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

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

This research tests whether using the VELYS non-invasive hip navigation system helps surgeons place the EMPHASYS acetabular cup more accurately during total hip replacement for people with osteoarthritis or other hip conditions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: DePuy Orthopaedics (Industry-sponsored)
• Locations: 5 sites (Sacramento, California and 4 other locations)
• Trial ID: NCT06631638 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults eligible for a primary uncemented total hip replacement using the EMPHASYS cup and an approved stem who can read and understand the consent, provide consent, and complete scheduled follow-up and outcome questionnaires.

Not a fit: Patients having cemented or revision hip replacements, those receiving a different cup system, or individuals unable to complete follow-up visits or outcome questionnaires are unlikely to receive benefit from this specific navigation-guided EMPHASYS protocol.

Why it matters

Potential benefit: If successful, navigation-guided cup placement could improve implant alignment and reduce risks such as dislocation, abnormal wear, and the need for revision, leading to better function and longer implant life.

How similar studies have performed: Previous studies of navigation and computer-assisted hip systems have often shown improved component placement accuracy, though evidence for consistent long-term clinical benefit is mixed and device-specific data remain limited.

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.

Where this trial is running

Sacramento, California and 4 other locations

• UC Davis Health System — Sacramento, California, United States (Not_yet_recruiting)
• Florida Orthopaedic Institute — Gainesville, Florida, United States (Recruiting)
• Northwell Health — Lake Success, New York, United States (Not_yet_recruiting)
• Montefiore Medical Center — The Bronx, New York, United States (Not_yet_recruiting)
• Carolina Orthopaedic and Sports Medicine Center — Gastonia, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Samantha Flamand

Conditions Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis; Congential Hip Dysplasia; Avascular Necrosis of the Femoral Head; Certain Cases of Ankylosis