Pelvic Ring Fragility Fractures: Are Surgery or No Surgery Better for Older Adults?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter prospective cohort that plans to enroll about 120 older adults with low-energy pelvic ring fragility fractures. The study aims to determine the feasibility of a future randomized trial comparing operative fixation versus nonoperative treatment by evaluating patient willingness to enroll, surgeon willingness to randomize, and completeness of data collection. It will document treatment choices, perioperative details, and short-term outcomes to inform design of a definitive trial. The investigation acknowledges evolving surgical techniques and seeks to clarify whether increased fixation translates into meaningful benefits for this vulnerable population. No efficacy conclusions are intended from this feasibility assessment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland, Baltimore
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Mark Gage, MD — University of Maryland, Baltimore
• Study coordinator: Mark Gage, MD
• Email: mgage@som.umaryland.edu
• Phone: 410-328-1868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.