← Back to Search
Hip Replacement Device
Trident II Tritanium for Hip Replacement
Egg Harbor Township, NJ
N/A
Waitlist Available
Research Sponsored by Stryker Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease
Must not have
Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation
Patient has had previous open surgery to the affected joint, not including arthroscopy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at the performance of a hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years.
See full description
Who is the study for?
This trial is for men and women aged 18-80 who need a primary hip replacement due to non-inflammatory joint disease. They must be able to follow the study's procedures after surgery. People with neuromuscular issues, previous hip surgeries (except arthroscopy), sensitivity to device materials, inflammatory arthritis, infections in the hip area, high steroid use, severe obesity (BMI ≥ 40), or certain systemic diseases are not eligible.Check my eligibility
What is being tested?
The Trident II Tritanium Acetabular Shell is being tested in patients undergoing cementless total hip replacements. The study aims to assess its performance by comparing the rate of revision surgeries within five years against similar devices already approved by the FDA.See study design
What are the potential side effects?
While specific side effects are not listed for this device, typical risks associated with hip replacement may include pain at the site, infection risk post-surgery, potential dislocation or loosening of the implant over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old and not pregnant.
show original
Select...
I have been diagnosed with a type of arthritis that is not caused by inflammation.
show original
Select...
I am eligible for a hip replacement without cement.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I might have an infection in or near my hip where a device will be implanted.
show original
Select...
I have had open surgery on the joint in question, but not arthroscopy.
show original
Select...
I need surgery to fix or replace my previous hip implant.
show original
Select...
I have a condition like Lupus or Paget's Disease affecting my bones.
show original
Select...
I need a specific type of joint liner implant.
show original
Select...
I have been diagnosed with inflammatory arthritis.
show original
Select...
I am on long-term steroids or have a weakened immune system.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell
Radiographic Stability
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: Trident II Tritanium Acetabular ShellExperimental Treatment1 Intervention
Find a Location
Closest Location:Rothman Institute· Egg Harbor Township, NJ
Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,079 Total Patients Enrolled
Manoshi StokerStudy DirectorSr Director, Clinical Research - Stryker Joint Replacement
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I might have an infection in or near my hip where a device will be implanted.I have had open surgery on the joint in question, but not arthroscopy.I am between 18 and 80 years old and not pregnant.I need surgery to fix or replace my previous hip implant.I am willing and able to follow up with all required post-surgery check-ups and scans.I have a condition like Lupus or Paget's Disease affecting my bones.You have a condition that affects your nerves or muscles, which may make it difficult to assess if the device is safe and effective for you.You have a known allergy or sensitivity to the materials used in the medical device.I need a specific type of joint liner implant.I have been diagnosed with inflammatory arthritis.I am on long-term steroids or have a weakened immune system.I have been diagnosed with a type of arthritis that is not caused by inflammation.I am eligible for a hip replacement without cement.You have a very high body weight compared to your height (Body Mass Index of 40 or higher).
Research Study Groups:
This trial has the following groups:- Group 1: Trident II Tritanium Acetabular Shell
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.