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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

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 below
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I have been diagnosed with a non-inflammatory joint disease.
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I am eligible for a hip replacement without using cement.
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I am 18 or older and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I might have an infection in or near my hip where a device will be implanted.
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I am on long-term steroids or have a weakened immune system.
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I need surgery to fix or replace my previous hip implant.
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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

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 more

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
20,201 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

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
~17 spots leftby Jul 2025
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