EMPHASYS cup placement with VELYS non-invasive hip navigation in total hip replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study collects clinical and radiographic (X-ray) data on acetabular cup position when the EMPHASYS cup is implanted using the VELYS Hip Navigation system with CUPTIMIZE Advanced Hip‑Spine Analysis. Participants are adults undergoing primary uncemented total hip replacement with an EMPHASYS cup and a CORAIL, EMPHASYS, or ACTIS stem via posterolateral, anterolateral, or direct lateral approaches in the lateral decubitus position. Outcomes include measured cup positioning on imaging and patient-reported outcome questionnaires (FJS-12, EQ-5D-5L, Hip Evaluation), with collected data compared to implantations using other cup positioning instruments and techniques. The multi-center design aims to characterize navigation-assisted placement performance in routine surgical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Florida Orthopaedic Institute
  Gainesville, Florida, United States Recruiting
• Carolina Orthopaedic and Sports Medicine Center
  Gastonia, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Samantha Flamand
• Email: SFlamand@its.jnj.com
• Phone: 610-241-3260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.