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

NCT ID: NCT04301622

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2032-08-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Primary Knee implants

Primary knee arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian de Beaubien, MD

Role: PRINCIPAL_INVESTIGATOR

Covenant Medical Center

Locations

Covenant Medical Center

Saginaw, Michigan, United States

Countries

United States

Other Identifiers

17K001

Identifier Type: -

Identifier Source: org_study_id