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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT06996158
Eligibility Criteria:
Inclusion Criteria:
1. All patients suitable for a cemented Total Knee Replacement, MBC design
2. All elective pathology (including Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis not requiring stemmed components, Avascular necrosis)
3. Willing to voluntarily sign the informed consent form
4. Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
Exclusion Criteria:
1. Skeletally immature (less than 21 years of age) at time of implantation
2. Active native knee joint infection
3. Post-traumatic arthritis requiring stemmed components
4. Malignancy around the knee
5. All patients who are personally unable to take part in fully informed consent (dementia, reduced AMTS etc)
6. Patients who will not be available to return for the predetermined appointments in order to complete the 10 years follow-up
7. Has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
8. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06996158
Study Brief:
Protocol Section:
NCT06996158