Status:
NOT_YET_RECRUITING
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.
Lead Sponsor:
FH ORTHO
Conditions:
Hip Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following...
Eligibility Criteria
Inclusion
- 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.
- Patient is at least 18 years of age.
- Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).
- In some countries, such as France, the patient will have to be socially insured to be included in the study.
Exclusion
- An infection, or latent infection.
- 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).
- Known Insufficient bone quality and/or bone stock.
- Known allergy to any component of the material listed on the product label.
- Metabolic diseases that could compromise bone regrowth.
- Metabolic and/or vascular treatment or disease that may compromise bone healing or consolidation.
- Drug dependency.
- Uncooperative patient unable to follow recommendations.
- Protected adult
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2038
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05966220
Start Date
December 1 2023
End Date
December 1 2038
Last Update
November 18 2023
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