Trident II Tritanium Acetabular Shell Outcomes Study

Last updated: December 2, 2024
Sponsor: Stryker Orthopaedics
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Trident II Tritanium Acetabular Shell

Clinical Study ID

NCT02999009
78
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to review the performance and success rate of an FDA approved cementless 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. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.

Eligibility Criteria

Inclusion

Inclusion Criteria:

A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.

B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.

C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.

D. Patient is a candidate for a primary cementless total hip replacement.

E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusion

Exclusion Criteria:

F. Patient has a Body Mass Index (BMI) ≥ 40.

G. Patient is diagnosed with Inflammatory Arthritis.

H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.

I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.

J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.

M. Patient has had previous open surgery to the affected joint, not including arthroscopy.

N. Patient requires implantation of a constrained liner.

O. Patient has a known sensitivity to device materials.

P. Patient is a prisoner.

Study Design

Total Participants: 383
Treatment Group(s): 1
Primary Treatment: Trident II Tritanium Acetabular Shell
Phase:
Study Start date:
January 20, 2017
Estimated Completion Date:
March 31, 2031

Connect with a study center

  • Tucson Orthopaedic Institute

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Southeast Orthopedic Specialists

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • American Hip Institute

    Des Plaines, Illinois 60018
    United States

    Site Not Available

  • Hinsdale Orthopaedics

    Westmont, Illinois 60559
    United States

    Site Not Available

  • Center for Orthopaedics and Spine, LLC

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • St. Joseph Mercy Hospital Health System

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Rothman Institute

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Northwell Health, Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • UNC Orthopaedics

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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