Spinal Stenosis
Conditions
Brief summary
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Detailed description
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).
Interventions
PROCEDUREDecompression
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
DEVICEPosterolateral Fusion and Implantation of Pedicle Screws
DEVICEImplantation of coflex Interlaminar Technology
Sponsors
MCRA
Paradigm Spine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Healthy volunteers
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With no Reoperations or Epidural (Up to Day 1825) | 5 years | No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit. |
| Number of Subjects With Improvement of at Least 15 Points in ODI | 5 years | 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). |
| Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation | 5 years | 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). |
| Number of Subjects With no Major Device Related Complications | 5 years | Assessment of major device-related complications at 5 years |
| Number of Subjects With no Epidural Injection(s) | 5 years | Assessment of lumbar epidural injections |
| Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit | 5 years | No persistent new or increasing sensory or motor deficit |
| Number of Subjects With no Persistent New or Increasing Sensory Deficit | 5 years | No persistent new or increasing sensory deficit |
| Number of Subjects With no Persistent New or Increasing Motor Deficit | 5 years | No persistent new or increasing motor deficit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Analog Scale Leg (Worse) Pain Score | 5 years | 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. |
| Mean Visual Analog Scale (VAS) Leg (Right) Pain Score | 5 years | 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. |
| Mean Visual Analog Scale (VAS) Leg (Left) Pain Score | 5 years | 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. |
| Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm | 5 years | 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. |
| Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm | 5 years | 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. |
| Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 5 years | 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. |
| Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points | 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. |
| Mean Short Form-12 Physical Component Score | 5 years | 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. |
| Mean Short Form-12 Mental Component Score | 5 years | 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. |
| Patient Survey: Satisfaction | 5 years | Subjects who responded Very Satisfied or Somewhat Satisfied. |
| Patient Survey: Recommendation of Treatment | 5 years | Subjects who responded Definitely Yes or Probably Yes |
| Pain Management: Class II Narcotics Usage by Device Group | 5 years | Number of subjects using Class II narcotics |
| Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group | 5 years | Number of subjects using NSAIDs/ASA/Acetaminophen |
| Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 5 years | 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. |
| Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points | 5 years | ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. |
| Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component | 5 years | 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. |
| Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component | 5 years | 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. |
| Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm | 5 years | 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. |
| Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm | 5 years | 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. |
| Mean Oswestry Disability Index (ODI) Score | 5 years | 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. |
| Mean Visual Analog Scale Back Pain Score | 5 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fusion Status | 5 years | The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion. |
| Interface Remodeling - At Level(s) of Implant | 5 years | Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface. |
| Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant | 5 years | 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. |
| Device Condition (Fusion Control) | 5 years | 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. |
| Device Mobility | 5 years | 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. |
| Device Condition (Coflex Arm) | 5 years | Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged. |
| Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant | 5 years | 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. |
| Foraminal Height (X-ray) (mm) - At Level(s) of Implant | 5 years | This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years. |
| Mean Rotation (F to E) in Degrees - At Level(s) of Implant | 5 years | 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. |
| Rotation (F to E) in Degrees - Below Level of Implant | 5 years | 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. |
| Rotation (F to E) in Degrees - Above Level of Implant | 5 years | 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. |
| Translation (mm) - At Level(s) of Implant | 5 years | 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. |
| Translation (mm) - Below Level of Implant | 5 years | 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. |
| Translation (mm) - Above Level of Implant | 5 years | 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. |
| Anterior Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Posterior Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Translation (F to E) in Percent (%) - At Level(s) of Implant | 5 years | As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years. |
