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

Joint Disease Clinical Trial

— AMETHYST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02351414
• Other study ID #: 13-LJK-001
• Status: Active, not recruiting
• Start date: June 15, 2015
• Est. completion date: December 2028

Study information

• Verified date: October 2022
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Device:
• Total Knee Arthroplasty (EVOLUTION®)

Locations

Country	Name	City	State
Belgium	AZ Maria-Middelares	Gent
Canada	The Ottawa Hospital	Ottawa	Ontario
Germany	Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr	Mülheim
United Kingdom	University Hospital Llandough	Penarth	South Glamorgan
United States	Illinois Bone & Joint Institute	Morton Grove	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)	To assess subject satisfaction with their TKA procedure	2-<5 years, 5-7 years, and 10 years
Secondary	Number of Radiolucencies	To summarize the number of radiolucencies in zones surrounding implanted components	2-<5 years, 5-7 years, and 10 years
Secondary	Size of Radiolucencies	To summarize the size of radiolucencies in zones surrounding implanted components	2-<5 years, 5-7 years, and 10 years