Actively Recruiting
Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study
Led by University of Southern California · Updated on 2025-10-15
48
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
O
Orthopaedic Trauma Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying older adults aged 60 years or older who have a specific type of pelvic fracture called a low-energy lateral compression type 1 (LC1) fragility fracture with less than 10 mm displacement. This pilot study aims to assess the feasibility of conducting a larger trial comparing two treatment approaches for this fracture type. The goal is to gather information that will help design a definitive trial to potentially improve patient care. Participants will be randomly assigned to one of two groups: early internal fixation or nonoperative care with early rehabilitation. Early internal fixation involves surgical procedures using devices like screws or implants to stabilize the pelvis. Nonoperative care involves early physical therapy starting within 24 hours of randomization to encourage mobilization, with possible delayed surgery if needed after five days. The study will follow participants for one year, with scheduled visits at 2 weeks, 6 weeks, 4 months, 8 months, and 1 year after the fracture. During these visits, researchers will collect information on mortality, walking ability, days spent healthy at home, and overall health status. The main focus is to evaluate how feasible it is to enroll participants, stick to assigned treatments, collect data effectively, and comply with the study protocol. The study is sponsored by the University of Southern California and aims to inform a larger future trial that may change treatment practices for older adults with this type of fracture.
CONDITIONS
Brief Title
Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 60 years of age or older
- Low energy injury caused by a fall from standing height
- LC1 pelvis fracture confirmed by X-ray, CT, or MRI
- Fracture manageable by early internal fixation or nonoperative care with early rehabilitation
- Fracture displacement less than 10 mm on pelvic CT
- Injury occurred within 21 days of screening
You will not qualify if you...
- Unable to walk before the injury
- Other condition or injury preventing weightbearing on any limb after surgery
- Retained implants around the pelvis that limit study treatments
- Infection around the hip area
- Pathologic fracture with lytic lesion preventing internal fixation
- Too ill for internal fixation or nonoperative care as judged by surgeon
- Problems expected with follow-up
- Expected survival less than 12 months due to injury or terminal illness
- Currently enrolled in conflicting study or prior enrollment in this trial
- Unable to give informed consent due to language barriers or lack of authorized representative
- Declined participation or missed patient
- Other exclusion approved by the study Methods Centre
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial treatment and rehabilitation lasting at least 5 days with ongoing care as needed
Participants receive either early internal fixation surgery or nonoperative care with early rehabilitation involving physical therapy to promote early mobilization.
Treatment starts shortly after randomization with at least 5 days of attempted mobilization
Duration - 12 months
Participants are monitored for recovery, mortality, ambulation, health status, and days spent at home over one year after their fracture.
Visits at 2 weeks, 6 weeks, 4 months, 8 months, and 1 year after fracture
Trial Site Locations
Total: 13 locations
1
University of Arizona
Phoenix, Arizona, United States, 85006
Not Yet Recruiting
2
Keck Medical Center of USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
7
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
10
The Curators of the University of Missouri - Missouri Orthopaedic Institute
Columbia, Missouri, United States, 65201
Actively Recruiting
11
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
12
University of Washington - Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
13
Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital
Barcelona, Spain, Spain, 08035
Not Yet Recruiting
Research Team
P
Pui Yan, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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