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.
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.
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).
Parallel
Early Internal Fixation
Procedure/SurgeryEarly 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 interventionNonoperative 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.
Feasibility of participant enrollment
Proportion of patients who provide informed consent
Feasibility of adherence to treatment allocation
Proportion of Adherence to early internal fixation treatment allocation and nonoperative care with early rehabilitation treatment allocation
Refine data collection methods
Proportion of participants with missing data for the primary composite outcome
Assess Protocol Compliance
Proportion of randomization errors
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.
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University of Southern California
Lead sponsor
Orthopaedic Trauma Association
Collaborator
McMaster University
Collaborator
University of Maryland, Baltimore
Collaborator
