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

Not Applicable

Recruiting

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

• Registration Number: NCT06631638
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-08
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-12
• Study Start: 2025-09-30
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite endpoint: Acetabular Cup Position Success at 6 Weeks	6 Weeks	For an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks: Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan and version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score	12 weeks	Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome.
EQ-5D-5L	12 weeks	EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Operating Room Times	Immediately after the Surgical Procedure	Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times.
Final Intraoperative Version	12 weeks	Number of participants with final intraoperative version will be reported.
Forgotten Joint Score	6 weeks	Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result.
Final Intraoperative Inclination	12 weeks	Number of participants with final intraoperative inclination will be reported.
Radiographic Outcomes	12 weeks	High quality antero-posterior and lateral radiographs of the operative hip will be obtained during the same intervals as for the clinical evaluations. Views include the Standing AP Hip, Standing AP Pelvis, and Lateral (Modified Lauenstein) Hip. Preoperatively an additional three views will be taken including Lateral flex-seated, Lateral Standing and Standing AP Pelvis.
Inclination Success	6 weeks	Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan.
Version Success	6 weeks	Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
Leg Length Discrepancy	Immediately after the Surgical Procedure	Leg Length discrepancy compared to surgeon target based on pre-operative planning
Complication Rates	90 days	90-day Complication Rate

Trial Locations

Locations (4)

UC Davis Health System; 🇺🇸 Sacramento, California, United States

Florida Orthopaedic Institute; 🇺🇸 Gainesville, Florida, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

Carolina Orthopaedic and Sports Medicine Center; 🇺🇸 Gastonia, North Carolina, United States