An interventional study of Decompression and Posterolateral Fusion and Implantation of Pedicle Screws in Spinal Stenosis, sponsored by Paradigm Spine. Completed. Per ClinicalTrials.gov, last updated 2020-02-06.
Sponsored by Paradigm Spine · Not applicable, Interventional, and Treatment
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 322 is above the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Paradigm Spine is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Control: Posterolateral fusion and implantation of pedicle screws after decompression
Procedure: Decompression · Device: Posterolateral Fusion and Implantation of Pedicle Screws
Investigative: Implantation of coflex Interlaminar Technology after decompression
Procedure: Decompression · Device: Implantation of coflex Interlaminar Technology
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
Number of Subjects With Improvement of at Least 15 Points in ODI
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).
Time frame: 5 years
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation
Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).
Time frame: 5 years
Number of Subjects With no Major Device Related Complications
Assessment of major device-related complications at 5 years
Time frame: 5 years
Number of Subjects With no Epidural Injection(s)
Assessment of lumbar epidural injections
Time frame: 5 years
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit
No persistent new or increasing sensory or motor deficit
Time frame: 5 years
Number of Subjects With no Persistent New or Increasing Sensory Deficit
No persistent new or increasing sensory deficit
Time frame: 5 years
Number of Subjects With no Persistent New or Increasing Motor Deficit
No persistent new or increasing motor deficit
Time frame: 5 years
Number of Subjects With no Reoperations or Epidural (Up to Day 1825)
No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.
Time frame: 5 years
Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Time frame: 5 years
Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Time frame: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component
Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
Time frame: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component
Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
Time frame: 5 years
Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Time frame: 5 years
Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Time frame: 5 years
Mean Oswestry Disability Index (ODI) Score
Assessment of disability from low back pain as measured by ODI (Oswestry Disability Index) mean score in each treatment group at 5 years. On a scale of 0-100, a higher score represents increased disability.
Time frame: 5 years
Mean Visual Analog Scale Back Pain Score
Assessment of Back Pain as measured by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Time frame: 5 years
Mean Visual Analog Scale Leg (Worse) Pain Score
Assessment of Worse Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Time frame: 5 years
Mean Visual Analog Scale (VAS) Leg (Right) Pain Score
Assessment of Right Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Time frame: 5 years
Mean Visual Analog Scale (VAS) Leg (Left) Pain Score
Assessment of Left Leg Pain by VAS mean score in both treatment groups at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Time frame: 5 years
Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Time frame: 5 years
Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Time frame: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Assessment of symptom severity by ZCQ mean score in both treatment groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Time frame: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Assessment of physical function by ZCQ mean score in both groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Time frame: 5 years
Mean Short Form-12 Physical Component Score
Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
Time frame: 5 years
Mean Short Form-12 Mental Component Score
Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
Time frame: 5 years
Patient Survey: Satisfaction
Subjects who responded "Very Satisfied" or "Somewhat Satisfied".
Time frame: 5 years
Patient Survey: Recommendation of Treatment
Subjects who responded "Definitely Yes" or "Probably Yes"
Time frame: 5 years
Pain Management: Class II Narcotics Usage by Device Group
Number of subjects using Class II narcotics
Time frame: 5 years
Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group
Number of subjects using NSAIDs/ASA/Acetaminophen
Time frame: 5 years
Mean Rotation (F to E) in Degrees - At Level(s) of Implant
As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Rotation (F to E) in Degrees - Below Level of Implant
As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level below the implant in both treatment groups at 5 years.
Time frame: 5 years
Rotation (F to E) in Degrees - Above Level of Implant
As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level above the implant in both treatment groups at 5 years.
Time frame: 5 years
Translation (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average measure of translation at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Translation (mm) - Below Level of Implant
As determined by independent radiographic lab, this is the average measure of translation at the level below the implant in both treatment groups at 5 years.
Time frame: 5 years
Translation (mm) - Above Level of Implant
As determined by independent radiographic lab, this is the average measure of translation at the level above the implant in both treatment groups at 5 years.
