Assessment of Treatment Variability for Pelvic Ring Fragility Fractures
University of Maryland, Baltimore
120 participants
May 25, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Patient 60 years of age or older.
- Low energy injury mechanism.
- LC1 pelvis fracture (AO/OTA 61B1.1,61B2.1, or 61B3.2) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
- Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
- Injury occurred within 21 days of screening.
Exclusion Criteria18
- Patient did not ambulate prior to injury.
- Severely frail patients (Clinical Frailty Scale ≥7).
- Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
- Retained implants around the pelvis that precludes or limits either study treatment.
- Infection around the hip (soft tissue or bone).
- Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
- Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
- Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Expected injury survival of less than 12 months.
- Terminal illness with expected survival of less than 12 months.
- Currently enrolled in a study that does not permit co-enrollment.
- Prior enrollment in the study.
- Unable to obtain informed consent due to language barriers.
- Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
- Did not provide informed consent (declined participation).
- Patient or LAR not approached to participate in the trial (missed patient).
- Other reason to exclude the patient, as approved by the Principal Investigator.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Surgical stabilization of pelvic fracture through placement of orthopaedic hardware.
Pelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07351123