Total Knee ArthroplastyNCT04727060
Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty and Knee Disease, run by Corin at 1 site in France.
Trial summary
The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement
- What is being tested?
- patient with knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 2,146 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2011to Nov 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: It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely. All patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) 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
- For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:
- Adult patients older than 18 years old.
- Patients who have undergone routine preoperative clinical evaluations prior to their Total Knee Replacement surgery and implanted with one of the following prostheses from the HLS range: HLS-1, HLS-2, HLS Evolution and HLS Noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
- Patients who have been informed about their participation into an observational study.
- For the HLS KneeTec prospective group (with retrospective surgeries):
- Adult patients older than 18 years old.
Show all 9Show fewer
- Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
- Patients who are willing and able to complete the scheduled FU visits.
- Patients who have been informed about their participation into an observational registry study
Who cannot join
- Patients mentally incompetent or unable to understand what participation in the study entails.
- Patients who present signs and symptoms of any of the known contraindications described in the Instruction for Use (IFU) of the study devices.
- Patients who deny their participation into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants
The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.
Read the detailed description
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.
All patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) 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.
Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis.
Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.
- Being tested
- patient with knee arthroplasty
- Keywords
- Knee Arthroplasty, Prosthesis, Implants, HLS implants, postero-stabilized prosthesis, third condyle, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient with knee arthroplastyDevice
Also called patient with HLS prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices
Implants survival
Measured: 10-year
Secondary outcomes (4)
Evaluation of clinical performance
Change of clinical performance using the International Knee Society (IKS) score
Measured: baseline (pre-surgery) to 10-year
Evaluation of patient satisfaction with the surgery
Patients satisfaction post-surgery and any change during time up to 10-year FU using satisfaction questionnaire
Measured: time up to 10-year FU
Radiographic evaluation
Implant positioning and stability, presence/absence of progressive radiolucent lines around implant components, any sign of loosening components via radiological evaluation from baseline (1-year FU) to 10-year FU.
Measured: baseline (1-year FU) to 10-year FU
Evaluation of safety of the study implants
Number, severity and causal relationship of procedure or implant-related Adverse Events (AEs) starting intraoperatively up to 10-year FU.
Measured: time 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 2021
- Study start15 Dec 2011
- Primary completionNov 2023
- Study completionNov 2023
Why it stopped: the clinical data collected to date are 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
- 2,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elvire SERVIEN, MD,PhD, Principal investigator, Service de chirurgie orthopédique. Hopital de la Croix-Rousse, Hospices Civils de Lyon - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727060
- Sponsor's protocol ID
- 0904-T-KNEE-RM
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2020
- 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
- A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants
- ClinicalTrials.gov ID
- NCT04727060
- Acronym / sponsor ID
- 0904-T-KNEE-RM
- Keywords
- Knee Arthroplasty, Prosthesis, Implants, HLS implants, postero-stabilized prosthesis, third condyle, Arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the clinical data collected to date are sufficient for regulatory requirements
- Enrolment
- 2,146 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2011 (actual)
- Primary completion
- Nov 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 27 Jan 2021 (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 purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.
Detailed description
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.
All patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) 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.
Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis.
Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely. All patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) 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 (9 listed)
- For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:
- Adult patients older than 18 years old.
- Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
- Patients who are willing and able to complete the scheduled FU visits.
- Patients who have been informed about their participation into an observational registry study
Key exclusion criteria (3 listed)
- Patients mentally incompetent or unable to understand what participation in the study entails.
- Patients who present signs and symptoms of any of the known contraindications described in the Instruction for Use (IFU) of the study devices.
- Patients who deny their participation into the study.
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 |
|---|---|---|
| patient with knee arthroplastyAlso: patient with HLS prosthesis | Device | – |
Primary outcome
Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices
Time frame: 10-year
Implants survival
4 secondary outcomes
Evaluation of clinical performance
Time frame: baseline (pre-surgery) to 10-year
Evaluation of patient satisfaction with the surgery
Time frame: time up to 10-year FU
Radiographic evaluation
Time frame: baseline (1-year FU) to 10-year FU
Evaluation of safety of the study implants
Time frame: time up to 10-year FU
Results and safety
The study was stopped early (reason given: the clinical data collected to date are 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.
Related trials for Total Knee Arthroplasty
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
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.
Elvire SERVIEN, MD,PhD principal investigator
Service de chirurgie orthopédique. Hopital de la Croix-Rousse, Hospices Civils de Lyon - France
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 9 inclusion and 3 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 are 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 long-term survivorship of total knee replacement surgeries with HLS devices (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.