Tritanium® Primary Acetabular Shell Study

Study Overview
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Brief Summary
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This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the X3® polyethylene insert alone as the bearing surface; the other half will use the MDMTM liner coupled with a compatible ADM/MDMTM X3® insert as the bearing surface. The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.

Detailed Description
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The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from CP Ti. The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® HA hemispherical acetabular shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 mm through 66 mm and is compatible with Trident® polyethylene liners and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study. prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer. Cases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and IRB approval. Non-compliance of a study center may result in termination of the center's participation in the study.

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

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Tritanium® Primary Acetabular Shell


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 years or older at time of study device implantation. C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 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 and rehabilitation. Exclusion Criteria: F. Patient has a Body Mass Index (BMI) ≥ 40. G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. I. 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. J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint. L. Patient has a known sensitivity to device materials. M. Patient is a prisoner.

Ages Eligible for Study
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Minimum Age: 18 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: Tritanium® Primary Acetabular Shell<br>Tritanium® Primary Acetabular Shell | Device: Tritanium® Primary Acetabular Shell<br>* Tritanium® Primary Acetabular Shell in total hip replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of acetabular revision | To evaluate the success rate of cementless primary THR in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Screw Fixation Usage in the Triathlon Acetabular Shell | Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® HA Hemispherical Shell group (Trident® X3® Polyethylene Insert Study). | Intraoperative | 
| Harris Hip Score | The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. 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 of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor | 1, 3, and 5 years | 
| SF-12 Heath Survey Scores | The SF-12 Health Survey is a 12-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. | 1, 3, and 5 years | 
| Lower Extremity Activity Scale (LEAS) Score | 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. | 1, 3, and 5 years | 
| EQ-5D | The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health. | 1,2,3,4, and 5 years | 
| Follow-Up Questionnaire | The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions: Patient satisfaction with the hip replacement Presence of any pain in the study hip Any surgeries performed on the study hip | 6, 7, 8, 9, and 10 years | 
| Acetabular Shell Radiographic Stability | Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable. | 6 weeks, 1, 3, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Traumatic arthritis, Avascular Necrosis