Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05822505




Registration number
NCT05822505
Ethics application status
Date submitted
6/04/2023
Date registered
20/04/2023
Date last updated
20/04/2023

Titles & IDs
Public title
Monocer AOANJRR Registry-nested Study
Scientific title
Prospective, Multicentre Study to Assess Performance of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement
Secondary ID [1] 0 0
P01.026.001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Survival, Prosthesis 0 0
Condition category
Condition code
Public Health 0 0 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.
Timepoint [3] 0 0
10 years
Secondary outcome [1] 0 0
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with EQ-5D-5L
Timepoint [1] 0 0
pre-op, 6 months, 1 year, 2 years, 5 years, 10 years
Secondary outcome [2] 0 0
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with OHS
Timepoint [2] 0 0
pre-op,6 months, 1 year, 2 years, 5 years, 10 years
Secondary outcome [3] 0 0
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with HOOS
Timepoint [3] 0 0
pre-op,6 months, 1 year, 2 years, 5 years, 10 years
Secondary outcome [4] 0 0
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with MONA
Timepoint [4] 0 0
6 months, 1 year, 2 years, 5 years, 10 years
Secondary outcome [5] 0 0
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with VAS
Timepoint [5] 0 0
pre-op,6 months, 1 year, 2 years, 5 years, 10 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Exclusion Criteria

- Rheumatoid arthritis.

- Patients with a history of active infection.

- Any case not described in the inclusion criteria.

- Revision procedures.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2032
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne Orthopaedic Group - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medacta International SA
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05822505
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jit Balakumar
Address 0 0
Melbourne Orthopaedic Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arianna Girardi
Address 0 0
Country 0 0
Phone 0 0
+41 91 696 60 60
Fax 0 0
Email 0 0
girardi@medacta.ch
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05822505