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

Launched by DEPUY ORTHOPAEDICS · Oct 7, 2024

Keywords

ClinConnect Summary

The EMPHASYS Cup Position in THA With Non-Invasive Navigation trial is studying a new way to place the hip 'cup' during total hip replacement surgery. This surgery is often needed for people with conditions like arthritis or hip dysplasia. The trial will use a special tool called the VELYS™ hip navigation system to help guide the placement of the EMPHASYS™ acetabular shell, which is part of the hip implant. Researchers will collect information on how well this method works by comparing it to other ways of positioning the hip cup.

To participate in this trial, you need to be at least 21 years old and planning to have a hip replacement surgery using specific devices and techniques. You should be able to understand and sign consent forms, and complete follow-up assessments about your hip's performance. However, some people may not qualify, such as those with active infections or certain medical conditions that could complicate the surgery. If eligible, participants can expect to contribute to important research that may improve hip surgery outcomes for future patients.

Gender

ALL

Eligibility 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 (and CUPTIMIZE pre-operative planning tool within the VELYS system).
• • 4. Individuals who are able to speak, read, and comprehend the Informed Consent Document and willing and able to provide informed subject 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.