Study protocol ROTATE-trial: anterior cruciate ligament rupture, the influence of a treatment algorithm and shared decision making on clinical outcome– a cluster randomized controlled trial

• Published in: BMC musculoskeletal disorders Vol. 23; no. 1; pp. 117 - 9
• Main Authors: de Vos, Floris H., Meuffels, Duncan E., de Mul, Marleen, Askari, Marjan, Ista, Erwin, Polinder, Suzanne, Waarsing, Erwin, Bierma-Zeinstra, Sita M., Reijman, Max
• Format: Journal Article
• Language: English
• Published: London BioMed Central 05.02.2022; BioMed Central Ltd; Springer Nature B.V; BMC
• Subjects: Adolescent; Algorithms; Analysis; Anterior cruciate ligament; Anterior Cruciate Ligament - diagnostic imaging; Anterior Cruciate Ligament - surgery; Anterior Cruciate Ligament Injuries - diagnostic imaging; Anterior Cruciate Ligament Injuries - surgery; Anterior Cruciate Ligament Reconstruction; Anterior cruciate ligament rupture; Care and treatment; Clinical outcomes; Clinical trials; Cost analysis; Cost-effectiveness; Decision making; Decision Making, Shared; Decision-making, Group; Diagnosis; Epidemiology; Health aspects; Hospitals; Humans; Internal Medicine; Knee; Knee Joint - surgery; Ligaments; Magnetic resonance imaging; Medical care, Cost of; Medical research; Medicine; Medicine & Public Health; Multicenter Studies as Topic; Musculoskeletal diseases; Orthopedics; Osteoarthritis; Patients; Performance evaluation; Preferences; Prognosis; Quality of life; Randomized Controlled Trials as Topic; Rehabilitation; Rheumatology; Rupture; Shared decision making; Sports injuries; Sports Medicine; Study Protocol; Trauma; Treatment algorithm; Treatment Outcome; Netherlands; Anterior cruciate ligament rupture; Shared decision making; Cost-effectiveness; Treatment algorithm
• ISSN: 1471-2474; 1471-2474
• DOI: 10.1186/s12891-021-04867-5

Background 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. Methods 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. Discussion 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. Trial registration 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.