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

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat a specific type of pelvic fracture called a lateral compression type 1 (LC1) fracture, which often happens in older adults after a low-energy fall, like tripping or slipping. The aim is to see if early internal fixation, a surgical procedure to stabilize the fracture, is more effective than nonoperative care that includes early rehabilitation, where patients start moving around with the help of rehabilitation providers. The trial will include adults aged 60 and older who have a specific injury pattern and minimal displacement of the fracture, meaning the bones haven’t moved too far apart.

If you or a family member are interested in participating, you would need to meet certain criteria, such as being 60 years or older and having experienced a low-energy fall that resulted in this type of fracture. Participants will be randomly assigned to one of the two treatment groups and followed for one year to monitor recovery and outcomes. This pilot study is important because it will help researchers gather information to design a larger trial in the future. It’s currently recruiting participants, so there is an opportunity to contribute to important research on pelvic fractures in older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient 60 years of age or older.
• • 2. Low energy injury mechanism defined as a fall from standing height.
• • 3. 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.
• • 4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
• • 5. Fracture displacement of \<10 mm of the posterior pelvic ring on computed tomography of the pelvis.
• • 6. Injury occurred within 21 days of screening.
• Exclusion Criteria:
• • 1. Patient did not ambulate prior to injury.
• • 2. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
• • 3. Retained implants around the pelvis that precludes or limits either study treatment.
• • 4. Infection around the hip (soft tissue or bone).
• • 5. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
• • 6. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
• • 7. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
• • 8. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
• • 9. Expected injury survival of less than 12 months.
• • 10. Terminal illness with expected survival of less than 12 months.
• • 11. Currently enrolled in a study that does not permit co-enrollment.
• • 12. Prior enrollment in the trial.
• • 13. Unable to obtain informed consent due to language barriers.
• • 14. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
• • 15. Did not provide informed consent (declined participation).
• • 16. Patient or LAR not approached to participate in the trial (missed patient).
• • 17. Other reason to exclude the patient, as approved by the Methods Centre.