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
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
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- 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