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

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ClinicalTrials.gov Identifier: NCT02351414
Recruitment Status : Active, not recruiting
First Posted : January 30, 2015
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

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.

Condition or disease Intervention/treatment
Joint Disease 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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Actual Study Start Date : June 15, 2015
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Component Survivorship (Kaplan-Meier estimates of survivorship for all components) [ Time Frame: 10 years post-operative ]
    The primary endpoints are Kaplan-Meier estimates of survivorship for all components at each follow-up interval out to 10 years


Secondary Outcome Measures :
  1. Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores) [ Time Frame: 2-<5 years, 5-7 years, and 10 years ]
    To characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-3L Scores

  2. Cumulative Revision Rate [ Time Frame: 2-<5 years, 5-7 years, and 10 years ]
    To determine the cumulative revision rate at specified intervals out to 10 years follow-up

  3. Subject Satisfaction (assessed by Patient Satisfaction Questionnaires) [ Time Frame: 2-<5 years, 5-7 years, and 10 years ]
    To assess subject satisfaction with their TKA procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351414


Locations
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United States, Illinois
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
Belgium
AZ Maria-Middelares
Gent, Belgium
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Germany
Universitätsklinikum Essen, Klinik für Orthopädie
Essen, Germany, D-45147
United Kingdom
University Hospital Llandough
Penarth, South Glamorgan, United Kingdom, CF64 2XX
Sponsors and Collaborators
MicroPort Orthopedics Inc.
Investigators
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Principal Investigator: Marcus Jäger Elbe Kliniken Buxtehude
Principal Investigator: Philippe Van Overschelde, MD Algemeen Ziekenhuis Maria Middelares
Principal Investigator: Rhys Llewellyn Williams, MD University Hospital Llandough
Principal Investigator: Ritesh Shah, MD Illinois Bone and Joint Institute
Principal Investigator: Geoffrey Dervin, MD Ottawa Hospital, General Campus, CCW 1646

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Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT02351414     History of Changes
Other Study ID Numbers: 13-LJK-001
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MicroPort Orthopedics Inc.:
Osteoarthritis
Ankylosis
Revision procedures
Correction of functional deformity
Rheumatoid arthritis
Arthritis

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases