EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))

Recruiting now · Not applicable

Conditions studied: Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congential Hip Dysplasia, Avascular Necrosis of the Femoral Head, Certain Cases of Ankylosis

In brief

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.

Key facts

Study ID: NCT06631638
Run by: DePuy Orthopaedics
People needed: 118
Starts: 2025-10-24
Expected to finish: 2027-12-31
Last updated by the study team: 2026-07-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All hip replacement component devices are to be used according to the approved indications.
The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.
The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced
Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
Individuals who are willing and able to complete follow-up as specified by the study protocol.
Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.
Individuals who are not bedridden per the discretion of the investigator.
Individuals who are a minimum age of 21 years at the time of consent

You may not qualify if…

Active local or systemic infection.
Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
Charcot's or Paget's disease.
The Subject is a woman who is pregnant or lactating.
Subject had a contralateral amputation.
Previous partial hip replacement in affected hip.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
Contralateral hip was replaced less than 6 months prior to surgery date.
Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
Subject has a medical condition with less than 2 years of life expectancy.
Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete subject reported questionnaires or be compliant with follow-up requirements.

Where it is running

Florida Orthopaedic Institute — Gainesville, Florida, United States (enrolling)
Carolina Orthopaedic and Sports Medicine Center — Gastonia, North Carolina, United States (enrolling)
UC Davis Health System — Sacramento, California, United States
Northwell Health — Lake Success, New York, United States
Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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