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

NCT06142669 | Recruiting FDA Device

• 1 other identifier: 18K001CS
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Diseases

Keywords

Knee Osteoarthritis; Revision Procedure; Knee arthroplasty

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Functional Scores

  Year 1,Year 3, Year 5, Year 7, and Year 10

• Functional Scores

  Year 1,Year 3, Year 5, Year 7, and Year 10

• Functional Scores

  Year 1,Year 3, Year 5, Year 7, and Year 10

• Subject Satisfaction

  Year 1,Year 3, Year 5, Year 7, and Year 10

• Radiolucencies

  Year 1,Year 3, Year 5, Year 7, and Year 10

Study Arms (1)

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

Interventions

EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert DEVICE

Primary knee arthroplasty or a revision knee that requires a revision procedure.

Revision Total Knee Arthroplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
• Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
• Willing to voluntarily sign the informed consent form
• 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.

You may not qualify if:

• Skeletally immature (less than 21 years of age) at time of implantation
• Has or had an overt infection at the time of implantation
• 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
• Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• Has or had documented substance abuse issues
• Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• Currently incarcerated or has impending incarceration
• 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

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Gaetano Pini Orthopedic Institute

Milan, Piazza C. Ferrari 1 20122 Milan, Italy

RECRUITING

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Osteoarthritis; Arthritis; Rheumatic Diseases

Study Officials

• Pietro I Randelli, Prof

  Gaetano Pini Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JoAnna-Marie N Becker, BS

CONTACT

+1 901 290 5280; joannamarie.becker@ortho.microport.com

Pietro Randelli, Prof

CONTACT

+39-335-5292-622; pietro.randelli@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: November 21, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: January 22, 2024

Record last verified: 2023-11

Locations

IT (1)