| Translation (F to E) in Percent (%) - Below Level of Implant | 5 years | 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. |
| Translation (F to E) in Percent (%) - Above Level of Implant | 5 years | 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. |
| Average Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant | 5 years | 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. |
| Disc Angle in Degrees - At Level(s) of Implant | 5 years | As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years. |
| Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant | 5 years | 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. |
| Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant | 5 years | 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. |
| Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant | 5 years | As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years. |
| Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant | 5 years | 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. |
| Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant | 5 years | 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. |
| Bony Bridging | 5 years | 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. |
| Heterotopic Ossification | 5 years | Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Posterolateral Fusion w/Pedicle Screws Control: Posterolateral fusion and implantation of pedicle screws after decompression
Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
Posterolateral Fusion and Implantation of Pedicle Screws | 107 |
| Coflex Interlaminar Technolgy Investigative: Implantation of coflex Interlaminar Technology after decompression
Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
Implantation of coflex Interlaminar Technology | 215 |
| Total | 322 |
Baseline characteristics
| Characteristic | Posterolateral Fusion w/Pedicle Screws | Total | Coflex Interlaminar Technolgy |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 9 | 62.8 years STANDARD_DEVIATION 9.2 | 62.1 years STANDARD_DEVIATION 9.2 |
| Comorbidities Cardiovascular | 74 Participants | 211 Participants | 137 Participants |
| Comorbidities Endocrine | 35 Participants | 90 Participants | 55 Participants |
| Comorbidities Musculoskeletal | 61 Participants | 173 Participants | 112 Participants |
| Current Smoker No | 92 Participants | 285 Participants | 193 Participants |
| Current Smoker Yes | 15 Participants | 37 Participants | 22 Participants |
| Duration of Back Pain 6 months to a year | 14 Participants | 38 Participants | 24 Participants |
| Duration of Back Pain Fewer than 6 months | 1 Participants | 4 Participants | 3 Participants |
| Duration of Back Pain More than one year | 92 Participants | 280 Participants | 188 Participants |
| Duration of Back Pain None | 0 Participants | 0 Participants | 0 Participants |
| Duration of Buttock Pain 6 months to a year | 22 Participants | 63 Participants | 41 Participants |
| Duration of Buttock Pain Fewer than 6 months | 7 Participants | 18 Participants | 11 Participants |
| Duration of Buttock Pain More than one year | 57 Participants | 188 Participants | 131 Participants |
| Duration of Buttock Pain None | 21 Participants | 53 Participants | 32 Participants |
| Duration of Groin Pain 6 months to a year | 12 Participants | 25 Participants | 13 Participants |
| Duration of Groin Pain Fewer than 6 months | 5 Participants | 11 Participants | 6 Participants |
| Duration of Groin Pain More than one year | 16 Participants | 55 Participants | 39 Participants |
| Duration of Groin Pain None | 74 Participants | 231 Participants | 157 Participants |
| Duration of Leg Pain (maximum) 6 months to a year | 22 Participants | 60 Participants | 38 Participants |
| Duration of Leg Pain (maximum) Fewer than 6 months | 8 Participants | 14 Participants | 6 Participants |
| Duration of Leg Pain (maximum) More than one year | 76 Participants | 246 Participants | 170 Participants |
| Duration of Leg Pain (maximum) None | 1 Participants | 2 Participants | 1 Participants |
| Height | 66.6 inches STANDARD_DEVIATION 4.1 | 66.9 inches STANDARD_DEVIATION 4.1 | 67.0 inches STANDARD_DEVIATION 4.1 |
| Race/Ethnicity, Customized American Indian / Alaskan Native | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 17 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 10 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 93 Participants | 284 Participants | 191 Participants |
| Region of Enrollment United States | 107 participants | 322 participants | 215 participants |
| Sex: Female, Male Female | 58 Participants | 164 Participants | 106 Participants |
| Sex: Female, Male Male | 49 Participants | 158 Participants | 109 Participants |
| Weight | 187.7 pounds STANDARD_DEVIATION 38.1 | 189.5 pounds STANDARD_DEVIATION 36.3 | 190.3 pounds STANDARD_DEVIATION 35.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 215 |
| other Total, other adverse events | 101 / 107 | 199 / 215 |
| serious Total, serious adverse events | 64 / 107 | 109 / 215 |
Outcome results
Primary
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
Population: The accounting #s in the Patient Flow include all subjects available for CCS evaluation; therefore, the overall # of participants analyzed for each Outcome Measure will differ from the number provided in the Participant Flow as the number provided for each Outcome Measure is the number of patients who completed or were assessed for that measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With Improvement of at Least 15 Points in ODI | 41 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With Improvement of at Least 15 Points in ODI | 101 Participants |
Primary
Number of Subjects With no Epidural Injection(s)
Assessment of lumbar epidural injections
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With no Epidural Injection(s) | 84 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With no Epidural Injection(s) | 177 Participants |
Primary
Number of Subjects With no Major Device Related Complications
