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Trident X3 Polyethylene Insert Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Stryker Orthopaedics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958191
First received: August 11, 2009
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
  Purpose

The primary objective of the study is to demonstrate the linear wear rates of the Trident X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.


Condition Intervention
Arthroplasty, Replacement, Hip
 Device: Trident X3 Polyethylene Insert

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident X3 Polyethylene Acetabular Inserts.

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • To determine the linear wear rates of the Trident X3 polyethylene insert by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patients in this study will have comparable results with regard to quality of life, clinical results, and radiographic stability when compared to the control device. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: May 2005
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Trident X3 Polyethylene Insert
    The purpose is to evaluate and compare the linear wear rates of the Trident X3 Polyethylene Insert to the control group at 5 years.
Detailed Description:

The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3® Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21- 75, males and non pregnant females.
  2. Signed Informed Consent.
  3. Primary total hip replacement required with cementless acetabular component.
  4. Primary diagnosis of NIDJD. Diagnosis of OA, TA, AVN, slipped capital epiphysis, pelvic fracture, failed fracture fixation or diastrophic variant.
  5. Willingness to comply with study requirements.

Exclusion Criteria:

  1. Infection of affected hip joint.
  2. Required revision of previous implant or hip fusion to the affected joint
  3. BMI > 45
  4. Neuromuscular / Neurosensory deficiency
  5. Systemic disease
  6. Immunological suppression or chronic steroids treatment in excess of 5mg
  7. Recent history of substance dependency
  8. Patient is a prisoner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958191

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Bonutti Research Inc.
Effingham, Illinois, United States, 62401
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202-5111
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
United States, Michigan
J. Wesley Mesko, MD
Lansing, Michigan, United States, 48910
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68845
United States, Pennsylvania
Greater Pittsburgh Orthopaedics Assoc
Pittsburgh, Pennsylvania, United States, 15108-4305
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: James D'Antonio, MD Greater Pittsburgh Orthopaedic Association
Principal Investigator: Benjamin Bierbaum, MD New England Baptist Hospital Deptartment of Orthopaedics
Principal Investigator: Peter Bonutti, MD Bonutti Clinic
Principal Investigator: William Capello, MD Indiana University School of Medicine
Principal Investigator: Michael Taunton, MD Mayo Clinic Department of Orthopaedic Surgery
Principal Investigator: Robert Johnson, MD University of Vermont College of Medicine Department of Orthopaedics & Rehabilitation
Principal Investigator: J. Wesley Mesko, MD Michigan Orthopaedic Center
Principal Investigator: James R Roberson, MD Emory Orthopaedics
Principal Investigator: John Wright, MD New West Orthopaedics
Principal Investigator: Daniel Ward, MD New England Baptist Hospital Department of Orthopaedics
Principal Investigator: Russell Meldrum, MD Indiana University School of Medicine
Principal Investigator: J. Andrew Parr, MD Indiana University School of Medicine
Principal Investigator: Steven Incavo, MD University of Vermont
Principal Investigator: Greg Erens, MD Emory Orthopaedics
Principal Investigator: Robert Trousdale, MD Mayo Clinic Department of Orthopaedic Surgery
Principal Investigator: Alren Hanssen, MD Mayo Clinic Department of Orthopaedic Surgery
  More Information

No publications provided

Responsible Party: Ellen Axelson/Director, Clinical Research, Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00958191     History of Changes
Other Study ID Numbers: 57
Study First Received: August 11, 2009
Last Updated: March 18, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013