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Follows people with knee osteoarthritis who received a revision knee implant

Observes how a revision knee implant system performs in adults with knee osteoarthritis.

Key facts

Who runs it
MicroPort Orthopedics Inc.
Where
Englewood, United StatesSee the site
Trial code
Registry title
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Status
Enrolling by invitation
People taking part
45 people, planned
Started
30 Sept 2020
Expected to end
1 Nov 2033
Type of study
Observational
Treatments tested
  • Revision Knee implants
Record updated
20 March 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who had, or are about to have, a revision knee replacement using the EVOLUTION Revision CCK knee parts. They must be willing to attend follow-up visits for 10 years.

Age
21 years or older
Sex
All sexes can join
Disease stage
People needing a revision knee replacement (a repeat knee replacement operation) that uses the EVOLUTION Revision Tibial System and EVOLUTION Revision CCK Femur with the EVOLUTION CCK Tibial Insert
Earlier treatment
The surgery with these study knee parts is already decided, whatever the research. People who already had it must join within 3 years (+6 months) of that surgery.

Main reasons for not taking part

  • Under 21 years of age at the time of the implant (skeletally immature)
  • Obvious infection at the time of the implant
  • Weak nerve and muscle function, poor bone quality or poor skin coverage around the joint
  • Taking part in another study that could affect this trial's results
  • Documented substance abuse, or a condition that stops them taking part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Has an overt infection at the time of implantation
  • Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
  • 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
  • Skeletally immature (less than 21 years of age) at time of implantation
  • Currently enrolled in another clinical investigation which would affect the endpoints of this protocol
  • Has documented substance abuse issues
  • Currently incarcerated or has impending incarceration

Where in United States

  • HCA Research Institute, OrthoONE at Swedish Medical CenterEnglewood, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

Treatments tested

  • Revision Knee implants

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Follows people with knee osteoarthritis who received a revision knee implantGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 March 2024