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.
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.
Study Type
OBSERVATIONAL
Enrollment
400
Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.
Straub Medical Center
Honolulu, Hawaii, United States
RECRUITINGSurvivorship - 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.
Time frame: 5 - 10-year follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 5 - 10 year follow-up
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