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

Description

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.

Conditions

Multiple Closed Pelvic Fractures with Disruption of Pelvic Ring, Fragility Fracture, Internal Fixation, Nonoperative Care

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Multiple Closed Pelvic Fractures with Disruption of Pelvic Ring
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Keck Medical Center of USC, Los Angeles, California, United States, 90033

Los Angeles

Los Angeles General Medical Center, Los Angeles, California, United States, 90033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patient 60 years of age or older.
  • 2. Low energy injury mechanism defined as a fall from standing height.
  • 3. LC1 pelvis fracture (AO/OTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
  • 4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
  • 5. Fracture displacement of \<10 mm of the posterior pelvic ring on computed tomography of the pelvis.
  • 6. Injury occurred within 21 days of screening.
  • 1. Patient did not ambulate prior to injury.
  • 2. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
  • 3. Retained implants around the pelvis that precludes or limits either study treatment.
  • 4. Infection around the hip (soft tissue or bone).
  • 5. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
  • 6. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
  • 7. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
  • 8. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
  • 9. Expected injury survival of less than 12 months.
  • 10. Terminal illness with expected survival of less than 12 months.
  • 11. Currently enrolled in a study that does not permit co-enrollment.
  • 12. Prior enrollment in the trial.
  • 13. Unable to obtain informed consent due to language barriers.
  • 14. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
  • 15. Did not provide informed consent (declined participation).
  • 16. Patient or LAR not approached to participate in the trial (missed patient).
  • 17. Other reason to exclude the patient, as approved by the Methods Centre.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

Joseph Patterson, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

2027-12-31