Arthritis Knee, Avascular Necrosis, Joint Diseases, Osteoarthritis
Conditions
Brief summary
MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.
Interventions
DEVICEEVOLUTION® NitrX™
EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Sponsors
MicroPort Orthopedics Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert 2. 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; 3. Willing to voluntarily sign the informed consent form 4. Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit. 5. Previously implanted subjects must be enrolled within 14 months of their primary TKA implantation. Prospective enrollment of a previously unimplanted contralateral knee is permitted in this study provided: 1. the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) are used, 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 and data collection specific to the second TKA. Bilateral subjects can have both TKAs enrolled in the study provided: 1. the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) were implanted in both, 2. all other aspects of the Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia | 10 years post-operative | The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year |
| Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur | 10 years post-operative | The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year. |
| Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts | 10 years post-operative | The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Scores | 10 years post-operative | To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS). |
| Subject Satisfaction | 10 years post-operative | To assess subject satisfaction with their TKA procedure via the Satisfaction Survey. |
| Radiolucencies | 10 years post-operative | To assess the presence of radiolucencies surrounding the implanted femoral and tibial components present in each of the 17 zones. |
| To assess subject safety: Adverse Events | 1, 3, 5, 7, 10 years | To assess safety of the EVOLUTION® NitrX™ system through device-related adverse event findings and/or adverse device effects during follow-up visits. |
| To assess device tolerability within subject: Adverse Events | 10 years post-operative | To assess tolerability of the EVOLUTION® NitrX™ system service-related adverse event findings and/or adverse device effects during follow-up visits. |
Countries
United Kingdom, United States
Outcome results
None listed