RSA Masterloc Study Australia

Radiostereometric Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05818878
• Other study ID #: P01.018.01
• Status: Active, not recruiting
• Start date: September 1, 2020
• Est. completion date: September 2023

Study information

• Verified date: April 2023
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 days and before weight bearing), 6 months, 1year and 2 years

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: September 2023
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Radiostereometric Analysis

Locations

Country	Name	City	State
Australia	Southerland Public Hospital	Sidney

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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