Who is eligible for clinical trial NCT06631638?

Participants must meet the protocol's inclusion criteria for Osteoarthritis. The stated age range is 21 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06631638 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-27

EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) (NCT06631638)

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

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: DePuy Orthopaedics

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (14 items).

Location: Florida Orthopaedic Institute — Gainesville, Florida

Age range: 21 Years

🧪 Interventions in This Study

EMPHASYS Cup with VHN (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Florida Orthopaedic Institute — Gainesville, Florida
Carolina Orthopaedic and Sports Medicine Center — Gastonia, North Carolina

📞 Contact the Study Coordinator

Phone: (610) 241-3260

Email: SFlamand@its.jnj.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