Knee DiseaseNCT04578951
Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.
An observational study of Knee Disease, run by FH ORTHO at 1 site in France.
Trial summary
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance… 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?
- FHK® total knee prosthesis
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2020to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Subject implanted with FHK® 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.
- Adults subjects (≥18 years old).
- Access to an internet connection allowing to complete the questionnaires on the online platform
Who cannot join
- Contraindications described in the instructions for use
- Subject who is not able to express his/her non-opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.
This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.
Read the detailed description
The primary objective of this study is to evaluate the quality of life in patients operated with a FHK® total knee prosthesis up to 2 years of follow-up.
The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.
- Conditions
- Knee Disease
- Being tested
- FHK® 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.
FHK® total knee prosthesisDevice
FHK® 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 a prosthesis from the FHK® range | Not described Receives: Device: FHK® total knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life EQ-5D-5L score
The primary outcome measures will be determined by the EQ-5D-5L score. The EQ-5D-5L score is a self-administered quality of life questionnaire by patients. The EQ-5D-5L consists of two parts, One part with a five-dimensional system and the last one is a visual analog scale graduated from 0 to 100. We will observe the evolution of this score according to the time frame.
Measured: 14 days preoperative ; 70 days post-op, 177 days post-op, 357 days post-op, 717 days post-op
Secondary outcomes (3)
Survival rate
Measured: 2 years post-op
Evolution of parameters describing pain, stability, knee mobility and patient autonomy
The secondary outcome measures will be determined by the KOOS-PS score, a patellar evaluation, and questions about physical abilities.
The KOOS-PS score is a score used in the clinical evaluation of various knee pathologies.This score assesses both the long and medium term consequences of a knee injury. It contains 42 items in 5 separately scored subscales (pain, other symptoms, function in daily life, function in leisure and sports and quality of life related to the knee).
The patellar evaluation is a questionnaire assessing the functional state of the knee with questions such as the level of pain in the anterior region of the knee, assessment of the strength of the quadriceps, the ability to rise from a chair.
Physical abilities will be assessed with questions like the patient's walking distance, the ability to cycle, the ability to go shopping.
Measured: From the preoperative visit to 2 years postoperative.
Rate of complications
Measured: All complications will be gathered during intervention and up to 2 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start28 Sep 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: Only 19% of the expected patients have been enroled. Patient's follow-up has not been realized as expected in the protocol
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
- 50 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
- NCT04578951
- Sponsor's protocol ID
- 2018-41
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2020
- Last updated
- 7 Nov 2023
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.
- ClinicalTrials.gov ID
- NCT04578951
- Acronym / sponsor ID
- 2018-41
- Conditions
- Knee Disease
- Keywords
- Knee, Arthroplasty, Replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Only 19% of the expected patients have been enroled. Patient's follow-up has not been realized as expected in the protocol
- Enrolment
- 50 participants (actual)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 8 Oct 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.
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.
This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.
Detailed description
The primary objective of this study is to evaluate the quality of life in patients operated with a FHK® total knee prosthesis up to 2 years of follow-up.
The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving a prosthesis from the FHK® range | – | Device: FHK® 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 (4 listed)
- Subject implanted with FHK® 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.
- Adults subjects (≥18 years old).
- Access to an internet connection allowing to complete the questionnaires on the online platform
Key exclusion criteria (2 listed)
- Contraindications described in the instructions for use
- 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 |
|---|---|---|
| FHK® total knee prosthesisFHK® 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 a prosthesis from the FHK® range |
Primary outcome
Quality of life EQ-5D-5L score
Time frame: 14 days preoperative ; 70 days post-op, 177 days post-op, 357 days post-op, 717 days post-op
The primary outcome measures will be determined by the EQ-5D-5L score. The EQ-5D-5L score is a self-administered quality of life questionnaire by patients. The EQ-5D-5L consists of two parts, One part with a five-dimensional system and the last one is a visual analog scale graduated from 0 to 100. We will observe the evolution of this score according to the time frame.
3 secondary outcomes
Survival rate
Time frame: 2 years post-op
Evolution of parameters describing pain, stability, knee mobility and patient autonomy
Time frame: From the preoperative visit to 2 years postoperative.
Rate of complications
Time frame: All complications will be gathered during intervention and up to 2 years postoperatively.
Results and safety
The study was stopped early (reason given: Only 19% of the expected patients have been enroled. Patient's follow-up has not been realized as expected in the protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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.
1 site 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 1 site 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Only 19% of the expected patients have been enroled. Patient's follow-up has not been realized as expected in the protocol). Results are not available in the source record.
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?
Quality of life EQ-5D-5L score (time frame: 14 days preoperative ; 70 days post-op, 177 days post-op, 357 days post-op, 717 days 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 7 Nov 2023.