Status:
RECRUITING
Mpact 3D Metal Cup PMS
Lead Sponsor:
Medacta International SA
Conditions:
Total Hip Arthroplasty
Eligibility:
All Genders
18-75 years
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 7 2032
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04801680
Start Date
November 7 2019
End Date
December 7 2032
Last Update
May 1 2024
Active Locations (1)
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1
IRRCCS Istituto Ortopedico Galeazzi
Milan, MI, Italy, 20161