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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT05947058
Eligibility Criteria:
Inclusion Criteria:
* Patients 60 years of age or older.
* Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
* Minimally displaced fracture that could be, in the judgment of the attending surgeon, optimally managed with either arthroplasty or in situ internal fixation without reduction.
* Low energy injury mechanism defined as a fall from standing height.
* Informed consent obtained from patient or proxy.
* Surgeons with expertise in total hip arthroplasty, hemiarthroplasty, and internal fixation are available to perform surgery. Note: Surgeons do not need to be experts in all techniques.
Exclusion Criteria:
* Unable to ambulate 10 feet pre-injury with any assistance.
* Associated lower extremity injury that prevents post-operative weightbearing.
* Retained hardware around the hip that precludes either study treatment.
* Infection around the hip (soft tissue or bone).
* Pathologic fracture with a lytic lesion in the femoral neck 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 arthroplasty.
* Unable to obtain informed consent due to language barriers.
* Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
* Currently enrolled in a study that does not permit co-enrollment.
* Prior enrollment in the trial.
* Other reason to exclude the patient, as approved by the Methods Centre.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05947058
Study Brief:
Protocol Section:
NCT05947058