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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT00510458
Eligibility Criteria:
Inclusion Criteria:
1. Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned.
2. Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger.
3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant
4. Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
5. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
6. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
1. Patient has an active infection within the affected hip joint.
2. Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. Patient has a Body Mass Index (BMI) ≥ 40.
4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
5. Patient is diagnosed with systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (i.e. Paget's disease, renal osteodystrophy, rheumatoid arthritis).
6. Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
7. Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
8. Patient is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00510458
Study Brief:
Protocol Section:
NCT00510458