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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Recruitment Status : Withdrawn (Not feasible - RSA machine not available.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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Joint Disease Osteoarthritis Device: PROFEMUR Preserve Classic Femoral Components Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
PROFEMUR Preserve RSA
Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components
 Device: PROFEMUR Preserve Classic Femoral Components
Other Name: Total Hip Arthroplasty System


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668211


Locations
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Canada, Quebec
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
MicroPort Orthopedics Inc.
More Information
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Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT02668211    
Other Study ID Numbers: 14LJH002
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Keywords provided by MicroPort Orthopedics Inc.:
osteoarthritis
radiostereometric analysis
correction of functional deformity
 procedures
total hip arthroplasty
musculoskeletal diseases
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases