Surgical Navigation System for Osteoarthritis

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

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™ 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.

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 data supports the effectiveness of the treatment EMPHASYS Cup with VHN for osteoarthritis?

The research shows that using navigation systems, like the electromagnetic navigation (EMN) system, improves the precision and accuracy of placing components in hip surgeries compared to doing it by hand. This suggests that similar navigation systems could help ensure precise placement of the EMPHASYS Cup, potentially improving outcomes for osteoarthritis treatment. ^{1 2 3 4 5}

Is the surgical navigation system for osteoarthritis safe for humans?

The studies reviewed focus on the accuracy and precision of navigation systems in hip surgeries, but they do not report any increase in complications or operative time, suggesting that these systems are generally safe for use in humans. ^{1 5 6 7 8}

How is the EMPHASYS Cup with VHN treatment for osteoarthritis different from other treatments?

The EMPHASYS Cup with VHN treatment is unique because it uses a surgical navigation system that does not rely on CT scans, making it less invasive and potentially more accurate in placing hip components during surgery. This system helps improve the positioning of the components, which can reduce the risk of dislocation and improve the longevity of the hip replacement. ^{3 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of Computed Tomography-Based Navigation for Cup Placement in Revision Total Hip Arthroplasty. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Intellijoint HIP®: a 3D mini-optical navigation tool for improving intraoperative accuracy during total hip arthroplasty. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Augmented marker tracking for peri-acetabular osteotomy surgery. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of three-dimensional mini-optical portable navigation and accelerometer-based portable navigation system for acetabular cup placement during total hip arthroplasty. [2023]

5. Sweden pubmed.ncbi.nlm.nih.gov

Electromagnetic navigation system for acetabular component placement in total hip arthroplasty is more precise and accurate than the freehand technique: a randomized, controlled trial with 84 patients. [2021]

6. France pubmed.ncbi.nlm.nih.gov

EOS-based cup navigation: Randomised controlled trial in 78 total hip arthroplasties. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Application of 3D printing guide plate in total hip arthroplasty for developmental dysplasia of the hip]. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Five years of experience in hip navigation using a mini-invasive anterior approach. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Improving alignment in total knee arthroplasty: a cadaveric assessment of a surgical navigation tool with computed tomography imaging. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Orientation and depth estimation for femoral components using image sensor, magnetometer and inertial sensors in THR surgeries. [2020]

11. England pubmed.ncbi.nlm.nih.gov

A hybrid CT-free navigation system for total hip arthroplasty. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted total hip navigation. [2008]