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NCT06631638 · ClinicalTrials.gov registry record · NA
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
A NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by DePuy Orthopaedics.
- Recruiting
- Registry status
- NA
- Development phase
- 118
- Enrollment target
- 5
- Study locations
NCT06631638: Recruiting NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by DePuy Orthopaedics.
NCT06631638 is a NA study of Rheumatoid Arthritis and Osteoarthritis that is actively recruiting participants, run by DePuy Orthopaedics. The registered enrollment target is 118 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06631638, a NA study of Rheumatoid Arthritis and Osteoarthritis, is actively recruiting participants, sponsored by DePuy Orthopaedics.
- RECRUITING
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE EMPHASYS Cup with VHN
Study Locations (5)
New York
- Northwell Health - Lake Success
- Montefiore Medical Center - The Bronx
California
- UC Davis Health System - Sacramento
Florida
- Florida Orthopaedic Institute - Gainesville
North Carolina
- Carolina Orthopaedic and Sports Medicine Center - Gastonia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT06631638 shows while recruiting
NCT06631638 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower).
The record links to 6 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which EMPHASYS Cup with VHN is the first listed.
NCT06631638 lists 5 locations in 4 states (New York, California, Florida).
Frequently Asked Questions
What is clinical trial NCT06631638 about?
NCT06631638 is a clinical study titled "EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))". 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 H...
What is the current status of trial NCT06631638?
This trial is currently recruiting. It is a NA study. The enrollment target is 118 participants. The study started on 2025-10-24. Estimated completion is 2027-12-31.
What conditions does trial NCT06631638 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Head, Certain Cases of Ankylosis.
What interventions are being tested in trial NCT06631638?
The interventions under investigation include: EMPHASYS Cup with VHN (DEVICE).
Who is sponsoring clinical trial NCT06631638?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06631638 being conducted?
This trial has 5 study locations across California, Florida, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06631638's enrollment target sits among peer trials
118 113th of 197 higher than 85 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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