RecruitingNot ApplicableNCT06631638

EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))

Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation


Sponsor

DePuy Orthopaedics

Enrollment

118 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether using a non-invasive computer navigation system (Velys Hip Navigation with CUPTIMIZE) helps surgeons position the hip cup component more accurately during total hip replacement surgery using the EMPHASYS cup. **You may be eligible if...** - You are 21 years or older - You are having a first-time, uncemented total hip replacement with the EMPHASYS cup - You are having surgery through the posterolateral, anterolateral, or direct lateral approach - You are willing and able to attend follow-up appointments and complete questionnaires **You may NOT be eligible if...** - You have an active local or systemic infection - You have very poor bone quality or conditions such as Charcot's or Paget's disease - You are pregnant or breastfeeding - You have had a hip replacement on the same side previously - You have a life expectancy of less than 2 years - You have a psychological or substance abuse disorder affecting compliance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEMPHASYS Cup with VHN

Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation


Locations(2)

Florida Orthopaedic Institute

Gainesville, Florida, United States

Carolina Orthopaedic and Sports Medicine Center

Gastonia, North Carolina, United States

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NCT06631638


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