Your session is about to expire
← Back to Search
Orthopedic Implant
Tritanium Acetabular Shell for Hip Replacement
N/A
Waitlist Available
Led By Daniel Del Gaizo, MD
Research Sponsored by Stryker Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
Patient is a candidate for a primary cementless total hip replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 7, 8, 9, and 10 years
Awards & highlights
Study Summary
This trial will compare two types of hip replacement technology to see which is more successful. One uses a Tritanium Acetabular Shell, and the other uses a similar technology. The study will last for five years.
Who is the study for?
This trial is for adults over 18 needing a primary cementless hip replacement due to non-inflammatory degenerative joint disease. Participants must be able to follow the study's procedures and visits. It excludes those with active infections, immune suppression, prior hip replacements or fusions, BMI ≥ 40, systemic diseases affecting bones, material sensitivities, or neuromuscular deficiencies.Check my eligibility
What is being tested?
The Tritanium® Acetabular Shell is being tested in patients undergoing total hip replacement. The study compares two types of bearing surfaces: one group receives the X3® polyethylene insert alone; another gets the MDMTM liner with an ADM/MDMTM X3® insert. Success rates will be measured against similar technologies.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with hip replacement may include pain at the site of surgery, infection risk around the implant area, possible dislocation or loosening of implants over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a non-inflammatory joint disease.
Select...
I am eligible for a hip replacement without using cement.
Select...
I am 18 or older and not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 7, 8, 9, and 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 7, 8, 9, and 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absence of Acetabular Revision
Secondary outcome measures
Acetabular Shell Radiographic Stability
EuroQol Five-dimensional (EQ-5D)
Follow-Up Questionnaire
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tritanium® Primary Acetabular ShellExperimental Treatment1 Intervention
Tritanium® Primary Acetabular Shell
Find a Location
Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
77 Previous Clinical Trials
19,999 Total Patients Enrolled
Daniel Del Gaizo, MDPrincipal InvestigatorUniversity of North Carolina
1 Previous Clinical Trials
16 Total Patients Enrolled
Timothy H Izant, MDPrincipal InvestigatorCrouse Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a non-inflammatory joint disease.You have a condition that affects your muscles or nerves, which may make it difficult to assess how safe and effective the device is for you.I am eligible for a hip replacement without using cement.I might have an infection in or near my hip where a device will be implanted.I am on long-term steroids or have a weakened immune system.I am 18 or older and not pregnant.You are known to have an allergic reaction to the materials used in the medical device.I need surgery to fix or replace my previous hip implant.I am willing and able to follow through with all after-surgery check-ups and rehab.You have a very high body weight for your height, known as severe obesity.I have a condition like Lupus or Paget's Disease affecting my bones.
Research Study Groups:
This trial has the following groups:- Group 1: Tritanium® Primary 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this trial being implemented in various venues?
"The current study is accruing patients from Mercy Medical Group in Sacramento, California, University of North carolina in Chapel Hill, North Carolina and Florida Medical Clinic in Tampa, Florida plus nine further sites."
Answered by AI
Is there still room for participants in this trial?
"Data on clinicaltrials.gov suggests that recruitment for this particular medical study has been halted; it was initially posted in July of 2011 and last edited in January 2022. However, there are an additional 26 trials with open enrollment at the present moment."
Answered by AI
Who else is applying?
What site did they apply to?
Florida Medical Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger