Clinical trial NCT04301622: Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
Official title: Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Osteoarthritis
Traumatic Arthritis of Knee
Avascular Necrosis
Degenerative Joint Disease of Knee
Rheumatoid Arthritis of Knee
Correction of Functional Deformity
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 150
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 Single study group with newly or previously implanted patients with EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur with Cruciate Sacrificing Insert

Brief 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. 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.

Detailed description: The objectives of this study are:

1. To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts
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 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
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;
   * willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
3. Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation

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. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
7. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
8. Unwilling or unable to sign the Informed Consent document
9. Has documented substance abuse issues
10. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
11. Currently incarcerated or has impending incarceration
12. 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- Knee Injury and Osteoarthritis Outcome Scores
timeFrame: 10 years post-operative
measure: Patient Reported Outcomes- EuroQol-5D-5L Scores
timeFrame: 10 years post-operative
measure: Patient Reported Outcomes- Forgotten Joint Score
timeFrame: 10 years post-operative
measure: Patient Reported Outcomes- Satisfaction Survey
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: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
Study officials:
affiliation: Covenant Medical Center
name: Brian de Beaubien, MD
role: PRINCIPAL_INVESTIGATOR
References: