Comparing early surgery to non-surgical care for pelvic fractures in older adults

Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study

This study is testing whether early surgery or non-surgical care with rehab works better for older adults with certain types of pelvic fractures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of Southern California (Academic / other)
• Locations: 13 sites (Phoenix, Arizona and 12 other locations)
• Trial ID: NCT06496867 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the feasibility of a larger trial comparing early internal fixation to nonoperative care with rehabilitation for older adults with minimally displaced lateral compression type 1 (LC1) pelvic fractures. Participants aged 60 and older will be randomized into two groups: one receiving surgical fixation and the other receiving nonoperative care with early rehabilitation. The study will follow participants for one year to gather data on outcomes such as mobility, hospital stay duration, and pain management. The findings will help refine the design of a definitive trial that could potentially change clinical practices for treating these fractures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 and older with a low-energy LC1 pelvic fracture and less than 10 mm displacement.

Not a fit: Patients who have not been able to ambulate prior to their injury or have other significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery outcomes and quality of life for older adults with pelvic fractures.

How similar studies have performed: Preliminary data suggest that early internal fixation may improve outcomes, but this approach remains largely untested in a definitive trial setting.

Eligibility criteria

Inclusion Criteria:

1. Patient 60 years of age or older.
2. Low energy injury mechanism defined as a fall from standing height.
3. LC1 pelvis fracture (AO/OTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
5. Fracture displacement of \<10 mm of the posterior pelvic ring on computed tomography of the pelvis.
6. Injury occurred within 21 days of screening.

Exclusion Criteria:

1. Patient did not ambulate prior to injury.
2. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
3. Retained implants around the pelvis that precludes or limits either study treatment.
4. Infection around the hip (soft tissue or bone).
5. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
6. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
7. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
8. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
9. Expected injury survival of less than 12 months.
10. Terminal illness with expected survival of less than 12 months.
11. Currently enrolled in a study that does not permit co-enrollment.
12. Prior enrollment in the trial.
13. Unable to obtain informed consent due to language barriers.
14. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
15. Did not provide informed consent (declined participation).
16. Patient or LAR not approached to participate in the trial (missed patient).
17. Other reason to exclude the patient, as approved by the Methods Centre.

Where this trial is running

Phoenix, Arizona and 12 other locations

• University of Arizona — Phoenix, Arizona, United States (Not_yet_recruiting)
• Keck Medical Center of USC — Los Angeles, California, United States (Recruiting)
• Los Angeles General Medical Center — Los Angeles, California, United States (Recruiting)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• University of California, Davis — Sacramento, California, United States (Recruiting)
• University of California San Francisco — San Francisco, California, United States (Recruiting)
• Indiana University — Indianapolis, Indiana, United States (Recruiting)
• University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
• The Curators of the University of Missouri - Missouri Orthopaedic Institute — Columbia, Missouri, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)
• University of Washington - Harborview Medical Center — Seattle, Washington, United States (Recruiting)
• Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital — Barcelona, Spain, Spain (Not_yet_recruiting)

Study contacts

• Principal investigator: Joseph Patterson, MD — University of Southern California
• Study coordinator: Pui Yan, MS

Conditions Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring; Fragility Fracture; Internal Fixation; Nonoperative Care; Lateral Compression type 1; Pelvis Fracture; Older Adults; Physical Therapy