NCT07351123 Assessment of Treatment Variability for Pelvic Ring Fragility Fractures
| NCT ID | NCT07351123 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Pelvic Fractures |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-05-25 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2026-05-25 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
The inclusion criteria are: 1. Patient 60 years of age or older. 2. Low energy injury mechanism. 3. 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. 4. Fracture displacement of \<10 mm of the posterior pelvic ring on computed tomography of the pelvis. 5. Injury occurred within 21 days of screening. The exclusion criteria are: 1. Patient did not ambulate prior to injury. 2. Severely frail patients (Clinical Frailty Scale ≥7). 3. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity. 4. Retained implants around the pelvis that precludes or limits either study treatment. 5. Infection around the hip (soft tissue or bone). 6. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation. 7. Patient is too ill, in the judgement of the attending surgeon, for internal fixation. 8. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care. 9. Problems, in the judgment of study personnel, with maintaining follow-up with the patient. 10. Expected injury survival of less than 12 months. 11. Terminal illness with expected survival of less than 12 months. 12. Currently enrolled in a study that does not permit co-enrollment. 13. Prior enrollment in the study. 14. Unable to obtain informed consent due to language barriers. 15. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable. 16. Did not provide informed consent (declined participation). 17. Patient or LAR not approached to participate in the trial (missed patient). 18. Other reason to exclude the patient, as approved by the Principal Investigator.
Contact & Investigator
Mark Gage, MD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT07351123 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Pelvic Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07351123 currently recruiting?
Yes, NCT07351123 is actively recruiting participants. Contact the research team at mgage@som.umaryland.edu for enrollment information.
Where is the NCT07351123 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07351123 clinical trial?
NCT07351123 is sponsored by University of Maryland, Baltimore. The principal investigator is Mark Gage, MD at University of Maryland, Baltimore. The trial plans to enroll 120 participants.