Time frame: 5 years
Anterior Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average measure of anterior disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Posterior Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average measure of posterior disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Translation (F to E) in Percent (%) - At Level(s) of Implant
As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Translation (F to E) in Percent (%) - Below Level of Implant
As determined by independent radiographic lab, this is the percentage of translation at the level below the implant in both treatment groups at 5 years.
Time frame: 5 years
Translation (F to E) in Percent (%) - Above Level of Implant
As determined by independent radiographic lab, this is the percentage of translation at the level above the implant in both treatment groups at 5 years.
Time frame: 5 years
Average Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average measure of disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average change from baseline for anterior disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average change from baseline for posterior disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average change from baseline for disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average change from immediate post-op for anterior disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average change from immediate post-op for posterior disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the average change from immediate post-op for disc height at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Disc Angle in Degrees - At Level(s) of Implant
As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant
As determined by independent radiographic lab, this is the mean change in disc angle from baseline at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant
As determined by independent radiographic lab, this is the mean change in disc angle from immediate post-op at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant
As determined by independent radiographic lab, this is the measure of the percentage of spondylolisthesis at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant
As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis from immediate post-op at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Foraminal Height (X-ray) (mm) - At Level(s) of Implant
This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant
This is the mean change in foraminal height via x-ray from baseline at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant
This is the mean change in foraminal height via x-ray from immediate post-op at the index level(s) in both treatment groups at 5 years.
Time frame: 5 years
Bony Bridging
Bridging through the posterolateral gutters, between the facet joints, between transverse processes, and/or between facet joint and transverse process will all be considered acceptable forms of bridging bone.
Time frame: 5 years
Heterotopic Ossification
Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant.
Time frame: 5 years
Fusion Status
The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.
Time frame: 5 years
Interface Remodeling - At Level(s) of Implant
Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface.
Time frame: 5 years
Device Condition (Coflex Arm)
Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged.
Time frame: 5 years
Device Condition (Fusion Control)
Per level; This assessment is applicable to the fusion arm only. Device Condition in the control subjects will be graded as: Intact, Loose Screws, or Failed Hardware.
Time frame: 5 years
Device Mobility
Per level; Assessment is applicable to coflex arm only. Device Mobility is an expected occurrence in some subjects and represents the amount of the of lift-off of the implant from the inferior spinous process.
Time frame: 5 years
| Milestone | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Started | 107 | 215 |
| Completed | 91 | 192 |
| Not completed | 16 | 23 |
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With Improvement of at Least 15 Points in ODI | 41 | 101 |
Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation | 87 | 179 |
Assessment of major device-related complications at 5 years
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With no Major Device Related Complications | 100 | 212 |
Assessment of lumbar epidural injections
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With no Epidural Injection(s) | 84 | 177 |
No persistent new or increasing sensory or motor deficit
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit | 70 | 135 |
No persistent new or increasing sensory deficit
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With no Persistent New or Increasing Sensory Deficit | 72 | 137 |
No persistent new or increasing motor deficit
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With no Persistent New or Increasing Motor Deficit | 72 | 144 |
No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With no Reoperations or Epidural (Up to Day 1825) | 71 | 149 |
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points | 40 | 100 |
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points | 38 | 98 |
Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component | 34 | 93 |
Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component | 31 | 72 |
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm | 40 | 104 |
Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm | 41 | 99 |
Assessment of disability from low back pain as measured by ODI (Oswestry Disability Index) mean score in each treatment group at 5 years. On a scale of 0-100, a higher score represents increased disability.
