Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Joint Diseases
- Sponsor
- Ortho Development Corporation
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Survivorship - The number of revision surgeries over time.
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Survivorship - The number of revision surgeries over time.
Time Frame: 5 - 10-year follow-up
The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component.
Secondary Outcomes
- General Health(5 - 10 year follow-up)
- Patient satisfaction.(5 - 10 year follow-up)
- Pain and Function(5 - 10 year follow-up)