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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Southern California
Study ID
NCT06496867
Status
Recruiting
Apply to this trial

Conditions

  • Fragility Fracture
  • Internal Fixation
  • Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring
  • Nonoperative Care

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Early Internal Fixation — PROCEDURE
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Active Comparator: 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

Primary Outcome Measure

Feasibility of participant enrollment [ Time Frame: 12 months post-randomization ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of ArizonaPhoenixArizona85006
Brock Walker, MD
[email protected]
602-521-3250
Joseph Walker, MD (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Geoffrey Marecek, MD
[email protected]
310-423-4566
Geoffrey Marecek, MD (PRINCIPAL_INVESTIGATOR)
Keck Medical Center of USCLos AngelesCalifornia90033
Pui Yan, MS
[email protected]
(323) 442-6984
Joseph Patterson, MD (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Pui Yan, MS
[email protected]
323-442-6984
Joseph Patterson, MD (PRINCIPAL_INVESTIGATOR)
University of California, DavisSacramentoCalifornia95817
Augustine Saiz, MD
[email protected]
916-734-2182
Augustine Saiz, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143
Saam Morshed, MD
[email protected]
415-647-3733
Saam Morshed, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Yohan Jang, MD
[email protected]
317-963-1966
Yohan Jang, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland, Baltimore - R Adams Cowley Shock Trauma CenterBaltimoreMaryland21201
Mark Gage, MD
[email protected]
410-328-1868
Mark Gage, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Arun Aneja, MD
[email protected]
617-726-9111
Arun Aneja, MD (PRINCIPAL_INVESTIGATOR)
The Curators of the University of Missouri - Missouri Orthopaedic InstituteColumbiaMissouri65201
Brett Crist, MD
[email protected]
573-882-6562
Brett Crist, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Lucas Marchand, MD
[email protected]
801-581-2121
Lucas Marchand, MD (PRINCIPAL_INVESTIGATOR)
University of Washington - Harborview Medical CenterSeattleWashington98104
Reza Firoozabadi, MD
[email protected]
206-744-3298

Find similar trials in Phoenix, AZ

By research site
University of Arizona· Phoenix, AZCedars-Sinai Medical Center· Los Angeles, CAKeck Medical Center of USC· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CAUniversity of California, Davis· Sacramento, CAUniversity of California San Francisco· San Francisco, CA

Related Studies