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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
|
| Clinical Trial Number(s) |
NCT00534235
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Randomized clinical trial
|
| 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
|
| 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.
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P110008 / PAS003 |
| Date Original Protocol Accepted |
08/05/2015
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| Date Current Protocol Accepted |
03/31/2021
|
| Study Name |
Coflex Actual Practice PAS USA
|
| Device Name |
COFLEX® INTERLAMINAR TECHNOLOGY
|
| Clinical Trial Number(s) |
NCT00534235
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
|
| 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
|
| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P110008 / PAS002 |
| Date Original Protocol Accepted |
10/17/2012
|
| Date Current Protocol Accepted |
04/23/2013
|
| Study Name |
Coflex Actual Practice PAS
|
| Device Name |
COFLEX® INTERLAMINAR TECHNOLOGY
|
| Clinical Trial Number(s) |
NCT00534235
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Randomized clinical trial
|
| Study Population |
The study population is comprised of patients with radiographic
confirmation of at least moderate degenerative spinal stenosis with constriction of the central spinal canal of one or two adjacent segments in the region L1 to L5.
|
| Sample Size |
The sample size is 230 patients. There will be 115 patients in
each group. There will be 115 patients with decompression surgery and without Coflex, and 115 patients with decompression surgery and the Coflex.
|
| Key Study Endpoints |
The primary endpoint is improvement of Oswestry Low Back
Pain Disability Index (ODI) after 24 months compared to control group.
Secondary endpoints encompass:
-Superior improvement of the Visual Analog Scale (VAS) for low back pain (on the 100
mm scale) within 24 months compared to control, group.
-Leg pain (Measurement via a 100 mm VAS)
-Zurich Claudication Questionnaire (ZCQ). This is a self rating questionnaire designed to assess symptom severity, physical functional status and patient satisfaction
-Assessment of significant migration of the implant or the complete expulsion
(significant is defined > 5 mm)
-Neurological status (assessment of the maintenance of the improvement after surgery
throughout the study duration)
- Walking distance test on a treadmill (assessment of improvement in walking distance)
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed for 2 years.
Patients will be evaluated pre-operatively, and at 3, 12 and 24
postoperative months.
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