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|
| General |
| Study Status |
Progress Adequate |
| Application Number |
P070001 / PAS001 |
| Current Plan Approved |
08/12/2008
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| Study Name |
OSB Lead-Long Term Study
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Design Description |
This is a prospective cohort to continue follow-up of the subjects who participated in (1) the IDE premarket study and (2) the continued access study.
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| Study Population Description |
The study population is as per device indication. The study includes IDE and CAS subjects. This device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDiscTM-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDiscTM-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDiscTM-C Total Disc Replacement.
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| Sample Size |
239 ProDiscTM -C (103 Randomized and 136 Continued Access) and 106 ACDF patients for a total of 345 patients
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| Data Collection |
A patient will be considered an overall success if all of the following conditions are met:
The patient's NDI score improves by at least 20% over preoperative baseline value;
The patient's neurologic parameters, i.e. motor sensory, and reflexes are maintained or improved as compared to preoperative baseline value
No removals, revisions, re-operations or additional fixation were required to modify any implant
No adverse events occur which are related to the treatment.
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| Follow-up Visits and Length of Follow-up |
Data will be collected at 36, 48, 60, 72 and 84 months postoperative
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| Interim or Final Data Summary |
| Interim Safety Information |
So far, since the approval of the device (December 17, 2007), a total of 86 Adverse Events (AEs) from 40 ProDisc-C patients (39% of 103) and 98 AEs from 47 ACDF control patients (44% of 106) have been reported in the post-approval period follow-up of the IDE cohort as of November 23, 2009. During the same period, 188 AEs from 74 ProDisc-C patients (54% of 136) reported in the CAS cohort. For implant-related AEs, the CAS cohort had 2 cases (1 upper extremity pain and one index level surgery); and ACDF patients in the IDE cohort had 1 implant-related surgery.
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