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NCT Number: NCT05785364

A Post Market Surveillance Study About the MONOCER Cup

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.

Recruiting

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Key information

Conditions

Total Hip Arthroplasty

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hirslanden, Clinique la Colline

Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Placido Bartolone, Dr

CONTACT

[email protected]

+41227022585

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Assessment of implant survivorship using Kaplan Meier curve

    Time frame: 10 years

    a Kaplan Meir survival curve will be calcuated

Secondary outcomes

  1. Assessment of Device stability throught a radiological exam

    Time frame: 6 months, 1 year, 5 and 10 years

    standard x-ray examination will be peformed during the visits

  2. Assessment of the clinical outcome following total hip replacement using the Harris Hip score

    Time frame: 6 months, 1 year, 5 and 10 years

    HHS score will be completed

  3. Device Safety assessed through adverse event collection

    Time frame: up to 10 yrs follow-up

    number of adverse event occurred

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Bonacina, PhD

CONTACT

[email protected]

+41 91 696 60 60

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study

Important dates

Study start
2022
Primary completion
2050
Study completion
2050
First posted
Mar 27, 2023
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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