The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation
UC Davis Health System
Sacramento, California, United States
NOT_YET_RECRUITINGFlorida Orthopaedic Institute
Gainesville, Florida, United States
RECRUITINGNorthwell Health
Lake Success, New York, United States
NOT_YET_RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
NOT_YET_RECRUITINGCarolina Orthopaedic and Sports Medicine Center
Gastonia, North Carolina, United States
RECRUITINGComposite 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.
Time frame: 6 Weeks
Inclination Success
Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan.
Time frame: 6 weeks
Version Success
Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
Time frame: 6 weeks
Final Intraoperative Inclination
Number of participants with final intraoperative inclination will be reported.
Time frame: 12 weeks
Final Intraoperative Version
Number of participants with final intraoperative version will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Operating Room Times
Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times.
Time frame: Immediately after the Surgical Procedure
Leg Length Discrepancy
Leg Length discrepancy compared to surgeon target based on pre-operative planning
Time frame: Immediately after the Surgical Procedure
Complication Rates
30-day Complication Rate
Time frame: 30 days
Complication Rates
90-day Complication Rate
Time frame: 90 days
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