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 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT01427361
Eligibility Criteria:
Inclusion Criteria:
1. Males or females, at least 21 years of age, inclusive, and skeletally mature.
2. Patient diagnosed with osteoarthritis of the hip requiring primary total hip resurfacing due to:
* Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
* Inflammatory arthritis such as rheumatoid arthritis.
3. Patient is willing to consent to participate in the study
4. Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
5. Patient meets medical clearance to have surgery required for this study
Exclusion Criteria:
1. Patient with infection or sepsis.
2. Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
3. Patient is pregnant or plans to become pregnant during the course of the study.
4. Patient known to have insufficient bone stock to support the BHR device including:
* Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or severe osteopenia.
* Subjects with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR.
* Subjects with multiple cysts of the femoral head (\>1cm) should not receive a BHR.
* Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
5. Patient has known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in systemic metal ion concentration.
6. Patient has a known sensitivity to materials in the device.
7. Patient is immuno-suppressed.
8. Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
9. Patient has BMI \>40.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01427361
Study Brief:
Protocol Section:
NCT01427361