Avascular Necrosis of Hip, Joint Diseases, Osteoarthritis, Hip, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
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.
Interventions
DEVICERoutine Total Hip Arthroplasty
Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.
Sponsors
Ortho Development Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship - The number of revision surgeries over time. | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain and Function | 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 | 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. | 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. |
Countries
United States
Contacts
Primary ContactSamantha Andrews, PhD
Outcome results
None listed