Trident II Tritanium Acetabular Shell 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 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.

Official Title
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A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Trident II Tritanium Acetabular Shell


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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<br> | Device: Trident II Tritanium Acetabular Shell<br>* A hemispherical acetabular shell indicated for cementless application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Revision for the Trident II Tritanium Acetabular Shell |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | Numerous parameters will be reviewed by zone, including radiolucency and migration. | 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years |