Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
NCT: NCT06631638 ·
Status: RECRUITING ·
Phase: N/A
· Sponsor: DePuy Orthopaedics
· Started: 2025-10-24
· Est. Completion: 2027-12-31
Official Summary
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 Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 118 participants
Interventions
- DEVICE: EMPHASYS Cup with VHN — Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation
Primary Outcomes
- Composite endpoint: Acetabular Cup Position Success at 6 Weeks (6 Weeks)
Secondary Outcomes
- Inclination Success (6 weeks)
- Version Success (6 weeks)
- Final Intraoperative Inclination (12 weeks)
- Final Intraoperative Version (12 weeks)
- Harris Hip Score (12 weeks)
Trial Locations
- UC Davis Health System, Sacramento, California, United States
- Florida Orthopaedic Institute, Gainesville, Florida, United States
- Northwell Health, Lake Success, New York, United States
- Montefiore Medical Center, The Bronx, New York, United States
- Carolina Orthopaedic and Sports Medicine Center, Gastonia, North Carolina, United States
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