A Post Market Surveillance Study About the MONOCER Cup

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

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.

Study Overview

• Status: Recruiting
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Device: Mpact 3D metal MONOCER cup

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Elisa Bonacina, PhD; Phone Number: +41 91 696 60 60; Email: bonacina@medacta.ch

Study Locations

• Switzerland
  • Genève, Switzerland, 1205
    • Recruiting
    • Hirslanden, Clinique la Colline
    • Contact: Placido Bartolone, Dr; Phone Number: +41227022585; Email: placido.bartolone@hirslanden.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients listed for a Total Hip Arthroplasty (THA) with Mpact 3D Metal MONOCER cup, meeting all inclusion/exclusion criteria, at the research site, will be proposed to take part to the current study during the preoperative visit.

The investigator will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of implant survivorship using Kaplan Meier curve	a Kaplan Meir survival curve will be calcuated	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Device stability throught a radiological exam	standard x-ray examination will be peformed during the visits	6 months, 1 year, 5 and 10 years
Assessment of the clinical outcome following total hip replacement using the Harris Hip score	HHS score will be completed	6 months, 1 year, 5 and 10 years
Device Safety assessed through adverse event collection	number of adverse event occurred	up to 10 yrs follow-up

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Placido Bartolone, Dr, Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Estimated): February 1, 2050
• Study Completion (Estimated): February 1, 2050

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: P01.026.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No