Osteoarthritis study: EMPHASYS Cup with VHN
Official title EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
ClinicalTrials.gov ID: NCT06631638
What this study is testing
- What it's testing
- The study will collect X‑ray and clinical data to see how well the EMPHASYS cup is positioned when guided by the Velys hip navigation system, compared with other positioning methods.
- Who it's for
- Adults who need a total hip replacement for osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, or certain ankylosis cases.
- What's involved
- Participants will have a total hip replacement using the EMPHASYS cup guided by the Velys navigation system. X‑ray scans and clinical follow‑ups will be taken to evaluate cup placement.
- Time commitment
- The study lasts until the final follow‑up after surgery, with several clinic visits and X‑ray appointments scheduled during recovery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join 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...
- 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...
- Individuals who are willing and able to complete follow-up as specified by the study protocol.
You likely can't join 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...
- Charcot's or Paget's disease.
- The Subject is a woman who is pregnant or lactating.
- Subject had a contralateral amputation.
See the full eligibility criteria
- 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...
- 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Gainesville, Florida, United States
- Gastonia, North Carolina, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gainesville, Florida, United States; Gastonia, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.