EMPHASYS Cup Positioning in Total Hip Replacement
This study is looking at how well a specific hip replacement component, the EMPHASYS™ acetabular shell (hip 'cup'), is positioned during total hip replacement surgery. Doctors will use a non-invasive navigation system called VELYS™ to help with placement. This research aims to collect information from X-rays and clinical assessments to see how successful the cup positioning is at 6 weeks after surgery. You may be able to join if you are an adult (21 years or older) needing a primary uncemented hip replacement due to conditions like osteoarthritis or avascular necrosis. The study is comparing this navigation system to other methods to understand its performance.
- Study design
- This is an interventional study planning to enroll 118 participants. It will compare data from hip replacements using the EMPHASYS Cup with VHN to other techniques.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, acetabular cup position success, is measured at 6 weeks after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
At a glance
Conditions
NCT06631638
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Carolina Orthopaedic and Sports Medicine Center
Gastonia, North Carolinano site contact published
Recruiting
Florida Orthopaedic Institute
Gainesville, Floridano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Composite endpoint: Acetabular Cup Position Success at 6 Weeks6 Weeks
For an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks: Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan and version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.