Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components

Osteoarthritis Clinical Trial

— TOPAZ  

Official title:

Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02668211
• Other study ID #: 14LJH002
• Status: Withdrawn
• Phase: N/A
• First received: November 9, 2015
• Last updated: December 13, 2016
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 76 Years

Eligibility

Inclusion Criteria:

• Subject is a candidate for primary THA for osteoarthritis

• Subject is able to undergo primary THA procedure

• Subject is a candidate to be implanted with the specified combination of components

• Subject is willing and able to complete required study visits and assessments

• Subject is willing to sign the approved Informed Consent document

Exclusion Criteria:

• Subject has any of the following contraindications at the time of the implantation:

• Overt infection;

• Distant foci of infections (which may cause hematogenous spread to the implant site);

• Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;

• Skeletally immature (less than 21 years of age at time of surgery);

• Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;

• Subjects 76 years of age or older

• Subjects with post-traumatic arthritis in the affected hip

• Subjects with rheumatoid arthritis in the affected hip

• Subjects with hip dysplasia in the affected hip

• Subjects with prior arthroplasty of the affected hip

• Subjects that are morbidly obese (BMI > 35)

• Subjects that are immuno-suppressed

• Subjects with known or tested-positive allergy to metals

• Subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol

• Subjects unwilling or unable to sign the Informed Consent document

• Subjects with substance abuse issues

• Subjects who are incarcerated or have pending incarceration

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• PROFEMUR Preserve Classic Femoral Components

Locations

Country	Name	City	State
Canada	Hopital Maisonneuve Rosemont	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.	Assessment of the quantity of migration to determine if the total migration of the stem and cup at 2 years post¬operatively are less than 1.2 mm and 2.6mm, and also less than 0.4mm. Assessment of continuous migration to determine if continuous migration, defined as 0.2mm of motion between 1 and 2 years as measured with RSA exists in the stem and cup.	24 months	No
Primary	Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA	Assessment of migration in each individual plane (x, y, and z), as measured in mm.	24 months	No
Primary	Assess if migration pattern is greater than 0.2mm between 1 and 2 years	To determine if the wear rate device is substantially less than the scientifically accepted threshold of 0.1 mm/year for osteolysis. The outcomes will be compared to data from the literature, which states that motion greater than 0.2mm between 1 and 2 years suggests an implant is at risk for early loosening.	24 months	No
Secondary	Patient functional outcomes (HOOS)	The secondary objective is to determine if there is a significant difference in health status and functional outcomes (using the HOOS questionnaire) before and after total hip arthroplasty (THA) using the PROFEMUR® Preserve Femoral Components.	24 months	No