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

Part of paid clinical trials in Englewood, Colorado.

Sponsor
MicroPort Orthopedics Inc.
Study ID
NCT04145401
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2020
Status verified
Mar 2024
Primary completion
May 1, 2033
Completion
Nov 1, 2033

Study Design

Enrollment
45 participants (estimated)

Primary Outcome Measure

Individual component survivorship [ Time Frame: 10 years post-operative ]

Locations (1)

FacilityCityStateZIPSite coordinators
HCA Research Institute, OrthoONE at Swedish Medical CenterEnglewoodColorado80113-

Find similar trials in Englewood, CO

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
HCA Research Institute, OrthoONE at Swedish Medical Center· Englewood, CO

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