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โ† Trials
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Mpact 3D Metal Cup PMS

Recruitingn/aAges 18 Years - 75 YearsAllMedacta International SA
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In plain words

What the trial is, and whether it could suit you

Cementless fixation, with or without screw augmentation, has evolved during the past few decades as the preferred method for acetabular reconstruction. Although major improvements have been recorded with regard to clinical outcomes and survivorship, acetabular component loosening remains among the most common causes of failure and revision. Patient age, poor bone quality and conditions, such as osteonecrosis and dysplasia, have been observed to influence negatively long-term clinical results. Initial stability is fundamental for survivorship of cementless cups. Prerequisites to achieve durable cementless cup fixation are close contact with viable native bone, primary mechanical stability and secondary bone integration. Press-fit techniques provide optimal conditions for bone ingrowth and fixation but research focused on cup material in order to improve primary stability. Pore size, bone

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Mpact 3D metal cup
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Where

1 site
IRRCCS Istituto Ortopedico Galeazzi
Milan, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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