Total Hip Arthroplasty
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMpact 3D metal MONOCER cup
adult patients requiring a total hip arthroplasty under 75 years old, will receive the Mpact 3D metal cup, as acetabular sheel device implanted
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use 2. Patients who have signed the informed consent to participate in the study
Exclusion criteria
1. Minor patients, patients over 75 years of age at the time of primary surgery; 2. Any patient who is unable or unwilling to give informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of implant survivorship using Kaplan Meier curve | 10 years | a Kaplan Meir survival curve will be calcuated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Device stability throught a radiological exam | 6 months, 1 year, 5 and 10 years | standard x-ray examination will be peformed during the visits |
| Assessment of the clinical outcome following total hip replacement using the Harris Hip score | 6 months, 1 year, 5 and 10 years | HHS score will be completed |
| Device Safety assessed through adverse event collection | up to 10 yrs follow-up | number of adverse event occurred |
Countries
Switzerland
Contacts
Primary ContactElisa Bonacina, PhD
Outcome results
None listed