Observing the effectiveness of a new 3D metal cup for hip replacement surgery
Official title: A Multicentric, Prospective Clinical Survey on Long Term Performance of an Acetabular Component in Primary Total Hip Arthroplasty
Run by Medacta International SA · NCT04801680 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | November 7, 2019 |
| Main results expected | December 7, 2032 |
| Study ends | December 7, 2032 |
| Registry record updated | May 1, 2024 |
| Trial ID | NCT04801680 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with acute or chronic infections, severe bone deformation, or osteoporosis may 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 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.
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 gone: Other studies have shown promising results with similar cementless fixation techniques, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
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IRRCCS Istituto Ortopedico Galeazzi
Milan, Mi, Italy Recruiting
Study contacts
- Study coordinator: Luigi Zagra, Dr
- Email: luigi.zagra@fastwebnet.it
- Phone: 00390266214834
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Quadroiliac Plane Block vs Transmuscular Quadratus Lumborum Block for Hip Replacement Pain
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Quadro‑Iliac Plane Block versus Erector Spinae Plane for pain after total hip replacement
This will test whether the quadro‑iliac plane block or the erector spinae plane block controls pain better after total hip replacement in adults having spinal anesthesia.
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Ultrasound-guided Quadro-Iliac Plane block for pain after total hip replacement
This trial will test whether an ultrasound-guided Quadro-Iliac Plane (QIP) block reduces opioid use and pain in adults having elective primary total hip arthroplasty.
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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.