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This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System.
The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years.
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes. | The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement. | 3 months, 1-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | All perioperative and postoperative device-related and surgical adverse events will be recorded during this study. | Post Operative - 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable.
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| Name | Affiliation | Role |
|---|---|---|
| Richard McCalden, MD | London Health Science Centre-University Hospital London Ontario | Principal Investigator |
| Colin Burnell, MD | Concordia Hospital, Winnipeg, Canada | Principal Investigator |
| James Comadoll, MD | Ro Medical Orthopedics, Salisbury NC | Principal Investigator |
| Richard Steinfeld, MD | Orthopaedic Center of Vero Beach, Vero Beach, FL | Principal Investigator |
| Craig Della Valle, MD | Rush University Medical Center | Principal Investigator |
| John Masonis, MD | OrthoCarolina Research Institute | Principal Investigator |
| Ryan Nunley, MD | Washington University Orthopedics | Principal Investigator |
| Michael Dunbar, MD | Halifax Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Center of Vero Beach | Vero Beach | Florida | 32960 | United States | ||
| Midwest Orthopedics at Rush University Medical Center |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Chicago |
| Illinois |
| 60612 |
| United States |
| Washington University Orthopedics | St Louis | Missouri | 63110 | United States |
| Ortho Carolina | Charlotte | North Carolina | 28207 | United States |
| Novant Health Pinnacle Orthopedics | Salisbury | North Carolina | 28144 | United States |
| Concordia Hip and Knee Institute | Winnipeg | Manitoba | R2K 2M9 | Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| London Health Science Center | London | Ontario | Canada |