Rotate trial

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.

Objectives

The aim of the current project is to evaluate the effectiveness and cost-effectiveness of the treatment algorithm for patients with a complete primary ACL rupture compared to current used treatment strategy. We hypothesize that the treatment algorithm will lead to earlier identification of the optimal treatment for the individual patient. We expect that fewer patients will receive a surgical reconstruction compared to the current practice and that fewer patients will need delayed surgery after non-operative treatment has failed. Hence, we hypothesize that with the treatment algorithm faster recovery of functional outcome will be achieved compared to the current practice (superiority study).  As secondary outcome we expect that a faster recovery of functional outcome will lead to a faster return to work and sports. Hence, we hypothesize that the treatment algorithm will lead to lower societal cost. The treatment algorithm provides extra information for the physician and as well for the patient, to include in their decision for a(n) (non-)operative treatment. Therefore we expect the treatment algorithm will impact the shared decision making communication process. 

Primary objective:

• Assessing whether the treatment algorithm for patients with a complete primary ACL rupture is superior to the current practice regarding recovery of functional outcome at two-year follow-up.

Secondary objectives:

• Assessing whether the treatment algorithm for patients with a complete primary ACL rupture is superior to the current practice regarding recovery of functional outcome during two-year follow-up.
• Assessing whether this treatment algorithm will increase the cost-effectiveness compared to the current practice. 
• Assessing whether this treatment algorithm will lead to less ACL reconstructions compared to the current practice. 
• Assessing whether this treatment algorithm will extend the (perception of) shared decision making during a physician-patient consultation.

Funds and grants

This research received a grant from ZonMw, an organization for health research and care innovation.

Publications:

de Vos FH, Meuffels DE, de Mul M, Askari M, Ista E, Polinder S, Waarsing E, Bierma-Zeinstra SM, Reijman M; ROTATE study group. 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. BMC Musculoskelet Disord. 2022 Feb 5;23(1):117. doi: 10.1186/s12891-021-04867-5. PMID: 35123469; PMCID: PMC8818161.