Knee OsteoarthritisNCT04145401
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
An observational study of Knee Osteoarthritis, run by MicroPort Orthopedics Inc. at 1 site in United States.
Trial summary
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Revision Knee implants
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 1 Nov 2033
- 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: Primary TKA or Revision Single study group with either newly or previously implanted patients with EVOLUTION® Revision Tibia and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Insert.
Who may be able to join
- Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
- Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
- Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
- Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.
- Bilateral subjects can have both TKAs enrolled in the study provided:
- the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both
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- all other aspects of the Inclusion/Exclusion Criteria are satisfied
- enrollment does not exceed the subject count specified
- the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
Who cannot join
- Skeletally immature (less than 21 years of age) at time of implantation.
- Has an overt infection at the time of implantation.
- Has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable.
- Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
- Has documented substance abuse issues.
- Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- Currently incarcerated or has impending incarceration.
- Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
HCA Research Institute, OrthoONE at Swedish Medical Center
Englewood, Colorado, 80113
About this study
Official title: Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.
Read the detailed description
The objectives of this study are:
- To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert.
- To find out the cumulative incidence of component revision of each component in this combination.
- To find out the functional outcome scores at early, midterm, and long-term follow-up.
- Conditions
- Knee Osteoarthritis
- Being tested
- Revision Knee implants
- Keywords
- Osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision Knee implantsDevice
Primary knee arthroplasty or a revision knee that requires a revision procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual component survivorship
Individual component survivorship for tibial base, femoral, and tibial insert at specified intervals out to 10 years follow-up.
Measured: 10 years post-operative
Secondary outcomes (4)
Patient Reported Outcomes- Questionnaires
- functional scores for subjects, as assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), out to 10 years follow-up
- functional scores for subjects, as assessed by EuroQol-5D-5L (EQ-5D-5L) Scores, out to 10 years follow-up
- subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Forgotten Joint Score
- subject satisfaction measures with their TKA procedure using the Satisfaction Survey
Measured: 10 years post-operative
Incidence of component revision
the cumulative incidence of component revision at specified intervals will be determined out to 10 years follow-up
Measured: 10 years post-operative
Radiolucencies
the presence, zone, and the size of radiolucencies surrounding implanted components will be determined
Measured: 10 years post-operative
Adverse Events and Adverse Device Effects
characterization of adverse events and adverse device effects
Measured: 10 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start30 Sep 2020
- Primary completion1 May 2033 (estimated)
- Study completion1 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145401
- Sponsor's protocol ID
- 18K001
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert
- ClinicalTrials.gov ID
- NCT04145401
- Acronym / sponsor ID
- 18K001
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 May 2033 (estimated)
- Study completion
- 1 Nov 2033 (estimated)
- First posted
- 30 Oct 2019 (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.
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.
Detailed description
The objectives of this study are:
- To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert.
- To find out the cumulative incidence of component revision of each component in this combination.
- To find out the functional outcome scores at early, midterm, and long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary TKA or Revision Single study group with either newly or previously implanted patients with EVOLUTION® Revision Tibia and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Insert.
Key inclusion criteria (9 listed)
- Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
- Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
- Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
- Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.
- the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both
Key exclusion criteria (8 listed)
- Skeletally immature (less than 21 years of age) at time of implantation.
- Has an overt infection at the time of implantation.
- Has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable.
- Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
- Has documented substance abuse issues.
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 |
|---|---|---|
| Revision Knee implantsPrimary knee arthroplasty or a revision knee that requires a revision procedure. | Device | – |
Primary outcome
Individual component survivorship
Time frame: 10 years post-operative
Individual component survivorship for tibial base, femoral, and tibial insert at specified intervals out to 10 years follow-up.
4 secondary outcomes
Patient Reported Outcomes- Questionnaires
Time frame: 10 years post-operative
Incidence of component revision
Time frame: 10 years post-operative
Radiolucencies
Time frame: 10 years post-operative
Adverse Events and Adverse Device Effects
Time frame: 10 years post-operative
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 20 Mar 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.
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 Osteoarthritis, run by MicroPort Orthopedics Inc. at 1 site in United States.
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 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: enrolling by invitation, as of the sponsor's last update on 20 Mar 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 United States. 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?
Individual 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 20 Mar 2024.