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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01952067
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring cemented primary total hip replacement.
* Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis
* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
* Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery
Exclusion Criteria:
* Patients who require revision of a previously implanted total hip replacement (THR)
* Patients who will receive a THR without cement
* Patients who have had a prior procedure of osteotomy on the femur
* Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI \>35)
* Patients with active or suspected infection
* Patients with malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT01952067
Study Brief:
Protocol Section:
NCT01952067