Knee OsteoarthritisNCT04301622
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
An observational study of Knee Osteoarthritis and Traumatic Arthritis of Knee, run by MicroPort Orthopedics Inc. at 1 site in United States.
Trial summary
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Osteoarthritis, Traumatic Arthritis of Knee, Avascular Necrosis
- What is being tested?
- Primary Knee implants
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to Aug 2032
- 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 Single study group with newly or previously implanted patients with EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur with Cruciate Sacrificing Insert
Who may be able to join
- Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel
- Has previously undergone or currently has determined to undergo a 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;
- willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
- Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation
Who cannot join
- Skeletally immature (less than 21 years of age) at time of implantation
- Has or had an overt infection at the time of implantation
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
- Has or had 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
- Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
Show all 12Show fewer
- Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Unwilling or unable to sign the Informed Consent document
- 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.
About this study
Official title: Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Read the detailed description
The objectives of this study are:
- To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts
- 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, Traumatic Arthritis of Knee, Avascular Necrosis, Degenerative Joint Disease of Knee, Rheumatoid Arthritis of Knee, Correction of Functional Deformity
- Being tested
- Primary Knee implants
- Medical subject headings
- Osteoarthritis, Knee, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Knee implantsDevice
Primary knee arthroplasty
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 CS insert at specified intervals out to 10 years follow-up.
Measured: 10 years post-operative
Secondary outcomes (7)
Patient Reported Outcomes- Knee Injury and Osteoarthritis Outcome Scores
-functional scores for subjects, as assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), out to 10 years follow-up
Measured: 10 years post-operative
Patient Reported Outcomes- EuroQol-5D-5L Scores
-functional scores for subjects, as assessed by EuroQol-5D-5L (EQ-5D-5L) Scores, out to 10 years follow-up
Measured: 10 years post-operative
Patient Reported Outcomes- Forgotten Joint Score
-subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Forgotten Joint Score
Measured: 10 years post-operative
Patient Reported Outcomes- Satisfaction Survey
-subject satisfaction measures with their Total Knee Arthroplasty (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 posted10 Mar 2020
- Study start3 Feb 2020
- Primary completionFeb 2032 (estimated)
- Study completionAug 2032 (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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian de Beaubien, MD, Principal investigator, Covenant Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301622
- Sponsor's protocol ID
- 17K001
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2020
- 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® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts
- ClinicalTrials.gov ID
- NCT04301622
- Acronym / sponsor ID
- 17K001
- Conditions
- Knee Osteoarthritis, Traumatic Arthritis of Knee, Avascular Necrosis, Degenerative Joint Disease of Knee, Rheumatoid Arthritis of Knee, Correction of Functional Deformity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Feb 2032 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 10 Mar 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.
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Detailed description
The objectives of this study are:
- To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts
- 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 Single study group with newly or previously implanted patients with EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur with Cruciate Sacrificing Insert
Key inclusion criteria (7 listed)
- Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel
- Has previously undergone or currently has determined to undergo a primary TKA for any of the following:
- Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation
Key exclusion criteria (12 listed)
- Skeletally immature (less than 21 years of age) at time of implantation
- Has or had an overt infection at the time of implantation
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
- Has or had 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
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 |
|---|---|---|
| Primary Knee implantsPrimary knee arthroplasty | Device | – |
Primary outcome
Individual component survivorship
Time frame: 10 years post-operative
Individual component survivorship for tibial base, femoral, and tibial CS insert at specified intervals out to 10 years follow-up.
7 secondary outcomes
Patient Reported Outcomes- Knee Injury and Osteoarthritis Outcome Scores
Time frame: 10 years post-operative
Patient Reported Outcomes- EuroQol-5D-5L Scores
Time frame: 10 years post-operative
Patient Reported Outcomes- Forgotten Joint Score
Time frame: 10 years post-operative
Patient Reported Outcomes- Satisfaction Survey
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. This study is not recruiting at the moment.
Brian de Beaubien, MD principal investigator
Covenant Medical Center
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 and Traumatic Arthritis of Knee, 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 7 inclusion and 12 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 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.