| 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 coflexâ„¢ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability). | 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. | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation | | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Subjects With no Major Device Related Complications | Assessment of major device-related complications at 5 years | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Subjects With no Epidural Injection(s) | Assessment of lumbar epidural injections | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit | No persistent new or increasing sensory or motor deficit | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Subjects With no Persistent New or Increasing Sensory Deficit | No persistent new or increasing sensory deficit | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Primary | Number of Subjects With no Persistent New or Increasing Motor Deficit | No persistent new or increasing motor deficit | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | mm | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | mm | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | mm | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | mm | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Patient Survey: Satisfaction | Subjects who responded "Very Satisfied" or "Somewhat Satisfied". | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Patient Survey: Recommendation of Treatment | Subjects who responded "Definitely Yes" or "Probably Yes" | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Pain Management: Class II Narcotics Usage by Device Group | Number of subjects using Class II narcotics | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group | Number of subjects using NSAIDs/ASA/Acetaminophen | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | degrees | | 5 years | Levels | Levels | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | This analysis was performed at the level below the 1- or 2-level device construct in both groups. | Posted | | Mean | Standard Deviation | degrees | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | This analysis was performed at the level above the 1- or 2-level device construct in both groups. | Posted | | Mean | Standard Deviation | degrees | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | This analysis was performed at the level below the 1- or 2-level device construct in both groups. | Posted | | Mean | Standard Deviation | mm | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | This analysis was performed at the level above the 1- or 2-level device construct in both groups. | Posted | | Mean | Standard Deviation | mm | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | percent | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | This analysis was performed at the level below the 1- or 2-level device construct in both groups. | Posted | | Mean | Standard Deviation | percent | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | This analysis was performed at the level above the 1- or 2-level device construct in both groups. | Posted | | Mean | Standard Deviation | percent | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | degrees | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | degrees | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | degrees | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | percent | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| 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. | 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. | Posted | | Count of Units | | Levels | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Heterotopic Ossification | Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant. | 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. | Posted | | Number | | participants | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| Other Pre-specified | Fusion Status | The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion. | 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. | Posted | | Count of Units | | Levels | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | 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. | Posted | | Count of Units | | Levels | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| 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. | 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. | Posted | | Count of Units | | Levels | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| 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. | 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. | Posted | | Count of Units | | Levels | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| 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. | 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. | Posted | | Count of Units | | Levels | | 5 years | Levels | Levels | | ID | Title | Description |
|---|
| OG000 | 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 |
| |