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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04301622
• Other study ID #: 17K001
• Status: Active, not recruiting
• Start date: February 3, 2020
• Est. completion date: August 2032

Study information

• Verified date: March 2024
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• 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® 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2032
• Est. primary completion date: February 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Correction of Functional Deformity
• Degenerative Joint Disease of Knee
• Joint Diseases
• Knee Osteoarthritis
• Necrosis
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatoid Arthritis of Knee
• Traumatic Arthritis of Knee

Intervention

Device:
• Primary Knee implants
Primary knee arthroplasty

Locations

Country	Name	City	State
United States	Covenant Medical Center	Saginaw	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Patient Reported Outcomes- Satisfaction Survey	-subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Satisfaction Survey	10 years post-operative
Secondary	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
Secondary	Radiolucencies	the presence, zone, and the size of radiolucencies surrounding implanted components will be determined	10 years post-operative
Secondary	Adverse Events and Adverse Device Effects	characterization of adverse events and adverse device effects	10 years post-operative