Trident® Tritanium™ Acetabular Shell Revision Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
| Estimated Enrollment: | 244 |
| 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 |
Inclusion Criteria:
- Males and non-pregnant females, 21-85 years of age at the time of surgery.
- Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
- Patient has signed an IRB approved study consent form.
- Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.
Exclusion Criteria:
- Patient is morbidly obese, BMI > 40.
- Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
- Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days).
- Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- Patient has an active or suspected latent infection on or about the hip joint.
- Patient is a prisoner.
Contacts and 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 | |
| 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: | August 30, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013