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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
DePuy Orthopaedics
Study ID
NCT06631638
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EMPHASYS Cup with VHN — DEVICE
    Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation

Study Details

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.

Key Dates

First listed
Oct 8, 2024
Start date
Oct 24, 2025
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: EMPHASYS Cup with VHN
    EMPHASYS Cup with Non-Invasive Navigation

Primary Outcome Measure

Composite endpoint: Acetabular Cup Position Success at 6 Weeks [ Time Frame: 6 Weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Florida Orthopaedic InstituteGainesvilleFlorida32607-
Carolina Orthopaedic and Sports Medicine CenterGastoniaNorth Carolina28054-

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