Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System

Study Overview
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Brief Summary
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The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.

Detailed Description
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Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries. This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.

Official Title
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Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System

Conditions
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Joint Diseases, Osteoarthritis, Hip, Rheumatoid Arthritis, Psoriatic Arthritis, Avascular Necrosis of Hip

Intervention / Treatment
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* Device: Routine Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years of age Patient is five years post total hip arthroplasty Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components Patient agrees to participate in the survey. Exclusion Criteria: Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovation and Ovation Tribute<br>All patients having undergone a total hip arthroplasty that received the Ovation® or Ovation Tribute® (Ortho Development, Draper, Utah) Hip system will be sent the survey. | Device: Routine Total Hip Arthroplasty<br>* Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship - The number of revision surgeries over time. | The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component. | 5 - 10-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Function | The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function. | 5 - 10 year follow-up | 
| General Health | The Veterans Rand - 12 (VR-12) will be used to measure general health, including the ability to carry out usual activities. | 5 - 10 year follow-up | 
| Patient satisfaction. | A four question patient satisfaction survey will be used to measure the patient's satisfaction with their surgery, pain control, function, and ability to participate in recreational activities. | 5 - 10 year follow-up |