Trident® Tritanium™ Acetabular Shell Revision Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00535626
First received: September 24, 2007
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.


Condition Intervention
Arthropathy of Hip
Device: Trident® Tritanium™ Acetabular Shell

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • It is expected that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years. [ Time Frame: 5 years postoperative ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: November 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trident® Tritanium™ Acetabular Shell
Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Device: Trident® Tritanium™ Acetabular Shell
To evaluate the rate of revision or pending revision 5 years after an acetabular revision using the Trident Tritanium Acetabular Shell.

Detailed Description:

Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.

Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.

Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.

It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.

The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and non-pregnant females, 21-85 years of age at the time of surgery.
  2. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
  3. Patient has signed an IRB approved study consent form.
  4. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.

Exclusion Criteria:

  1. Patient is morbidly obese, BMI > 40.
  2. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
  3. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days).
  4. Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
  5. Patient has an active or suspected latent infection on or about the hip joint.
  6. Patient is a prisoner.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535626

Locations
United States, California
Orthopedic Specialty Institute
Orange, California, United States, 92868
United States, Florida
Heekin Institute for Orthopedic Research, Inc.
Jacksonville, Florida, United States, 32204
Cedars Medical Center
Miami, Florida, United States, 33136
United States, Illinois
Illinois Bone & Joint Institute
Glenview, Illinois, United States, 60025
United States, Kentucky
University of Louisville, 201 Abraham Flexner Way, Suite 100
Louisville, Kentucky, United States, 40202
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
United States, Michigan
St Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Crystal Clinic
Akron, Ohio, United States, 44333
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
United States, Washington
Rockwood Clinic
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: Arthur Malkani, MD University of Louisville
Principal Investigator: Michael Masini, MD St Joseph Mercy Hospital
Principal Investigator: Daniel Ward, MD New England Baptist Hospital
Principal Investigator: Benjamin Bierbaum, MD New England Baptist Hospital
Principal Investigator: Kirby Hitt, MD Scott & White Memorial Hospital
Principal Investigator: Kenneth Greene, MD Crystal Clinic
Principal Investigator: Jim Kudrna, MD Illinois Bone & Joint Institute
Principal Investigator: Ivan Tomek, MD Dartmouth-Hitchcock Medical Center
Principal Investigator: Stephen Kantor, MD Dartmouth-Hitchcock Medical Center
Principal Investigator: Steven Barnett, MD Orthopedic Specialty Institute
Principal Investigator: Robert Molloy, MD The Cleveland Clinic
Principal Investigator: Joseph Zuckerman, MD NYU Hospital for Joint Diseases
Principal Investigator: Fredrick Jaffe, MD NYU Hospital for Joint Diseases
Principal Investigator: Stephen Incavo, MD The Methodist Hospital System
Principal Investigator: Timothy Lovell, MD Rockwood Clinic
Principal Investigator: Sean Scully, MD Cedars Medical Center
Principal Investigator: Amar Ranawat, MD Hospital for Special Surgery, New York
Principal Investigator: Geoffrey Westrich, MD Hospital for Special Surgery, New York
Principal Investigator: R D Heekin, MD Heekin Institute for Orthopedic Research, Inc.
Principal Investigator: Bryce Allen, MD Scott & White Memorial Hospital
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00535626     History of Changes
Other Study ID Numbers: 61
Study First Received: September 24, 2007
Last Updated: October 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014