Actively Recruiting
EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
Led by MicroPort Orthopedics Inc. · Updated on 2024-01-22
45
Participants Needed
1
Research Sites
682 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. 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
Official Title
EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has previously undergone or is scheduled for revision knee arthroplasty requiring the EVOLUTION4 Revision Tibial System and EVOLUTION4 STEMMED CS Femur with EVOLUTION4 MP CS Tibial Insert
- Decision to perform the surgery with these study components is made before enrollment
- Previously implanted subjects must enroll within 3 years plus 6 months of their surgery
- Willing to voluntarily sign the informed consent form
- Able and willing to comply with the protocol and complete required forms through 10 years of follow-up
You will not qualify if you...
- Under 21 years old at time of implantation
- Has or had an active infection at the time of surgery
- Has inadequate neuromuscular status, poor bone stock, or poor skin coverage around the joint making surgery unjustifiable
- Currently enrolled in another clinical study that could affect this study's endpoints
- Has documented substance abuse issues
- Has emotional or neurological conditions preventing participation
- Currently incarcerated or facing incarceration
- Has medical conditions judged by the investigator to interfere with study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Gaetano Pini Orthopedic Institute
Milan, Piazza C. Ferrari 1 20122 Milan, Italy
Actively Recruiting
Research Team
J
JoAnna-Marie N Becker, BS
CONTACT
P
Pietro Randelli, Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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