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

NCT04301622 | Active Not Recruiting FDA Device

• 1 other identifier: 17K001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient Reported Outcomes- Knee Injury and Osteoarthritis Outcome Scores

  10 years post-operative

• Patient Reported Outcomes- EuroQol-5D-5L Scores

  10 years post-operative

• Patient Reported Outcomes- Forgotten Joint Score

  10 years post-operative

• Patient Reported Outcomes- Satisfaction Survey

  10 years post-operative

• Incidence of component revision

  10 years post-operative

Interventions

Primary Knee implants DEVICE

Primary 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

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

You may qualify if:

• 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
• 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.
• Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation

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 a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
• Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram 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
• Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
• Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• Unwilling or unable to sign the Informed Consent document
• Has documented substance abuse issues
• Has 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)

Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian de Beaubien, MD

  Covenant Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: February 3, 2020
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): August 1, 2032
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)