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.
All hip replacement component devices are to be used according to the approved indications.
The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.
The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced
Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
Active local or systemic infection.
Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
Charcot's or Paget's disease.
Single group
EMPHASYS Cup with VHN
DeviceTotal Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation
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.
Inclination Success
Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan.
Version Success
Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
Final Intraoperative Inclination
Number of participants with final intraoperative inclination will be reported.
Final Intraoperative Version
Number of participants with final intraoperative version will be reported.
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