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.

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Interventions

DEVICESMS femoral stem

Locations(4)

Herz-Jesu Krankenhaus

Vienna, Austria

Istituto Ortopedico Galezzi

Milan, Milan, Italy

Bürgerspital Solothurn

Solothurn, Switzerland

The Elective Orthopaedic Centre (EOC)

Epsom, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT02748408


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