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

Last updated: March 26, 2025
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

Nonoperative Care with Early Rehabilitation

Early Internal Fixation

Clinical Study ID

NCT06496867
HS-24-00309
  • Ages > 60
  • All Genders

Study 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 Criteria

Inclusion

Inclusion 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 resonanceimaging.

  4. Fracture pattern that could be, in the judgment of the attending surgeon, managedwith either early internal fixation or nonoperative care with early rehabilitation.

  5. Fracture displacement of <10 mm of the posterior pelvic ring on computed tomographyof the pelvis.

  6. Injury occurred within 21 days of screening.

Exclusion

Exclusion Criteria:

  1. Patient did not ambulate prior to injury.

  2. Patient has another condition, injury, or fracture that prevents post-operativeweightbearing 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 precludesinternal fixation.

  6. Patient is too ill, in the judgement of the attending surgeon, for internalfixation.

  7. Patient is too ill, in the judgement of the attending surgeon, for nonoperativecare.

  8. Problems, in the judgment of study personnel, with maintaining follow-up with thepatient.

  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.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Nonoperative Care with Early Rehabilitation
Phase:
Study Start date:
November 12, 2024
Estimated Completion Date:
December 31, 2027

Study Description

More than half of fragility fractures of the pelvis in older adults exhibit a lateral compression type 1 fracture pattern (LC1), with fractures of the posterior pelvic ring involving the sacrum bone and a corresponding disruption of the anterior pelvic ring. Nonoperative treatment has remained the standard of care for older adults with minimally displaced (<10 mm) LC1 fragility fractures of the pelvis, as patients are often able to mobilize within a few days with a walking aid. However, preliminary data have suggested that early internal fixation may lead to better patient outcomes, including improved ambulation, shorter hospital stay, less use of opioid pain medication, greater likelihood of returning home after hospital admission, and a lower risk of death compared to nonoperative care. While the preliminary data supporting the use of early internal fixation for minimally displaced LC1 fragility fractures of the pelvis is promising, the necessary evidence to make this significant practice change remains lacking.

The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for older adults who experience a minimally displaced LC1 fragility fracture of the pelvis. Treating minimally displaced LC1 fragility fractures of the pelvis with early internal fixation, instead of nonoperative care, would be a paradigm shift in clinical care. This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary. If feasibility is successfully demonstrated, the pilot activities will be considered a vanguard phase for the definitive clinical 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. Patients will be followed for 1 year, with visits occurring at 2 weeks, 6 weeks, 4 months, 8 months, and 1 year after fracture. At each follow-up, mortality, ambulation, healthy days at home, and health status will be collected.

The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial. The feasibility outcomes will include participant enrollment, adherence to treatment allocation, data collection methods, and compliance with key aspects of the protocol.

Connect with a study center

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

    Barcelona, 08035
    Spain

    Site Not Available

  • University of Arizona

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of California, Davis

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • The Curators of the University of Missouri - Missouri Orthopaedic Institute

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Washington - Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

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