Surgical Navigation System for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: DePuy Orthopaedics

No Placebo Group

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.

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

+5 more

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

+10 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: EMPHASYS Cup with VHNExperimental Treatment1 Intervention

EMPHASYS Cup with Non-Invasive Navigation