Observing the performance of the MONOCER Cup in hip surgeries
Official title: Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study
Run by Medacta International SA · NCT05785364 · Data updated 2026-11-12
This study is testing how well a new hip implant works for people under 75 who are having hip surgery, by checking in with them over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Geneva) |
| Status | Recruiting |
| Started | January 25, 2022 |
| Main results expected | February 1, 2050 |
| Study ends | February 1, 2050 |
| Registry record updated | May 1, 2024 |
| Trial ID | NCT05785364 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients under 75 years old who are scheduled for total hip arthroplasty and will receive the Mpact 3D Metal MonoCER cup.
✕Probably not a fit
Patients over 75 years old or those unable to provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER cup. It aims to evaluate the long-term performance of this innovative cup design over a period of 10 years, with follow-up visits scheduled at 6 months, 1 year, 5 years, and 10 years post-surgery. The study will include patients under 75 years old who consent to participate, ensuring they receive standard treatment regardless of their participation. The goal is to gather data on the effectiveness and durability of the cup in real-world settings.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of the MONOCER Cup, potentially improving outcomes for patients undergoing hip replacement surgery.
How similar studies have gone: While there have been studies on hip arthroplasty, this specific observational approach to assess the MONOCER Cup's long-term performance is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use 2. Patients who have signed the informed consent to participate in the study Exclusion Criteria: 1. Minor patients, patients over 75 years of age at the time of primary surgery; 2. Any patient who is unable or unwilling to give informed consent to participate in the study.
Where it's running
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Hirslanden, Clinique la Colline
Geneva, Switzerland Recruiting
Study contacts
- Principal investigator: Placido Bartolone, Dr — Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève
- Study coordinator: Elisa Bonacina, PhD
- Email: bonacina@medacta.ch
- Phone: +41 91 696 60 60
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.