Joint DiseaseAMETHYSTNCT02351414
Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 5 sites in 5 countries.
Trial summary
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Joint Disease
- What is being tested?
- Total Knee Arthroplasty (EVOLUTION®)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 15 Jun 2015to Dec 2028
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts
Who may be able to join
- To be included in the study, subjects must meet all of the following criteria:
- Has previously undergone primary TKA for any of the following:
- non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis
- correction of functional deformity.
- Subject was implanted with the specified combination of components
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- Subject is willing and able to complete required study visits and assessments
- Subject plans to be available through the 10 year postoperative follow-up visit
- Subject is willing to sign the approved Informed Consent document
- Subject must be at least 2 years post TKA prior to informed consent.
- Previously implanted bilateral subjects can have both TKAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second TKA. Prospective enrollment of a previously unimplanted knee is not permitted in this study.
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- Subject was skeletally immature (less than 21 years of age) at time of implantation
- Subject is currently enrolled in another clinical investigation
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject has a body mass index (BMI) of greater than 40
- Subject is currently incarcerated or has impending incarceration
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053
Germany1 site
Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr
Mülheim, D-45468
United Kingdom1 site
University Hospital Llandough
Penarth, South Glamorgan, CF64 2XX
About this study
Official title: Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Read the detailed description
MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.
- Conditions
- Joint Disease
- Being tested
- Total Knee Arthroplasty (EVOLUTION®)
- Keywords
- Osteoarthritis, Ankylosis, Revision procedures, Correction of functional deformity, Rheumatoid arthritis, Arthritis
- Medical subject headings
- Joint Diseases, Osteoarthritis, Ankylosis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty (EVOLUTION®)Device
Also called EVOLUTION® Total Knee Arthroplasty System with CS Inserts, EVOLUTION® CS
| Study group | Role | What they receive |
|---|---|---|
| Primary Total Knee Arthroplasty | Single study group previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts Receives: Device: Total Knee Arthroplasty (EVOLUTION®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Component Survivorship
The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years
Measured: 10 years post-operative
Secondary outcomes (5)
Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores)
To characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-3L Scores
Measured: 2-<5 years, 5-7 years, and 10 years
Cumulative Revision Rate
To determine the cumulative revision rate at specified intervals out to 10 years follow-up
Measured: 2-<5 years, 5-7 years, and 10 years
Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)
To assess subject satisfaction with their TKA procedure
Measured: 2-<5 years, 5-7 years, and 10 years
Number of Radiolucencies
To summarize the number of radiolucencies in zones surrounding implanted components
Measured: 2-<5 years, 5-7 years, and 10 years
Size of Radiolucencies
To summarize the size of radiolucencies in zones surrounding implanted components
Measured: 2-<5 years, 5-7 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study start15 Jun 2015
- Primary completionJun 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- More trials run by MicroPort Orthopedics Inc.The 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351414
- Sponsor's protocol ID
- 13-LJK-001
- Acronym
- AMETHYST
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2015
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
- ClinicalTrials.gov ID
- NCT02351414
- Acronym / sponsor ID
- AMETHYST / 13-LJK-001
- Conditions
- Joint Disease
- Keywords
- Osteoarthritis, Ankylosis, Revision procedures, Correction of functional deformity, Rheumatoid arthritis, Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Jan 2015 (estimated)
- 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.
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Detailed description
MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Total Knee Arthroplasty | – | Device: Total Knee Arthroplasty (EVOLUTION®)Single study group previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts
Key inclusion criteria (11 listed)
- Has previously undergone primary TKA for any of the following:
- non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis
- correction of functional deformity.
- Subject was implanted with the specified combination of components
Key exclusion criteria (8 listed)
- Subject was skeletally immature (less than 21 years of age) at time of implantation
- Subject is currently enrolled in another clinical investigation
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in 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 |
|---|---|---|
| Total Knee Arthroplasty (EVOLUTION®)Also: EVOLUTION® Total Knee Arthroplasty System with CS Inserts, EVOLUTION® CS | Device | Primary Total Knee Arthroplasty |
Primary outcome
Component Survivorship
Time frame: 10 years post-operative
The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years
5 secondary outcomes
Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores)
Time frame: 2-<5 years, 5-7 years, and 10 years
Cumulative Revision Rate
Time frame: 2-<5 years, 5-7 years, and 10 years
Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)
Time frame: 2-<5 years, 5-7 years, and 10 years
Number of Radiolucencies
Time frame: 2-<5 years, 5-7 years, and 10 years
Size of Radiolucencies
Time frame: 2-<5 years, 5-7 years, and 10 years
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 13 Oct 2022.
- 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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 5 sites in 5 countries.
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 11 inclusion and 8 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Canada, Germany, United Kingdom. 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?
Component Survivorship (time frame: 10 years post-operative). 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 13 Oct 2022.