Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Total Hip Arthroplasty | Device | Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Identification will occur from a list of patients having undergone total hip arthroplasty at Straub Medical Center between 2012 and the end of December 2015. Identified patients will then be screened for eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Andrews, PhD | Contact | 8085224822 | samantha.andrews@straub.net |
| Name | Affiliation | Role |
|---|---|---|
| Cass Nakasone, MD | Hawai'i Pacific Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Straub Medical Center | Recruiting | Honolulu | Hawaii | 96813 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D015207 | Osteoarthritis, Hip |
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided