Trial Outcomes & Findings for Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis (NCT NCT00534235)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

322 participants

Primary outcome timeframe

5 years

Results posted on

2020-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	107	215
Overall Study COMPLETED	91	192
Overall Study NOT COMPLETED	16	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Posterolateral Fusion w/Pedicle Screws n=107 Participants 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	Coflex Interlaminar Technolgy n=215 Participants 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	Total n=322 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 9.0 • n=5 Participants	62.1 years STANDARD_DEVIATION 9.2 • n=7 Participants	62.8 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	106 Participants n=7 Participants	164 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	109 Participants n=7 Participants	158 Participants n=5 Participants
Race/Ethnicity, Customized American Indian / Alaskan Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized White	93 Participants n=5 Participants	191 Participants n=7 Participants	284 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants	215 participants n=7 Participants	322 participants n=5 Participants
Weight	187.7 pounds STANDARD_DEVIATION 38.1 • n=5 Participants	190.3 pounds STANDARD_DEVIATION 35.4 • n=7 Participants	189.5 pounds STANDARD_DEVIATION 36.3 • n=5 Participants
Height	66.6 inches STANDARD_DEVIATION 4.1 • n=5 Participants	67.0 inches STANDARD_DEVIATION 4.1 • n=7 Participants	66.9 inches STANDARD_DEVIATION 4.1 • n=5 Participants
Current Smoker Yes	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Current Smoker No	92 Participants n=5 Participants	193 Participants n=7 Participants	285 Participants n=5 Participants
Comorbidities Cardiovascular	74 Participants n=5 Participants	137 Participants n=7 Participants	211 Participants n=5 Participants
Comorbidities Musculoskeletal	61 Participants n=5 Participants	112 Participants n=7 Participants	173 Participants n=5 Participants
Comorbidities Endocrine	35 Participants n=5 Participants	55 Participants n=7 Participants	90 Participants n=5 Participants
Duration of Back Pain None	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Duration of Back Pain Fewer than 6 months	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Duration of Back Pain 6 months to a year	14 Participants n=5 Participants	24 Participants n=7 Participants	38 Participants n=5 Participants
Duration of Back Pain More than one year	92 Participants n=5 Participants	188 Participants n=7 Participants	280 Participants n=5 Participants
Duration of Leg Pain (maximum) None	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Duration of Leg Pain (maximum) Fewer than 6 months	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Duration of Leg Pain (maximum) 6 months to a year	22 Participants n=5 Participants	38 Participants n=7 Participants	60 Participants n=5 Participants
Duration of Leg Pain (maximum) More than one year	76 Participants n=5 Participants	170 Participants n=7 Participants	246 Participants n=5 Participants
Duration of Buttock Pain None	21 Participants n=5 Participants	32 Participants n=7 Participants	53 Participants n=5 Participants
Duration of Buttock Pain Fewer than 6 months	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Duration of Buttock Pain 6 months to a year	22 Participants n=5 Participants	41 Participants n=7 Participants	63 Participants n=5 Participants
Duration of Buttock Pain More than one year	57 Participants n=5 Participants	131 Participants n=7 Participants	188 Participants n=5 Participants
Duration of Groin Pain None	74 Participants n=5 Participants	157 Participants n=7 Participants	231 Participants n=5 Participants
Duration of Groin Pain Fewer than 6 months	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Duration of Groin Pain 6 months to a year	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Duration of Groin Pain More than one year	16 Participants n=5 Participants	39 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=126 Participants 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
Number of Subjects With Improvement of at Least 15 Points in ODI	41 Participants	101 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=107 Participants 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	Coflex Interlaminar Technolgy n=215 Participants 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
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation	87 Participants	179 Participants

PRIMARY outcome

Timeframe: 5 years

Assessment of major device-related complications at 5 years

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=107 Participants 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	Coflex Interlaminar Technolgy n=215 Participants 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
Number of Subjects With no Major Device Related Complications	100 Participants	212 Participants

PRIMARY outcome

Timeframe: 5 years

Assessment of lumbar epidural injections

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=107 Participants 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	Coflex Interlaminar Technolgy n=215 Participants 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
Number of Subjects With no Epidural Injection(s)	84 Participants	177 Participants

PRIMARY outcome

Timeframe: 5 years

No persistent new or increasing sensory or motor deficit

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=74 Participants 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	Coflex Interlaminar Technolgy n=145 Participants 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
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit	70 Participants	135 Participants

PRIMARY outcome

Timeframe: 5 years

No persistent new or increasing sensory deficit

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=75 Participants 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	Coflex Interlaminar Technolgy n=146 Participants 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
Number of Subjects With no Persistent New or Increasing Sensory Deficit	72 Participants	137 Participants

