Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
88 participants
OBSERVATIONAL
2024-02-28
2030-12-31
Brief Summary
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Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure.
In recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation.
The current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Mpact 3D Metal Monolith
THA with Mpact 3D Metal Monolith
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Medacta International SA
INDUSTRY
Responsible Party
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Locations
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Clinique Brétéché
Nantes, , France
Hôpital Lariboisière
Paris, , France
Hôpital Cochin
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Kamel Ajouy
Role: primary
Pascal Bizot
Role: primary
Philippe Anract
Role: primary
Other Identifiers
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P01.028.01
Identifier Type: -
Identifier Source: org_study_id