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NCT04301622 · ClinicalTrials.gov registry record
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
A clinical trial of Knee Osteoarthritis and Avascular Necrosis, sponsored by MicroPort Orthopedics.
- Active
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT04301622 is a study of Knee Osteoarthritis and Avascular Necrosis that is active but no longer recruiting, run by MicroPort Orthopedics. The registered enrollment target is 150 participants, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04301622, a study of Knee Osteoarthritis and Avascular Necrosis, is active but no longer recruiting, sponsored by MicroPort Orthopedics.
- ACTIVE NOT RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Conditions Studied
Interventions
- DEVICE Primary Knee implants
Study Locations (1)
Michigan
- Covenant Medical Center - Saginaw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2032-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04301622
The ClinicalTrials.gov registry entry for NCT04301622 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (50% lower). The listed sponsor is MicroPort Orthopedics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Primary Knee implants is the first listed.
NCT04301622 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT04301622 about?
NCT04301622 is a clinical study titled "Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur". MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authori...
What is the current status of trial NCT04301622?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2020-02-03. Estimated completion is 2032-08.
What conditions does trial NCT04301622 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Avascular Necrosis, Degenerative Joint Disease of Knee, Rheumatoid Arthritis of Knee, Correction of Functional Deformity.
What interventions are being tested in trial NCT04301622?
The interventions under investigation include: Primary Knee implants (DEVICE).
Who is sponsoring clinical trial NCT04301622?
This trial is sponsored by MicroPort Orthopedics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04301622 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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