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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT01145157
Eligibility Criteria:
Inclusion Criteria:
* Patient is of legal age and skeletally mature
* Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis).
* Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk
* The patient will be available for follow up throughout the duration of the study.
Exclusion Criteria:
* Patient is unable to have an MRI scan due to the following conditions:
* Cardiac pacemaker
* Surgical clips in head (aneurysm clips)
* Some artificial heart valves
* Electronic inner ear implants
* Metal fragments in eyes
* Electronic stimulators
* Implanted pumps
* Patient has active infection or sepsis (treated or untreated)
* Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
* Patient is female of child-bearing age and not taking contraceptive precautions.
* Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia).
* Patient has known moderate to severe renal insufficiency.
* Patient has a known or suspected metal sensitivity.
* Patient is immunosuppressed or receiving high doses of corticosteroids.
* Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
* Patient has BMI \>40.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01145157
Study Brief:
Protocol Section:
NCT01145157