To assess the relation between component rotation in total knee replacement and clinical outcomes.

Prospective, observational cohort study.

Deventer hospital, Deventer, The Netherlands.

498 adults aged 18 years and older undergoing total knee replacement.

Participants underwent Persona posterior stabilised total knee replacement. Femoral and tibial component rotation was measured using low-dose CT scans.

The primary outcome was the change in Oxford Knee Score from baseline to 1 year, analysed in relation to femoral, tibial and combined component rotation.

Binary logistic regression analysis showed no statistically significant association between femoral component rotation (OR=1.04, 95% CI 0.89 to 1.21, p=0.644), tibial component rotation (OR=0.99, 95% CI 0.94 to 1.03, p=0.467), or combined rotation (OR=0.99, 95% CI 0.95 to 1.03, p=0.552), and achievement of the minimal clinically important difference of 5 points for the 48-point Oxford Knee Score.

This prospective study of 498 patients undergoing total knee replacement did not provide evidence of a relation between the rotational alignment of total knee arthroplasty components and clinical outcomes. These findings do not support routine evaluation of rotational alignment as a basis for revision surgery in patients with persistent pain in the absence of mechanical problems.

Dutch Trial registry ID: 23362.

Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

DRKS00034899.

V2.1, 6 June 2024.