Assessment of major device-related complications at 5 years
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With no Major Device Related Complications | 100 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With no Major Device Related Complications | 212 Participants |
Primary
Number of Subjects With no Persistent New or Increasing Motor Deficit
No persistent new or increasing motor deficit
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With no Persistent New or Increasing Motor Deficit | 72 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With no Persistent New or Increasing Motor Deficit | 144 Participants |
Primary
Number of Subjects With no Persistent New or Increasing Sensory Deficit
No persistent new or increasing sensory deficit
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With no Persistent New or Increasing Sensory Deficit | 72 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With no Persistent New or Increasing Sensory Deficit | 137 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit | 70 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit | 135 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With no Reoperations or Epidural (Up to Day 1825) | 71 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With no Reoperations or Epidural (Up to Day 1825) | 149 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation | 87 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation | 179 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Oswestry Disability Index (ODI) Score | 26.1 units on a scale | Standard Deviation 22.2 |
| Coflex Interlaminar Technolgy | Mean Oswestry Disability Index (ODI) Score | 24.5 units on a scale | Standard Deviation 20.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Short Form-12 Mental Component Score | 54.8 units on a scale | Standard Deviation 8.4 |
| Coflex Interlaminar Technolgy | Mean Short Form-12 Mental Component Score | 54.1 units on a scale | Standard Deviation 9.7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Short Form-12 Physical Component Score | 42.1 units on a scale | Standard Deviation 12.6 |
| Coflex Interlaminar Technolgy | Mean Short Form-12 Physical Component Score | 42.1 units on a scale | Standard Deviation 11.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Visual Analog Scale Back Pain Score | 29.0 mm | Standard Deviation 31 |
| Coflex Interlaminar Technolgy | Mean Visual Analog Scale Back Pain Score | 25.4 mm | Standard Deviation 27.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Visual Analog Scale Leg (Worse) Pain Score | 25.2 mm | Standard Deviation 31.2 |
| Coflex Interlaminar Technolgy | Mean Visual Analog Scale Leg (Worse) Pain Score | 22.8 mm | Standard Deviation 28.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Visual Analog Scale (VAS) Leg (Left) Pain Score | 17.0 mm | Standard Deviation 26.8 |
| Coflex Interlaminar Technolgy | Mean Visual Analog Scale (VAS) Leg (Left) Pain Score | 18.4 mm | Standard Deviation 27 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Visual Analog Scale (VAS) Leg (Right) Pain Score | 16.0 mm | Standard Deviation 24.5 |
| Coflex Interlaminar Technolgy | Mean Visual Analog Scale (VAS) Leg (Right) Pain Score | 14.9 mm | Standard Deviation 21.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 1.81 units on a scale | Standard Deviation 0.79 |
| Coflex Interlaminar Technolgy | Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score | 1.67 units on a scale | Standard Deviation 0.68 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 2.17 units on a scale | Standard Deviation 0.85 |
| Coflex Interlaminar Technolgy | Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score | 2.08 units on a scale | Standard Deviation 0.84 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm | 40 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm | 104 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm | 37 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm | 78 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm | 36 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm | 90 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points | 40 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points | 100 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points | 38 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points | 98 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm | 41 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm | 99 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component | 31 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component | 72 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component | 34 Participants |
| Coflex Interlaminar Technolgy | Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component | 93 Participants |
Secondary
Pain Management: Class II Narcotics Usage by Device Group
Number of subjects using Class II narcotics
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Pain Management: Class II Narcotics Usage by Device Group | 17 Participants |
| Coflex Interlaminar Technolgy | Pain Management: Class II Narcotics Usage by Device Group | 32 Participants |
Secondary
Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group
Number of subjects using NSAIDs/ASA/Acetaminophen
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group | 24 Participants |
| Coflex Interlaminar Technolgy | Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group | 55 Participants |
Secondary
Patient Survey: Recommendation of Treatment
Subjects who responded Definitely Yes or Probably Yes
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Patient Survey: Recommendation of Treatment | 70 Participants |
| Coflex Interlaminar Technolgy | Patient Survey: Recommendation of Treatment | 145 Participants |
Secondary
Patient Survey: Satisfaction
Subjects who responded Very Satisfied or Somewhat Satisfied.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Patient Survey: Satisfaction | 72 Participants |
