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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT01613833
Eligibility Criteria:
Inclusion Criteria:
Group 1, Non-traumatic primary OA:
1. Subject scheduled to undergo primary unilateral total knee arthroplasty for primary osteoarthritis as determined by an orthopedic surgeon
2. Subject is male or female over 45-75 years of age
3. Subject is able to read and understand informed consent form and must subsequently sign and date consent form
Group 2, Secondary post-traumatic/overuse OA:
1. Subject scheduled to undergo unilateral total knee arthroplasty secondary osteoarthritis as determined by an orthopedic surgeon, which MUST include either previous injury or surgery to the operative knee.
2. Subject is male or female 45-75 years of age
3. Subject is able to read and understand informed consent form and must subsequently sign and date consent form
Exclusion Criteria:
Group 1, Non-traumatic primary OA:
1. History of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis)
2. Indication for surgery other than osteoarthritis
3. Revision total knee arthroplasty
4. Age \>75, age \<44
5. Unable to read, understand, or sign informed consent form
6. Previous knee infection
7. Congenital disorders of the knee, calcium pyrophosphate dehydrate deposition disease
Group 2, Secondary post-traumatic/overuse OA:
1. History of inflammatory arthritis (e.g. rheumatoid arthritis, ankyolosing spondylitis)
2. Indication for surgery other than osteoarthritis
3. Age \>75, age \<44
4. Unable to read, understand, or sign informed consent form
5. Previous knee infection
6. Congenital disorders of the knee, calcium pyrophosphate dehydrate deposition disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT01613833
Study Brief:
Protocol Section:
NCT01613833