FH ORTHO SAS Knee Observatory

ConditionKnee Surgery

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorFH ORTHO

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

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.

Treatment groups

487 Participants

are divided into 2 treatment groups

Group A: Arthroplasty1 intervention

Group B: Ligament reconstruction1 intervention

Trial outcomes

Primary outcomes

Revision rate

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

Time frame

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

Time frame

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

Secondary outcomes

International Knee Society (IKS 2011) score

Mobility, Pain and Function for Arthroplasty arm. It includes a 100-point objective score and a subjective score made up of 3 domains evaluating satisfaction on 40 points, patient expectations on 15 points using different items between the pre- and post-operative phases, as well as functional activities on 100 points. The total score was 255 points. There are no levels and the results are expressed as raw scores. Higher scores mean a better outcome.

Time frame

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

Complications/Adverse events

any adverse events leading or not to re-intervention (with or without change of the implant), including device malfunctions

Time frame

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

International Knee Documentation Committee (IKDC 2000) score

Mobility, Pain and Function for Ligament Reconstruction arm This self-questionnaire is divided into three parts (symptoms, sporting activities, function) and gives a score between 0 (worst) and 100 (best). This score is interpreted as a measure of functional capacity, with the highest scores representing the best levels of function and the lowest levels representing symptoms. A score of 100 means that there are no limits to daily activities and sports and that symptoms are non-existent.

Time frame

Pre-operative, 1 year, 2 years

Lysholm Knee Scoring Scale

Mobility, Pain and Function for Ligament Reconstruction arm The Lysholm Knee Score is a questionnaire that the patient completes with the therapist. The questionnaire is designed to assess the degree of knee instability, in terms of both impairment and limitation. The Lysholm Knee Score calculates and rates an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, weight bearing, instability and oedema. Doctors use this condition-specific subjective outcome score to assess a patient's progress after knee surgery or injury. Scores between 95 and 100 are considered exceptional, those between 84 and 94 acceptable, those between 65 and 83 fair and those below 65 poor.

Time frame

Pre-operative, 1 year, 2 years

Other outcomes

Patient satisfaction

A simple questionnaire consisting of 3 questions will be proposed to the patient. The 2 first one will be to graduate the satisfaction regarding the mobility and the pain of the operated knee and the last one is the yes/No question regarding the surgery reiteration.

Time frame

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

X-ray

check the position of the prosthesis using medical imaging. Desired position: Yes or No

Time frame

3-6months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FH ORTHO

Lead sponsor

Source ClinicalTrials.gov

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