| Coflex Interlaminar Technolgy | Patient Survey: Satisfaction | 151 Participants |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Anterior Disc Height (mm) - At Level(s) of Implant | 8.13 mm | Standard Deviation 3.19 |
| Coflex Interlaminar Technolgy | Anterior Disc Height (mm) - At Level(s) of Implant | 8.89 mm | Standard Deviation 3.68 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Average Disc Height (mm) - At Level(s) of Implant | 6.34 mm | Standard Deviation 2.09 |
| Coflex Interlaminar Technolgy | Average Disc Height (mm) - At Level(s) of Implant | 6.67 mm | Standard Deviation 2.45 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Bony Bridging | NA | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Bony Bridging | No | 17 Levels |
| Posterolateral Fusion w/Pedicle Screws | Bony Bridging | Yes | 84 Levels |
| Posterolateral Fusion w/Pedicle Screws | Bony Bridging | Indeterminate | 10 Levels |
| Coflex Interlaminar Technolgy | Bony Bridging | Indeterminate | 0 Levels |
| Coflex Interlaminar Technolgy | Bony Bridging | NA | 209 Levels |
| Coflex Interlaminar Technolgy | Bony Bridging | Yes | 0 Levels |
| Coflex Interlaminar Technolgy | Bony Bridging | No | 0 Levels |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant | -1.82 mm | Standard Deviation 1.39 |
| Coflex Interlaminar Technolgy | Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant | -0.98 mm | Standard Deviation 2.06 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant | -1.33 mm | Standard Deviation 0.97 |
| Coflex Interlaminar Technolgy | Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant | -1.44 mm | Standard Deviation 1.47 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant | -1.57 degrees | Standard Deviation 2.25 |
| Coflex Interlaminar Technolgy | Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant | 1.56 degrees | Standard Deviation 3.82 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant | -1.81 mm | Standard Deviation 1.74 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant | -0.85 mm | Standard Deviation 1 |
| Coflex Interlaminar Technolgy | Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant | -1.90 mm | Standard Deviation 1.65 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant | -3.4 percent | Standard Deviation 9.9 |
| Coflex Interlaminar Technolgy | Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant | -3.2 percent | Standard Deviation 11.2 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant | -1.08 mm | Standard Deviation 3.37 |
| Coflex Interlaminar Technolgy | Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant | -1.01 mm | Standard Deviation 3.78 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant | -0.77 mm | Standard Deviation 1.92 |
| Coflex Interlaminar Technolgy | Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant | -0.44 mm | Standard Deviation 1.91 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant | -1.38 mm | Standard Deviation 1.58 |
| Coflex Interlaminar Technolgy | Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant | -1.32 mm | Standard Deviation 1.75 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant | -0.93 mm | Standard Deviation 1.02 |
| Coflex Interlaminar Technolgy | Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant | -1.02 mm | Standard Deviation 1.24 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant | -1.41 degrees | Standard Deviation 3.1 |
| Coflex Interlaminar Technolgy | Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant | -1.00 degrees | Standard Deviation 2.91 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant | -0.47 mm | Standard Deviation 1.29 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant | -0.49 mm | Standard Deviation 1.19 |
| Coflex Interlaminar Technolgy | Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant | -0.72 mm | Standard Deviation 1.26 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant | -0.12 mm | Standard Deviation 2.28 |
| Coflex Interlaminar Technolgy | Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant | -0.56 mm | Standard Deviation 1.82 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Coflex Arm) | NA | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Coflex Arm) | Intact | 184 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Coflex Arm) | Deformed | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Coflex Arm) | Fractured | 3 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Coflex Arm) | Migrated | 11 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Coflex Arm) | Dislodged | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Coflex Arm) | Indeterminate | 11 Levels |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Fusion Control) | NA | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Fusion Control) | Intact | 90 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Fusion Control) | Failed Graft | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Fusion Control) | Loose Screws | 10 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Fusion Control) | Fractured Hardware | 2 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Condition (Fusion Control) | Indeterminate | 9 Levels |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Device Mobility | NA | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Mobility | < 5 mm | 181 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Mobility | >= 5 mm | 15 Levels |
| Posterolateral Fusion w/Pedicle Screws | Device Mobility | Indeterminate | 13 Levels |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Disc Angle in Degrees - At Level(s) of Implant | 6.02 degrees | Standard Deviation 4.64 |
| Coflex Interlaminar Technolgy | Disc Angle in Degrees - At Level(s) of Implant | 7.28 degrees | Standard Deviation 5.19 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Foraminal Height (X-ray) (mm) - At Level(s) of Implant | 17.33 mm | Standard Deviation 2.75 |
Other Pre-specified
Fusion Status
The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.
