A Post Market Surveillance Study About the MONOCER Cup

Rekrutierend

NCT-Nummer:
NCT05785364

Studienbeginn:
Januar 2022

Letztes Update:
01.05.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medacta International SA

Collaborator:
-

Studienleiter

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

Kontakt

Elisa Bonacina, PhD
Kontakt:
Phone: +41 91 696 60 60
E-Mail: bonacina@medacta.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Hirslanden, Clinique la Colline
1205 Genève
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Placido Bartolone, Dr
Phone: +41227022585
E-Mail: placido.bartolone@hirslanden.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Assessment of implant survivorship using Kaplan Meier curve (Time Frame - 10 years):
a Kaplan Meir survival curve will be calcuated

Secondary outcome:

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

Geprüfte Regime

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

Quelle: ClinicalTrials.gov