A Post Market Surveillance Study About the MONOCER Cup
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mpact 3D metal MONOCER cup.
- Who it may be relevant to
- Registry conditions: Total Hip Arthroplasty. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study
Overview
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
- Device Mpact 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
Primary outcome measures
- Assessment of implant survivorship using Kaplan Meier curve [Time frame: 10 years]
Secondary outcome measures (3)
- Assessment of Device stability throught a radiological exam [Time frame: 6 months, 1 year, 5 and 10 years]
- Assessment of the clinical outcome following total hip replacement using the Harris Hip score [Time frame: 6 months, 1 year, 5 and 10 years]
- Device Safety assessed through adverse event collection [Time frame: up to 10 yrs follow-up]
Eligibility criteria
Inclusion criteria
- Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use
- Patients who have signed the informed consent to participate in the study
Exclusion criteria
- Minor patients, patients over 75 years of age at the time of primary surgery;
- Any patient who is unable or unwilling to give informed consent to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Hirslanden, Clinique la Colline — Geneva
Identifiers
NCT: NCT05785364 · P01.026.02