|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P010001 / PAS001 |
Date Original Protocol Accepted |
02/03/2003
|
Date Current Protocol Accepted |
 
|
Study Name |
Ceramic Transcend Hip
|
Device Name |
CERAMIC TRANSCEND HIP ARTICULATION 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 |
There is No PAS study protocol for this examination. As per approval order the sponsor agreed to provide long term (i.e., 5 years) data for a minimum of 175 procedures selected from the original PMA complete follow-up cohort and 25% of N=630 Continued Access Procedures. A minimum of 175 procedures were to have completed the Hip Survey and underwent independent radiographic review at a minimum of 5 postoperative years.
|
Study Population |
This device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis. The study population is subjects from the premarket cohort.
|
Sample Size |
175 Patients
|
Key Study Endpoints |
Used the Ceramic TRANSCEND Hip Study Survey form and A-P and lateral radiographs of the implanted hip. Questions on the Ceramic TRANSCEND Hip Study Survey Form: 1. Is your artificial hip in place? Yes or No; If not, when was it removed? 2. How well do you feel your artificial hip is functioning?; Excellent, good, fair, poor; 3. Have you had x-rays taken of your hip in the last year? Yes or No; 4. Do you expect to have your hip implant removed or replaced in the immediate future? Yes or No; If yes, when?___________________; Name of doctor who will remove or replace your hip implant_________________
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Follow-up Visits and Length of Follow-up |
Required continued follow-up through 5 years with annual assessments.
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