Trident® Tritanium™ Acetabular Shell Revision Study



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 85
Updated:11/22/2017
Start Date:November 2006
End Date:September 2016

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A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell

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

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.

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.
We found this trial at
15
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Jacksonville, FL
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1400 12th Ave
Miami, Florida 33136
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Miami, FL
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Akron, Ohio 44333
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Akron, OH
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Boston, Massachusetts 02120
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Boston, MA
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Glenview, Illinois 60025
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Glenview, IL
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Houston, Texas 77030
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Houston, TX
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201 Abraham Flexner Way
Louisville, Kentucky 40202
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Louisville, KY
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New York, New York 10003
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New York, NY
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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Orange, California 92868
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Orange, CA
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Spokane, Washington 99204
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Spokane, WA
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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Temple, TX
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Ypsilanti, Michigan 48197
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Ypsilanti, MI
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