About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EMPHASYS Cup with VHN

Treatment groups

118 Participants
are divided into 1 treatment group

Locations

5
UC Davis Health System95817, SacramentoCalifornia, United States
Florida Orthopaedic Institute32607, GainesvilleFlorida, United States
Northwell Health11042, Lake SuccessNew York, United States
Montefiore Medical Center10461, The BronxNew York, United States

Sponsors and collaborators

DePuy Orthopaedics

Lead sponsor