Clinical trial NCT04816773: Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Official title: Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Joint Diseases
Osteoarthritis
Arthritis Knee
Avascular Necrosis
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single study group with either newly or previously implanted patients with all EVOLUTION® NitrX™ components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and EVOLUTION® MP CS tibial insert

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.


Eligibility criteria: 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/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 implantation can occur at different time periods for the same subject.

Exclusion Criteria:

1. Skeletally immature (less than 21 years of age) at time of implantation
2. Has or had an overt infection at the time of implantation
3. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
5. 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
6. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
7. Has documented substance abuse issues
8. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
9. Currently incarcerated or has impending incarceration
10. 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

Primary outcomes:
measure: Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia
timeFrame: 10 years post-operative
measure: Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur
timeFrame: 10 years post-operative
measure: Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Functional Scores
timeFrame: 10 years post-operative
measure: Functional Scores
timeFrame: 10 years post-operative
measure: Functional Scores
timeFrame: 10 years post-operative
measure: Subject Satisfaction
timeFrame: 10 years post-operative
measure: Radiolucencies
timeFrame: 10 years post-operative
measure: To assess subject safety: Adverse Events
timeFrame: 1, 3, 5, 7, 10 years
measure: To assess device tolerability within subject: Adverse Events
timeFrame: 10 years post-operative
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Sah Orthopaedic Associates
state: California
city: Grantham
country: United Kingdom
facility: MSK Doctors, The Keep Clinic
state: Lincolnshire
Study officials:
References: