Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK

NCT04145401 | Enrolling By Invitation FDA Device

• 1 other identifier: 18K001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; traumatic arthritis; avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures

Outcome Measures

Primary Outcomes (1)

• Individual component survivorship

  Individual component survivorship for tibial base, femoral, and tibial insert at specified intervals out to 10 years follow-up.

  10 years post-operative

Secondary Outcomes (4)

• Patient Reported Outcomes- Questionnaires

  10 years post-operative

• Incidence of component revision

  10 years post-operative

• Radiolucencies

  10 years post-operative

• Adverse Events and Adverse Device Effects

  10 years post-operative

Interventions

Revision Knee implants DEVICE

Primary knee arthroplasty or a revision knee that requires a revision procedure.

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 Revision Single study group with either newly or previously implanted patients with EVOLUTION® Revision Tibia and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Insert.

You may qualify if:

• Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
• Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
• Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
• Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.
• Bilateral subjects can have both TKAs enrolled in the study provided:
• the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both

You may not qualify if:

• enrollment does not exceed the subject count specified
• the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
• Skeletally immature (less than 21 years of age) at time of implantation.
• Has an overt infection at the time of implantation.
• Has 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.
• Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
• 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)

HCA Research Institute, OrthoONE at Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 30, 2019
• Study Start: September 30, 2020
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): November 1, 2033
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)