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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT05966220
Eligibility Criteria:
Inclusion Criteria:
1. Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO Company for hip arthroplasty and traumatology, used in accordance with their approved Instruction For Use, in one of the centers participating in the Observatory.
2. Patient is at least 18 years of age.
3. Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).
4. In some countries, such as France, the patient will have to be socially insured to be included in the study.
Exclusion Criteria:
1. An infection, or latent infection.
2. A mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, failure of prosthetic fixation, or post-operative complications (except for the HIP\&GO Double mobility cemented cup and, if applicable, the associated stems and heads when assembled together).
3. Known Insufficient bone quality and/or bone stock.
4. Known allergy to any component of the material listed on the product label.
5. Metabolic diseases that could compromise bone regrowth.
6. Metabolic and/or vascular treatment or disease that may compromise bone healing or consolidation.
7. Drug dependency.
8. Uncooperative patient unable to follow recommendations.
9. Protected adult
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05966220
Study Brief:
Protocol Section:
NCT05966220