| units on a scale | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Oswestry Disability Index (ODI) Score | 26.1 ± 22.2 | 24.5 ± 20.5 |
Assessment of Back Pain as measured by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Visual Analog Scale Back Pain Score | 29.0 ± 31.0 | 25.4 ± 27.6 |
Assessment of Worse Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Visual Analog Scale Leg (Worse) Pain Score | 25.2 ± 31.2 | 22.8 ± 28.1 |
Assessment of Right Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Visual Analog Scale (VAS) Leg (Right) Pain Score | 16.0 ± 24.5 | 14.9 ± 21.6 |
Assessment of Left Leg Pain by VAS mean score in both treatment groups at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Visual Analog Scale (VAS) Leg (Left) Pain Score | 17.0 ± 26.8 | 18.4 ± 27.0 |
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm | 36 | 90 |
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm | 37 | 78 |
Assessment of symptom severity by ZCQ mean score in both treatment groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
| units on a scale | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 2.17 ± 0.85 | 2.08 ± 0.84 |
Assessment of physical function by ZCQ mean score in both groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
| units on a scale | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 1.81 ± 0.79 | 1.67 ± 0.68 |
Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
| units on a scale | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Short Form-12 Physical Component Score | 42.1 ± 12.6 | 42.1 ± 11.2 |
Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
| units on a scale | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Short Form-12 Mental Component Score | 54.8 ± 8.4 | 54.1 ± 9.7 |
Subjects who responded "Very Satisfied" or "Somewhat Satisfied".
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Patient Survey: Satisfaction | 72 | 151 |
Subjects who responded "Definitely Yes" or "Probably Yes"
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Patient Survey: Recommendation of Treatment | 70 | 145 |
Number of subjects using Class II narcotics
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Pain Management: Class II Narcotics Usage by Device Group | 17 | 32 |
Number of subjects using NSAIDs/ASA/Acetaminophen
| Participants | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group | 24 | 55 |
As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the index level(s) in both treatment groups at 5 years.
| degrees | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Mean Rotation (F to E) in Degrees - At Level(s) of Implant | 0.98 ± 1.17 | 3.13 ± 3.43 |
As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level below the implant in both treatment groups at 5 years.
| degrees | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Rotation (F to E) in Degrees - Below Level of Implant | 5.62 ± 3.69 | 5.83 ± 4.17 |
As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level above the implant in both treatment groups at 5 years.
| degrees | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Rotation (F to E) in Degrees - Above Level of Implant | 3.59 ± 2.89 | 3.52 ± 3.16 |
As determined by independent radiographic lab, this is the average measure of translation at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Translation (mm) - At Level(s) of Implant | 0.23 ± 0.32 | 0.82 ± 0.84 |
As determined by independent radiographic lab, this is the average measure of translation at the level below the implant in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Translation (mm) - Below Level of Implant | 0.63 ± 0.57 | 0.64 ± 0.61 |
As determined by independent radiographic lab, this is the average measure of translation at the level above the implant in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Translation (mm) - Above Level of Implant | 0.69 ± 0.57 | 0.83 ± 0.80 |
As determined by independent radiographic lab, this is the average measure of anterior disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Anterior Disc Height (mm) - At Level(s) of Implant | 8.13 ± 3.19 | 8.89 ± 3.68 |
As determined by independent radiographic lab, this is the average measure of posterior disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Posterior Disc Height (mm) - At Level(s) of Implant | 4.56 ± 1.65 | 4.46 ± 1.89 |
As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years.
| percent | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Translation (F to E) in Percent (%) - At Level(s) of Implant | 0.69 ± 0.89 | 2.38 ± 2.43 |
As determined by independent radiographic lab, this is the percentage of translation at the level below the implant in both treatment groups at 5 years.
| percent | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Translation (F to E) in Percent (%) - Below Level of Implant | 1.95 ± 1.95 | 1.97 ± 1.88 |
As determined by independent radiographic lab, this is the percentage of translation at the level above the implant in both treatment groups at 5 years.
