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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident II Tritanium Acetabular Shell | Other | The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell intended for use in a cementless application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident II Tritanium Acetabular Shell | Device | A hemispherical acetabular shell indicated for cementless application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 years |
| Radiographic Stability |
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Inclusion Criteria:
A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.
C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.
D. Patient is a candidate for a primary cementless total hip replacement.
E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Exclusion Criteria:
F. Patient has a Body Mass Index (BMI) ≥ 40.
G. Patient is diagnosed with Inflammatory Arthritis.
H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
M. Patient has had previous open surgery to the affected joint, not including arthroscopy.
N. Patient requires implantation of a constrained liner.
O. Patient has a known sensitivity to device materials.
P. Patient is a prisoner.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Barga | Director, Clinical Research - Stryker Joint Replacement | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States | ||
| Southeast Orthopedic Specialists |
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Numerous parameters will be reviewed by zone, including radiolucency and migration.
| 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| American Hip Institute | Des Plaines | Illinois | 60018 | United States |
| Center for Orthopaedics and Spine, LLC | Lake Charles | Louisiana | 70605 | United States |
| St. Joseph Mercy Hospital Health System | Ypsilanti | Michigan | 48197 | United States |
| Rothman Institute | Egg Harbor | New Jersey | 08234 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Northwell Health, Lenox Hill Hospital | New York | New York | 10075 | United States |
| UNC Orthopaedics | Chapel Hill | North Carolina | 27599 | United States |