Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis

Recruiting now · Not applicable

Conditions studied: Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring, Fragility Fracture, Internal Fixation, Nonoperative Care

In brief

The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \<10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.

Key facts

Study ID: NCT06496867
Run by: University of Southern California
People needed: 48
Starts: 2024-11-12
Expected to finish: 2027-12-31
Last updated by the study team: 2026-07-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient 60 years of age or older.
Low energy injury mechanism defined as a fall from standing height.
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.
Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
Injury occurred within 21 days of screening.

You may not qualify if…

Patient did not ambulate prior to injury.
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 trial.
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 Methods Centre.

Where it is running

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

Full record on ClinicalTrials.gov

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