PRIMARY outcome

Timeframe: 5 years

No persistent new or increasing motor deficit

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=74 Participants 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	Coflex Interlaminar Technolgy n=146 Participants 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
Number of Subjects With no Persistent New or Increasing Motor Deficit	72 Participants	144 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=107 Participants 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	Coflex Interlaminar Technolgy n=215 Participants 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
Number of Subjects With no Reoperations or Epidural (Up to Day 1825)	71 Participants	149 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=126 Participants 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
Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points	40 Participants	100 Participants

SECONDARY outcome

Timeframe: 5 years

ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=126 Participants 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
Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points	38 Participants	98 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=44 Participants 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	Coflex Interlaminar Technolgy n=106 Participants 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
Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component	34 Participants	93 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=44 Participants 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	Coflex Interlaminar Technolgy n=106 Participants 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
Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component	31 Participants	72 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=53 Participants 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	Coflex Interlaminar Technolgy n=124 Participants 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
Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm	40 Participants	104 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=53 Participants 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	Coflex Interlaminar Technolgy n=124 Participants 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
Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm	41 Participants	99 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=126 Participants 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
Mean Oswestry Disability Index (ODI) Score	26.1 units on a scale Standard Deviation 22.2	24.5 units on a scale Standard Deviation 20.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=124 Participants 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
Mean Visual Analog Scale Back Pain Score	29.0 mm Standard Deviation 31.0	25.4 mm Standard Deviation 27.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=124 Participants 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
Mean Visual Analog Scale Leg (Worse) Pain Score	25.2 mm Standard Deviation 31.2	22.8 mm Standard Deviation 28.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=124 Participants 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
Mean Visual Analog Scale (VAS) Leg (Right) Pain Score	16.0 mm Standard Deviation 24.5	14.9 mm Standard Deviation 21.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=124 Participants 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
Mean Visual Analog Scale (VAS) Leg (Left) Pain Score	17.0 mm Standard Deviation 26.8	18.4 mm Standard Deviation 27.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=53 Participants 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	Coflex Interlaminar Technolgy n=124 Participants 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
Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm	36 Participants	90 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=53 Participants 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	Coflex Interlaminar Technolgy n=122 Participants 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
Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm	37 Participants	78 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=126 Participants 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
Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score	2.17 units on a scale Standard Deviation 0.85	2.08 units on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=54 Participants 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	Coflex Interlaminar Technolgy n=126 Participants 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
Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score	1.81 units on a scale Standard Deviation 0.79	1.67 units on a scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=47 Participants 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	Coflex Interlaminar Technolgy n=118 Participants 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
Mean Short Form-12 Physical Component Score	42.1 units on a scale Standard Deviation 12.6	42.1 units on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=47 Participants 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	Coflex Interlaminar Technolgy n=118 Participants 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
Mean Short Form-12 Mental Component Score	54.8 units on a scale Standard Deviation 8.4	54.1 units on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: 5 years

Subjects who responded "Very Satisfied" or "Somewhat Satisfied".

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=87 Participants 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	Coflex Interlaminar Technolgy n=160 Participants 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
Patient Survey: Satisfaction	72 Participants	151 Participants

SECONDARY outcome

Timeframe: 5 years

Subjects who responded "Definitely Yes" or "Probably Yes"

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=87 Participants 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	Coflex Interlaminar Technolgy n=160 Participants 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
Patient Survey: Recommendation of Treatment	70 Participants	145 Participants

SECONDARY outcome

Timeframe: 5 years

Number of subjects using Class II narcotics

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=81 Participants 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	Coflex Interlaminar Technolgy n=156 Participants 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
Pain Management: Class II Narcotics Usage by Device Group	17 Participants	32 Participants

SECONDARY outcome

Timeframe: 5 years

Number of subjects using NSAIDs/ASA/Acetaminophen

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=81 Participants 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	Coflex Interlaminar Technolgy n=156 Participants 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
Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group	24 Participants	55 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=105 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Mean Rotation (F to E) in Degrees - At Level(s) of Implant	0.98 degrees Standard Deviation 1.17	3.13 degrees Standard Deviation 3.43

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: This analysis was performed at the level below the 1- or 2-level device construct in both groups.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=74 Participants 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	Coflex Interlaminar Technolgy n=140 Participants 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
Rotation (F to E) in Degrees - Below Level of Implant	5.62 degrees Standard Deviation 3.69	5.83 degrees Standard Deviation 4.17

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: This analysis was performed at the level above the 1- or 2-level device construct in both groups.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=76 Participants 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	Coflex Interlaminar Technolgy n=146 Participants 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
Rotation (F to E) in Degrees - Above Level of Implant	3.59 degrees Standard Deviation 2.89	3.52 degrees Standard Deviation 3.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=103 Levels 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	Coflex Interlaminar Technolgy n=204 Levels 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
Translation (mm) - At Level(s) of Implant	0.23 mm Standard Deviation 0.32	0.82 mm Standard Deviation 0.84

