Total Knee ArthroplastyNCT04427722
PMCF Study of MPS-Flex® Knee System in TKA
An observational study of Total Knee Arthroplasty, run by Zimmer Biomet at 1 site in China.
Trial summary
The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- MPS-Flex Total Knee Joint Prostheses
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2021to 31 Dec 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population for primary statistical analysis will consist of patients who have already underwent their surgery with MPS-Flex® Total Knee Joint Prostheses for their primary TKA and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the MPS-Flex® Total Knee Joint Prostheses.
Who may be able to join
- A patient must meet the following criteria to be eligible for participation:
- Age 18 to 75 years old, inclusive.
- Had a primary unilateral or bilateral (simultaneous or staged)TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
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- Moderate valgus, varus, or flexion deformities.
- Had received MPS-Flex® Total Knee Joint Prostheses per the approved indications for use for the TKA.
- Willing and able to provide written informed consent by signing and dating the EC approved informed consent form.
- Willing and able to complete scheduled study procedures and follow-up evaluations.
Who cannot join
- A patient must not meet the following criteria to be eligible for participation:
- The patient is:
- A prisoner
- Mentally incompetent or unable to understand what participation in the study entails
- A known alcohol or drug abuser
- Anticipated to be non-compliant
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- Meet any of the following contraindications of the product.
- Had previous infection in the operative knee joint, and/or has systemic inflection that could affect prosthesis
- Insufficient bone stock of tibia or tibia surface
- Skeleton immaturity
- Neuropathic arthropathy
- Osteoporosis, muscle structure or neuromuscular lesions which affects lower limb function
- The affected joint occurs fusion in the satisfactory functional position and form stable,
- A history of rheumatoid arthritis with skin ulcers or recurrent skin damage
- Has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- Known sensitivity or allergic reaction to one or more of the implanted materials.
- Known local bone tumors and/or cysts in the operative knee
- Known to be pregnant
- Body Mass Index (BMI) ≥ 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre Post Market Clinical Follow-Up Study of MPS-Flex® Total Knee Joint Prostheses in Total Knee Arthroplasty
The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee arthroplasty (TKA).
Read the detailed description
This is a retrospective and prospective, multi-centre, post-market clinical follow-up study involving orthopedic surgeons skilled in TKA and experienced implanting the devices included in this study. Patient demographic and operative information will be collected retrospectively. Postoperative clinical outcome, radiographic assessment and adverse events will be collected prospectively starting from the first year of postoperative follow up visit.
All study subjects have undergone routine preoperative clinical evaluations prior to their THA, and implanted MPS-Flex® Total Knee Joint Prostheses in accordance to indications and intended use, and appropriate surgical technique(s) will be invited to participate in the study at their first year of postoperative follow up visit, and sign ICF.
- Conditions
- Total Knee Arthroplasty
- Being tested
- MPS-Flex Total Knee Joint Prostheses
- Keywords
- Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPS-Flex Total Knee Joint ProsthesesDevice
Patients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| MPS-Flex Total Knee Joint Prostheses | Patients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol. Receives: Device: MPS-Flex Total Knee Joint Prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survivorship based on revision
Implant survival will be summarized using a Kaplan-Meier method.
Measured: 10 years
Secondary outcomes (3)
Functional outcome based on Knee Society Score
The Knee Society Scoring System combines an objective physician-derived component with a subjective patient-derived component that evaluates pain relief, functional abilities, satisfaction, and fulfillment of expectations. It consists of four subscales: (1) Objective Knee Score (seven items; 100 points), (2) Satisfaction Score (five items; 40 points), (3) Expectation Score (three items; 15 points), and (4) Functional Activity Score (19 items; 100 points).
Measured: 10 years
Quality of life based on EQ-5D questionnaire
EQ-5D is a standardized measure of health-related quality of life states consisting of 5 dimensions, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L version was used in the study. Each dimension has 5 responses recording 5 levels of severity (no problems/slight problems/moderate problems/severe problems or extreme problems). The responses to the EQ-5D dimensions are used to obtain a single EQ-5D index value where 1 represents full health and 0 represents death. The questionnaire also includes a vertical, visual analogue scale (EQ VAS) for the respondents to record their self-rated health where the 2 extreme ends of the scale are labelled as 'Best imaginable health state' and 'Worst imaginable health state' respectively.
Measured: 10 years
Safety assessment
Summarize the category, incidence and frequency of adverse events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start25 Feb 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: No plan to extend CE mark
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.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhenzhong Guo, Professor, Principal investigator, Jizhong Erengy Fengfeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427722
- Sponsor's protocol ID
- CSA2019-11K
- Status last verified
- Jul 2024
- First submitted
- 9 Jun 2020
- Last updated
- 24 Jul 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Post Market Clinical Follow-Up Study of MPS-Flex® Total Knee Joint Prostheses in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04427722
- Acronym / sponsor ID
- CSA2019-11K
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: No plan to extend CE mark
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jun 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.
The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee arthroplasty (TKA).
Detailed description
This is a retrospective and prospective, multi-centre, post-market clinical follow-up study involving orthopedic surgeons skilled in TKA and experienced implanting the devices included in this study. Patient demographic and operative information will be collected retrospectively. Postoperative clinical outcome, radiographic assessment and adverse events will be collected prospectively starting from the first year of postoperative follow up visit.
All study subjects have undergone routine preoperative clinical evaluations prior to their THA, and implanted MPS-Flex® Total Knee Joint Prostheses in accordance to indications and intended use, and appropriate surgical technique(s) will be invited to participate in the study at their first year of postoperative follow up visit, and sign ICF.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPS-Flex Total Knee Joint Prostheses | – | Device: MPS-Flex Total Knee Joint ProsthesesPatients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for primary statistical analysis will consist of patients who have already underwent their surgery with MPS-Flex® Total Knee Joint Prostheses for their primary TKA and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the MPS-Flex® Total Knee Joint Prostheses.
Key inclusion criteria (10 listed)
- Age 18 to 75 years old, inclusive.
- Had a primary unilateral or bilateral (simultaneous or staged)TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Had received MPS-Flex® Total Knee Joint Prostheses per the approved indications for use for the TKA.
- Willing and able to provide written informed consent by signing and dating the EC approved informed consent form.
- Willing and able to complete scheduled study procedures and follow-up evaluations.
Key exclusion criteria (19 listed)
- The patient is:
- Meet any of the following contraindications of the product.
- Has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- Known sensitivity or allergic reaction to one or more of the implanted materials.
- Known local bone tumors and/or cysts in the operative knee
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 |
|---|---|---|
| MPS-Flex Total Knee Joint ProsthesesPatients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol. | Device | MPS-Flex Total Knee Joint Prostheses |
Primary outcome
Implant survivorship based on revision
Time frame: 10 years
Implant survival will be summarized using a Kaplan-Meier method.
3 secondary outcomes
Functional outcome based on Knee Society Score
Time frame: 10 years
Quality of life based on EQ-5D questionnaire
Time frame: 10 years
Safety assessment
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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.
Zhenzhong Guo, Professor principal investigator
Jizhong Erengy Fengfeng Hospital
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, run by Zimmer Biomet at 1 site in China.
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 10 inclusion and 19 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: paused, as of the sponsor's last update on 24 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 China. 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?
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?
Implant survivorship based on revision (time frame: 10 years). 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 24 Jul 2024.