RSA Masterloc Study Australia

NCT05818878 | Active Not Recruiting

• 1 other identifier: P01.018.01
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Radiostereometric Analysis

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

26 patients who entirely fulfil the inclusion/exclusion criteria. The patients will be recruited in a period of 12 months.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Southerland Public Hospital

Sydney, Australia

Location

Study Officials

• Michael Dixon, Medicine

  Southerland Public Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)