| percent | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Translation (F to E) in Percent (%) - Above Level of Implant | 2.07 ± 1.68 | 2.40 ± 2.31 |
As determined by independent radiographic lab, this is the average measure of disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Average Disc Height (mm) - At Level(s) of Implant | 6.34 ± 2.09 | 6.67 ± 2.45 |
As determined by independent radiographic lab, this is the average change from baseline for anterior disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant | -1.38 ± 1.58 | -1.32 ± 1.75 |
As determined by independent radiographic lab, this is the average change from baseline for posterior disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant | -0.49 ± 1.19 | -0.72 ± 1.26 |
As determined by independent radiographic lab, this is the average change from baseline for disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant | -0.93 ± 1.02 | -1.02 ± 1.24 |
As determined by independent radiographic lab, this is the average change from immediate post-op for anterior disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant | -1.82 ± 1.39 | -0.98 ± 2.06 |
As determined by independent radiographic lab, this is the average change from immediate post-op for posterior disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant | -0.85 ± 1.00 | -1.90 ± 1.65 |
As determined by independent radiographic lab, this is the average change from immediate post-op for disc height at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant | -1.33 ± 0.97 | -1.44 ± 1.47 |
As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years.
| degrees | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Disc Angle in Degrees - At Level(s) of Implant | 6.02 ± 4.64 | 7.28 ± 5.19 |
As determined by independent radiographic lab, this is the mean change in disc angle from baseline at the index level(s) in both treatment groups at 5 years.
| degrees | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant | -1.41 ± 3.10 | -1.00 ± 2.91 |
As determined by independent radiographic lab, this is the mean change in disc angle from immediate post-op at the index level(s) in both treatment groups at 5 years.
| degrees | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant | -1.57 ± 2.25 | 1.56 ± 3.82 |
As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant | -1.08 ± 3.37 | -1.01 ± 3.78 |
As determined by independent radiographic lab, this is the measure of the percentage of spondylolisthesis at the index level(s) in both treatment groups at 5 years.
| percent | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant | -3.4 ± 9.9 | -3.2 ± 11.2 |
As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant | -0.12 ± 2.28 | -0.56 ± 1.82 |
As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis from immediate post-op at the index level(s) in both treatment groups at 5 years.
| mm | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant | -0.77 ± 1.92 | -0.44 ± 1.91 |
This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years.
| mm | Coflex Interlaminar Technolgy |
|---|---|
| Foraminal Height (X-ray) (mm) - At Level(s) of Implant | 17.33 ± 2.75 |
This is the mean change in foraminal height via x-ray from baseline at the index level(s) in both treatment groups at 5 years.
| mm | Coflex Interlaminar Technolgy |
|---|---|
| Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant | -0.47 ± 1.29 |
This is the mean change in foraminal height via x-ray from immediate post-op at the index level(s) in both treatment groups at 5 years.
| mm | Coflex Interlaminar Technolgy |
|---|---|
| Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant | -1.81 ± 1.74 |
Bridging through the posterolateral gutters, between the facet joints, between transverse processes, and/or between facet joint and transverse process will all be considered acceptable forms of bridging bone.
| Levels | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| NA | 0 | 209 |
| No | 17 | 0 |
| Yes | 84 | 0 |
| Indeterminate | 10 | 0 |
Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant.
| participants | Coflex Interlaminar Technolgy |
|---|---|
| NA | 0 |
| None | 91 |
| Grade I | 0 |
| Grade II | 24 |
| Grade III | 73 |
| Bony Bridging | 3 |
| Indeterminate | 18 |
The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.
| Levels | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| NA | 0 | 0 |
| Not fused | 19 | 196 |
| Fused | 78 | 3 |
| Indeterminate | 14 | 10 |
Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface.
| Levels | Coflex Interlaminar Technolgy |
|---|---|
| NA | 0 |
| None | 75 |
| Mild | 70 |
| Moderate | 16 |
| Severe | 20 |
| Indeterminate | 28 |
Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged.
| Levels | Coflex Interlaminar Technolgy |
|---|---|
| NA | 0 |
| Intact | 184 |
| Deformed | 0 |
| Fractured | 3 |
| Migrated | 11 |
| Dislodged | 0 |
| Indeterminate | 11 |
Per level; This assessment is applicable to the fusion arm only. Device Condition in the control subjects will be graded as: Intact, Loose Screws, or Failed Hardware.
