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Clinical Trials in the USA / NCT04145401
Enrolling by invitation Observational

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

NCT04145401 · tracked via the Priya Life Science USA tracker
Sponsor
MicroPort Orthopedics Inc
Phase
Observational
Started
2020-09-30
Last updated
2024-03-20

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Revision Knee implants

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

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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) 2. 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. 3. Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery 4. 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: 1. the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both 2. all other aspects of the Inclusion/Exclusion Criteria are satisfied 3. enrollment does not exceed the subject count specified 4. the subject agrees to a second Informed Consent document and data collection specific to the second TKA. Exclusion Criteria: 1. Skeletally immature (less than 21 years of age) at time of implantation. 2. Has an overt infection at the time of implantation. 3. 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. 4. Currently enrolled in another clinical investigation which would affect the endpoints of this protocol. 5. Has documented substance abuse issues. 6. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study. 7. Currently incarcerated or has impending incarceration. 8. 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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
HCA Research Institute, OrthoONE at Swedish Medical Center Englewood Colorado

More MicroPort Orthopedics Inc. trials in the USA

Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert Enrolling by invitation
Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert Active, not recruiting
Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts Active, not recruiting
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem Enrolling by invitation
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur Active, not recruiting

Other trials for the same condition

GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION) Active, not recruiting
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis Active, not recruiting
Knee Biofeedback Rehabilitation Through Game Therapy Recruiting
Innovations in Genicular Outcomes Registry Recruiting
Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04145401 on ClinicalTrials.gov ↗ ← All trials in the USA