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
| Autor: | de Vos, Floris H., Meuffels, Duncan E., de Mul, Marleen, Askari, Marjan, Ista, Erwin, Polinder, Suzanne, Waarsing, Erwin, Bierma-Zeinstra, Sita M.A., Reijman, Max, Janssen, Rob P.A. |
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| Přispěvatelé: | Orthopaedic Biomechanics, Orthopedics and Sports Medicine, Health Services Management & Organisation (HSMO), Department of Technology and Operations Management, Internal Medicine, Public Health, General Practice |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Knee Joint
Adolescent Anterior Cruciate Ligament Reconstruction Anterior Cruciate Ligament Injuries Decision Making Anterior cruciate ligament rupture Anterior Cruciate Ligament Injuries/diagnostic imaging Diseases of the musculoskeletal system Anterior Cruciate Ligament/diagnostic imaging Knee Joint/surgery Shared Study Protocol Treatment Outcome Rheumatology RC925-935 Treatment algorithm Humans Multicenter Studies as Topic Orthopedics and Sports Medicine Cost-effectiveness Anterior Cruciate Ligament Decision Making Shared Shared decision making Algorithms Randomized Controlled Trials as Topic |
| Zdroj: | BMC Musculoskeletal Disorders, 23(1):117. BioMed Central BMC Musculoskeletal Disorders BMC Musculoskeletal Disorders, Vol 23, Iss 1, Pp 1-9 (2022) BMC Musculoskeletal Disorders, 23(1):117. BioMed Central Ltd. |
| ISSN: | 1471-2474 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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