ABC/Trident® Ceramic Post Approval Study

Study Overview
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Brief Summary
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The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.

Detailed Description
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The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.

Official Title
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Post-Approval Study of the ABC and Trident® Systems

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
* Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
* Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB). The individual is between the ages of 21 and 75 years. The individual is not classified as morbidly obese. The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history. The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant). The individual does not have an active infection within the affected hip joint. The individual has not had a previous total hip replacement or hip fusion to the affected hip joint. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse). The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device. The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements. The individual is skeletally mature. The individual is not pregnant. The individual is not a prisoner. The individual has no plans to relocate to another geographic area before the completion of the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trident®System<br>Trident® Ceramic Insert/Trident® AD HA Acetabular Shell | Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell<br>* Trident® Ceramic Insert/Trident® AD HA Acetabular Shell<br>|
| Experimental: ABC System<br>Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell | Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell<br>* Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell<br>|
| Active Comparator: Control<br>OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell | Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell<br>* OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Component Revision and Complications | The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor | 3-5 and 10 Years | 
| Radiographic Evaluation | Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm. | 3-5 and 10 years | 
| Hip Follow-Up Questionnaire | A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as satisfied below); whether they have any study hip pain (noted as no pain below); and whether they have had any surgery on the study hip during the previous year noted as no surgery below). | 6-10 years |