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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070001 / PAS001 |
| Date Original Protocol Accepted |
12/17/2007
|
| Date Current Protocol Accepted |
08/12/2008
|
| Study Name |
Long Term Study
|
| Device Name |
PRODISC TM-C TOTAL DISC REPLACEMENT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
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 |
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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| Key Study Endpoints |
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 Results |
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.
|
| Actual Number of Patients Enrolled |
PDC: 103
ACDF: 106
PDC-CA: 135
Total: 345
|
| Actual Number of Sites Enrolled |
Clinical sites: 14
|
| Patient Follow-up Rate |
At 84-month:
PDC: 93.9%
ACDF: 92.8%
PDC-CA: 83%
|
| Final Safety Findings |
Death: There were 12 instances of death for enrolled subjects though 10 deaths (10/345, 2.9%) occurred within the
study window. There are 3 deaths in the PDC cohort (3/103, 2.9%), which is not significantly different from the
control group
Adverse events: PRODISC C is not statistically different from ACDF when categorizing the data by the
number of AEs. In the PDC group, there are 47 mild AEs (47/103, 45.6%), 38 moderate AEs (38/103,
36.9%), and 38 severe AEs (38/103, 36.9%).
Device Underwent Surgical Intervention: 6 PDC subjects (6/103, 5.8%), 6 PDC-CA (6/135, 4.4%) subjects
and 18 ACDF (18/106, 17.0%) subjects underwent subsequent surgical interventions at the index level.
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| Final Effect Findings |
The results of Overall Success analyses indicate that the PRODISC C maintains non-inferiority to the
ACDF control group in 7-year follow-up in both the primary analysis (Sponsor’s definition) and the
additional analysis (FDA’s definition) of Overall Success.
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| Study Strengths & Weaknesses |
This is a clinical study with a control group as the comparator which increased the internal validity in
clinical interpretation. This study has a long range of follow-up (7 years) with a decent follow-up rate for
a large sample size (345 patients).
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term data from the post-approval study. The
labeling change should include a new section on the label showing a summary of the post-approval
study methods (including study objectives, design, population, number of enrolled sites/subjects, key
endpoints, follow–up visits etc.), final results and study strengths and limitations of the PAS.
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