RecruitingNot ApplicableNCT06496867

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

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


Sponsor

University of Southern California

Enrollment

48 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Early Internal Fixation and Nonoperative Care with Early Rehabilitation for people with fragility fracture, internal fixation, and other related conditions. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEarly 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.

OTHERNonoperative 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

Bloomington, 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

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NCT06496867


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