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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02912351
Eligibility Criteria:
Inclusion Criteria:
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
* Patients with ability to understand and provide written authorization for use and disclosure of personal health information
* Patients must be willing to comply with the post-operative evaluation schedule.
* Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
* Patients must have received a GMK Revision component
* Patients must be at minimum 2 year (24 months) post-treatment
* The operation was performed or supervised by the investigator.
* No age limit criteria
Exclusion Criteria:
* History of alcoholism
* Currently on chemotherapy or radiation therapy
* Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
* History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
* History of chronic pain issues for reasons other than knee pain
* Women that are pregnant
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT02912351
Study Brief:
Protocol Section:
NCT02912351