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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05818878




Registration number
NCT05818878
Ethics application status
Date submitted
5/04/2023
Date registered
19/04/2023
Date last updated
19/04/2023

Titles & IDs
Public title
RSA Masterloc Study Australia
Scientific title
Prospective, Multicentric Study to Assess Stability of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
Secondary ID [1] 0 0
P01.018.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiostereometric Analysis 0 0
Condition category
Condition code

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
RSA imaging
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
* 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.
Minimum age
No limit
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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,
* 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Southerland Public Hospital - Sidney
Recruitment postcode(s) [1] 0 0
- Sidney

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

Ethics approval
Ethics application status

Summary
Brief 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 days and before weight bearing), 6 months, 1year and 2 years
Trial website
https://clinicaltrials.gov/study/NCT05818878
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Dixon, Medicine
Address 0 0
Southerland Public Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05818878