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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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This study is designed as a prospective, multi-centre, non-randomized, non-controlled study. This study does not limit the procedures involved in the treatment of the subject as long as the protocol specified products are utilized.
The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys Stem using model-based RSA over the first two years post-implantation. Additionally, the data from this study will be compared to historical Pinnacle Acetabular Shell data obtained in study DSJ_2018_02.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emphasys Hip Solutions | Other | Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emphasys Hip Solutions | Device | Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migration - Shell | The mean vertical subsidence (Y translation, also known as superior shell migration) at 2 years as measured with RSA. | 2 Years |
| Migration - Stem | The mean vertical subsidence (Y translation, also known as inferior stem migration) at 2 years as measured with RSA. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Subsidence - Emphasys Shell | RSA measured subsidence of the Emphasys Shell at 6 months and 1 year and to compare it to historical Pinnacle Shell data | 6 months, 1 Year |
| Subsidence - Emphasys Stem |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Tran | Contact | 204-926-1231 | stran@orthoinno.com | |
| Shalini Hari Kumar | Contact | 204-926-1232 | skumar@orthoinno.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD | Concordia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Innovation Centre | Recruiting | Winnipeg | Manitoba | R2K 2M9 | 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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RSA measured subsidence of the Emphasys Stemat 6 months and 1 year
| 6 months, 1 Year |
| Other RSA measurements - Emphasys Shell | Other RSA measurements of the Emphasys Shell (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to historical Pinnacle Shell data. | 6 Weeks, 6 months, 1 year and 2 years |
| Other RSA measurements - Emphasys Stem | Other RSA measurements of the Emphasys Stem (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to historical Pinnacle Shell data. | 6 Weeks, 6 months, 1 year and 2 years |
| Head Penetration (in mm) | Linear head penetration (in mm) at 1 year and 2 years. This endpoint will be compared to historical Pinnacle data. | 1 year and 2 years |
| HOOS Jr. | Functional and health status will be measured with HOOS Jr. This is a patient-reported outcome measure for which scores range from 0 to 100; a score of 0 indicating total hip disability and 100 indicating optimal hip health.These endpoints will be compared to historical Pinnacle data. | Pre-op, 6 weeks, 6 months, 1 year and 2 years |
| Harris Hip Score | Functional score will be measured with Harris Hip Score. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). These endpoints will be compared to historical Pinnacle data. | Pre-op, 6 weeks, 6 months, 1 year and 2 years |
| Forgotten Joint Score (FJS-12) | Functional and health status will be measured with the Forgotten Joint Score (FJS-12). The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness. These endpoints will be compared to historical Pinnacle data. | Pre-op, 6 weeks, 6 months, 1 year and 2 years |
| D012216 |
| Rheumatic Diseases |