Back to resultsComparison of Two Hydroxy-apatite Coated Hip Stems
Primary Purpose
Hip Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Avenir cementless hip stem
Corail HA-coated hip stem
Sponsored by
About this trial
This is an interventional other trial for Hip Osteoarthritis
Eligibility Criteria
Inclusion Criteria
- Symptomatic osteoarthritis of the hip undergoing primary total hip arthroplasty
- Between the ages of 18 and 79 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Exclusion Criteria
- Requires specialty implant (e.g., suspected metal allergy, coxa vera implant)
- Avascular necrosis
- Unresolved infection of the hip
- Hip fracture
- Hip dysplasia
- At risk for loss to follow-up
- Prior surgery to the ipsilateral hip
- Severe proximal femoral deformity preventing the use of standard proximal press-fit femoral components
- Medical condition precluding major surgery
- Current or pending patient incarceration
Sites / Locations
- Concordia Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Avenir cementless hip stem
Corail HA-coated hip stem
Arm Description
Total hip arthroplasty: Avenir vs Corail
Total hip arthroplasty: Corail vs Avenir
Outcomes
Primary Outcome Measures
Migration
Measured via radiosteriometric analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT03577522
First Posted
June 20, 2018
Last Updated
June 26, 2023
Sponsor
Canadian Radiostereometric Analysis Network
1. Study Identification
Unique Protocol Identification Number
NCT03577522
Brief Title
Comparison of Two Hydroxy-apatite Coated Hip Stems
Official Title
Randomized Controlled Trial Comparison of Two Hydroxy-apatite Coated Hip Stems Utilizing Radiostereometric Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Radiostereometric Analysis Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
In this study, the investigators propose to randomize 80 subjects to receive either the Avenir cementless hip stem or a competing, HA-coated hip stem (Corail, DePuy-Synthes) and follow these patients for a period of 2 years post-surgery. The investigators aim to determine if the Avenir cementless hip stem has equivalent or better fixation and clinical outcomes compared to a predicate hip stem with longer clinical history.
Detailed Description
This is a multi-center, randomized controlled trial of patients undergoing primary total hip arthroplasty. This study will be focused on enrollment at a single site with possible expansion to additional centers should patient enrollment occur at a slower than expected rate. Decision to expand the study to additional centers will be mutually agreed upon by both the clinical site and the study sponsor.
Patients will be randomized to two study groups:
Zimmer Avenir cementless, HA-coated femoral hip stem with matching Trilogy IT cup;
DePuy-Synthes Corail cementless, HA-coated, non-collared femoral hip stem with matching Pinnacle cup Patient allocation to the study groups will occur following a randomized 4-block design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avenir cementless hip stem
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty: Avenir vs Corail
Arm Title
Corail HA-coated hip stem
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty: Corail vs Avenir
Intervention Type
Device
Intervention Name(s)
Avenir cementless hip stem
Intervention Description
Avenir cementless hip stem vs Corail HA-coated hip stem
Intervention Type
Device
Intervention Name(s)
Corail HA-coated hip stem
Intervention Description
Avenir cementless hip stem vs Corail HA-coated hip stem
Primary Outcome Measure Information:
Title
Migration
Description
Measured via radiosteriometric analysis
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Symptomatic osteoarthritis of the hip undergoing primary total hip arthroplasty
Between the ages of 18 and 79 inclusive
Patients willing and able to comply with follow-up requirements and self-evaluations
Ability to give informed consent
Exclusion Criteria
Requires specialty implant (e.g., suspected metal allergy, coxa vera implant)
Avascular necrosis
Unresolved infection of the hip
Hip fracture
Hip dysplasia
At risk for loss to follow-up
Prior surgery to the ipsilateral hip
Severe proximal femoral deformity preventing the use of standard proximal press-fit femoral components
Medical condition precluding major surgery
Current or pending patient incarceration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD
Organizational Affiliation
Concordia Joint Replacement Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concordia Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Hydroxy-apatite Coated Hip Stems
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