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
University of Southern California
48 participants
Nov 12, 2024
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
Plain Language Summary
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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
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.
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)
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NCT06496867