Mpact 3D Metal Cup PMS

Launched by MEDACTA INTERNATIONAL SA · Mar 16, 2021

Keywords

ClinConnect Summary

The Mpact 3D Metal Cup PMS trial is studying a new type of acetabular cup used in total hip replacement surgery. This cup is designed to improve the way it attaches to the bone, which is important for the long-term success of the surgery. The researchers want to see how well this new cup performs over time, especially for patients with challenging hip conditions or poor bone quality.

To participate in this trial, you need to be between 18 and 75 years old and have certain hip issues, like arthritis or hip dysplasia. You should also be eligible for a total hip replacement surgery where the Mpact 3D Metal cup will be used. Participants will need to give their consent to join the study and will be monitored for clinical outcomes and imaging results over the long term. It’s important to know that people with certain infections, severe bone conditions, or other specific health issues may not qualify for this trial.

Gender

ALL

Eligibility 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