A Post Market Surveillance Study About the MONOCER Cup

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785364
• Other study ID #: P01.026.02
• Status: Recruiting
• Start date: January 25, 2022
• Est. completion date: February 1, 2050

Study information

• Verified date: April 2024
• Source: Medacta International SA
• Contact: Elisa Bonacina, PhD
• Phone: +41 91 696 60 60
• Email: bonacina[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 1, 2050
• Est. primary completion date: February 1, 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

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

Locations

Country	Name	City	State
Switzerland	Hirslanden, Clinique la Colline	Genève

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of implant survivorship using Kaplan Meier curve	a Kaplan Meir survival curve will be calcuated	10 years
Secondary	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
Secondary	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
Secondary	Device Safety assessed through adverse event collection	number of adverse event occurred	up to 10 yrs follow-up