Clinical trial NCT02351414: Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Official title: Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Joint Disease
Keywords: Osteoarthritis
Ankylosis
Revision procedures
Correction of functional deformity
Rheumatoid arthritis
Arthritis
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-30
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: Patients who have been previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts

Brief summary: MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Detailed description: MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.

Eligibility criteria: Inclusion Criteria:

To be included in the study, subjects must meet all of the following criteria:

* Has previously undergone 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.
* Subject was implanted with the specified combination of components
* Subject is willing and able to complete required study visits and assessments
* Subject plans to be available through the 10 year postoperative follow-up visit
* Subject is willing to sign the approved Informed Consent document
* Subject must be at least 2 years post TKA prior to informed consent.

Previously implanted bilateral subjects can have both TKAs enrolled in the study provided: 1) the specified combination of components 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 specific to the second TKA. Prospective enrollment of a previously unimplanted knee is not permitted in this study.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

* Subject was skeletally immature (less than 21 years of age) at time of implantation
* Subject is currently enrolled in another clinical investigation
* Subject is unwilling or unable to sign the Informed Consent document
* Subject has documented substance abuse issues
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* Subject has a body mass index (BMI) of greater than 40
* Subject is currently incarcerated or has impending incarceration

Primary outcomes:
measure: Component Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores)
timeFrame: 2-<5 years, 5-7 years, and 10 years
measure: Cumulative Revision Rate
timeFrame: 2-<5 years, 5-7 years, and 10 years
measure: Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)
timeFrame: 2-<5 years, 5-7 years, and 10 years
measure: Number of Radiolucencies
timeFrame: 2-<5 years, 5-7 years, and 10 years
measure: Size of Radiolucencies
timeFrame: 2-<5 years, 5-7 years, and 10 years
Other outcomes:
Locations:
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Gent
country: Belgium
facility: AZ Maria-Middelares
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Mülheim
country: Germany
facility: Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr
city: Penarth
country: United Kingdom
facility: University Hospital Llandough
state: South Glamorgan
Study officials:
References: