The purpose of this study is to review the performance and success rate of an FDA cleared 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Lafayette General Orthopedic Center
Lafayette, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Number of Cases Free From Trident II Acetabular Shell Revision
To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative.
Time frame: 6 Weeks, 3-6 Months, 1 Year and 2 Years
Radiographic Stability
Radiographic stability is a composite endpoint evaluating radiolucency and migration. Radiographic stability is defined as cases (hips implanted) which do not present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones.
Time frame: 6 Weeks and 3-6 Months
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University of Massachusetts
Worcester, Massachusetts, United States
Beaumont Hospital Research Institute
Royal Oak, Michigan, United States
The Orthopaedic & Fracture Clinic, P.A.
Mankato, Minnesota, United States
Reno Orthopedic Center Foundation
Reno, Nevada, United States
OrthoNY
Albany, New York, United States
Syracuse Orthopedic Specialists
New York, New York, United States
University of Utah
Salt Lake City, Utah, United States