Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur

Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. 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: Active, not recruiting
• Conditions: Knee Osteoarthritis; Avascular Necrosis; Degenerative Joint Disease of Knee; Rheumatoid Arthritis of Knee; Correction of Functional Deformity; Traumatic Arthritis of Knee
• Intervention / Treatment: Device: Primary Knee implants

Detailed Description

The objectives of this study are:

1. To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts
2. To find out the cumulative incidence of component revision of each component in this combination.
3. To find out the functional outcome scores at early, midterm, and long term follow-up.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Covenant Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary TKA or Single study group with newly or previously implanted patients with EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur with Cruciate Sacrificing Insert

Description

Inclusion Criteria:

1. Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel

2. Has previously undergone or currently has determined to undergo a 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;
   • willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
3. Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation

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 a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
5. 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
6. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
7. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
8. Unwilling or unable to sign the Informed Consent document
9. Has documented substance abuse issues
10. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
11. Currently incarcerated or has impending incarceration
12. 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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual component survivorship	Individual component survivorship for tibial base, femoral, and tibial CS insert at specified intervals out to 10 years follow-up.	10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of component revision	the cumulative incidence of component revision at specified intervals will be determined out to 10 years follow-up	10 years post-operative
Radiolucencies	the presence, zone, and the size of radiolucencies surrounding implanted components will be determined	10 years post-operative
Adverse Events and Adverse Device Effects	characterization of adverse events and adverse device effects	10 years post-operative
Patient Reported Outcomes- Knee Injury and Osteoarthritis Outcome Scores	-functional scores for subjects, as assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), out to 10 years follow-up	10 years post-operative
Patient Reported Outcomes- EuroQol-5D-5L Scores	-functional scores for subjects, as assessed by EuroQol-5D-5L (EQ-5D-5L) Scores, out to 10 years follow-up	10 years post-operative
Patient Reported Outcomes- Forgotten Joint Score	-subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Forgotten Joint Score	10 years post-operative
Patient Reported Outcomes- Satisfaction Survey	-subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Satisfaction Survey	10 years post-operative

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Brian de Beaubien, MD, Covenant Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): August 1, 2032

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases; Necrosis
• Other Study ID Numbers: 17K001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes