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Monocer AOANJRR Registry-nested Study

Sponsored by Medacta International SA

About this trial

Last updated 2 years ago

Study ID

P01.026.001

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Trial Timing

Started 5 years ago

What is this trial about?

This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year clinical outcome of the MonoCer Acetabular Cup in Primary Total Hip Replacement. The primary outcome measure is mortality and secondary measures are PROMs and complications.

What are the Participation Requirements?

Inclusion Criteria:

- Patients undergoing a primary total conventional hip replacement and are suitable for
cementless acetabular cup according to the indications for use (On-label use).

- Use of the Medacta Mpact 3D Metal MonoCer acetabular cup prosthesis.

- Adults aged between 18 and 75 years at the time of registration.

- Ability to give informed consent.

- Patients who are informed of the conditions of the study and are willing to
participate for the length of the prescribed follow-up period.

Exclusion Criteria:

Exclusion Criteria

- Rheumatoid arthritis.

- Patients with a history of active infection.

- Any case not described in the inclusion criteria.

- Revision procedures.

Locations

Location

Status

Recruiting