RecruitingNCT02748408
The Medacta International SMS Post-Marketing Surveillance Study
The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
Sponsor
Medacta International SA
Enrollment
550 participants
Start Date
Jul 1, 2015
Study Type
OBSERVATIONAL
Conditions
Summary
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Plain Language Summary
Simplified for easier understanding
This study is tracking the long-term outcomes — over 10 years — of patients who receive a specific hip replacement implant (the Medacta SMS system), to monitor how well the artificial joint performs over time.
**You may be eligible if...**
- You are between 18 and 75 years old
- You are scheduled for your first (primary) total hip replacement
- Your hip is severely painful or limited due to osteoarthritis, traumatic arthritis, developmental hip problems, or bone death (avascular necrosis) in the hip joint
**You may NOT be eligible if...**
- You have an active infection
- You are pregnant
- You have a mental illness that would affect your ability to consent or complete follow-up visits over 10 years
- Your hip anatomy is severely abnormal
- You have a bone-softening condition (osteomalacia) that makes uncemented implants unsafe
- You have active rheumatoid arthritis or other disqualifying conditions in the surgeon's judgment
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
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Interventions
DEVICESMS femoral stem
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02748408
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