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: This analysis was performed at the level below the 1- or 2-level device construct in both groups.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=72 Participants 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	Coflex Interlaminar Technolgy n=139 Participants 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
Translation (mm) - Below Level of Implant	0.63 mm Standard Deviation 0.57	0.64 mm Standard Deviation 0.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: This analysis was performed at the level above the 1- or 2-level device construct in both groups.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=74 Participants 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	Coflex Interlaminar Technolgy n=145 Participants 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
Translation (mm) - Above Level of Implant	0.69 mm Standard Deviation 0.57	0.83 mm Standard Deviation 0.80

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Anterior Disc Height (mm) - At Level(s) of Implant	8.13 mm Standard Deviation 3.19	8.89 mm Standard Deviation 3.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Posterior Disc Height (mm) - At Level(s) of Implant	4.56 mm Standard Deviation 1.65	4.46 mm Standard Deviation 1.89

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=105 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Translation (F to E) in Percent (%) - At Level(s) of Implant	0.69 percent Standard Deviation 0.89	2.38 percent Standard Deviation 2.43

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: This analysis was performed at the level below the 1- or 2-level device construct in both groups.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=74 Participants 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	Coflex Interlaminar Technolgy n=140 Participants 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
Translation (F to E) in Percent (%) - Below Level of Implant	1.95 percent Standard Deviation 1.95	1.97 percent Standard Deviation 1.88

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: This analysis was performed at the level above the 1- or 2-level device construct in both groups.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=76 Participants 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	Coflex Interlaminar Technolgy n=146 Participants 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
Translation (F to E) in Percent (%) - Above Level of Implant	2.07 percent Standard Deviation 1.68	2.40 percent Standard Deviation 2.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Average Disc Height (mm) - At Level(s) of Implant	6.34 mm Standard Deviation 2.09	6.67 mm Standard Deviation 2.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=106 Levels 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	Coflex Interlaminar Technolgy n=200 Levels 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
Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant	-1.38 mm Standard Deviation 1.58	-1.32 mm Standard Deviation 1.75

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=106 Levels 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	Coflex Interlaminar Technolgy n=149 Participants 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
Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant	-0.49 mm Standard Deviation 1.19	-0.72 mm Standard Deviation 1.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=106 Levels 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	Coflex Interlaminar Technolgy n=200 Levels 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
Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant	-0.93 mm Standard Deviation 1.02	-1.02 mm Standard Deviation 1.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant	-1.82 mm Standard Deviation 1.39	-0.98 mm Standard Deviation 2.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant	-0.85 mm Standard Deviation 1.00	-1.90 mm Standard Deviation 1.65

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant	-1.33 mm Standard Deviation 0.97	-1.44 mm Standard Deviation 1.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=111 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Disc Angle in Degrees - At Level(s) of Implant	6.02 degrees Standard Deviation 4.64	7.28 degrees Standard Deviation 5.19

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=109 Levels 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	Coflex Interlaminar Technolgy n=200 Levels 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
Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant	-1.41 degrees Standard Deviation 3.10	-1.00 degrees Standard Deviation 2.91

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=111 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant	-1.57 degrees Standard Deviation 2.25	1.56 degrees Standard Deviation 3.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant	-1.08 mm Standard Deviation 3.37	-1.01 mm Standard Deviation 3.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant	-3.4 percent Standard Deviation 9.9	-3.2 percent Standard Deviation 11.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=106 Levels 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	Coflex Interlaminar Technolgy n=200 Levels 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
Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant	-0.12 mm Standard Deviation 2.28	-0.56 mm Standard Deviation 1.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=108 Levels 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	Coflex Interlaminar Technolgy n=205 Levels 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
Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant	-0.77 mm Standard Deviation 1.92	-0.44 mm Standard Deviation 1.91

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=205 Levels 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	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
Foraminal Height (X-ray) (mm) - At Level(s) of Implant	17.33 mm Standard Deviation 2.75	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=200 Levels 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	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
Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant	-0.47 mm Standard Deviation 1.29	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=149 Participants 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	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
Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant	-1.81 mm Standard Deviation 1.74	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=111 Levels 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	Coflex Interlaminar Technolgy n=209 Levels 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
Bony Bridging NA	0 Levels	209 Levels
Bony Bridging No	17 Levels	0 Levels
Bony Bridging Yes	84 Levels	0 Levels
Bony Bridging Indeterminate	10 Levels	0 Levels

