RSA Masterloc Study Australia

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

Study Overview

• Status: Active, not recruiting
• Conditions: Radiostereometric Analysis

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 Type: Observational
• Enrollment (Estimated): 26

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Southerland Public Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Michael Dixon, Medicine, Southerland Public Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: P01.018.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No