NCT07351123

Assessment of Treatment Variability for Pelvic Ring Fragility Fractures

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. This multicenter prospective cohort study will evaluate 120 patients to determine the feasibility of a randomized controlled trial comparing operative and nonoperative treatment, by evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.

Detailed description

Fragility fractures of the pelvic ring are a common injury that is increasing in incidence with an aging population. These injuries are associated with high healthcare costs and poor patient outcomes, including decline in ambulatory function, decreased independence, and a one-year mortality of 11-27%. Historically, older adults with fragility fractures of the pelvis received nonoperative treatment with supportive care because operative management was deemed too invasive for this patient population. However, the development of percutaneous and less invasive surgical techniques has led to an increased frequency of operative stabilization of pelvis fractures in older adults. It is unclear if the increasing use of surgical fixation is improving outcomes for patients with pelvic fragility fractures. There are significant limitations with the current body of evidence that precludes its ability to guide clinical practice. Randomized controlled trials testing the efficacy of operative management are urgently needed to determine when surgical fixation is warranted. Two pilot randomized controlled trials have been performed on this patient population, and both have not progressed to a definitive study citing a lack of recruitment feasibility. This is due to both the lack of agreement amongst surgeons for which patients should receive randomized treatment, as well as a lack of patient willingness to enroll in a trial. Furthermore, loss to follow up is a concern in both the orthopaedic trauma population and in older adult study patients. This prospective cohort study will evaluate 120 patients from six hospitals to determine the feasibility of a randomized controlled trial (RCT) comparing operative versus nonoperative management of fragility fractures of the pelvic ring. This will be accomplished by three aims evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.

Conditions

• Pelvic Fractures
• Fragility Fractures of the Pelvis (FFP)

Interventions

Type	Name	Description
PROCEDURE	Surgical stabilization of pelvic fracture	Surgical stabilization of pelvic fracture through placement of orthopaedic hardware.
OTHER	Closed treatment of pelvic fracture	Pelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-08-31
• Completion: 2027-09-30
• First posted: 2026-01-20
• Last updated: 2026-03-27