OsteoarthritisNCT06631638
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
A study testing EMPHASYS Cup with VHN in people with Osteoarthritis and Traumatic Arthritis, run by DePuy Orthopaedics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- EMPHASYS Cup with VHN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- Subject has a medical condition with less than 2 years of life expectancy.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Florida Orthopaedic Institute
Gainesville, Florida, 32607
- Recruiting
Carolina Orthopaedic and Sports Medicine Center
Gastonia, North Carolina, 28054
About this study
Official title: Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
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.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congential Hip Dysplasia, Avascular Necrosis of the Femoral Head, Certain Cases of Ankylosis
- Being tested
- EMPHASYS Cup with VHN
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPHASYS Cup with VHNDevice
Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation
| Study group | Role | What they receive |
|---|---|---|
| EMPHASYS Cup with VHN | Other | EMPHASYS Cup with Non-Invasive Navigation Receives: Device: EMPHASYS Cup with VHN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: Acetabular Cup Position Success at 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.
Measured: 6 Weeks
Secondary outcomes (12)
Inclination Success
Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan.
Measured: 6 weeks
Version Success
Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
Measured: 6 weeks
Final Intraoperative Inclination
Number of participants with final intraoperative inclination will be reported.
Measured: 12 weeks
Final Intraoperative Version
Number of participants with final intraoperative version will be reported.
Measured: 12 weeks
Harris Hip Score
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.
Measured: 12 weeks
Radiographic Outcomes
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.
Measured: 12 weeks
EQ-5D-5L
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Measured: 12 weeks
Forgotten Joint Score
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.
Measured: 6 weeks
Operating Room Times
Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times.
Measured: Immediately after the Surgical Procedure
Leg Length Discrepancy
Leg Length discrepancy compared to surgeon target based on pre-operative planning
Measured: Immediately after the Surgical Procedure
Complication Rates
30-day Complication Rate
Measured: 30 days
Complication Rates
90-day Complication Rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start24 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631638
- Sponsor's protocol ID
- DSJ202006
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
- ClinicalTrials.gov ID
- NCT06631638
- Acronym / sponsor ID
- DSJ202006
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congential Hip Dysplasia, Avascular Necrosis of the Femoral Head, Certain Cases of Ankylosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMPHASYS Cup with VHN | Other | Device: EMPHASYS Cup with VHNEMPHASYS Cup with Non-Invasive Navigation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPHASYS Cup with VHNTotal Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation | Device | EMPHASYS Cup with VHN |
Primary outcome
Composite endpoint: Acetabular Cup Position Success at 6 Weeks
Time frame: 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.
12 secondary outcomes
Inclination Success
Time frame: 6 weeks
Version Success
Time frame: 6 weeks
Final Intraoperative Inclination
Time frame: 12 weeks
Final Intraoperative Version
Time frame: 12 weeks
Harris Hip Score
Time frame: 12 weeks
Radiographic Outcomes
Time frame: 12 weeks
EQ-5D-5L
Time frame: 12 weeks
Forgotten Joint Score
Time frame: 6 weeks
Operating Room Times
Time frame: Immediately after the Surgical Procedure
Leg Length Discrepancy
Time frame: Immediately after the Surgical Procedure
Complication Rates
Time frame: 30 days
Complication Rates
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPHASYS Cup with VHN in people with Osteoarthritis and Traumatic Arthritis, run by DePuy Orthopaedics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Flamand (610-241-3260, SFlamand@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint: Acetabular Cup Position Success at 6 Weeks (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.