Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02668211
Recruitment Status : Withdrawn (Not feasible - RSA machine not available. RSA images needed for study endpoints)
First Posted : January 29, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

Tracking Information
First Submitted Date  ICMJE November 9, 2015
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date December 15, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Joint Disease
  • Osteoarthritis
Intervention  ICMJE Device: PROFEMUR Preserve Classic Femoral Components
Other Name: Total Hip Arthroplasty System
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 13, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2016)
32
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02668211
Other Study ID Numbers  ICMJE 14LJH002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MicroPort Orthopedics Inc.
Study Sponsor  ICMJE MicroPort Orthopedics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MicroPort Orthopedics Inc.
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP