Actively Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Led by DePuy Orthopaedics · Updated on 2026-05-08
118
Participants Needed
5
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All hip replacement devices must be used according to approved indications
- Undergoing standard primary uncemented hip replacement with EMPHASYS cup and CORAIL, EMPHASYS, or ACTIS stem via posterolateral, anterolateral, or direct lateral approach with lateral decubitus position
- Candidate for implantation using VELYS Hip Navigation system with CUPTIMIZE Advanced Hip-Spine Analysis
- Able to speak, read, and understand consent document and willing to provide consent
- Willing and able to complete study follow-up as specified
- Willing and able to complete Subject Hip Outcomes questionnaires (FJS-12, EQ-5D-5L, Hip Evaluation)
- Not bedridden as determined by investigator
- Minimum age of 21 years at time of consent
You will not qualify if you...
- Active local or systemic infection
- Loss of musculature, neuromuscular issues, or vascular problems in affected limb making surgery unjustified
- Poor bone quality such as osteoporosis risking prosthesis migration or fracture
- Charcot's or Paget's disease
- Pregnant or lactating women
- Previous contralateral amputation
- Previous partial hip replacement in affected hip
- Participation in another clinical trial with investigational product in last 3 months
- Contralateral hip replacement less than 6 months before surgery
- Involvement in personal injury litigation or worker's compensation claims
- Diagnosed muscular disorder treated with prescription medications limiting mobility due to stiffness and pain
- Medical condition with less than 2 years life expectancy
- Drug or alcohol abuse or psychological disorder affecting compliance or questionnaire completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
UC Davis Health System
Sacramento, California, United States, 95817
Not Yet Recruiting
2
Florida Orthopaedic Institute
Gainesville, Florida, United States, 32607
Actively Recruiting
3
Northwell Health
Lake Success, New York, United States, 11042
Not Yet Recruiting
4
Montefiore Medical Center
The Bronx, New York, United States, 10461
Not Yet Recruiting
5
Carolina Orthopaedic and Sports Medicine Center
Gastonia, North Carolina, United States, 28054
Actively Recruiting
Research Team
S
Samantha Flamand
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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