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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Southern California

About this trial

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

Qualifiers

Patient 60 years of age or older.

Low energy injury mechanism defined as a fall from standing height.

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.

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

Disqualifiers

Patient did not ambulate prior to injury.

Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.

Retained implants around the pelvis that precludes or limits either study treatment.

Infection around the hip (soft tissue or bone).

Trial design

Treatments tested in this trial

  • Early Internal Fixation
  • Nonoperative Care with Early Rehabilitation

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Southern California

Lead sponsor

Orthopaedic Trauma Association

Collaborator

McMaster University

Collaborator

University of Maryland, Baltimore

Collaborator