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

NCT06631638 | Recruiting FDA Device

• 1 other identifier: DSJ202006
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Congential Hip Dysplasia; Certain Cases of Ankylosis; Traumatic Arthritis; Avascular Necrosis of the Femoral Head

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Weeks

Secondary Outcomes (12)

• Inclination Success

  6 weeks

• Version Success

  6 weeks

• Final Intraoperative Inclination

  12 weeks

• Final Intraoperative Version

  12 weeks

• Harris Hip Score

  12 weeks

Study Arms (1)

EMPHASYS Cup with VHN

OTHER

EMPHASYS Cup with Non-Invasive Navigation

Device: EMPHASYS Cup with VHN

Interventions

EMPHASYS Cup with VHN DEVICE

Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation

EMPHASYS Cup with VHN

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (5)

UC Davis Health System

Sacramento, California, 95817, United States

NOT YET RECRUITING

Florida Orthopaedic Institute

Gainesville, Florida, 32607, United States

RECRUITING

Northwell Health

Lake Success, New York, 11042, United States

NOT YET RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

NOT YET RECRUITING

Carolina Orthopaedic and Sports Medicine Center

Gastonia, North Carolina, 28054, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samantha Flamand

CONTACT

610-241-3260; SFlamand@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 8, 2024
• Study Start: October 24, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (5)