Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis
NCT Number: NCT06496867
Acronym: PIVOT-LC1-Pi
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring|Fragility Fracture|Internal Fixation|Nonoperative Care
Interventions: PROCEDURE: Early Internal Fixation|OTHER: Nonoperative Care with Early Rehabilitation
Sponsor: University of Southern California
Collaborators: Orthopaedic Trauma Association|McMaster University|University of Maryland, Baltimore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-12-31
Locations: Keck Medical Center of USC, Los Angeles, California, 90033, United States

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.

Primary Outcome Measures: Feasibility of participant enrollment, • Proportion of patients who provide informed consent, 12 months post-randomization|Feasibility of adherence to treatment allocation, • Adherence to early internal fixation treatment allocation and nonoperative care with early rehabilitation treatment allocation, 12 months post-randomization|Refine data collection methods, • Proportion of participants with missing data for the primary composite outcome, 12 months post-randomization|Assess Protocol Compliance, • Proportion of randomization errors, 12 months post-randomization
Secondary Outcome Measures: Composite hierarchical outcome of mortality, ambulation, and health days at home., The secondary outcome (clinical primary outcome) will be a composite endpoint that will hierarchically assess its components in the following order: 1) mortality, 2) ambulation, and 3) healthy days at home. Mortality will consist of all causes of death. Ambulation will be defined as the ability of the patient to ambulate 10 feet or across the room a) without a walking aid or human assistance, b) with a waking aid and without human assistance, c) with human assistance, or d) unable to ambulate. Healthy days at home will be defined by subtracting the following measure components from the number of days in the time frame: mortality days, the total number of days spent in inpatient, observation, skilled nursing facilities (SNF), inpatient psychiatry, inpatient rehabilitation and long-term hospital settings as well as the number of outpatient emergency department and home health visits. The secondary outcomes will be assessed by a per-protocol analysis., 4 months post-randomization