Knee surgery with FH Ortho devices: This clinical investigation is a real-life observatory designed to collect long-term clinical data on patients who have undergone knee joint replacement or knee ligament reconstruction.
In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.
Study 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 the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved instructions for use (IFU).
The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an knee arthroplasty. The observatory must also be able to cover devices used in ligament reconstruction surgery.
The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.
Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on smartphone/tablet/computer) when feasible.
The data to be collected and the different follow-up times are based on our state-of-the-art, clinical evaluation plans and clinical evaluation reports.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Revision rate — 2 months, 3-6 months, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years Evaluate the revision rate at the longest follow-up possible for arthroplasty arm
Revision rate — 2 months, 3-6 months, 1 year, 2 years, 5 years Evaluate the revision rate at the longest follow-up possible for ligament reconstruction arm
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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