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

• ClinicalTrials.gov Identifier: NCT02668211
• Recruitment Status: Withdrawn
• First Posted: January 29, 2016
• Last Update Posted: December 15, 2016
• Sponsor: MicroPort Orthopedics Inc.
• Information provided by (Responsible Party): MicroPort Orthopedics Inc.

Tracking Information

• First Submitted Date: November 9, 2015
• First Posted Date: January 29, 2016
• Last Update Posted Date: December 15, 2016
• Study Start Date: November 2016
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2016)

• Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance. [ Time Frame: 24 months ]
  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.
• Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA [ Time Frame: 24 months ]
  Assessment of migration in each individual plane (x, y, and z), as measured in mm.
• Assess if migration pattern is greater than 0.2mm between 1 and 2 years [ Time Frame: 24 months ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 26, 2016)

Patient functional outcomes (HOOS) [ Time Frame: 24 months ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
• Official Title: Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Joint Disease
• Osteoarthritis

Intervention

Device: PROFEMUR Preserve Classic Femoral Components

Other Name: Total Hip Arthroplasty System

Study Arms

PROFEMUR Preserve RSA

Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components

Intervention: Device: PROFEMUR Preserve Classic Femoral Components

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 13, 2016): 0
• Original Estimated Enrollment (submitted: January 26, 2016): 32
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 76 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02668211
• Other Study ID Numbers: 14LJH002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: MicroPort Orthopedics Inc.
• Study Sponsor: MicroPort Orthopedics Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: MicroPort Orthopedics Inc.
• Verification Date: December 2016