A Post Market Surveillance Study About the MONOCER Cup

Recruiting now

Conditions studied: Total Hip Arthroplasty

In brief

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.

Key facts

Study ID

NCT05785364

Run by

Medacta International SA

People needed

250

Starts

2022-01-25

Expected to finish

2050-02-01

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hirslanden, Clinique la Colline — Geneva, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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