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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT02239406
Eligibility Criteria:
Inclusion Criteria:
* Patients being revised for an aseptic metal on metal acetabular revision.
* Patient is greater than one year postoperative.
* Patient has had cobalt and chromium metal ion levels tested within 6 months of the planned revision surgery.
* Understands the local language and is willing and able to follow the requirements of the protocol.
* Understands the informed consent and signs the institutional review board or independent ethics committee (IRB/IEC) approved informed consent form.
Exclusion Criteria:
* History of infection
* Evidence of current substance or alcohol abuse
* Being treated with radiation, chemotherapy, immunosupression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
* Is a prisoner
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02239406
Study Brief:
Protocol Section:
NCT02239406