Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: EMPHASYS Cup with VHN for Osteoarthritis

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.

Official registry: https://clinicaltrials.gov/study/NCT06631638 · DePuy Orthopaedics · enrollment listed as 118

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are EMPHASYS Cup with VHN. The registry lists allocation as na. 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.

They plan to enroll about 118 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: EMPHASYS Cup with VHN

Primary outcome (registry wording): Composite endpoint: Acetabular Cup Position Success at 6 Weeks

Who it is for (from inclusion criteria)

  • Ages 21 Years to any
  • 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 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

Public study contact (from the registry)

Samantha Flamand

610-241-3260

SFlamand@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT06631638 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06631638?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06631638?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary