Conservative or operative therapy in patients with a fragility fracture of the pelvis: study protocol for a prospective, randomized controlled trial.

ABSTRACT

BACKGROUND: The incidence of fragility fractures of the pelvis is rising. Whereas the treatment for FFP type I, III, and IV is clear, the optimal treatment for FFP type II remains a topic of discussion. Traditionally these fractures have been treated conservatively. However, there is a shift toward early surgical stabilization with percutaneous screw fixation to reduce pain and promote mobility in an already frail patient population. High-quality evidence, however, is lacking. Therefore, a randomized clinical trial was designed to compare conservative management to early percutaneous screw fixation in patients with type II fragility fractures. METHODS: This is a monocenter randomized controlled trial. All patients with a FFP type II are screened for inclusion. After obtaining informed consent, patients are randomized between conservative management and surgical stabilization. Conservative management consists of early mobilization under guidance of physiotherapy and analgesics. Patients randomized for surgical treatment are operated on within 72 h using percutaneous screw fixation. The primary endpoint is mobility measured by the DEMMI score. Secondary endpoints are other dimensions of mobility, pain levels, quality of life, mortality, and morbidity. The total follow-up is 1 year. The required sample size is 68. DISCUSSION: The present study aims to give certainty on the potential benefit of surgical treatment. Current literature on this topic remains unclear. According to the volume of FFP at the study hospital, we assume that the number of patients needed for this study is gathered within 2 years. TRIAL REGISTRATION ClinicalTrials.gov NCT04744350. Registered on February 8, 2021.