Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care with Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: a Pilot Study
Comparing Surgical and Non-Surgical Treatments for Pelvis Fractures
Yohan Jang
Primary Investigator
Brief description of study
The overall goal of this research is to determine if early surgical treatment is more effective than nonoperative care and early rehabilitation at lowering the risk of complications in patients with pelvis fractures. 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.
Detailed description of 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Fragility Fracture, Pelvic Fracture, Internal Fixation Multiple Closed Pelvic Fractures with Disruption of Pelvic Ring, Nonoperative Care
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Age: 60 years - 100 years
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Gender: All
Inclusion Criteria:
- 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.
- Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
- Injury occurred within 21 days of screening.
Exclusion Criteria:
- 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).
- Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
- Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
- Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Expected injury survival of less than 12 months.
- Terminal illness with expected survival of less than 12 months.
- Currently enrolled in a study that does not permit co-enrollment.
- Prior enrollment in the trial.
- Unable to obtain informed consent due to language barriers.
- Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
- Did not provide informed consent (declined participation).
- Patient or LAR not approached to participate in the trial (missed patient).
- Other reason to exclude the patient, as approved by the Methods Centre.
This study investigates the effectiveness of early surgical treatment compared to non-surgical care with early rehabilitation for pelvis fractures. A pelvis fracture is a break in one or more of the bones of the pelvis. The study focuses on patients aged 60 years or older with a specific type of pelvis fracture, known as a low-energy lateral compression type 1 fracture. This type of fracture occurs when the pelvis is compressed from the sides, often due to a fall.
Participants will be randomly assigned to one of two study arms: early internal fixation or nonoperative care with early rehabilitation. Internal fixation involves surgically securing the broken bones with hardware. Nonoperative care involves rehabilitation efforts to help the patient move around. Participants will have follow-up visits over the course of a year to monitor their recovery and health status. Key outcomes like survival, ability to walk, and overall health will be recorded during these visits.
- Who can participate: Adults aged 60 or older with a low-energy pelvis fracture from a fall can participate. Eligible fractures must be confirmed by imaging and have less than 10 mm displacement. Participants must have sustained the injury within 21 days of screening.
- Study details: Participants will be assigned to either receive surgical treatment or non-surgical care with rehabilitation. The non-surgical care arm involves at least five days of mobilization efforts by rehabilitation providers. Participants will be followed for a year to monitor outcomes.
- Study timelines and visits: The study will last 1 year. The study requires 5 visits.
