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NCT02351414 · ClinicalTrials.gov registry record
Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
A clinical trial of Joint Disease, sponsored by MicroPort Orthopedics.
- Active
- Registry status
- 150
- Enrollment target
- 5
- Study locations
NCT02351414: Active study of Joint Disease, sponsored by MicroPort Orthopedics.
NCT02351414 is a study of Joint Disease that is active but no longer recruiting, run by MicroPort Orthopedics. The registered enrollment target is 150 participants, above the 135-participant average among 4 other Joint Disease trials with a reported enrollment target (11% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02351414, a study of Joint Disease, is active but no longer recruiting, sponsored by MicroPort Orthopedics.
- ACTIVE NOT RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 5
- Study locations
Study Summary
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Primary Outcome
The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years
Conditions Studied
Interventions
- DEVICE Total Knee Arthroplasty (EVOLUTION®)
Study Locations (5)
Other
- AZ Maria-Middelares - Ghent
- Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr - Mülheim
Illinois
- Illinois Bone & Joint Institute - Morton Grove
Ontario
- The Ottawa Hospital - Ottawa
South Glamorgan
- University Hospital Llandough - Penarth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-06-15 |
| Est. Completion | 2028-12 |
What the registry record for NCT02351414 still lists
NCT02351414 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 4 other Joint Disease trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Joint Disease appearing as the primary indexed condition, and to 1 intervention - of which Total Knee Arthroplasty (EVOLUTION®) is the first listed.
NCT02351414 lists 5 locations in 4 states (Other, Illinois, Ontario).
Frequently Asked Questions
What is clinical trial NCT02351414 about?
NCT02351414 is a clinical study titled "Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts". MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the t...
What is the current status of trial NCT02351414?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2015-06-15. Estimated completion is 2028-12.
What conditions does trial NCT02351414 study?
This clinical trial studies the following conditions: Joint Disease.
What interventions are being tested in trial NCT02351414?
The interventions under investigation include: Total Knee Arthroplasty (EVOLUTION®) (DEVICE).
Who is sponsoring clinical trial NCT02351414?
This trial is sponsored by MicroPort Orthopedics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02351414 being conducted?
This trial has 5 study locations across Illinois, Ontario, South Glamorgan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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