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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.
Assessment method [1] 0 0
Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.
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.
Assessment method [2] 0 0
Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.
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.
Assessment method [3] 0 0
Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates. Analysis of reasons for revisions.
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
Assessment method [1] 0 0
Assessments / Questionnaires (Patient Reported Outcome Measures) EQ-5D-5L (EuroQol) min=0 (worst score) max=100 (best score) The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
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
Assessment method [2] 0 0
Assessments / Questionnaires (Patient Reported Outcome Measures) OHS The OHS is a short 12-item survey that can be done with pen and paper, or online. Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
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
Assessment method [3] 0 0
Assessments / Questionnaires (Patient Reported Outcome Measures): HOOS HOOS: The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process. The HOOS questionnaire is a patient-administered self-report questionnaire and takes 7 to 10 minutes to complete. It is designed to be self-explanatory and user-friendly\[1\]. The HOOS includes 40 items with five possible responses, graded from 0 to 4 (0 points = worst possible score; 100 points = best possible score).
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
Assessment method [4] 0 0
Assessments / Questionnaires (Patient Reported Outcome Measures): MONA (Melbourne Orthopaedic Noise assesment) MONA questionnaire, which has a high sensitivity for the detection of noises, concerning noise frequency and the quality of noise. Patients were asked if any noise had been heard from their hip joint at any time after surgery.
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
Assessment method [5] 0 0
Assessments / Questionnaires (Patient Reported Outcome Measures): VAS (Visual Analog Scale) from 0 (worst) to 100 (best) score. The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between paints with similar conditions.
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Jit Balakumar
Address 0 0
Melbourne Orthopaedic Group
Country 0 0
Phone 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
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