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RECRUITING
NCT06496867
NA

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

Sponsor: University of Southern California

View on ClinicalTrials.gov

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-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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-11-12

Completion Date

2027-12-31

Last Updated

2025-10-15

Healthy Volunteers

No

Interventions

PROCEDURE

Early Internal Fixation

Early internal fixation of the LC1 fragility fracture of the pelvis will be defined as percutaneous anterior and/or posterior pelvic internal fixation with cannulated screw(s), medullary implant(s), or sacroiliac joint fusion device(s). The implant number, design, diameter, thread type (fully-threaded or partially-threaded), sacral segment (S1, S2, S3, or any combination there of), length, trajectory including sacroiliac or transsacral-transiliac, application with or without a washer, and ingrowth or ongrowth surface designs will be at the discretion of the treating surgeon.

OTHER

Nonoperative Care with Early Rehabilitation

Nonoperative care with early rehabilitation will consist of nonoperative treatment of the pelvis fracture, including early consultation of the physical therapist, physiotherapist, or local equivalent rehabilitation provider at the time of randomization for a first attempt at mobilization of the patient within 24 hours of randomization. Patients who are unable to ambulate with assistance after five or more days of attempted mobilization by rehabilitation providers may be considered for delayed internal fixation treatment at the discretion of the patient and the treating surgeon. Delayed internal fixation after five or more days of attempted mobilization by rehabilitation providers will not be considered a treatment crossover event.

Locations (13)

University of Arizona

Phoenix, Arizona, United States

Keck Medical Center of USC

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Indiana University

Indianapolis, Indiana, United States

University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Curators of the University of Missouri - Missouri Orthopaedic Institute

Columbia, Missouri, United States

University of Utah

Salt Lake City, Utah, United States

University of Washington - Harborview Medical Center

Seattle, Washington, United States

Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital

Barcelona, Spain, Spain