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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02256904
Eligibility Criteria:
Inclusion Criteria:
1. Patient qualifies for primary TKA
2. Patient understands the study conditions
3. Patient is capable of giving informed consent
Exclusion Criteria:
1. Other joint damage of the lower limbs
2. Extra-articular knee deformation of the lower limb
3. Hip arthroplasty on the surgical side
4. Contraindication to CT-scan
5. Acute or chronic infection of the lower limb
6. Progressive local or systemic infection
7. Alcohol or drug abuse
8. Psychiatric illness/mental disorder
9. Pregnancy
10. Less than 18 years of age
11. Known allergy to the implant materials
12. Muscular loss, neuromuscular disease or vascular deficiency of the affected limb making the operation unjustifiable
13. Any neuromuscular disorder
14. Severe instability secondary to advanced destruction of osteochondral structures or loss of integrity of the lateral ligament
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02256904
Study Brief:
Protocol Section:
NCT02256904