Trident II Revision Outcomes Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Trident II Acetabular Shell in a Revision Indication

Conditions
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Arthroplasty, Hip Revision

Intervention / Treatment
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* Device: Trident II Tritanium Acetabular Shell for Revision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Patient has signed an IRB approved, study specific Informed Patient Consent Form. B. Patient is a male or non-pregnant female age 18-85 years of age at the time of study device implantation. C. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component. D. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. Exclusion Criteria: E. Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. 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 mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. J. Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis. K. 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. L. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trident II Tritanium Acetabular Shell for Revision<br> | Device: Trident II Tritanium Acetabular Shell for Revision<br>* A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Weeks, 3-6 Months, 1 Year and 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Weeks and 3-6 Months |