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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Diseases
• Intervention / Treatment: Device: EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: JoAnna-Marie N Becker, BS; Phone Number: +1 901 290 5280; Email: joannamarie.becker@ortho.microport.com
• Study Contact Backup: Name: Pietro Randelli, Prof; Phone Number: +39-335-5292-622; Email: pietro.randelli@unimi.it

Study Locations

• Italy
  • Piazza C. Ferrari 1 20122 Milan
    • Milan, Piazza C. Ferrari 1 20122 Milan, Italy
      • Recruiting
      • Gaetano Pini Orthopedic Institute
      • Contact: Pietro Randelli, Prof; Phone Number: +39-335-5292-622; Email: pietro.randelli@unimi.it
      • Principal Investigator: Pietro Randelli, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Multicenter, prospective follow-up study of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of the study index surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Revision Total Knee Arthroplasty; Single study group with either newly or previously implanted subjects with the EVOLUTION® Revision Tibia and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Insert.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Pietro I Randelli, Prof, Gaetano Pini Orthopedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Knee arthroplasty; Revision Procedure
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 18K001CS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes