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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01107769
Eligibility Criteria:
Inclusion Criteria:
Patients must meet all of the inclusion criteria.
1. Patient is diagnosed with degenerative joint disease of the knee requiring a unilateral TKA.
2. Patient is of legal age to consent, and is skeletally mature.
3. Patient is willing to sign and date an IRB/IEC approved consent form.
Exclusion Criteria:
Patients must not meet any of the exclusion criteria.
1. Patient has poor bone stock making a TKA unjustifiable.
2. Patient has active, local infection or previous intra-articular infections.
3. Patient has neuropathic (Charcot) joint.
4. Patient is pregnant or may become pregnant during the course of the study.
5. Patient is severely overweight (BMI \>40).
6. Patient is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01107769
Study Brief:
Protocol Section:
NCT01107769