NCT05818878

RSA Masterloc Study Australia

Prospective, Multicentric Study to Assess Stability of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 26 (estimated)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: —

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

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

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2025-11-01
• First posted: 2023-04-19
• Last updated: 2025-09-29

Locations

1 site across 1 country: Australia