A Post Market Surveillance Study About the MONOCER Cup
ConditionTotal Hip Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedacta International SA
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mpact 3D metal MONOCER cup
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov