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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the EMPHASYS hip cup is placed during total hip replacement using the VELYS navigation system and CUPTIMIZE software. It is for adults age 21 or older having a first hip replacement without bone cement. The study will compare health and X-ray results with results from other cup placement tools and methods.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 21 years old.
  • All hip replacement parts will be used for their approved purposes.
  • You will have a first hip replacement without bone cement, using an EMPHASYS cup and a CORAIL, EMPHASYS, or ACTIS stem.
  • Your surgery will use one of the allowed side or back-side approaches while you lie on your side.
  • You can have surgery using VELYS Hip Navigation with CUPTIMIZE software.
  • You can speak, read, and understand the consent form, agree to join, and allow your information to be sent to DePuy Synthes.
  • You are willing and able to attend follow-up visits and fill out the study's hip and health surveys.
  • The study doctor decides that you are not confined to bed.

Who can't join

  • You have an active infection, or muscle loss, nerve or muscle problems, or poor blood flow in the affected leg that makes surgery unsuitable.
  • Your bones are too weak to support the implant safely, or you have Charcot's disease, which damages joints, or Paget's disease, which affects bone growth.
  • You are pregnant or breastfeeding.
  • Your opposite leg has been amputated, you had a partial replacement of the affected hip, or your opposite hip was replaced less than 6 months before surgery.
  • You took part in a study of an experimental drug or device in the past 3 months.
  • You are involved in a personal injury lawsuit, a medical legal claim, or a workers' compensation claim.
  • You take prescribed medicine for a diagnosed muscle disorder that limits movement through severe stiffness and pain, such as fibromyalgia or polymyalgia, or you have a condition with a life expectancy under 2 years.
  • The study doctor believes you misuse drugs or alcohol, or have a mental health condition that could keep you from completing surveys or follow-up visits.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (2)

FL

NC