Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial.

INTRODUCTION

Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practices. Recently, there have been new insights into treatment strategies, such as early diagnosis and minimally invasive operative treatment. The aim of this study is to implement an evidence-based and experience-based treatment clinical pathway to improve outcomes in this fragile patient population.

METHODS AND ANALYSIS

This study will be a regional stepped-wedge cluster randomised controlled trial. All older adult patients (≥50 years old) who suffered a pelvic fragility fracture after low-energetic trauma are eligible for inclusion. The pathway aims to optimise the diagnostic process, to guide the decision-making process for further treatment (eg, operative or conservative), to structure the follow-up and to provide guidelines on pain management, weight-bearing and osteoporosis workup. The primary outcome is mobility, measured by the Parker Mobility Score. Secondary outcomes are mobility measured by the Elderly Mobility Scale, functional performance, quality of life, return to home rate, level of pain, type and dosage of analgesic medications, the number of falls after treatment, the number of (fracture-related) complications, 1-year and 2-year mortality. Every 6 weeks, a cluster will switch from current practice to the clinical pathway. The aim is a total of 393 inclusions, which provides an 80% statistical power for an improvement in mobility of 10%, measured by the Parker mobility score.

ETHICS AND DISSEMINATION

The Medical Research Ethics Committee of Academic Medical Center has exempted the PELVIC study from the Medical Research Involving Human Subjects Act (WMO). Informed consent will be obtained using the opt-out method and research data will be stored in a database and handled confidentially. The final study report will be shared via publication without restrictions from funding parties and regardless of the outcome.

TRIAL REGISTRATION NUMBER

NCT06054165.

PROTOCOL VERSION

V.1.0, 19 July 2022.