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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04831918
Eligibility Criteria:
Inclusion Criteria:
1. The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;
2. The patient diagnosis is one or more of the following:
* Patient with advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;
* Patient with avascular necrosis of the femoral head or fracture of the femoral neck;
* Patient with congenital or acquired deformity;
* Patient with failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty.
3. The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
Exclusion Criteria:
The patient should be excluded from the study if he/she meets any of the following criteria, which reflect the cemented acetabular cup contraindication for use:
1. Acute or chronic infections, local or systemic infections;
2. Serious muscular, neurological or vascular diseases affecting the concerned limb;
3. Any concomitant disease and dependence that might affect the implanted prosthesis;
4. Allergy to material;
5. Metal-on-metal systems: patients with renal impairment.
6. Patient's age\<18
7. Female patients who are pregnant, nursing, or planning a pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04831918
Study Brief:
Protocol Section:
NCT04831918