Trident® Tritanium™ Acetabular Shell Revision Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.

Detailed Description
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Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection. Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation. Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system. It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events. The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.

Official Title
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A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Trident® Tritanium™ Acetabular Shell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and non-pregnant females, 21-85 years of age at the time of surgery. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component. Patient has signed an IRB approved study consent form. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations. Exclusion Criteria: Patient is morbidly obese, BMI > 40. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days). Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. Patient has an active or suspected latent infection on or about the hip joint. Patient is a prisoner.

Ages Eligible for Study
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Minimum Age: 21 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® Tritanium™ Acetabular Shell<br>Trident® Tritanium™ Acetabular Shell used in revision total hip replacement | Device: Trident® Tritanium™ Acetabular Shell<br>* Trident® Tritanium™ Acetabular Shell<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation |  | 5 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor. | pre-op, 3 month, 1, 2, 3, 4, 5 years | 
| Change in SF-36 From Pre-operative to Post-operative Visits | The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | pre-op, 3 month, 1, 2, 3, 4, 5 years | 
| Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones. | 3 month, 1, 2, 3, 4, 5 years | 
| Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks. | 3 month, 1, 2, 3, 4, 5 years | 
| Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. | pre-op, 3 month, 1, 2, 3, 4, 5 years |