Time frame: 5 years
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Fusion Status | NA | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Fusion Status | Not fused | 19 Levels |
| Posterolateral Fusion w/Pedicle Screws | Fusion Status | Fused | 78 Levels |
| Posterolateral Fusion w/Pedicle Screws | Fusion Status | Indeterminate | 14 Levels |
| Coflex Interlaminar Technolgy | Fusion Status | Indeterminate | 10 Levels |
| Coflex Interlaminar Technolgy | Fusion Status | NA | 0 Levels |
| Coflex Interlaminar Technolgy | Fusion Status | Fused | 3 Levels |
| Coflex Interlaminar Technolgy | Fusion Status | Not fused | 196 Levels |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Heterotopic Ossification | NA | 0 participants |
| Posterolateral Fusion w/Pedicle Screws | Heterotopic Ossification | None | 91 participants |
| Posterolateral Fusion w/Pedicle Screws | Heterotopic Ossification | Grade I | 0 participants |
| Posterolateral Fusion w/Pedicle Screws | Heterotopic Ossification | Grade II | 24 participants |
| Posterolateral Fusion w/Pedicle Screws | Heterotopic Ossification | Grade III | 73 participants |
| Posterolateral Fusion w/Pedicle Screws | Heterotopic Ossification | Bony Bridging | 3 participants |
| Posterolateral Fusion w/Pedicle Screws | Heterotopic Ossification | Indeterminate | 18 participants |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Interface Remodeling - At Level(s) of Implant | Indeterminate | 28 Levels |
| Posterolateral Fusion w/Pedicle Screws | Interface Remodeling - At Level(s) of Implant | NA | 0 Levels |
| Posterolateral Fusion w/Pedicle Screws | Interface Remodeling - At Level(s) of Implant | None | 75 Levels |
| Posterolateral Fusion w/Pedicle Screws | Interface Remodeling - At Level(s) of Implant | Mild | 70 Levels |
| Posterolateral Fusion w/Pedicle Screws | Interface Remodeling - At Level(s) of Implant | Moderate | 16 Levels |
| Posterolateral Fusion w/Pedicle Screws | Interface Remodeling - At Level(s) of Implant | Severe | 20 Levels |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Mean Rotation (F to E) in Degrees - At Level(s) of Implant | 0.98 degrees | Standard Deviation 1.17 |
| Coflex Interlaminar Technolgy | Mean Rotation (F to E) in Degrees - At Level(s) of Implant | 3.13 degrees | Standard Deviation 3.43 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Posterior Disc Height (mm) - At Level(s) of Implant | 4.56 mm | Standard Deviation 1.65 |
| Coflex Interlaminar Technolgy | Posterior Disc Height (mm) - At Level(s) of Implant | 4.46 mm | Standard Deviation 1.89 |
Other Pre-specified
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
Population: This analysis was performed at the level above the 1- or 2-level device construct in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Rotation (F to E) in Degrees - Above Level of Implant | 3.59 degrees | Standard Deviation 2.89 |
| Coflex Interlaminar Technolgy | Rotation (F to E) in Degrees - Above Level of Implant | 3.52 degrees | Standard Deviation 3.16 |
Other Pre-specified
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
Population: This analysis was performed at the level below the 1- or 2-level device construct in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Rotation (F to E) in Degrees - Below Level of Implant | 5.62 degrees | Standard Deviation 3.69 |
| Coflex Interlaminar Technolgy | Rotation (F to E) in Degrees - Below Level of Implant | 5.83 degrees | Standard Deviation 4.17 |
Other Pre-specified
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
Population: This analysis was performed at the level above the 1- or 2-level device construct in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Translation (F to E) in Percent (%) - Above Level of Implant | 2.07 percent | Standard Deviation 1.68 |
| Coflex Interlaminar Technolgy | Translation (F to E) in Percent (%) - Above Level of Implant | 2.40 percent | Standard Deviation 2.31 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Translation (F to E) in Percent (%) - At Level(s) of Implant | 0.69 percent | Standard Deviation 0.89 |
| Coflex Interlaminar Technolgy | Translation (F to E) in Percent (%) - At Level(s) of Implant | 2.38 percent | Standard Deviation 2.43 |
Other Pre-specified
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
Population: This analysis was performed at the level below the 1- or 2-level device construct in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Translation (F to E) in Percent (%) - Below Level of Implant | 1.95 percent | Standard Deviation 1.95 |
| Coflex Interlaminar Technolgy | Translation (F to E) in Percent (%) - Below Level of Implant | 1.97 percent | Standard Deviation 1.88 |
Other Pre-specified
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
Population: This analysis was performed at the level above the 1- or 2-level device construct in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Translation (mm) - Above Level of Implant | 0.69 mm | Standard Deviation 0.57 |
| Coflex Interlaminar Technolgy | Translation (mm) - Above Level of Implant | 0.83 mm | Standard Deviation 0.8 |
Other Pre-specified
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
Population: This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Translation (mm) - At Level(s) of Implant | 0.23 mm | Standard Deviation 0.32 |
| Coflex Interlaminar Technolgy | Translation (mm) - At Level(s) of Implant | 0.82 mm | Standard Deviation 0.84 |
Other Pre-specified
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
Population: This analysis was performed at the level below the 1- or 2-level device construct in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Translation (mm) - Below Level of Implant | 0.63 mm | Standard Deviation 0.57 |
| Coflex Interlaminar Technolgy | Translation (mm) - Below Level of Implant | 0.64 mm | Standard Deviation 0.61 |