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General |
Study Status |
Completed |
Application Number / Requirement Number |
P070001 / PAS001 |
Date Original Protocol Accepted |
12/17/2007
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Date Current Protocol Accepted |
08/12/2008
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Study Name |
Long Term Study
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Device Name |
PRODISC TM-C TOTAL DISC REPLACEMENT
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
New Data Collection
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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 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.
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Actual Number of Patients Enrolled |
PDC: 103 ACDF: 106 PDC-CA: 135 Total: 345
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Actual Number of Sites Enrolled |
Clinical sites: 14
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Patient Follow-up Rate |
At 84-month: PDC: 93.9% ACDF: 92.8% PDC-CA: 83%
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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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