Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06631638 | RECRUITING | Osteoarthritis

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

DePuy Orthopaedics

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.

Condition or disease

Osteoarthritis

Traumatic Arthritis

Rheumatoid Arthritis

Congential Hip Dysplasia

Avascular Necrosis of the Femoral Head

Certain Cases of Ankylosis

Intervention/treatment

EMPHASYS Cup with VHN

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 118 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
Actual Study Start Date : 2025-10-24
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))

Location Details

NCT06631638

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

UC Davis Health System

Sacramento, California, United States, 95817

RECRUITING

United States, Florida

Florida Orthopaedic Institute

Gainesville, florida, United States, 32607

NOT YET RECRUITING

United States, New York

Northwell Health

Lake Success, New York, United States, 11042

NOT YET RECRUITING

United States, New York

Montefiore Medical Center

The Bronx, New York, United States, 10461

RECRUITING

United States, North Carolina

Carolina Orthopaedic and Sports Medicine Center

Gastonia, North Carolina, United States, 28054