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Enrolling by invitation NCT04145401

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

— Observational Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Revision Knee implants.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert

Overview

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.

Detailed description

The objectives of this study are:

1. To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert. 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.

Interventions

  • Device Revision Knee implants
    Primary knee arthroplasty or a revision knee that requires a revision procedure.

Primary outcome measures

  • Individual component survivorship [Time frame: 10 years post-operative]
Secondary outcome measures (4)
  • Patient Reported Outcomes- Questionnaires [Time frame: 10 years post-operative]
  • Incidence of component revision [Time frame: 10 years post-operative]
  • Radiolucencies [Time frame: 10 years post-operative]
  • Adverse Events and Adverse Device Effects [Time frame: 10 years post-operative]

Eligibility criteria

Inclusion criteria

  • 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
  • all other aspects of the Inclusion/Exclusion Criteria are satisfied
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • HCA Research Institute, OrthoONE at Swedish Medical Center — Englewood

Identifiers

NCT: NCT04145401 · 18K001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