Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts (AMETHYST)

Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Joint Disease
• Intervention / Treatment: Device: Total Knee Arthroplasty (EVOLUTION®)

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • AZ Maria-Middelares
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
• Germany
  • Mülheim, Germany, D-45468
    • Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr
• United Kingdom
  • South Glamorgan
    • Penarth, South Glamorgan, United Kingdom, CF64 2XX
      • University Hospital Llandough
• United States
  • Illinois
    • Morton Grove, Illinois, United States, 60053
      • Illinois Bone & Joint Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Total Knee Arthroplasty; Single study group previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts	Device: Total Knee Arthroplasty (EVOLUTION®); Other Names: EVOLUTION® Total Knee Arthroplasty System with CS Inserts; EVOLUTION® CS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Component Survivorship	The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years	10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores)	To characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-3L Scores	2-<5 years, 5-7 years, and 10 years
Cumulative Revision Rate	To determine the cumulative revision rate at specified intervals out to 10 years follow-up	2-<5 years, 5-7 years, and 10 years
Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)	To assess subject satisfaction with their TKA procedure	2-<5 years, 5-7 years, and 10 years
Number of Radiolucencies	To summarize the number of radiolucencies in zones surrounding implanted components	2-<5 years, 5-7 years, and 10 years
Size of Radiolucencies	To summarize the size of radiolucencies in zones surrounding implanted components	2-<5 years, 5-7 years, and 10 years

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2015
• Primary Completion (Anticipated): June 1, 2027
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Rheumatoid arthritis; Correction of functional deformity; Ankylosis; Revision procedures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 13-LJK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO