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Trident II Tritanium Acetabular Shell Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02999009
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Brief 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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Device: Trident II Tritanium Acetabular Shell Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Trident II Tritanium Acetabular Shell Device: Trident II Tritanium Acetabular Shell
A hemispherical acetabular shell indicated for cementless application.




Primary Outcome Measures :
  1. Absence of Revision for the Trident II Tritanium Acetabular Shell [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell [ Time Frame: 10 years ]
    Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated

  2. Radiographic Stability [ Time Frame: 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years ]
    Numerous parameters will be reviewed by zone, including radiolucency and migration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999009


Contacts
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Contact: Alice Cruz 201-831-5859 alice.cruz@stryker.com
Contact: Jillian Mohn 201-831-5496 jillian.mohn@stryker.com

Locations
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United States, Arizona
Tucson Orthopaedic Institute Active, not recruiting
Tucson, Arizona, United States, 85712
United States, Florida
Southeast Orthopedic Specialists Recruiting
Jacksonville, Florida, United States, 32204
Contact: Daniel McMahon    904-634-0640    dmcmahon@se-ortho.com   
Principal Investigator: Max Lincoln, MD         
United States, Illinois
American Hip Institute Active, not recruiting
Des Plaines, Illinois, United States, 60018
United States, Louisiana
Center for Orthopaedics and Spine, LLC Recruiting
Lake Charles, Louisiana, United States, 70605
Contact: DeAnne Winey    337-312-8405    DWiney@imperialhealth.com   
Principal Investigator: John Noble, MD         
United States, Michigan
St. Joseph Mercy Hospital Health System Active, not recruiting
Ypsilanti, Michigan, United States, 48197
United States, New Jersey
Rothman Institute Active, not recruiting
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Hospital for Special Surgery Active, not recruiting
New York, New York, United States, 10021
Northwell Health, Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: John Tarazi       JTarazi@northwell.edu   
Principal Investigator: Jason Oh, MD         
Sub-Investigator: Michael Mont, MD         
United States, North Carolina
UNC Orthopaedics Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Stryker Orthopaedics
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Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT02999009    
Other Study ID Numbers: 78
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes