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

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis; Joint Disease
• Intervention / Treatment: Device: PROFEMUR Preserve Classic Femoral Components

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve Rosemont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PROFEMUR Preserve RSA; Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components	Device: PROFEMUR Preserve Classic Femoral Components; Other Names: Total Hip Arthroplasty System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: osteoarthritis; total hip arthroplasty; correction of functional deformity; procedures; radiostereometric analysis; musculoskeletal diseases
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: 14LJH002