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

Active, not recruiting

• Conditions: Avascular Necrosis; Traumatic Arthritis of Knee; Degenerative Joint Disease of Knee; Correction of Functional Deformity; Knee Osteoarthritis; Rheumatoid Arthritis of Knee

• Registration Number: NCT04301622
• Lead Sponsor: MicroPort Orthopedics Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2020-02-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2032-02
• Study Completion: 2032-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Covenant Medical Center; 🇺🇸 Saginaw, Michigan, United States