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

Primary Purpose

Joint Disease, Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PROFEMUR Preserve Classic Femoral Components
Sponsored by
MicroPort Orthopedics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Disease focused on measuring osteoarthritis, radiostereometric analysis, correction of functional deformity, procedures, total hip arthroplasty, musculoskeletal diseases

Eligibility Criteria

21 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Maisonneuve Rosemont

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PROFEMUR Preserve RSA

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 9, 2015
Last Updated
December 13, 2016
Sponsor
MicroPort Orthopedics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02668211
Brief Title
Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
Acronym
TOPAZ
Official Title
Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Not feasible - RSA machine not available. RSA images needed for study endpoints
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort Orthopedics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease, Osteoarthritis
Keywords
osteoarthritis, radiostereometric analysis, correction of functional deformity, procedures, total hip arthroplasty, musculoskeletal diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROFEMUR Preserve RSA
Arm Type
Other
Arm Description
Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components
Intervention Type
Device
Intervention Name(s)
PROFEMUR Preserve Classic Femoral Components
Other Intervention Name(s)
Total Hip Arthroplasty System
Primary Outcome Measure Information:
Title
Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.
Description
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.
Time Frame
24 months
Title
Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA
Description
Assessment of migration in each individual plane (x, y, and z), as measured in mm.
Time Frame
24 months
Title
Assess if migration pattern is greater than 0.2mm between 1 and 2 years
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient functional outcomes (HOOS)
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hopital Maisonneuve Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

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

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