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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110008 / PAS001 |
| Date Original Protocol Accepted |
10/17/2012
|
| Date Current Protocol Accepted |
04/23/2013
|
| Study Name |
Coflex Long-Term PAS
|
| Device Name |
COFLEX® INTERLAMINAR TECHNOLOGY
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Randomized clinical trial
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| Study Population |
The study population is comprised of patients who received the device during the IDE or controls that underwent Anterior Cervical Decompression and Fusion (ACDF) during the IDE
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| Sample Size |
A total of 191 coflex and 104 fusion patients comprise the sample size.
|
| Key Study Endpoints |
The following criteria will be used to evaluate CCS at each post year 2 follow-up point including at year 5. These are the same as used for the two year study only modified to accommodate the longer-term follow-up. For the year 5 endpoint, these are:
Improvement of at least 15 points in the Oswestry Low Back Pain Disability Index (ODI) at 5 years compared to baseline;
No reoperations, revisions, removals, or supplemental fixation;
No major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 5 years; and
No epidural steroid injections in the lumbar spine.
In addition to the principal endpoint of survivorship, information on the following efficacy outcomes will be assessed:
Oswestry Disability Index (ODI)
Zurich Claudication Questionnaire (ZCQ)
Leg (right, left) Pain Visual Analog Scale
(VAS) (100mm scale)
Back Pain Visual Analog Scale (VAS) (100mm scale)
Quality of Life (SF-12)
Neurological Status
In addition, each component of the composite clinical success will be used to evaluate coflex® device performance in absolute terms and relative to fusion control, including overall device survival.
The anterior/posterior and lateral radiographs will be assessed for evidence of:
Radiolucency
Migration
Range of motion and translation in flexion/extension, at the implanted and adjacent level(s) as measured on lateral standing flexion/extension films.
Adjacent level breakdown
Radiographic Observations: Fractures, Heterotopic Ossification, etc.
Patients with an unresolved spinous process fracture at 24 months, observed via independent radiographic assessment, will be subjected to a CT scan at 5 years to determine if the spinous process has healed, pending patient and IRB approval.
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| Follow-up Visits and Length of Follow-up |
5 years.
Patients in the long-term follow-up study will be asked to
return for follow-up evaluations annually (± 4month) at 36,
48 months, and 60 60 months post-surgery. The follow-up evaluations will include assessment of complications, administration of the Oswestry Disability Index (ODI), Leg (right, left, max) and Back Pain
VAS, Zurich Claudication Questionnaire (ZCQ), and SF-12, and radiographic evaluation.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
207 in investigation device group and 107 controls
|
| Actual Number of Sites Enrolled |
21
|
| Patient Follow-up Rate |
Investigational device group: 90.7%
Control group: 86.0%
|
| Final Safety Findings |
No evidence raising serious concerns was found. The 60-month device failure rates are 3.6% and 2.4% for the investigational device group and controls (fusion), respectively. The results are similar when comparing one level procedure and two level procedures.
|
| Final Effect Findings |
Overall success outcomes including the FDA-defined criteria were met at the end of
60 months. The composite clinical success (CCS) at 60 months were 49.5% and
44.0% (p=0.385) for the investigational device group and the controls, respectively. The results were similar when comparing one level procedure and two level procedures. Other outcomes, including Improvement of at least 15 points in ODI at Month 60 compared to baseline, No reoperation or epidural, No reoperations, revisions, removals, or supplemental fixation, No epidural injection at any lumbar level up to and including the Month 60 visit, No persistent2 new or increasing
sensory or motor deficit at 60 months, No persistent new or increasing sensory deficit at 60 months, and No persistent new or increasing motor deficit at 60 months, were all comparable between coflex and the fusion controls.
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| Study Strengths & Weaknesses |
This Extended Follow-Up study was capable of demonstrating comparable outcomes between coflex and fusion, as well as between one level and two level coflex procedures. However, the data are only so far available from the subjects in the IDE study, which may not be
necessarily repetitive of the real world evidence.
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| Recommendations for Labeling Changes |
No labeling change is recommended, since all of the observed complications have already been listed in the product labeling and no unusually higher rates of AEs and complications have been observed in the PAS.
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