← 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
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 is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 7, 8, 9, and 10 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
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.

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.
Select...
I am on long-term steroids or have a weakened immune system.
Select...
I need surgery to fix or replace my previous hip implant.
Select...
I have a condition like Lupus or Paget's Disease affecting my bones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 7, 8, 9, and 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 7, 8, 9, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absence of Acetabular Revision
Secondary study objectives
Acetabular Shell Radiographic Stability
EuroQol Five-dimensional (EQ-5D)
Follow-Up Questionnaire
+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: Tritanium® Primary Acetabular ShellExperimental Treatment1 Intervention
Tritanium® Primary Acetabular Shell

Find a Location

Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,213 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
John Diana, MDPrincipal InvestigatorAdventist Health St. Helena
Stephen Duncan, MDPrincipal InvestigatorUniversity of Kentucky Research Foundation
1 Previous Clinical Trials
73 Total Patients Enrolled
Stephen Raterman, MDPrincipal InvestigatorFlorida Medical Clinic
Kevin Kopko, MDPrincipal InvestigatorSyracuse Orthopedic Specialists, P.C.
John Noble, MDPrincipal InvestigatorCenter for Orthopaedics and Spine, LLP
1 Previous Clinical Trials
680 Total Patients Enrolled
Carmen Crofoot, MDPrincipal InvestigatorNorthern Light Eastern Maine Medical Center
Brock Lindsey, MDPrincipal InvestigatorWest Virginia University

Media Library

Tritanium® Primary Acetabular Shell (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT01063751 — N/A
Hip Replacement Research Study Groups: Tritanium® Primary Acetabular Shell
Hip Replacement Clinical Trial 2023: Tritanium® Primary Acetabular Shell Highlights & Side Effects. Trial Name: NCT01063751 — N/A
Tritanium® Primary Acetabular Shell (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01063751 — N/A
~16 spots leftby Jan 2026
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.
Back to top