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|
| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P050039 / PAS001 |
| Date Original Protocol Accepted |
07/05/2007
|
| Date Current Protocol Accepted |
12/09/2010
|
| Study Name |
Long Term
|
| Device Name |
NOVATION CERAMIC ARTICULATION HIP SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center, open label clinical study. Up to ten (10) centers around the United States will participate in this study. 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.
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| Study Population |
The study population is comprised of patients implanted in the United States and potentially outside the United States in Greece and/or France. Sample size and power calculations are not provided in the protocol. Patients who receive the Novation Ceramic Articulation System for Non-inflammatory Degenerative Joint Disease
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| Sample Size |
prospective and retrospective cohort, active surveillance, up to 10 clinical sites in prospective and retrospective cohort, and 7 sites in active surveillance
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| Key Study Endpoints |
The first phase of the study extending through 5 years of patient follow-up, will consist of clinical examination, including the determination of a Harris Hip Score, radiographic examination and the collection of subject self-assessment data. These data will be obtained pre-operatively, immediately post-operatively, at three months, and annually up to five years. An independent radiographic review will be conducted at five years
In the second phase, during postoperative years 6-10, an outcomes questionnaire will be mailed to subjects to determine the status of their hip replacement. No clinical and/or radiographic examinations are proposed for this time period.
The study endpoints are as follows:
Efficacy Endpoints
1) Survivorship of the Novation Ceramic AHS system at 2, 5, and 10 years.
2) Patient success defined as:
- Absence of revision
- Harris Hip Score greater than or equal to 70
- No complete radiolucencies
The following endpoints will also be evaluated at the 2-year follow-up:
- Harris Hip Score
- Radiographic assessment
- SF-12
Safety endpoints will encompass complication rates, including incidence, severity and the relationship to the device.
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| Follow-up Visits and Length of Follow-up |
The length of patient follow-up is 10 years. Follow-up visits will occur pre-operatively, immediately post-operatively, at six weeks, six months, and annually up to five years.
Study subjects will receive annual questionnaires from postoperative years 6 through 10.
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