Observing the performance of the MONOCER Cup in hip surgeries
Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study
Medacta International SA · NCT05785364
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medacta International SA (industry) |
| Locations | 1 site (Geneva) |
| Trial ID | NCT05785364 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients over 75 years old or those unable to provide informed consent will not benefit from this study.
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 performed: While there have been studies on hip arthroplasty, this specific observational approach to assess the MONOCER Cup's long-term performance is relatively novel.
Eligibility criteria
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 this trial is running
Geneva
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Hip Arthroplasty