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Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.
All patients candidated to receive a total hip arthroplasty under 75 years old, who will receive a Mpact 3D Metal cup will be proposed to take part to the study. They will receive the same treatment in case they will not partecipate; the study is an observational study according to standard practice. The study aim to assess the long term peformance of the cup at 10 years after surgery. The patients will be visited at 6 months, 1, 5 and 10 years after surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mpact 3D metal MONOCER cup | Device | adult patients requiring a total hip arthroplasty under 75 years old, will receive the Mpact 3D metal cup, as acetabular sheel device implanted |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of implant survivorship using Kaplan Meier curve | a Kaplan Meir survival curve will be calcuated | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Device stability throught a radiological exam | standard x-ray examination will be peformed during the visits | 6 months, 1 year, 5 and 10 years |
| Assessment of the clinical outcome following total hip replacement using the Harris Hip score |
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Inclusion Criteria:
Exclusion Criteria:
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Patients listed for a Total Hip Arthroplasty (THA) with Mpact 3D Metal MONOCER cup, meeting all inclusion/exclusion criteria, at the research site, will be proposed to take part to the current study during the preoperative visit.
The investigator will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Bonacina, PhD | Contact | +41 91 696 60 60 | bonacina@medacta.ch |
| Name | Affiliation | Role |
|---|---|---|
| Placido Bartolone, Dr | Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirslanden, Clinique la Colline | Recruiting | Geneva | 1205 | Switzerland |
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HHS score will be completed |
| 6 months, 1 year, 5 and 10 years |
| Device Safety assessed through adverse event collection | number of adverse event occurred | up to 10 yrs follow-up |