Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06496867
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06496867
Study Brief:
Protocol Section:
NCT06496867