Radiostereometric AnalysisNCT05818878
RSA Masterloc Study Australia
An observational study of Radiostereometric Analysis, run by Medacta International SA at 1 site in Australia.
Trial summary
This is a prospective, multicentric study that aim to assess stability of a tapered porous coated stem and a cementless hemispherical acetabular component. Main Translation and rotation around the x., y-, and z-axis of the femoral and cup component by radiostereometric analysis (RSA) at immediate post op (within 5… Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Radiostereometric Analysis
- How many people
- 26 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2020to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- Child, Adult, Older adult
Study population: 26 patients who entirely fulfil the inclusion/exclusion criteria. The patients will be recruited in a period of 12 months.
Who may be able to join
- Primary osteoarthritis of the hip necessitating primary hip replacement,
- Suitability for straight cementless stem,
- Adult male and female under 70years old,
- Ability to give informed consent,
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
Who cannot join
- Post-traumatic deformity in the affected hip,
- Patient suffering by rheumatoid arthritis,
- Patient suffering by congenital or developmental deformity,
- Severe osteoporosis,
- Earlier surgery in the hip to be operated on,
- Perioperative fracture,
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- Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,
- Patients with a history of active infection
- Pregnant women or those seeking to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicentric Study to Assess Stability of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
This is a prospective, multicentric study that aim to assess stability of a tapered porous coated stem and a cementless hemispherical acetabular component.
Main Translation and rotation around the x., y-, and z-axis of the femoral and cup component by radiostereometric analysis (RSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years
Read the detailed description
Aim of this study is to assess stem and cup migration over the time in patient subjected to a total hip arthroplasty. Medical Device Research Australia will perform image analysis services and reporting for model based radiostereometric analysis (RSA) of cementless fixation of the femoral and acetabular cup components. Migration of the components will be measured with model-based RSA (MBRSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years A subgroup of 26 patients will be invited to be evaluated also by additional RSA analysis: the first 13 patients for each investigator who will accept.
The results of this work will establish the mechanical stability of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), provide a general estimate of survivorship, and establish clinical safety and efficacy as measured by RSA and clinical outcomes.
- Conditions
- Radiostereometric Analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
RSA imaging
All RSA analysis will be performed Computer Aided Design (CAD) based Roentgen Stereophotogrammetry Analysis (RSA).
The micro-motion results will be calculated and reported as translations and rotations along and about the three anatomic axes. The subsidence of the hip stem is included in the results. The motion of the femoral stem and acetabular cup will be described in relation to the marker beads placed in the proximal femur and acetabular bone during surgery respectively.
The first CAD based RSA examination (within 5 days and prior to weight bearing) serves as the reference baseline. All subsequent evaluations of micromotion are related to the relative position of the implanted medical device with respect to the bone (bone markers) at the time of the evaluation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Sep 2020
- Primary completion1 Sep 2022
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiostereometric AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dixon, Medicine, Principal investigator, Southerland Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818878
- Sponsor's protocol ID
- P01.018.01
- Status last verified
- Sep 2025
- First submitted
- 5 Apr 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric Study to Assess Stability of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
- ClinicalTrials.gov ID
- NCT05818878
- Acronym / sponsor ID
- P01.018.01
- Conditions
- Radiostereometric Analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicentric study that aim to assess stability of a tapered porous coated stem and a cementless hemispherical acetabular component.
Main Translation and rotation around the x., y-, and z-axis of the femoral and cup component by radiostereometric analysis (RSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years
Detailed description
Aim of this study is to assess stem and cup migration over the time in patient subjected to a total hip arthroplasty. Medical Device Research Australia will perform image analysis services and reporting for model based radiostereometric analysis (RSA) of cementless fixation of the femoral and acetabular cup components. Migration of the components will be measured with model-based RSA (MBRSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years A subgroup of 26 patients will be invited to be evaluated also by additional RSA analysis: the first 13 patients for each investigator who will accept.
The results of this work will establish the mechanical stability of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), provide a general estimate of survivorship, and establish clinical safety and efficacy as measured by RSA and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 26 patients who entirely fulfil the inclusion/exclusion criteria. The patients will be recruited in a period of 12 months.
Key inclusion criteria (5 listed)
- Primary osteoarthritis of the hip necessitating primary hip replacement,
- Suitability for straight cementless stem,
- Adult male and female under 70years old,
- Ability to give informed consent,
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
Key exclusion criteria (9 listed)
- Post-traumatic deformity in the affected hip,
- Patient suffering by rheumatoid arthritis,
- Patient suffering by congenital or developmental deformity,
- Severe osteoporosis,
- Earlier surgery in the hip to be operated on,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RSA imaging
Time frame: 2 years
All RSA analysis will be performed Computer Aided Design (CAD) based Roentgen Stereophotogrammetry Analysis (RSA). The micro-motion results will be calculated and reported as translations and rotations along and about the three anatomic axes. The subsidence of the hip stem is included in the results. The motion of the femoral stem and acetabular cup will be described in relation to the marker beads placed in the proximal femur and acetabular bone during surgery respectively. The first CAD based RSA examination (within 5 days and prior to weight bearing) serves as the reference baseline. All subsequent evaluations of micromotion are related to the relative position of the implanted medical device with respect to the bone (bone markers) at the time of the evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dixon, Medicine principal investigator
Southerland Public Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiostereometric Analysis, run by Medacta International SA at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSA imaging (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.