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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT00375856
Eligibility Criteria:
Inclusion Criteria:
* Age 45-75 years
* Undergoing primary total knee arthroplasty
* Clinically significant osteoarthritic degeneration
Exclusion Criteria:
* Active articular infections
* Bilateral knee replacement (simultaneous)
* Previous joint infections
* Significant concurrent ipsilateral hip osteoarthritis
* Chronic pain syndrome requiring medications for control
* History of chemical addiction
* Significant spinal stenosis, significant symptomatic sciatica
* Patients who are unlikely to comply with, participate in, or return for follow-up visits as described in the protocol
* Osteomyelitis, septicemia or other infections that may spread to other areas of the body
* Highly communicable diseases, immuno-compromising conditions and/or conditions that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)
* Decreased mental comprehension and literacy
* Prior high tibial osteotomy
* Prior patellectomy
* Rheumatoid arthritis
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT00375856
Study Brief:
Protocol Section:
NCT00375856