Observing the effectiveness of a new 3D metal cup for hip replacement surgery
A Multicentric, Prospective Clinical Survey on Long Term Performance of an Acetabular Component in Primary Total Hip Arthroplasty
Medacta International SA · NCT04801680
This study is testing a new 3D metal cup for hip replacement surgery to see if it stays in place better without cement and how different factors like age and bone quality affect recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medacta International SA (industry) |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT04801680 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the Mpact 3D metal cup used in total hip arthroplasty, particularly examining its effectiveness in achieving stable fixation without cement. The study aims to evaluate how factors such as patient age, bone quality, and specific conditions like osteonecrosis affect the long-term outcomes of the implant. By analyzing the initial stability and bone integration of the cup, the research seeks to identify improvements in clinical outcomes and reduce the risk of component loosening. Participants will be monitored for their recovery and overall satisfaction post-surgery.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 75 suffering from conditions like hip arthrosis, dysplasia, or avascular necrosis who are suitable for total hip arthroplasty.
Not a fit: Patients with acute or chronic infections, severe bone deformation, or osteoporosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes and reduced revision rates for patients undergoing hip replacement surgery.
How similar studies have performed: Other studies have shown promising results with similar cementless fixation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Those suffering from hip primary arthrosis, post-traumatic arthrosis, hip dysplasia or avascular necrosis of femoral head, rheumatic arthrosis * Those aged between 18 and 75 years old at the surgery time * those suitable to undergo to a primary total hip arthroplasty for whom the Mpact 3D Metal cup will be implanted (according to the label indication/contraindications) * Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery Exclusion Criteria: * Those with acute or chronic infection * Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups. * Those suffered by severe deformation, at the discretion of surgeon * Those suffered by osteoporosis * Those with metabolic disorders that may involve bone metabolism for which cementless implants are contraindicated * Those suffered by muscular atrophy or neuromuscular disease * Those allergic to medical device material previewed for the surgery * Those unable to give their consent to participate in the study or who do not want to participate * Those whose functional recovery is compromised by
Where this trial is running
Milan, MI
- IRRCCS Istituto Ortopedico Galeazzi — Milan, MI, Italy (RECRUITING)
Study contacts
- Study coordinator: Luigi Zagra, Dr
- Email: luigi.zagra@fastwebnet.it
- Phone: 00390266214834
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