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.
This study is a prospective, open-label, post-market, non-randomized evaluation of the Trident II Tritanium Acetabular Shell for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
383
A hemispherical acetabular shell indicated for cementless application.
Tucson Orthopaedic Institute
Tucson, Arizona, United States
Southeast Orthopedic Specialists
Jacksonville, Florida, United States
American Hip Institute
Des Plaines, Illinois, United States
Center for Orthopaedics and Spine, LLC
Absence of Revision for the Trident II Tritanium Acetabular Shell
To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components.
Time frame: 5 years
All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell
Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated
Time frame: 10 years
Radiographic Stability
Numerous parameters will be reviewed by zone, including radiolucency and migration.
Time frame: 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years
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Lake Charles, Louisiana, United States
St. Joseph Mercy Hospital Health System
Ypsilanti, Michigan, United States
Rothman Institute
Egg Harbor, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
Northwell Health, Lenox Hill Hospital
New York, New York, United States
UNC Orthopaedics
Chapel Hill, North Carolina, United States