Actively Recruiting
Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
Led by DePuy Orthopaedics · Updated on 2026-06-05
118
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are gathering clinical and X-ray information about the placement of the EMPHASYS acetabular shell, also called a hip cup, in total hip replacement surgery. This study evaluates the use of a non-invasive surgical navigation system called the VELYS hip navigation system with CUPTIMIZE Advanced Hip-Spine Analysis software. Data from this method will be compared with data from surgeries using other cup positioning tools and techniques to assess performance. The study involves the use of the EMPHASYS cup combined with the VELYS Hip Navigation system during primary uncemented hip replacement surgery. Participants receive this device through one of three surgical approaches while lying on their side. The procedures are standard of care, and the navigation system is used to guide cup placement. The study collects data immediately after surgery and follows participants for up to 12 weeks, including specific assessments at 6 weeks and 12 weeks. Participants will be monitored through clinical assessments, X-rays, and questionnaires about hip function and quality of life. Researchers measure outcomes such as the accuracy of cup positioning, hip scores, leg length differences, operating room times, and any complications within 30 and 90 days. Participants complete follow-up visits and questionnaires as specified, with the total participation spanning at least 12 weeks after surgery to observe surgical outcomes and patient experiences.
CONDITIONS
Brief 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 used according to approved indications
- Undergoing primary uncemented hip replacement with EMPHASYS cup and CORAIL, EMPHASYS, or ACTIS stem via posterolateral, anterolateral, or direct lateral approach
- Candidate for implantation using VELYS Hip Navigation system with CUPTIMIZE
- Able to read, understand, and consent to participate and authorize data transfer
- Willing and able to complete follow-up and hip outcome questionnaires
- Not bedridden per investigator's judgment
- At least 21 years old at consent
You will not qualify if you...
- Active local or systemic infection
- Loss of musculature, neuromuscular compromise, or vascular deficiency making procedure unjustified
- Poor bone quality such as osteoporosis risking prosthesis migration or fracture
- Charcot's or Paget's disease
- Pregnant or lactating women
- Contralateral amputation
- Previous partial hip replacement in affected hip
- Participation in clinical investigation with investigational product in last 3 months
- Contralateral hip replaced less than 6 months before surgery
- Involvement in personal injury litigation or worker's compensation claims
- Taking prescription medications for muscular disorders limiting mobility due to severe 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo total hip replacement surgery with the EMPHASYS Acetabular shell using the Velys Hip Navigation system and receive immediate post-operative care.
1 visit (in-person)
Duration - Up to 12 weeks
Participants are monitored for recovery, complications, and hip function after surgery.
Multiple visits up to 12 weeks
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
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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