A Post Market Surveillance Study About the MONOCER Cup

Sponsor

Medacta International SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05785364

Collaborator

(none)

250

Enrollment

Location

336.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	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 Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 25, 2022

Anticipated Primary Completion Date :

Feb 1, 2050

Anticipated Study Completion Date :

Feb 1, 2050

Outcome Measures

Primary Outcome Measures

Assessment of implant survivorship using Kaplan Meier curve [10 years]
a Kaplan Meir survival curve will be calcuated

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hirslanden, Clinique la Colline	Genève		Switzerland	1205

Sponsors and Collaborators

Medacta International SA

Investigators

Principal Investigator: Placido Bartolone, Dr, Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medacta International SA

ClinicalTrials.gov Identifier:

NCT05785364

Other Study ID Numbers:

P01.026.02

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 27, 2023