Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
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|ClinicalTrials.gov Identifier: NCT03986918|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment|
|Joint Diseases Osteoarthritis, Hip Rheumatoid Arthritis Psoriatic Arthritis Avascular Necrosis of Hip||Device: Routine Total Hip Arthroplasty|
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|
|Estimated Enrollment :||400 participants|
|Official Title:||Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2024|
Ovation and Ovation Tribute
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
Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and 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.
- Pain and Function [ Time Frame: 5 - 10 year follow-up ]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.
- General Health [ Time Frame: 5 - 10 year follow-up ]The Veterans Rand - 12 (VR-12) will be used to measure general health, including the ability to carry out usual activities.
- Patient satisfaction. [ Time Frame: 5 - 10 year follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986918
|Contact: Samantha Andrews, PhDemail@example.com|
|United States, Hawaii|
|Straub Medical Center||Recruiting|
|Honolulu, Hawaii, United States, 96813|
|Contact: Samantha Andrews, PhD 808-522-4855 firstname.lastname@example.org|
|Principal Investigator:||Cass Nakasone, MD||Hawai'i Pacific Health|