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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00289133
Eligibility Criteria:
Inclusion Criteria:
1. Osteoarthritis of the affected joint appropriate for Total Knee Arthroplasty.
2. Diagnosis of any of the following: rheumatoid or other inflammatory arthritis, post-traumatic arthritis, juvenile rheumatoid arthritis.
3. Radiographic evidence of sufficient sound bone stock to seat and support the prosthesis.
4. Subject requires a primary total knee replacement and is considered to be suitable for the specific knee prosthesis identified in protocol.
5. Subject has given consent to the transfer of his/her information to sponsor.
6. Subject will be compliant with requirements of protocol by returning for follow-up visits.
Exclusion Criteria:
1. History of recent/active joint sepsis.
2. Charcot neuropathy.
3. Psycho-social disorders that would limit rehabilitation.
4. Women who are pregnant or planning on being pregnant.
5. Greater than 80 years of age at the time of surgery.
6. Prior ipsilateral knee arthroplasty.
7. Metabolic disorders of calcified tissues, such as Paget's disease.
8. Severe diabetes mellitus that is not controlled by diet or oral agents.
9. Require joint replacement due to immunodeficiency syndromes.
10. Skeletal immaturity.
11. Avascular necrosis of the affected knee.
12. Chronic renal disease.
13. Subjects involved in medical-legal or worker's compensation claims.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
80 Years
Study:
NCT00289133
Study Brief:
Protocol Section:
NCT00289133