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The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insignia uncemented Hip Stem | Other | The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Insignia™ Hip Stems are intended for 'cement less' use only and are intended for total arthroplasty procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insignia uncemented Hip Stem | Device | Device: Replacement of arthritic hip with Insignia uncemented Hip Stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | Evaluation of the survival rate for Insignia Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture. | 10 years |
| Harris Hip Score (HHS) | The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor | pre-op, 6 week, 1,2,5 and 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The MORE Foundation | Phoenix | Arizona | 85023 | United States | ||
| University of California, San Francisco |
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| EQ-5D - Descriptive System | The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. | pre-op, 6 week, 1,2,3, 4,5,7 and 10 years |
| EQ-5D - Visual analogue scale (VAS) | The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. With the EQ Visual Analogue Scale (VAS) the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | pre-op, 6 week, 1,2,3, 4,5,7 and 10 years |
| Survival Rate | Evaluation of the survival rate for Insignia™ Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture Success rate at two (2) years postoperative with the Insignia™ Hip Stem is not worse than 98 % with a non-inferiority margin of 3.5%. Success rate at 10 years postoperative with the Insignia™ Hip Stem is not worse than 95% with a non-inferiority margin of 5%. | 2 years |
| San Francisco |
| California |
| 94158 |
| United States |
| Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States |
| Reno Orthopedic Center Foundation | Reno | Nevada | 89503 | United States |
| Northwell Health: University Orthopaedic Associates | Great Neck | New York | 11021 | United States |
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States |
| Alleghany Health Network- Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| TOA Research Foundation | Nashville | Tennessee | 37204 | United States |
| Baylor Scott and White Medical Center | Temple | Texas | 76508 | United States |
| Orthopedic Physician Associates | Seattle | Washington | 98122 | United States |
| Providence Orthopedics and Sports Medicine | Spokane | Washington | 99208 | United States |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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