Active — Not RecruitingNot Applicable

Monocer AOANJRR Registry-nested Study

Australia280 participantsStarted 2021-01-30

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.

Timeframe: 2 years

Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.

Timeframe: 5 years

Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.

Timeframe: 10 years

Trial details

NCT IDNCT05822505

SponsorMedacta International SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-01

View on ClinicalTrials.gov More Survival, Prosthesis trials