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The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYSâ„¢ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYSâ„¢ hip navigation system with CUPTIMIZEâ„¢ Advanced Hip-Spine Analysis software.
Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMPHASYS Cup with VHN | Other | EMPHASYS Cup with Non-Invasive Navigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMPHASYS Cup with VHN | Device | Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint: Acetabular Cup Position Success at 6 Weeks | For an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks: Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan and version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inclination Success | Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan. | 6 weeks |
| Version Success | Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Flamand | Contact | 610-241-3260 | SFlamand@its.jnj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health System | Not yet recruiting | Sacramento | California | 95817 | United States | |
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| 6 weeks |
| Final Intraoperative Inclination | Number of participants with final intraoperative inclination will be reported. | 12 weeks |
| Final Intraoperative Version | Number of participants with final intraoperative version will be reported. | 12 weeks |
| Harris Hip Score | Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. | 12 weeks |
| Radiographic Outcomes | High quality antero-posterior and lateral radiographs of the operative hip will be obtained during the same intervals as for the clinical evaluations. Views include the Standing AP Hip, Standing AP Pelvis, and Lateral (Modified Lauenstein) Hip. Preoperatively an additional three views will be taken including Lateral flex-seated, Lateral Standing and Standing AP Pelvis. | 12 weeks |
| EQ-5D-5L | EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. | 12 weeks |
| Forgotten Joint Score | Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. | 6 weeks |
| Operating Room Times | Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times. | Immediately after the Surgical Procedure |
| Leg Length Discrepancy | Leg Length discrepancy compared to surgeon target based on pre-operative planning | Immediately after the Surgical Procedure |
| Complication Rates | 30-day Complication Rate | 30 days |
| Complication Rates | 90-day Complication Rate | 90 days |
| Florida Orthopaedic Institute |
| Recruiting |
| Gainesville |
| Florida |
| 32607 |
| United States |
| Northwell Health | Not yet recruiting | Lake Success | New York | 11042 | United States |
| Montefiore Medical Center | Not yet recruiting | The Bronx | New York | 10461 | United States |
| Carolina Orthopaedic and Sports Medicine Center | Recruiting | Gastonia | North Carolina | 28054 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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