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

Last updated: May 7, 2026
Sponsor: DePuy Orthopaedics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Osteoarthritis

Arthritis And Arthritic Pain

Treatment

EMPHASYS Cup with VHN

Clinical Study ID

NCT06631638
DSJ202006
DSJ202006
  • Ages > 21
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All hip replacement component devices are to be used according to the approvedindications.

  2. The subject is undergoing a standard of care primary uncemented hip replacement withthe EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral,anterolateral, or direct lateral approach with the subject in the lateral decubitusposition.

  3. The subject is a candidate for implantation utilizing the VELYS Hip Navigationsystem with CUPTIMIZE advanced

  4. Individuals who are able to speak, read, and comprehend the Informed ParticipantConsent Document and willing and able to provide consent for participation in thestudy and have authorized the transfer of his/her information to DePuy Synthes.

  5. Individuals who are willing and able to complete follow-up as specified by the studyprotocol.

  6. Individuals who are willing and able to complete the Subject Hip Outcomesquestionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the studyprotocol.

  7. Individuals who are not bedridden per the discretion of the investigator.

  8. Individuals who are a minimum age of 21 years at the time of consent

Exclusion

Exclusion Criteria:

  1. Active local or systemic infection.

  2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affectedlimb rendering the procedure unjustified.

  3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, therecould be considerable migration of the prosthesis or a significant chance offracture of the femoral shaft and/or the lack of adequate bone to support theimplant(s).

  4. Charcot's or Paget's disease.

  5. The Subject is a woman who is pregnant or lactating.

  6. Subject had a contralateral amputation.

  7. Previous partial hip replacement in affected hip.

  8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.

  9. Contralateral hip was replaced less than 6 months prior to surgery date.

  10. Subject is currently involved in any personal injury litigation, medical-legal orworker's compensation claims.

  11. Subject was diagnosed and is taking prescription medications to treat a musculardisorder that limits mobility due to severe stiffness and pain such as fibromyalgiaor polymyalgia.

  12. Subject has a medical condition with less than 2 years of life expectancy.

  13. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has apsychological disorder that could affect their ability to complete subject reportedquestionnaires or be compliant with follow-up requirements.

Study Design

Total Participants: 118
Treatment Group(s): 1
Primary Treatment: EMPHASYS Cup with VHN
Phase:
Study Start date:
October 24, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • UC Davis Health System

    Sacramento, California 95817
    United States

    Site Not Available

  • UC Davis Health System

    Sacramento 5389489, California 5332921 95817
    United States

    Site Not Available

  • Florida Orthopaedic Institute

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Florida Orthopaedic Institute

    Gainesville 4156404, Florida 4155751 32607
    United States

    Site Not Available

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10461
    United States

    Site Not Available

  • Northwell Health

    Lake Success 5123853, New York 5128638 11042
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • CaroMont Hospital

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Carolina Orthopaedic and Sports Medicine Center

    Gastonia, North Carolina 28054
    United States

    Active - Recruiting

  • Carolina Orthopaedic and Sports Medicine Center

    Gastonia 4467732, North Carolina 4482348 28054
    United States

    Site Not Available

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