💬In plain words
What the trial is, and whether it could suit you
Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. This multicenter prospective cohort study will evaluate 120 patients to determine the feasibility of a randomized controlled trial comparing operative and nonoperative treatment, by evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
The inclusion criteria are:
1. Patient 60 years of age or older.
2. Low energy injury mechanism.
3. LC1 pelvis fracture (AO/OTA 61B1.1,61B2.1, or 61B3.2) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
4. Fracture displacement of \<10 mm of the posterior pelvic ring on computed tomography of the pelvis.
5. Injury occurred within 21 days of screening.
The exclusion criteria are:
1. Patient did not ambulate prior to injury.
2. Severely frail patients (Clinical Frailty Scale ≥7).
3. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
4. Retained implants around the pelvis that precludes or limits either study treatment.
5. Infection around the hip (soft tissue or bone).
6. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
7. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
8. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
9. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
10. Expected injury survival of less than 12 months.
11. Terminal illness with expected survival of less than 12 months.
12. Currently enrolled in a study that does not permit co-enrollment.
13. Prior enrollment in the study.
14. Unable to obtain informed consent due to language barriers.
15. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
16. Did not provide informed consent (declined participation).
17. Patient or LAR not approached to participate in the trial (missed patient).
18. Other reason to exclude the patient, as approved by the Principal Investigator.
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