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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P110008 / PAS003 |
| Date Original Protocol Accepted |
08/05/2015
|
| Date Current Protocol Accepted |
03/31/2021
|
| Study Name |
Coflex Actual Practice PAS USA
|
| Device Name |
COFLEX® INTERLAMINAR TECHNOLOGY
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Study Objective: To conduct 2 and 5 year comparative evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the Coflex® Interlaminar Technology.
Study Design: multicenter, non-randomized but concurrently enrolled, propensity score controlled clinical study (new enrollment, patient-blinded)
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| Study Population |
Patients suffering from a confirmed diagnosis of moderate spinal stenosis with concomitant low back pain at one or two contiguous levels from L1-L5 that require surgical decompression and who meet all of the inclusion/exclusion criteria.
Group A: decompression surgery without any further stabilization by an implant (control group)
Group B: decompression surgery with additional stabilization with the coflex® Interlaminar Technology (treatment group).
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| Sample Size |
The total enrolled will be 186 coflex® patients and 220 decompression control patients at up to 20 investigational sites (up to 10 coflex and 10 control sites). This sample size is based on 150 per group (300 total) plus 15% to account for lost to follow-up in both groups, plus 20% in the control group and 5% in the study device group to account for trimming of control patients and possible trimming of study device patients during the propensity score design.
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| Key Study Endpoints |
Primary endpoint is CCS:
At least 15 point improvement relative to pretreatment in the Oswestry Disability Index (ODI).
No reoperations, revisions, removals, or supplemental fixation at index level(s).
No greater than or equal to 2 injections or series of injections for the treated level, or nerve block procedures performed to treat spinal stenosis for the index level(s); or a single injection within 12 months of the 5 year endpoint.
As an exploratory analysis, primary hypothesis will be tested using:
At least 15 point improvement relative to pretreatment in ODI.
No reoperations, revisions, removals, or supplemental fixation at index level(s).
No epidural injections or nerve block at any level at any time.
Secondary Endpoints:
ODI change compared to baseline at 24 and 60 months.
Change in Visual Analog Scale (VAS) for low back pain after 24 and 60 months compared to baseline.
Change in leg pain using VAS after 24 and 60 months compared to baseline.
Change in worst leg pain using VAS after 24 and 60 months compared to baseline.
Change of Zurich Claudication Questionnaire (ZCQ) after 24 and 60 months compared to baseline.
Maintenance or improvement in EQ-5D compared to baseline.
Change from baseline to Month 24 and Month 60 in maximum walking time from treadmill test.
Neurological status. Radiography Endpoints:
1. Migration of the implant or the complete expulsion
2. Spinous process fracture
3. Maintenance of foraminal height
4. Adjacent level disease
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| Follow-up Visits and Length of Follow-up |
60-months
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