Comparison of Two Hydroxy-apatite Coated Hip Stems
Randomized Controlled Trial Comparison of Two Hydroxy-apatite Coated Hip Stems Utilizing Radiostereometric Analysis
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedStudy Start
First participant enrolled
July 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedDecember 4, 2025
December 1, 2025
4.6 years
June 20, 2018
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Migration
Measured via radiosteriometric analysis
2 years
Study Arms (2)
Avenir cementless hip stem
ACTIVE COMPARATORTotal hip arthroplasty: Avenir vs Corail
Corail HA-coated hip stem
ACTIVE COMPARATORTotal hip arthroplasty: Corail vs Avenir
Interventions
Avenir cementless hip stem vs Corail HA-coated hip stem
Avenir cementless hip stem vs Corail HA-coated hip stem
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Concordia Hospital
Winnipeg, Manitoba, R2K 3S8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Turgeon, MD
Concordia Joint Replacement Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 5, 2018
Study Start
July 19, 2018
Primary Completion
February 9, 2023
Study Completion
January 30, 2024
Last Updated
December 4, 2025
Record last verified: 2025-12