Surgical Navigation System for Osteoarthritis

Recruiting at 4 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

Must not be taking: Muscular disorder medications

Disqualifiers: Infection, Osteoporosis, Pregnancy, Amputation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for placing a hip component called the EMPHASYS cup during hip replacement surgery. The VELYS hip navigation system, a non-invasive tool, assists surgeons in positioning the cup more accurately. The trial aims to compare this new method's performance to traditional techniques. Suitable participants are those undergoing standard, uncemented hip replacement surgery using the EMPHASYS cup. As an unphased trial, it offers patients the chance to contribute to innovative surgical advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.

What prior data suggests that this surgical navigation system is safe for hip replacement surgery?

Research has shown that the EMPHASYS™ hip 'cup' and the VELYS™ navigation system aim to enhance hip replacement surgeries. Although specific study details on safety are not provided, the EMPHASYS™ system belongs to a new generation of hip solutions, suggesting improvements in performance. When a treatment is in a "Not Applicable" phase in a trial, the focus typically shifts to its effectiveness or usage rather than basic safety, implying that initial safety assessments have been completed. Additionally, similar navigation systems have not extended surgery duration, indicating positive outcomes for both safety and efficiency. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPHASYS Cup with VHN because it offers a non-invasive navigation system for treating osteoarthritis, which could enhance the precision of surgical interventions. Unlike traditional surgical procedures that rely heavily on the surgeon's experience and visual estimates, this system integrates advanced technology to guide the placement of implants more accurately. This could potentially improve outcomes, reduce recovery times, and lessen the risk of complications, making it a highly promising advancement over existing approaches like total knee replacements or hip arthroplasty.

What evidence suggests that this surgical navigation system is effective for osteoarthritis?

Research has shown that the EMPHASYS™ acetabular shell, used in this trial, can be accurately positioned with the VELYS™ hip navigation system. This non-invasive system requires no cuts or incisions and assists surgeons in placing the hip cup with greater precision. Accurate placement is crucial, as it can enhance joint movement and reduce pain for patients with osteoarthritis. Early findings suggest that this navigation system does not extend surgery time, which is beneficial. Overall, these tools aim to improve outcomes in hip replacement surgeries. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with various hip conditions such as avascular necrosis, arthritis, osteoarthritis, ankylosis, developmental dysplasia of the hip, congenital hip dislocation, rheumatoid arthritis, and hip dysplasia who require a total hip replacement.

Inclusion Criteria

I can understand and agree to the study's consent form and allow my information to be shared.

I am at least 21 years old.

Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol

Exclusion Criteria

I have been diagnosed with osteoporosis.

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

Subject has participated in a clinical investigation with an investigational product in the last three months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo total hip replacement surgery using the VELYS™ hip navigation system

1 day

1 visit (in-person)

Immediate Post-Operative Assessment

Assessment of leg length discrepancy and operating room times immediately after surgery

Immediately after the Surgical Procedure

Treatment Follow-up

Participants are monitored for inclination and anteversion success, and functional outcomes using various scores

6 weeks

Extended Follow-up

Further monitoring of functional and health status using Harris Hip Score, EQ-5D-5L, and radiographic outcomes

12 weeks

Long-term Follow-up

Monitoring of complication rates over a 90-day period

90 days

What Are the Treatments Tested in This Trial?

Interventions

• EMPHASYS Cup with VHN

Trial Overview The study tests the placement of EMPHASYS acetabular shell in total hip replacements using VELYS Hip Navigation system. It compares this non-invasive navigation method's effectiveness to other cup positioning techniques.

How Is the Trial Designed?

Group I: EMPHASYS Cup with VHN Experimental Treatment 1 Intervention

EMPHASYS Cup with Non-Invasive Navigation

Who Is Running the Clinical Trial?

DePuy Orthopaedics

Lead Sponsor

Trials

81

Recruited

26,000+

Massimo Calafiore

DePuy Orthopaedics

Chief Executive Officer since 2023

MBA from Harvard Business School

Dr. Michael Stein

DePuy Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06631638

EMPHASYS Cup Positioning in THA With Non-Invasive ... Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess ...

2. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/osteoarthritis

Osteoarthritis clinical trials at University of California Health The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup ...

3. jnjmedtech.com jnjmedtech.com/en-US/products/enabling-tech/velys-hip-solutions

VELYS™ Hip Solutions | DePuy Synthes - J&J MedTech VELYS™ Hip Navigation is a non-invasive, integrated software system for pre-operative planning and intraoperative execution that is designed to provide accurate ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12179719/

Evaluating the Impact of Mixed-Reality Technology on ... A MR navigation system for THA did not appear to prolong operative times when utilized. Further studies are needed to determine its effect on long-term ...

5. biotechhunter.com biotechhunter.com/trials/NCT06631638

EMPHASYS Cup Positioning in THA With Non-Invasive ... EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)). NA RecruitingINTERVENTIONAL. Enrollment. 118. Participants. Timeline.

6. jnjmedtech.com jnjmedtech.com/system/files/pdf/233138-221118%20EMPHASYS%20Acetabular%20Solutions%20Design%20Rationale%20Final.pdf

EMPHASYS™ EMPHASYS™ Hip Solutions is the next generation system designed through purposeful component improvements and.