|
|
| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P040048 / PAS001 |
| Date Original Protocol Accepted |
06/28/2006
|
| Date Current Protocol Accepted |
06/28/2006
|
| Study Name |
Long term
|
| Device Name |
TRILOGY AB ACETABULAR SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The post-approval study is a prospective, multi-center, uncontrolled cohort study of subjects in whom the device was implanted after FDA approval.
The purpose of the post-approval study is to evaluate the safety and effectiveness of the Trilogy AB Acetabular System through long-term follow-up of 10 years. However, because of the lack of progress on the original PAS, FDA asked the sponsor to redesign the PAS. The PAS was revised per a FDA letter dated 7/14/09. The new protocol is not approved yet [Aug 13,2010]. The description presented here is for the old study
|
| Study Population |
Study population is as per device indication and it includes: age from 21 to 80 years, body mass index less than 30, willing and able to provide informed consent. The device is indicated for either cemented or noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
|
| Sample Size |
250 patients
|
| Key Study Endpoints |
Endpoints not mentioned
|
| Follow-up Visits and Length of Follow-up |
During the first five years of the study clinical, radiographic, and subject self assessment information will be collected for each subject. Data will be collected pre-operatively, immediately post-operatively, at three months and annually up to five years. An independent radiographic review will be conducted at five years. For the sixth through the tenth postoperative years, patients will be asked to return an outcomes questionnaire designed to determine the status of their hip replacement. In addition, you have agreed to record and report each adverse event regarding full details of the nature of the complication, treatment and outcome on the appropriate Case Report Form. You will send in Interim Study Status Reports to the FDA every six months for the first two years of the study and annually thereafter until a Final Study Report has been submitted. The results of this long-term data must be reflected in the product labeling (via supplement) when the post-approval study is completed.
|
