FH ORTHO SAS Knee Observatory

NCT06207968 | Not Yet Recruiting

• 1 other identifier: 2021-02
• Study Type: observational
• Target: 487
• Locations: 1 country
• Sites: 10

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 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.

Conditions

Knee Surgery

Outcome Measures

Primary Outcomes (2)

• Revision rate

  Evaluate the revision rate at the longest follow-up possible for arthroplasty arm

  2 months, 3-6 months, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years

• Revision rate

  Evaluate the revision rate at the longest follow-up possible for ligament reconstruction arm

  2 months, 3-6 months, 1 year, 2 years, 5 years

Secondary Outcomes (10)

• International Knee Society (IKS 2011) score

  Pre-operative, 3-6months, 1 year, 2 years, 5 years, 10 years

• Complications/Adverse events

  During surgery, Immediate (0-2months), 3-6months, 1 year, 2 years, 5 years, 10 years

• International Knee Documentation Committee (IKDC 2000) score

  Pre-operative, 1 year, 2 years

• Lysholm Knee Scoring Scale

  Pre-operative, 1 year, 2 years

• Tegner activity level scale

  Pre-operative, 1 year, 2 years

Other Outcomes (2)

• Patient satisfaction

  3-6months, 1 year, 2 years, 5 years, 10 years

• X-ray

  3-6months

Study Arms (2)

Arthroplasty

Knee prostheses are intended for patients suffering from functionally serious diseases of the knee causing daily disability that is insufficiently improved by medical treatment. The functional diseases are among: * Knee osteoarthrosis * Osteonecrosis of the knee * Inflammatory disease * Patellofemoral arthritis The patients having benefited from an arthroplasty will be followed for at least 15 years (until 20 years).

Device: Knee surgery with FH Ortho devices

Ligament reconstruction

Ligament reconstruction surgery should be considered for patient who have undergone a rupture of the anterior and/or posterior cruciate ligaments requiring partial or total reconstruction. The patients having benefited from a ligament reconstruction will be followed for at least 5 years.

Device: Knee surgery with FH Ortho devices

Interventions

Knee surgery with FH Ortho devices DEVICE

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.

Arthroplasty; Ligament reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population will be representative of the target population of the medical devices. The aim is to recruit in the first 3 years in 15-20 sites in France, 487 patients who have benefited from knee arthroplasty or ligament reconstruction of the knee. Arthroplasty arm: Knee prostheses are intended for patients suffering from functionally serious diseases of the knee causing daily disability that is insufficiently improved by medical treatment (Knee osteoarthrosis, Osteonecrosis of the knee, Inflammatory disease, or Patellofemoral arthritis). Ligament reconstruction arm: Ligament reconstruction surgery should be considered for patient who have undergone a rupture of the anterior and/or posterior cruciate ligaments requiring partial or total reconstruction.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• FH ORTHO: lead

Study Sites (10)

Clinique De La Chataigneraie

Beaumont, 63541, France

Location

Clinique De La Miotte

Belfort, 90002, France

Location

Polyclinique St Privat

Boujan-sur-Libron, 34760, France

Location

Clinique Du Val D'Ouest

Écully, 69130, France

Location

C.H. Raymond Poincare

Garches, 92380, France

Location

Hôpital Saint Vincent de Paul

Lille, 59000, France

Location

Hôpital Prive St Grégoire

Saint-Grégoire, 35768, France

Location

Polyclinique De L'Europe

Saint-Nazaire, 44615, France

Location

Medipole Garonne

Toulouse, 31036, France

Location

Hôpital Privé Océane

Vannes, 56000, France

Location

Study Officials

• Charles KAJETANEK, MD

  Hôpitaux Privés Rennais - Saint-Grégoire (Vivalto Santé) Institut Locomoteur de l'Ouest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Lai

CONTACT

631315494; c.lai@fhortho.com

Stephanie Lhuillier

CONTACT

607345965; s.lhuillier@fhortho.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 17, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2044
• Study Completion (Estimated): June 1, 2044
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)