Clinical trial NCT04145401: Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Official title: Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
traumatic arthritis
avascular necrosis
rheumatoid arthritis
correction of functional deformity
revision procedures
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary TKA or Revision

Single study group with either newly or previously implanted patients with EVOLUTION® Revision Tibia and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Insert.

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.

Eligibility criteria: 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.

Exclusion Criteria:

1. Skeletally immature (less than 21 years of age) at time of implantation.
2. Has an overt infection at the time of implantation.
3. Has 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.
4. Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
5. Has documented substance abuse issues.
6. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
7. Currently incarcerated or has impending incarceration.
8. 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: Individual component survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Patient Reported Outcomes- Questionnaires
timeFrame: 10 years post-operative
measure: Incidence of component revision
timeFrame: 10 years post-operative
measure: Radiolucencies
timeFrame: 10 years post-operative
measure: Adverse Events and Adverse Device Effects
timeFrame: 10 years post-operative
Other outcomes:
Locations:
city: Englewood
country: United States
facility: HCA Research Institute, OrthoONE at Swedish Medical Center
state: Colorado
Study officials:
References: