12 and 24 months. Primary outcome will be function of the knee measured by the International Knee Documentation Committee (IKDC) questionnaire. Secondary outcomes are, among others, the Tegner activity score, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Healthcare use, productivity and satisfaction with ((non-)operative) care are also measured by means of questionnaires. In total 230 patients will be included, resulting in 23 patients per hospital.
The ROTATE study aims to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture compared to current used treatment strategy. Using a treatment algorithm might give the much-wanted personalized treatment recommendation.
This study is approved by the Medical Research Ethics Committee of Erasmus Medical Center in Rotterdam and prospectively registered at the Dutch Trial Registry on May 13th, 2020. Registration number: NL8637.
前交叉韧带（ACL）断裂是运动活跃人群中非常常见的膝关节损伤。对于个体患者，哪种治疗方法（手术或非手术）最佳存在很多争议。为了提供更个性化的建议，我们旨在评估针对完全性原发性 ACL 断裂患者的治疗算法的有效性和成本效益。
ROTATE 试验是一项多中心、开放性、集群随机对照试验，具有优越性设计。随机分组将在医院层面进行（n=10）。患者必须符合以下所有标准：年龄在 18 岁或以上，存在完全性原发性 ACL 断裂（经 MRI 和体格检查证实），且非手术治疗时间最长为 6 周。排除标准包括需要手术干预的多韧带损伤、存在影响下肢活动水平的其他疾病、怀孕以及荷兰语水平不足。将调查的干预措施将是一种调整后的治疗决策策略，包括我们的治疗算法的建议。将在基线、3、6、12 和 24 个月时进行患者报告的结果。在基线、12 和 24 个月时进行膝关节体格检查。主要结局是国际膝关节文献委员会（IKDC）问卷测量的膝关节功能。次要结局包括 Tegner 活动评分、膝关节损伤和骨关节炎结果评分（KOOS）以及 9 项共享决策制定问卷（SDM-Q-9）。还通过问卷测量医疗保健的使用、生产力和对（非）手术护理的满意度。总共将纳入 230 例患者，每个医院纳入 23 例患者。
ROTATE 研究旨在评估针对完全性原发性 ACL 断裂患者的治疗算法与当前使用的治疗策略相比的有效性和成本效益。使用治疗算法可能会给出急需的个性化治疗建议。
该研究已获得鹿特丹伊拉斯谟医疗中心医学伦理委员会的批准，并于 2020 年 5 月 13 日在荷兰试验注册处进行了前瞻性注册。注册号：NL8637。
