Trident II Revision Outcomes Study

Last updated: November 30, 2023
Sponsor: Stryker Orthopaedics
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Trident II Tritanium Acetabular Shell for Revision

Clinical Study ID

NCT04317586
79
  • Ages 18-85
  • All Genders

Study Summary

The purpose of this study is to review the performance and success rate of an FDA cleared 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 IRB approved, study specific Informed Patient Consent Form.

B. Patient is a male or non-pregnant female age 18-85 years of age at the time of studydevice implantation. C. Patient is a candidate for a revision of a failed acetabular component with a cementlessacetabular component. D. Patient is willing and able to comply with postoperative scheduled clinical andradiographic evaluations.

Exclusion

Exclusion Criteria:

E. Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with InflammatoryArthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active orsuspected latent infection in or about the affected hip joint at time of study deviceimplantation. I. Patient has a mental or neuromuscular disorder which would create an unacceptable riskof prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

J. Patient has compromised bone stock which cannot provide adequate support and/or fixationto the prosthesis.

K. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolicdisorder (e.g. Paget's Disease) leading to progressive bone deterioration. L. Patient is immunologically suppressed or receiving steroids in excess of normalphysiological requirements (e.g. > 30 days). M. Patient has a known sensitivity to devicematerials. N. Patient is a prisoner.

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: Trident II Tritanium Acetabular Shell for Revision
Phase:
Study Start date:
June 23, 2020
Estimated Completion Date:
January 27, 2023

Connect with a study center

  • Southeast Orthopedic Specialists

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Lafayette General Orthopedic Center

    Lafayette, Louisiana 70506
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Massachusetts

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Beaumont Hospital Research Institute

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • The Orthopaedic & Fracture Clinic, P.A.

    Mankato, Minnesota 56001
    United States

    Site Not Available

  • Reno Orthopedic Center Foundation

    Reno, Nevada 89503
    United States

    Site Not Available

  • OrthoNY

    Albany, New York 12205
    United States

    Site Not Available

  • Syracuse Orthopedic Specialists

    New York, New York 13214
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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