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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avenir cementless hip stem | Active Comparator | Total hip arthroplasty: Avenir vs Corail |
|
| Corail HA-coated hip stem | Active Comparator | Total hip arthroplasty: Corail vs Avenir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avenir cementless hip stem | Device | Avenir cementless hip stem vs Corail HA-coated hip stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migration | Measured via radiosteriometric analysis | 2 years |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD | Concordia Joint Replacement Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Hospital | Winnipeg | Manitoba | R2K 3S8 | Canada |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Corail HA-coated hip stem | Device | Avenir cementless hip stem vs Corail HA-coated hip stem |
|
| D012216 |
| Rheumatic Diseases |