Status:
RECRUITING
Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Orthopaedic Trauma Association
McMaster University
Conditions:
Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring
Fragility Fracture
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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-en...
Detailed Description
More than half of fragility fractures of the pelvis in older adults exhibit a lateral compression type 1 fracture pattern (LC1), with fractures of the posterior pelvic ring involving the sacrum bone a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06496867
Start Date
November 12 2024
End Date
December 31 2027
Last Update
October 15 2025
Active Locations (13)
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1
University of Arizona
Phoenix, Arizona, United States, 85006
2
Keck Medical Center of USC
Los Angeles, California, United States, 90033
3
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048