An interventional study of EMPHASYS Cup with VHN in Osteoarthritis, Traumatic Arthritis and Rheumatoid Arthritis, sponsored by DePuy Orthopaedics. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by DePuy Orthopaedics (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 118 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →DePuy Orthopaedics is the lead sponsor of 45 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
First submitted after DePuy Orthopaedics became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EMPHASYS Cup with Non-Invasive Navigation
Device: EMPHASYS Cup with VHN
Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation
Composite endpoint: Acetabular Cup Position Success at 6 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.
Time frame: 6 Weeks
Inclination Success
Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan.
Time frame: 6 weeks
Version Success
Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
Time frame: 6 weeks
Final Intraoperative Inclination
Number of participants with final intraoperative inclination will be reported.
Time frame: 12 weeks
Final Intraoperative Version
Number of participants with final intraoperative version will be reported.
Time frame: 12 weeks
Harris Hip Score
Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome.
Time frame: 12 weeks
Radiographic Outcomes
High quality antero-posterior and lateral radiographs of the operative hip will be obtained during the same intervals as for the clinical evaluations. Views include the Standing AP Hip, Standing AP Pelvis, and Lateral (Modified Lauenstein) Hip. Preoperatively an additional three views will be taken including Lateral flex-seated, Lateral Standing and Standing AP Pelvis.
Time frame: 12 weeks
EQ-5D-5L
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Time frame: 12 weeks
Forgotten Joint Score
Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result.
Time frame: 6 weeks
Operating Room Times
Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times.
Time frame: Immediately after the Surgical Procedure
Leg Length Discrepancy
Leg Length discrepancy compared to surgeon target based on pre-operative planning
Time frame: Immediately after the Surgical Procedure
Complication Rates
30-day Complication Rate
Time frame: 30 days
Complication Rates
90-day Complication Rate
Time frame: 90 days
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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