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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02362867
Eligibility Criteria:
Inclusion Criteria:
* Loss of joint configuration and joint function.
* Osteoarthritis of the knee joint.
* Rheumatoid arthritis of the knee joint.
* Post-traumatic arthritis of the knee joint.
* Moderate valgus, varus, or flexion deformities.
Exclusion Criteria:
* Any patient not experiencing a compromised quality of life by loss of joint function and/or joint configuration, or pain from arthritis disease.
* Any patient whose knee cannot be returned to normal function and normal stability through reconstructive procedures, including ligamentous balancing.
* Active infection in or near the knee joint, fever and/or local inflammation signs, and elevation of sedimentation rate unexplained by other diseases should not be treated unless preoperative infection is ruled out.
* Distant foci of infection, such as genitourinary, pulmonary, skin (chronic lesions or ulcerations), and other sites, which may result in hematogenous spread to the implant site.
* Rapid joint destruction or bone absorption apparent on roentgenograms.
* Neuromuscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits gained by the patient from usage of the prosthesis.
* Mental disorders which would compromise essential patient post-operative care.
* A painless, stable arthrodesis in a functional position.
* Allergic reactions to implant materials, and/or tissue reactions to the products of corrosion or wear.
* Skeletal immaturity.
* Any patient who is unwilling or unable to comply with post-operative instructions or clinical study requirements.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02362867
Study Brief:
Protocol Section:
NCT02362867