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

Floris H. de Vos*, ROTATE study group

*Corresponding author for this work

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Abstract

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.

Original languageEnglish
Article number117
JournalBMC Musculoskeletal Disorders
Volume23
Issue number1
DOIs
Publication statusPublished - 5 Feb 2022

Bibliographical note

Funding:
Subsidy was granted by ZonMw (project number: 852002032), a Dutch
organization for health research and care innovation. This organization was
not involved in the study design, data-collection, analysis and interpretation of
data, nor in writing the manuscript.

Publisher Copyright: © 2022. The Author(s).

Funding Information:
The ROTATE study group consists of the following persons: E.R.A. van Arkel, MD PhD6; R.W. Brouwer, MD PhD7; A.R.J. Langeveld, MD8; R. Riedijk, MD9; J.A.C. Zijl, MD10; R.P.A. Janssen, MD PhD11; D.J. Hofstee, MD12; R.G. Zuurmond, MD PhD13; M.A. van Rhee MD14. 1 Department of Orthopaedics and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 2 Erasmus School of Health Policy & Management, Erasmus University Rotterdam, The Netherlands. 3 Department of Internal Medicine, section Nursing Science, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 4 Department of Public Health, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 5 Department of General Practice, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 6 Department of Orthopaedic Surgery, Haaglanden Medical Center, The Hague, The Netherlands. 7 Department of Orthopaedic Surgery, Martini Hospital, Groningen, The Netherlands. 8 Department of Orthopaedic Surgery, Reinier Haga Orthopaedic Center, Zoetermeer, The Netherlands. 9 Department of Orthopaedic Surgery, Tergooi Hospital, Hilversum, The Netherlands. 10 Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands. 11 Department of Orthopaedic Surgery, Maxima Medical Center, Eindhoven, The Netherlands. 12 Department of Orthopaedic Surgery, Northwest Clinics, Alkmaar, The Netherlands. 13 Department of Orthopaedic Surgery, Isala Hospital, Zwolle, The Netherlands. 14 Department of Orthopaedic Surgery, Annatommie MC, Amstelveen/Utrecht, The Netherlands.

Publisher Copyright:
© 2022, The Author(s).

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