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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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?
No
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05822505