Randomized trial of surgery vs. non-surgical management for pelvic fragility fractures

Steven F Shannon; John David Black; Richard S Yoon; Ryan Michels; Michael Hadeed; Gillian Soles; Edward Westrick; Kristoff Reid; Daniel Cher; Robyn Capobianco; Douglas Dirschl

doi:10.1016/j.injury.2025.112462

Randomized trial of surgery vs. non-surgical management for pelvic fragility fractures

Injury. 2025 May 31;56(8):112462. doi: 10.1016/j.injury.2025.112462. Online ahead of print.

Authors

Affiliations

¹ Bryan Health Trauma Center, Lincoln, NE, 68506, USA. Electronic address: stevenshannonmd@gmail.com.
² Kadlec Northwest Clinic, Richland, WA, 99352, USA.
³ Rutgers- RWJBH - Cooperman Barnabas/ Jersey City Medical Center, Jersey City, NJ, 07302, USA.
⁴ Orthopedic Associates of Reading, Wyomissing, PA 19611, USA.
⁵ University of Virginia, Charlottesville, VA, 22903, USA.
⁶ University of California at Davis, Sacramento, CA 95817, USA.
⁷ Allegheny General Hospital, Pittsburgh, PA 15212, USA.
⁸ Medical University of South Carolina, Charleston, SC, 29407, USA.
⁹ SI-BONE, Inc, Santa Clara, CA 95050, USA.
¹⁰ Baylor College of Medicine, Houston, TX 77030, USA.

PMID: 40483940
DOI: 10.1016/j.injury.2025.112462

Abstract

Objectives: Non-surgical management (NSM) of posterior pelvic fragility fractures (PFF) can lead to prolonged disability, morbidity, and death. Surgical management (SM) also has risks but has been reported to rapidly restore mobility. This study sought to compare improvement in mobility between NSM and SM in a prospective cohort of patients with PFF.

Methods: Design: Prospective, randomized controlled trial of SM vs NSM SETTING: Academic and community trauma centers PATIENT SELECTION CRITERIA: PFF patients without significant cognitive impairment who are bedbound OUTCOME MEASURES AND COMPARISONS: The primary endpoint was time to regain two points on a modified functional mobility scale (MFMS). Secondary endpoints included PROMIS physical function and pain interference, Oswestry Disability Index (ODI), and numeric rating scale (NRS) pain score. A 12-month CT scan was performed in the SM group only.

Results: Enrollment was challenging despite modifying the study to include an observational cohort. 28 subjects were enrolled (age 78±9.8); 16 underwent SM and 12 received NSM. The primary endpoint occurred at a median of 10 days in the SM group and 16 days in the NSM group (p = .1). 100 % of SM and 83 % of NSM subjects achieved the primary endpoint by 6 weeks. Five subjects who received SM could be considered NSM failures; including these failed subjects in the NSM group widened the difference in primary endpoint success rates (100 % in SM vs. 48 % in NSM, p < 0001). Some trends in secondary outcome measures favored SM, but they did not reach statistical significance. There were no device- or procedure-related serious adverse events.

Conclusion: Despite enrollment challenges, consistent trends were observed to suggest that SM may be superior to NSM in patients with painful PFF. Key challenges in enrollment in geriatric fracture trials comparing NSM to SM were identified. It is conceivable that studies such as this may represent the most robust investigations possible in comparing SM to NSM in PFF.

Level of evidence: II.

Keywords: Pelvic fragility fracture; Percutaneous fixation; Porous threaded implants; Sacral fragility fracture; Sacroiliac joint fusion.