NCT05822505

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
74mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2021Jun 2032

Study Start

First participant enrolled

January 30, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

September 29, 2025

Status Verified

June 1, 2025

Enrollment Period

9.9 years

First QC Date

April 6, 2023

Last Update Submit

September 23, 2025

Conditions

Survival, Prosthesis

Outcome Measures

Primary Outcomes (3)

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

    Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.

    2 years

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

    Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.

    5 years

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

    Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates. Analysis of reasons for revisions.

    10 years

Secondary Outcomes (5)

  • Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with EQ-5D-5L

    pre-op, 6 months, 1 year, 2 years, 5 years, 10 years

  • Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with OHS

    pre-op,6 months, 1 year, 2 years, 5 years, 10 years

  • Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with HOOS

    pre-op,6 months, 1 year, 2 years, 5 years, 10 years

  • Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with MONA

    6 months, 1 year, 2 years, 5 years, 10 years

  • Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with VAS

    pre-op,6 months, 1 year, 2 years, 5 years, 10 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

At least 280 patients will be recruited who will have the Mpact 3D Metal MonoCer acetabular cup prosthesis from four surgeons in Australia.

You may qualify if:

  • 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.

You may not qualify if:

  • Rheumatoid arthritis.
  • Patients with a history of active infection.
  • Revision procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melbourne Orthopaedic Group

Melbourne, Australia

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jit Balakumar

    Melbourne Orthopaedic Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 20, 2023

Study Start

January 30, 2021

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

June 1, 2032

Last Updated

September 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)