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|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P040006 / PAS001 |
| Date Original Protocol Accepted |
10/26/2004
|
| Date Current Protocol Accepted |
10/26/2004
|
| Study Name |
Charite Artificial Disc
|
| Device Name |
CHARITE ARTIFICIAL DISC
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Admin Database
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective cohort to continue follow-up of subjects enrolled in IDE study comparing CHARITÉ Artificial Disc to the BAK cage fusion
|
| Study Population |
Study populationis as per device indications. This device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than 3)mm of spondylolisthesis at the involved level. Study included subjects enrolled in the IDE study who meet the following inclusion criteria:- Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study. - Still have the original implant they received in their index surgery. - Ability and willingness to comply with follow-up regimen.- Voluntarily signed the approved subject informed consent form.
|
| Sample Size |
maximum of 268 CHARITÉ subjects (67 Training and 201 Randomized), and 98 BAK cage fusion subjects.
|
| Key Study Endpoints |
Study endpoints include - Quality of Life (SF-36) - Oswestry Disability Index (ODI) - Subject Satisfaction - Visual Analog Scale (VAS) for Pain - Clinical Assessment: work status, medication use, neurological status, and adverse events since the subject was last seen.- Radiographic assessment of Anterior / Posterior x-ray, Lateral x-ray, Flexion / Extension x-ray. The primary endpoint of this study is Overall Success, which is defined as: - improvement of at least 15 points in the ODI compared with the score at baseline- no device failures requiring revision, re operation, or removal, - absence of major complications, defined as major vessel injury or major neurological deterioration (e.g., nerve root injury) , and- maintenance or improvement in neurological status vs. baseline, with no permanent neurological deficits compared to baseline status.
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| Follow-up Visits and Length of Follow-up |
Study subjects are to be seen annually (i.e., 36-, 48- and 60-month post-operation) until they complete the 60-month evaluation.
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