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Hip Replacement Device

Trident II Tritanium for Hip Replacement

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study 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.

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 below

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I am between 18 and 80 years old and not pregnant.

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I have been diagnosed with a type of arthritis that is not caused by inflammation.

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I am eligible for a hip replacement without cement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, 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 Revision for the Trident II Tritanium Acetabular Shell

Secondary outcome measures

All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell

Radiographic Stability

Trial Design

1Treatment groups

Experimental Treatment

Group I: Trident II Tritanium Acetabular ShellExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor

77 Previous Clinical Trials

19,850 Total Patients Enrolled

Manoshi StokerStudy DirectorSr Director, Clinical Research - Stryker Joint Replacement

Media Library

Trident II Tritanium Acetabular Shell (Hip Replacement Device) Clinical Trial Eligibility Overview. Trial Name: NCT02999009 — N/A

Hip Replacement Research Study Groups: Trident II Tritanium Acetabular Shell

Hip Replacement Clinical Trial 2023: Trident II Tritanium Acetabular Shell Highlights & Side Effects. Trial Name: NCT02999009 — N/A

Trident II Tritanium Acetabular Shell (Hip Replacement Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02999009 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I a suitable candidate for this clinical experiment?

"This experiment is open to 360 individuals aged 18-80 that have arthroplasty. To be eligible, participants must sign an Informed Patient Consent Form approved by the Institutional Review Board and should either be male or nonpregnant female candidates for a primary cementless total hip replacement procedure."

Answered by AI

What is the intake capacity of this research endeavor?

"Affirmative, clinicaltrials.gov displays that this research initiative is currently in the process of locating participants. The trial was initially advertised on January 20th 2017 and underwent its most recent update on August 26 2022. Furthermore, the study requires 360 people to be recruited from two separate medical centres."

Answered by AI

Is the enrollment period for this trial still open?

"Clinicaltrials.gov confirms this study's current active recruitment status, which began on January 20th 2017 and was most recently modified on August 26th 2022."

Answered by AI