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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT06207968
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
For Arthroplasty:
1. Infection, or latent infection
2. A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
3. Insufficient bone stock for proper implant fixation
4. 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.
5. Metabolic diseases that might compromise bone regrowth
6. Drug addiction
7. Incomplete bone growth
For Ligament reconstruction:
1. Infection, or latent infection
2. A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
3. Insufficient bone stock
4. Known allergies to one of the compounds of the material listed on the product label.
5. Metabolic diseases that might compromise bone regrowth
6. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06207968
Study Brief:
Protocol Section:
NCT06207968