Total Knee ArthroplastyNCT05211141
Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)
An observational study of Total Knee Arthroplasty and Knee Disease, run by Corin at 1 site in France.
Trial summary
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement
- What is being tested?
- HLS KneeTec Deep Dish
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2017to 21 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated with HLS KneeTec Deep Dish implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study
Who may be able to join
- Male or female aged 18 - 80 years old at the time of the surgery
- Implanted with an HLS KneeTec Deep Dish TKP according to the Instructions for Use (IFU) after the 1st of february, 2017
- Patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study.
Who cannot join
- Patients under guardianship and/or those who, according to the investigator or his delegated research team, will not be able to comply with the study procedures. (e.g. illiteracy, recent psychotic or manic disorders and/or inability to comply with routine follow-up visits.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study for the Evaluation of Long Term Performance and Safety of the HLS KneeTec Deep Dish Prosthesis in Total Knee Arthroplasty
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice
Read the detailed description
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a single French site where Total Knee Arthroplasty with HLS Kneetec Deep Dish prosthesis is performed routinely
All patients treated with HLS KneeTec Deep Dish implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study.
Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (FU) visits as following: 3 months (+/- 1 months); 15 months (+/- 3 months); 5 years (+/- 6 months) and 10 years (+/- 6 months).
- Being tested
- HLS KneeTec Deep Dish
- Keywords
- Knee Arthroplasty, Prosthesis, ultracongruent prosthesis, Implants, HLS implants, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLS KneeTec Deep DishDevice
total knee arthroplasty with HLS KneeTec Deep Dish prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Patient with knee arthroplasty | patient with HLS KneeTec Deep Dish prosthesis Receives: Device: HLS KneeTec Deep Dish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery
kaplan Meier survival rate
Measured: 10-year
Secondary outcomes (7)
Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery
International Knee Society (IKS) score
Measured: preoperatively, 15 months, 5 years and 10 years
Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery
Oxford Knee Score (OKS) _ score of each question from 0 to 4 with 4 being the best outcome
Measured: 15 months, 5 years and 10 years
Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery
Devane's score_level of activity 1 to 5 with 5 being the high level of activity
Measured: preoperatively, 15 months, 5 years and 10 years
Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery
Satisfaction score on a 4-point Likert-type scale, level of satisfaction 1 to 4 with 4 being the high level of satisfaction
Measured: 15 months, 5 years and 10 years
radiographic evaluation of the performance of HLS KneeTec Deep Dish
component positioning
Measured: preoperatively up to 10 years
radiographic evaluation of the performance of HLS KneeTec Deep Dish
number, severity and location of radiolucencies or osteolysis
Measured: preoperatively up to 10 years
Evaluation of safety performance during the surgery up to 10 years after the surger
Number, severity and casual relationship of procedure or implant-related adverse events
Measured: starting intraoperatively up to 10-year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start28 Feb 2017
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Why it stopped: the clinical data collected to date is sufficient for regulatory requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Other
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier ROCHE, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211141
- Sponsor's protocol ID
- CSP2017-07
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Evaluation of Long Term Performance and Safety of the HLS KneeTec Deep Dish Prosthesis in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05211141
- Acronym / sponsor ID
- CSP2017-07
- Keywords
- Knee Arthroplasty, Prosthesis, ultracongruent prosthesis, Implants, HLS implants, arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the clinical data collected to date is sufficient for regulatory requirements
- Enrolment
- 119 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 27 Jan 2022 (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.
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice
Detailed description
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a single French site where Total Knee Arthroplasty with HLS Kneetec Deep Dish prosthesis is performed routinely
All patients treated with HLS KneeTec Deep Dish implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study.
Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (FU) visits as following: 3 months (+/- 1 months); 15 months (+/- 3 months); 5 years (+/- 6 months) and 10 years (+/- 6 months).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with knee arthroplasty | – | Device: HLS KneeTec Deep Dishpatient with HLS KneeTec Deep Dish prosthesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with HLS KneeTec Deep Dish implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study
Key inclusion criteria (3 listed)
- Male or female aged 18 - 80 years old at the time of the surgery
- Implanted with an HLS KneeTec Deep Dish TKP according to the Instructions for Use (IFU) after the 1st of february, 2017
- Patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study.
Key exclusion criteria (1 listed)
- Patients under guardianship and/or those who, according to the investigator or his delegated research team, will not be able to comply with the study procedures. (e.g. illiteracy, recent psychotic or manic disorders and/or inability to comply with routine follow-up visits.)
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 |
|---|---|---|
| HLS KneeTec Deep Dishtotal knee arthroplasty with HLS KneeTec Deep Dish prosthesis | Device | Patient with knee arthroplasty |
Primary outcome
Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery
Time frame: 10-year
kaplan Meier survival rate
7 secondary outcomes
Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery
Time frame: preoperatively, 15 months, 5 years and 10 years
Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery
Time frame: 15 months, 5 years and 10 years
Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery
Time frame: preoperatively, 15 months, 5 years and 10 years
Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery
Time frame: 15 months, 5 years and 10 years
radiographic evaluation of the performance of HLS KneeTec Deep Dish
Time frame: preoperatively up to 10 years
radiographic evaluation of the performance of HLS KneeTec Deep Dish
Time frame: preoperatively up to 10 years
Evaluation of safety performance during the surgery up to 10 years after the surger
Time frame: starting intraoperatively up to 10-year FU
Results and safety
The study was stopped early (reason given: the clinical data collected to date is sufficient for regulatory requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
Olivier ROCHE, MD principal investigator
CHRU Nancy
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 Total Knee Arthroplasty and Knee Disease, run by Corin 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 3 inclusion and 1 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 16 Jul 2024. 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: the clinical data collected to date is sufficient for regulatory requirements). 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?
Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery (time frame: 10-year). 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 16 Jul 2024.