Actively Recruiting
Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study
Led by Medacta International SA · Updated on 2024-05-01
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term performance of the Mpact 3D Metal MonoCER cup used in total hip arthroplasty for patients under 75 years old. This observational study aims to assess how well the implant lasts and functions over a period of 10 years after the surgery. The study focuses on patients receiving this specific metal cup as part of their hip replacement. Participants will receive the Mpact 3D Metal cup as an acetabular shell device during their total hip arthroplasty surgery. The study follows standard treatment practices, and patients who choose not to participate will receive the same care. Follow-up visits are scheduled at 6 months, 1 year, 5 years, and 10 years after surgery to monitor outcomes. During these visits, researchers will check the implant's survivorship using Kaplan Meier analysis and assess device stability through radiological exams. They will also evaluate clinical outcomes using the Harris Hip score and monitor safety by collecting any adverse events up to 10 years after surgery. This comprehensive follow-up helps ensure detailed understanding of the device's long-term effects and performance.
CONDITIONS
Brief Title
A Post Market Surveillance Study About the MONOCER Cup
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use
- Patients who have signed the informed consent to participate in the study
You will not qualify if you...
- Patients younger than 18 years or older than 75 years at the time of primary surgery
- Any patient who is unable or unwilling to give informed consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay
Participants receive a total hip arthroplasty with the Mpact 3D metal MONOCER cup implanted.
1 surgical visit (in-person)
Duration - Up to 10 years after surgery
Participants are monitored at regular intervals to assess implant stability, clinical outcomes, and device safety.
Visits at 6 months, 1 year, 5 years, and 10 years (in-person)
Trial Site Locations
Total: 1 location
1
Hirslanden, Clinique la Colline
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
E
Elisa Bonacina, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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