Knee DiseaseNCT04221581
Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device
An observational study of Knee Disease, run by FH ORTHO at 3 sites in France.
Trial summary
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Disease
- What is being tested?
- Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Jan 2020to 22 Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from participating hospitals will be enrolled as part of their clinical routine care
Who may be able to join
- Adults subjects (≥18 years old).
- Subject implanted with FHK ASYMETRIQUE prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
- Subject who received an information form and is willing to participate in the study.
Who cannot join
- Contraindications described in the instructions for use
- Usual surgical contraindications
- Patients objecting to participate in this study
- Subject who is not able to express his/her non-opposition
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Pasteur
Colmar, 68000
Clinique Mutualiste de la Porte de l'Orient
Lorient, 56324
Médipôle Garonne
Toulouse, 31036
About this study
Official title: Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.
Read the detailed description
The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up.
The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.
- Conditions
- Knee Disease
- Being tested
- Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis
- Keywords
- Knee, Arthroplasty, Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee prosthesis - FHK ASYMETRIQUE total knee prosthesisDevice
FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving FHK ASYMETRIQUE prosthesis | Not described Receives: Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Survival rate
Measured: 10 years post-op
Secondary outcomes (3)
Radiological evaluation
Radiological results such as stability, osteointegration will be evaluated. The HKA angle will be measured. It is the angle (in degrees) between the center of the femoral head, the center of the knee and the center of the tibio-fibular mortise. This radiological evaluation is a usual assessment used in the follow-up of patients operated for a total knee replacement.
Measured: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Rate of complications
All complications will be gathered during intervention and up to 10 years postoperatively.
Measured: peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility.
Functional outcomes will be determined by the IKS score. New IKS score range from 0 to 200 with a physical score on 100 points (pain, knee's mobility, abnormal laxity, flexion deformity and Hips knee Ankle) and a functional score on 100 points (walking distance, difficulty with stairs and use of walking aids).
Measured: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start22 Jan 2020
- Primary completion22 Jan 2034 (estimated)
- Study completion22 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221581
- Sponsor's protocol ID
- 2018-38
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years
- ClinicalTrials.gov ID
- NCT04221581
- Acronym / sponsor ID
- 2018-38
- Conditions
- Knee Disease
- Keywords
- Knee, Arthroplasty, Replacement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 22 Jan 2034 (estimated)
- Study completion
- 22 Jan 2034 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.
Detailed description
The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up.
The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving FHK ASYMETRIQUE prosthesis | – | Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from participating hospitals will be enrolled as part of their clinical routine care
Key inclusion criteria (3 listed)
- Adults subjects (≥18 years old).
- Subject implanted with FHK ASYMETRIQUE prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
- Subject who received an information form and is willing to participate in the study.
Key exclusion criteria (4 listed)
- Contraindications described in the instructions for use
- Usual surgical contraindications
- Patients objecting to participate in this study
- Subject who is not able to express his/her non-opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee prosthesis - FHK ASYMETRIQUE total knee prosthesisFHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function. | Device | Patients receiving FHK ASYMETRIQUE prosthesis |
Primary outcome
Safety evaluation
Time frame: 10 years post-op
Survival rate
3 secondary outcomes
Radiological evaluation
Time frame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Rate of complications
Time frame: peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility.
Time frame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Disease, run by FH ORTHO at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation (time frame: 10 years post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.