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Trident II Tritanium Acetabular Shell Outcomes Study

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ClinicalTrials.gov Identifier: NCT02999009
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : August 23, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
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.



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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
Contact: Alana Levine, MS 201-831-5492 alana.levine@stryker.com

Locations
United States, Arizona
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Samantha Castro    520-784-6146    scastro@tucsonortho.com   
Principal Investigator: Russell Cohen, MD         
United States, Illinois
Hinsdale Orthopaedics Recruiting
Westmont, Illinois, United States, 60559
Contact: Joseph Ornelas, PhD    630-920-2323    joe.ornelas@hoasc.com   
Principal Investigator: Benjamin Domb, MD         
United States, Michigan
St. Joseph Mercy Hospital Health System Active, not recruiting
Ypsilanti, Michigan, United States, 48197
United States, New Jersey
Rothman Institute Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Reynaldo McFarlane    609-677-7015    Reynaldo.McFarlane@rothmaninstitute.com   
Contact: Andres Duque    609-407-6446    andres.duque@rothmaninstitute.com   
Principal Investigator: Fabio Orozco, MD         
Sub-Investigator: Alvin Ong, MD         
Sub-Investigator: Zachary Post, MD         
United States, New York
Hopsital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Taylor Hardy    212-606-1510    hardyt@hss.edu   
Contact: Kaitlin Carroll    646-714-6084    carrollk@HSS.EDU   
Principal Investigator: Geoffrey Westrich, MD         
Sub-Investigator: Seth Jerabek, MD         
United States, North Carolina
UNC Orthopaedics Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Brent Henderson    919-966-5495    brent_henderson@med.unc.edu   
Principal Investigator: Daniel Del Gaizo, MD         
Sponsors and Collaborators
Stryker Orthopaedics

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT02999009     History of Changes
Other Study ID Numbers: 78
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No