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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively).
The primary study objective is to establish the mean superior migration of the Pinnacle Gription Sector acetabular cup, irrespective of standard or dual mobility articulation, using model-based radiostereometric analysis. As both prior studies utilize the same acetabular component, a combined analysis will be performed with an additional sub-analysis on those with a Pinnacle Dual Mobility system. Additional objectives include comparison of acetabular cup migration between surgical approach groups (posterolateral, direct lateral, direct anterior) at all time points, linear head penetration at 1 and 2 years, as well as functional and health status outcomes. Patients will be followed to the original end point of 2 years post-surgery using the same radiographic and patient-reported outcome measures at the primary studies; Harris Hip Score, Hip Evaluation, HOOS Jr., and Forgotten Joint Score. Results of this study will be published in orthopaedic journals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pinnacle Gription | Other | Pinnacle Gription Acetabular Cup |
|
| Pinnacle Dual Mobility | Other | Pinnacle Dual Mobility System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pinnacle Gription Acetabular Cup | Device | Pinnacle Gription cup with Corail/ACTIS stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year | Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis | Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| Subsidence profiles | Comparing RSA exams at the specified time points to determine relative movement of the device | 6-months, 1-year, 2-year |
| Change of functional outcome over 2 year follow-up period (Harris Hip Score) |
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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 |
|---|---|---|---|---|---|---|
| Orthopaedic Innovation Centre | Winnipeg | Manitoba | R2K 2M9 | Canada | ||
| London Health Sciences Centre |
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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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| Pinnacle Dual Mobility | Device | Bi-Mentum AltrX liner |
|
The Harris Hip Score (HHS) is a score used in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100, any result <70 is considered a poor result; The HHS is an outcome measure administered by a qualified health care professional.
| Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively |
| Pain and Function | The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function. | Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively |
| Forgotten Joint Score (FJS) | 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. | Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively |
| Complications | Evaluate the type and frequency of the complications/adverse events. | Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively |
| London |
| Ontario |
| N6A 5W9 |
| Canada |
| D012216 |
| Rheumatic Diseases |