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=209 Levels 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	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
Heterotopic Ossification NA	0 participants	—
Heterotopic Ossification None	91 participants	—
Heterotopic Ossification Grade I	0 participants	—
Heterotopic Ossification Grade II	24 participants	—
Heterotopic Ossification Grade III	73 participants	—
Heterotopic Ossification Bony Bridging	3 participants	—
Heterotopic Ossification Indeterminate	18 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=111 Levels 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	Coflex Interlaminar Technolgy n=209 Levels 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
Fusion Status NA	0 Levels	0 Levels
Fusion Status Not fused	19 Levels	196 Levels
Fusion Status Fused	78 Levels	3 Levels
Fusion Status Indeterminate	14 Levels	10 Levels

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=209 Levels 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	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
Interface Remodeling - At Level(s) of Implant NA	0 Levels	—
Interface Remodeling - At Level(s) of Implant None	75 Levels	—
Interface Remodeling - At Level(s) of Implant Mild	70 Levels	—
Interface Remodeling - At Level(s) of Implant Moderate	16 Levels	—
Interface Remodeling - At Level(s) of Implant Severe	20 Levels	—
Interface Remodeling - At Level(s) of Implant Indeterminate	28 Levels	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=209 Levels 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	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
Device Condition (Coflex Arm) NA	0 Levels	—
Device Condition (Coflex Arm) Intact	184 Levels	—
Device Condition (Coflex Arm) Deformed	0 Levels	—
Device Condition (Coflex Arm) Fractured	3 Levels	—
Device Condition (Coflex Arm) Migrated	11 Levels	—
Device Condition (Coflex Arm) Dislodged	0 Levels	—
Device Condition (Coflex Arm) Indeterminate	11 Levels	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=111 Levels 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	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
Device Condition (Fusion Control) NA	0 Levels	—
Device Condition (Fusion Control) Intact	90 Levels	—
Device Condition (Fusion Control) Failed Graft	0 Levels	—
Device Condition (Fusion Control) Loose Screws	10 Levels	—
Device Condition (Fusion Control) Fractured Hardware	2 Levels	—
Device Condition (Fusion Control) Indeterminate	9 Levels	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Posterolateral Fusion w/Pedicle Screws n=209 Levels 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	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
Device Mobility < 5 mm	181 Levels	—
Device Mobility >= 5 mm	15 Levels	—
Device Mobility Indeterminate	13 Levels	—
Device Mobility NA	0 Levels	—

Adverse Events

Posterolateral Fusion w/Pedicle Screws

Serious events: 64 serious events

Other events: 101 other events

Deaths: 0 deaths

Coflex Interlaminar Technolgy

Serious events: 109 serious events

Other events: 199 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Fran Magee, DVM

Paradigm Spine

Phone: 212-367-7274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Posterolateral Fusion w/Pedicle Screws n=107 participants at risk 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	Coflex Interlaminar Technolgy n=215 participants at risk 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
Musculoskeletal and connective tissue disorders Component Loosening	4.7% 5/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	1.4% 3/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Component Breakage	0.93% 1/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.00% 0/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Tear > 5mm	0.93% 1/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.00% 0/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Fracture	0.93% 1/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	1.9% 4/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Hematoma Requiring Drainage	0.93% 1/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.00% 0/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Infection (deep)	0.00% 0/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.93% 2/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Pain; new, increased frequency, or worsening	17.8% 19/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	13.5% 29/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Pseudarthrosis	1.9% 2/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.00% 0/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Wound problems	1.9% 2/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	2.8% 6/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Metabolism and nutrition disorders Other	10.3% 11/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	4.7% 10/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer/Neoplasm	9.3% 10/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	2.3% 5/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Cardiac disorders Cardiovascular	4.7% 5/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	7.9% 17/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Ear and labyrinth disorders Eye, Ear, Nose and Throat (EENT)	0.93% 1/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.47% 1/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Endocrine disorders Endocrine/Metabolic	1.9% 2/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	1.9% 4/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Gastrointestinal disorders Gastrointestinal	5.6% 6/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	4.7% 10/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
General disorders Genitourinary	4.7% 5/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	2.3% 5/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Blood and lymphatic system disorders Hematological	0.00% 0/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.47% 1/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Musculoskeletal and connective tissue disorders Musculoskeletal	15.0% 16/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	14.9% 32/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Nervous system disorders Neurological	3.7% 4/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	2.3% 5/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Psychiatric disorders Psychiatric/Substance Abuse	2.8% 3/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.00% 0/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Respiratory, thoracic and mediastinal disorders Respiratory	0.00% 0/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	2.3% 5/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Skin and subcutaneous tissue disorders Skin and Subcutaneous	0.93% 1/107 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure	0.47% 1/215 • 5 years In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE): * is life threatening * results in permanent impairment of a body function or permanent damage to a body structure; or * necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure