EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol

Joint Diseases Clinical Trial

Official title:

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142669
• Other study ID #: 18K001CS
• Status: Recruiting
• Start date: October 31, 2023
• Est. completion date: December 2036

Study information

• Verified date: November 2023
• Source: MicroPort Orthopedics Inc.
• Contact: JoAnna-Marie N Becker, BS
• Phone: +1 901 290 5280
• Email: joannamarie.becker[@]ortho.microport.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. 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.

Description:

The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up.

The secondary objectives include:

• Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up;

• Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up;

• To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey;

• To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up;

• To assess safety and characterize protocol defined adverse events and adverse device effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2036
• Est. primary completion date: June 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert)

2. Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;

3. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery

4. Willing to voluntarily sign the informed consent form

5. Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.

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 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

4. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol

5. Has or had documented substance abuse issues

6. Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study

7. Currently incarcerated or has impending incarceration

8. 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

Related Conditions & MeSH terms

• Joint Diseases

Intervention

Device:
• EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
Primary knee arthroplasty or a revision knee that requires a revision procedure.

Locations

Country	Name	City	State
Italy	Gaetano Pini Orthopedic Institute	Milan	Piazza C. Ferrari 1 20122 Milan

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years.	Percentage of knees survived with no revision or replacement at 10-year	up to 10 years
Primary	The proportion of EVOLUTION® STEMMED CS Femoral components survivorship out to 10 years.	Percentage of knees survived with no revision or replacement at 10-year	up to 10 years
Primary	The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years.	Percentage of knees survived with no revision or replacement at 10-year	up to 10 years
Secondary	Functional Scores	To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS Scores) out to 10 years follow-up.	Year 1,Year 3, Year 5, Year 7, and Year 10
Secondary	Functional Scores	To assess subject satisfaction with their Total Knee Arthroplasty (TKA) procedure utilizing the Forgotten Joint Score (FJS) at specified intervals out to 10 years follow-up.	Year 1,Year 3, Year 5, Year 7, and Year 10
Secondary	Functional Scores	To assess functional scores utilizing EQ-5D-5L at specified intervals out to 10 years follow-up.	Year 1,Year 3, Year 5, Year 7, and Year 10
Secondary	Subject Satisfaction	To assess subject satisfaction with their TKA procedure via the Satisfaction Survey at specified intervals out to 10 years follow-up.	Year 1,Year 3, Year 5, Year 7, and Year 10
Secondary	Radiolucencies	To assess the presence of radiolucencies surrounding the implanted components at specified intervals out to 10 years follow-up.	Year 1,Year 3, Year 5, Year 7, and Year 10
Secondary	To assess subject safety: Adverse Events o Adverse Events related to study device or the index surgical procedure	To assess safety and characterize protocol defined adverse events and adverse device effects.	Year 1,Year 3, Year 5, Year 7, and Year 10
Secondary	Incidence of component revision	Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up.	Year 1,Year 3, Year 5, Year 7, and Year 10