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:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT04025866
Eligibility Criteria:
Inclusion Criteria:
1. Older men or women aged 65 years and older (with no upper age limit).
2. An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation.
3. Low energy fracture (defined as a fall from standing height).
4. No other major trauma.
5. Admission to the rehabilitation clinic from 8 to 12 days after the surgery
6. Patients autonomous prior to fracture.
7. Provision of informed consent by patient.
Exclusion Criteria:
1. Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip) or upper extremity (i.e., radius, ulna or humerus fracture).
2. Orthopedic contraindications to mobilization and to lower extremity operated load;
3. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
4. Patients with neurological diseases.
5. Patients with important cardiac diseases.
6. Patients with a pathologic fracture.
7. Patients with subtrochanteric fracture or with a fracture AO Type 31-B or 31-C (Muller Classification).
8. Patients with a previous history of frank dementia.
9. Terminally-ill (life expectation \< 6 months).
10. Patients who lived in an institution before the fracture event or were not self-sufficient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04025866
Study Brief:
Protocol Section:
NCT04025866