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Procedure

Surgical Navigation System for Osteoarthritis

N/A
Waitlist Available
Research Sponsored by DePuy Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals who are a minimum age of 21 years at the time of consent
The subject is undergoing a standard of care primary uncemented hip replacement with specific components and approach
Must not have
Active local or systemic infection
Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the surgical procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to collect information about the placement of a hip cup during hip replacement surgery using a new surgical navigation system. The data collected will be compared to data from surgeries using different techniques to evaluate how

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for the navigation system itself, typical risks associated with total hip replacement may include pain at the surgery site, infection risk post-surgery and potential complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 21 years old.
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I am having a standard hip replacement without cement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an infection.
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My affected limb cannot be operated on due to muscle loss or poor blood flow.
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I have Charcot's disease or Paget's disease.
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I have been diagnosed with osteoporosis.
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I am currently pregnant or breastfeeding.
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I have had a partial hip replacement in the affected hip.
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I have had an amputation on the opposite side of my body.
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I am diagnosed with a muscular disorder and am on prescription medication for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anteversion Success
Inclination Success
Secondary study objectives
Complication Rates
EQ-5D-5L
Forgotten Joint Score
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EMPHASYS Cup with VHNExperimental Treatment1 Intervention
EMPHASYS Cup with Non-Invasive Navigation

Find a Location

Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor
80 Previous Clinical Trials
25,839 Total Patients Enrolled
45 Trials studying Osteoarthritis
10,913 Patients Enrolled for Osteoarthritis
~79 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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