Status:
NOT_YET_RECRUITING
FH ORTHO SAS Knee Observatory
Lead Sponsor:
FH ORTHO
Conditions:
Knee Surgery
Eligibility:
All Genders
18+ years
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...
Detailed Description
PMCF as part of CE mark renewal, to answer questions related to the safety and clinical performance of the devices, when used according to their approved instructions for use. This is an European, pr...
Eligibility Criteria
Inclusion
- Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO SAS for knee arthroplasty and ligament reconstruction, used in accordance with their approved IFU, in one of the centers participating in the Observatory.
- Patient is at least 18 years old at the time of surgery
- 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
- For Arthroplasty:
- Infection, or latent infection
- A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
- Insufficient bone stock for proper implant fixation
- It is the surgeon's responsibility to make sure that the patient does not have any known allergies to one of the compounds of the material listed on the product label.
- Metabolic diseases that might compromise bone regrowth
- Drug addiction
- Incomplete bone growth
- For Ligament reconstruction:
- Infection, or latent infection
- A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
- Insufficient bone stock
- Known allergies to one of the compounds of the material listed on the product label.
- Metabolic diseases that might compromise bone regrowth
- Uncooperative patient unable to follow recommendations
- As the medical devices are used in real life according to their indications, pregnant or breastfeeding women are not excluded from the study, but for safety reasons it is not advisable to include them in the study.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2044
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT06207968
Start Date
May 1 2024
End Date
June 1 2044
Last Update
February 22 2024
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinique De La Chataigneraie
Beaumont, France, 63541
2
Clinique De La Miotte
Belfort, France, 90002
3
Polyclinique St Privat
Boujan-sur-Libron, France, 34760
4
Clinique Du Val D'Ouest
Écully, France, 69130