Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures
Brief 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. 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: 1. To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert. 2. To find out the cumulative incidence of component revision of each component in this combination. 3. To find out the functional outcome scores at early, midterm, and long-term follow-up.
Interventions
DEVICERevision Knee implants
Primary knee arthroplasty or a revision knee that requires a revision procedure.
Sponsors
MicroPort Orthopedics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. 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. 3. Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery 4. 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: 1. the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both 2. all other aspects of the Inclusion/
Exclusion criteria
are satisfied 3. enrollment does not exceed the subject count specified 4. the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individual component survivorship | 10 years post-operative | Individual component survivorship for tibial base, femoral, and tibial insert at specified intervals out to 10 years follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes- Questionnaires | 10 years post-operative | * 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 |
| Incidence of component revision | 10 years post-operative | the cumulative incidence of component revision at specified intervals will be determined out to 10 years follow-up |
| Radiolucencies | 10 years post-operative | the presence, zone, and the size of radiolucencies surrounding implanted components will be determined |
| Adverse Events and Adverse Device Effects | 10 years post-operative | characterization of adverse events and adverse device effects |
Countries
United States
Outcome results
None listed