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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
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Scientific title
Prospective, Multicentre Study to Assess Performance of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement
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Secondary ID [1]
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P01.026.001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Survival, Prosthesis
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Condition category
Condition code
Public Health
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Other public health
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.
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Assessment method [1]
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Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.
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Timepoint [1]
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2 years
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Primary outcome [2]
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Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.
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Assessment method [2]
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Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.
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Timepoint [2]
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5 years
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Primary outcome [3]
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Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.
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Assessment method [3]
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Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates.
Analysis of reasons for revisions.
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Timepoint [3]
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10 years
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Secondary outcome [1]
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Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with EQ-5D-5L
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Assessment method [1]
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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.
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Timepoint [1]
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pre-op, 6 months, 1 year, 2 years, 5 years, 10 years
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Secondary outcome [2]
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Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with OHS
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Assessment method [2]
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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.
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Timepoint [2]
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pre-op,6 months, 1 year, 2 years, 5 years, 10 years
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Secondary outcome [3]
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Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with HOOS
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Assessment method [3]
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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).
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Timepoint [3]
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pre-op,6 months, 1 year, 2 years, 5 years, 10 years
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Secondary outcome [4]
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Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with MONA
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Assessment method [4]
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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.
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Timepoint [4]
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6 months, 1 year, 2 years, 5 years, 10 years
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Secondary outcome [5]
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Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with VAS
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Assessment method [5]
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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.
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Timepoint [5]
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pre-op,6 months, 1 year, 2 years, 5 years, 10 years
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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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
Exclusion Criteria
- Rheumatoid arthritis.
- Patients with a history of active infection.
- Any case not described in the inclusion criteria.
- Revision procedures.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2032
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Actual
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Sample size
Target
280
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Melbourne Orthopaedic Group - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medacta International SA
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05822505
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jit Balakumar
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Address
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Melbourne Orthopaedic Group
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Arianna Girardi
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Address
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Country
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Phone
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+41 91 696 60 60
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05822505
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