Hip OsteoarthritisNCT03577522
Comparison of Two Hydroxy-apatite Coated Hip Stems
A study testing Avenir cementless hip stem and Corail HA-coated hip stem in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Avenir cementless hip stem and Corail HA-coated hip stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jul 2018to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparison of Two Hydroxy-apatite Coated Hip Stems Utilizing Radiostereometric Analysis
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Avenir cementless hip stem, Corail HA-coated hip stem
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avenir cementless hip stemDevice
Avenir cementless hip stem vs Corail HA-coated hip stem
Corail HA-coated hip stemDevice
Avenir cementless hip stem vs Corail HA-coated hip stem
| Study group | Role | What they receive |
|---|---|---|
| Avenir cementless hip stem | Active comparator | Total hip arthroplasty: Avenir vs Corail Receives: Device: Avenir cementless hip stem |
| Corail HA-coated hip stem | Active comparator | Total hip arthroplasty: Corail vs Avenir Receives: Device: Corail HA-coated hip stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration
Measured via radiosteriometric analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start19 Jul 2018
- Primary completion9 Feb 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, Concordia Joint Replacement Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577522
- Sponsor's protocol ID
- B2018-031
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparison of Two Hydroxy-apatite Coated Hip Stems Utilizing Radiostereometric Analysis
- ClinicalTrials.gov ID
- NCT03577522
- Acronym / sponsor ID
- B2018-031
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avenir cementless hip stem | Active comparator | Device: Avenir cementless hip stemTotal hip arthroplasty: Avenir vs Corail |
| Corail HA-coated hip stem | Active comparator | Device: Corail HA-coated hip stemTotal hip arthroplasty: Corail vs Avenir |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Requires specialty implant (e.g., suspected metal allergy, coxa vera implant)
- Avascular necrosis
- Unresolved infection of the hip
- Hip fracture
- Hip dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avenir cementless hip stemAvenir cementless hip stem vs Corail HA-coated hip stem | Device | Avenir cementless hip stem |
| Corail HA-coated hip stemAvenir cementless hip stem vs Corail HA-coated hip stem | Device | Corail HA-coated hip stem |
Primary outcome
Migration
Time frame: 2 years
Measured via radiosteriometric analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Turgeon, MD principal investigator
Concordia Joint Replacement Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avenir cementless hip stem and Corail HA-coated hip stem in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.