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

August 27, 2026 updated by: DePuy Orthopaedics

Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Florida Orthopaedic Institute
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Carolina Orthopaedic and Sports Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. All hip replacement component devices are to be used according to the approved indications.
  2. 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.
  3. The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced
  4. 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.
  5. Individuals who are willing and able to complete follow-up as specified by the study protocol.
  6. 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.
  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 Criteria:

  1. Active local or systemic infection.
  2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
  3. 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).
  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 or worker's compensation claims.
  11. 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.
  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 a psychological disorder that could affect their ability to complete subject reported questionnaires or be compliant with follow-up requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EMPHASYS Cup with VHN
EMPHASYS Cup with Non-Invasive Navigation
Device: EMPHASYS Cup with VHN
Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint: Acetabular Cup Position Success at 6 Weeks
Time Frame: 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.
6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: 12 weeks
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.
12 weeks
EQ-5D-5L
Time Frame: 12 weeks
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
12 weeks
Forgotten Joint Score
Time Frame: 6 weeks
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.
6 weeks
Leg Length Discrepancy
Time Frame: Immediately after the Surgical Procedure
Leg Length discrepancy compared to surgeon target based on pre-operative planning
Immediately after the Surgical Procedure
Complication Rates
Time Frame: 30 days
30-day Complication Rate
30 days
Complication Rates
Time Frame: 90 days
90-day Complication Rate
90 days
Inclination Success
Time Frame: 6 weeks
Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan.
6 weeks
Version Success
Time Frame: 6 weeks
Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
6 weeks
Final Intraoperative Inclination
Time Frame: 12 weeks
Number of participants with final intraoperative inclination will be reported.
12 weeks
Final Intraoperative Version
Time Frame: 12 weeks
Number of participants with final intraoperative version will be reported.
12 weeks
Radiographic Outcomes
Time Frame: 12 weeks
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.
12 weeks
Operating Room Times
Time Frame: Immediately after the Surgical Procedure
Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times.
Immediately after the Surgical Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSJ202006 (DePuy Orthopaedics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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