Mpact 3D Metal Monolit Study

Launched by MEDACTA INTERNATIONAL SA · Dec 23, 2024

Keywords

ClinConnect Summary

The Mpact 3D Metal Monolith Study is a clinical trial focused on improving total hip arthroplasty (THA), a common surgery that replaces damaged hip joints to help patients regain mobility and improve their quality of life. This study is specifically looking at a new type of hip implant made of porous titanium, which is designed to help the bone grow into the implant more effectively. The goal is to see how well this new implant functions and how stable it is over two years, as well as its long-term success over five years.

To participate in the trial, you need to be between 18 and 75 years old and eligible for a primary total hip replacement. You should not have certain conditions like inflammatory arthritis, previous hip surgery, or severe muscle or nerve issues. If you join, you can expect regular check-ups to monitor your hip's performance and stability. Additionally, this trial is open to all genders, and participants must be covered by a health insurance plan in France or a similar program. This study aims to provide valuable information that could enhance future hip surgeries and improve patient outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)
• • 2. Patient eligible for primary total hip arthroplasty
• • 3. Patient aged between 18 and 75 years
• • 4. Patient covered by the French Social Security system or an equivalent protection scheme.
• • 5. Patient able, in the investigator's opinion, to comply with the requirements of the study.
• Exclusion Criteria:
• • 1. Patient suffering from inflammatory arthritis
• • 2. Previously operated hip
• • 3. Patient requiring a transplant
• • 4. Hip tumour involved
• • 5. Patient with progressive local or systemic infection
• • 6. Severe acetabular dysplasia
• • 7. Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb.
• • 4. Patient with known medical problems that may compromise independent recovery of mobility 5. Patient with a BMI greater than 40 kg/m². 6. Patient with major cognitive impairment that prevents him/her from fully understanding the requirements of the study 7. Patient living in a geographical area where study follow-up is not possible. 8. Patient taking part in interventional research 9. Minor patient 10. Protected adult patient 11. Vulnerable person according to article L1121-6 of the Public Health Code