Assessing the MonoCer Acetabular Cup in Hip Replacement
Prospective, Multicentre Study to Assess Performance of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement
This study looks at how well the MonoCer Acetabular Cup works for people getting a hip replacement due to severe arthritis over ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Melbourne) |
| Trial ID | NCT05822505 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the ten-year clinical outcomes of the MonoCer Acetabular Cup in patients undergoing primary total hip replacement due to end-stage osteoarthritis. Utilizing a multicentre registry-nested approach, the study collects data through the AOANJRR's web-based system to monitor mortality, patient-reported outcomes, and complications. All participants will receive standard care for hip arthroplasty, ensuring that the MonoCer device is used according to its approved labeling without any investigational techniques. The study aims to provide insights into the long-term performance and survivorship of this specific prosthesis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 undergoing primary total hip replacement who are suitable for a cementless acetabular cup.
Not a fit: Patients with rheumatoid arthritis, active infections, or those requiring revision procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the long-term effectiveness and safety of the MonoCer Acetabular Cup, potentially improving patient outcomes in hip replacement surgeries.
How similar studies have performed: Other studies assessing similar prosthetic devices have shown promising outcomes, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing a primary total conventional hip replacement and are suitable for cementless acetabular cup according to the indications for use (On-label use). * Use of the Medacta Mpact 3D Metal MonoCer acetabular cup prosthesis. * Adults aged between 18 and 75 years at the time of registration. * Ability to give informed consent. * Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period. Exclusion Criteria: Exclusion Criteria * Rheumatoid arthritis. * Patients with a history of active infection. * Any case not described in the inclusion criteria. * Revision procedures.
Where this trial is running
Melbourne
- Melbourne Orthopaedic Group — Melbourne, Australia (Recruiting)
Study contacts
- Principal investigator: Jit Balakumar — Melbourne Orthopaedic Group
- Study coordinator: Arianna Girardi
- Email: girardi@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.