| Levels | Posterolateral Fusion w/Pedicle Screws |
|---|---|
| NA | 0 |
| Intact | 90 |
| Failed Graft | 0 |
| Loose Screws | 10 |
| Fractured Hardware | 2 |
| Indeterminate | 9 |
Per level; Assessment is applicable to coflex arm only. Device Mobility is an expected occurrence in some subjects and represents the amount of the of lift-off of the implant from the inferior spinous process.
| Levels | Coflex Interlaminar Technolgy |
|---|---|
| NA | 0 |
| < 5 mm | 181 |
| >= 5 mm | 15 |
| Indeterminate | 13 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | 0/107 (0%) | 64/107 (59.8%) | 101/107 (94.4%) |
| Coflex Interlaminar Technolgy | 0/215 (0%) | 109/215 (50.7%) | 199/215 (92.6%) |
| Event | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| Pain; new, increased frequency, or worseningMusculoskeletal and connective tissue disorders | 19/107 | 29/215 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 16/107 | 32/215 |
| OtherMetabolism and nutrition disorders | 11/107 | 10/215 |
| Cancer/NeoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 10/107 | 5/215 |
| CardiovascularCardiac disorders | 5/107 | 17/215 |
| GastrointestinalGastrointestinal disorders | 6/107 | 10/215 |
| Component LooseningMusculoskeletal and connective tissue disorders | 5/107 | 3/215 |
| GenitourinaryGeneral disorders | 5/107 | 5/215 |
| NeurologicalNervous system disorders | 4/107 | 5/215 |
| Psychiatric/Substance AbusePsychiatric disorders | 3/107 | 0/215 |
| Event | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy |
|---|---|---|
| MusculoskeletalMusculoskeletal and connective tissue disorders | 65/107 | 119/215 |
| Pain; new, increased frequency, or worseningMusculoskeletal and connective tissue disorders | 29/107 | 61/215 |
| NeurologicalNervous system disorders | 23/107 | 56/215 |
| OtherMusculoskeletal and connective tissue disorders | 20/107 | 46/215 |
| Wound problemsMusculoskeletal and connective tissue disorders | 9/107 | 24/215 |
| CardiovascularCardiac disorders | 11/107 | 15/215 |
| GastrointestinalGastrointestinal disorders | 11/107 | 11/215 |
| Skin and Subcutaneous TissueSkin and subcutaneous tissue disorders | 9/107 | 16/215 |
| GenitourinaryGeneral disorders | 8/107 | 11/215 |
| RespiratoryRespiratory, thoracic and mediastinal disorders | 7/107 | 7/215 |
| Age, Continuous(years) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| Mean | 64.1 ± 9.0 | 62.1 ± 9.2 | 62.8 ± 9.2 |
| Sex: Female, Male(Participants) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| Female | 58 | 106 | 164 |
| Male | 49 | 109 | 158 |
| Race/Ethnicity, Customized(Participants) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| American Indian / Alaskan Native | 3 | 1 | 4 |
| Asian | 3 | 4 | 7 |
| Black or African American | 6 | 11 | 17 |
| White | 93 | 191 | 284 |
| Other | 2 | 8 | 10 |
| Region of Enrollment(participants) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| United States | 107 | 215 | 322 |
| Weight(pounds) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| Mean | 187.7 ± 38.1 | 190.3 ± 35.4 | 189.5 ± 36.3 |
| Height(inches) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| Mean | 66.6 ± 4.1 | 67.0 ± 4.1 | 66.9 ± 4.1 |
| Current Smoker(Participants) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| Yes | 15 | 22 | 37 |
| No | 92 | 193 | 285 |
| Comorbidities(Participants) | Posterolateral Fusion w/Pedicle Screws | Coflex Interlaminar Technolgy | Total |
|---|---|---|---|
| Cardiovascular | 74 | 137 | 211 |
| Musculoskeletal | 61 | 112 | 173 |
| Endocrine | 35 | 55 | 90 |
4 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Paradigm Spine