Trial Outcomes & Findings for Neurogenic Intermittent Claudication Evaluation Study (NCT NCT00905359)

Last Updated: 2017-02-10

Results Overview

ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

163 participants

Primary outcome timeframe

1 year

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Aperius™ PercLID™ System Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Overall Study STARTED	82	81
Overall Study 12 Months Follow up	68	72
Overall Study 24 Months Follow up	58	65
Overall Study COMPLETED	58	65
Overall Study NOT COMPLETED	24	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Aperius™ PercLID™ System Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Overall Study Lost to Follow-up	17	10
Overall Study Death	2	0
Overall Study Withdrawal consent	5	6

Baseline Characteristics

Neurogenic Intermittent Claudication Evaluation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aperius™ PercLID™ System n=77 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.	Total n=152 Participants Total of all reporting groups
Age, Continuous	65.29 years STANDARD_DEVIATION 10.91 • n=99 Participants	64.59 years STANDARD_DEVIATION 10.22 • n=107 Participants	64.94 years STANDARD_DEVIATION 10.55 • n=206 Participants
Gender Female	41 Participants n=99 Participants	37 Participants n=107 Participants	78 Participants n=206 Participants
Gender Male	36 Participants n=99 Participants	38 Participants n=107 Participants	74 Participants n=206 Participants
BMI	28.54 kg/m^2 STANDARD_DEVIATION 3.50 • n=99 Participants	28.07 kg/m^2 STANDARD_DEVIATION 3.54 • n=107 Participants	28.31 kg/m^2 STANDARD_DEVIATION 3.51 • n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Per-protocol analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire	-32.31 percentage change from baseline Standard Deviation 32.06	-37.48 percentage change from baseline Standard Deviation 22.79

SECONDARY outcome

Timeframe: 14 days, 6 weeks, 6 months, and 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire at 14 days	-19.70 percentage change from baseline Standard Deviation 28.87	-18.52 percentage change from baseline Standard Deviation 28.07
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire at 6 weeks	-32.17 percentage change from baseline Standard Deviation 27.36	-34.60 percentage change from baseline Standard Deviation 24.19
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire at 6 months	-34.94 percentage change from baseline Standard Deviation 25.92	-38.11 percentage change from baseline Standard Deviation 21.70
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire at 24 months	-37.86 percentage change from baseline Standard Deviation 21.72	-35.15 percentage change from baseline Standard Deviation 22.78

SECONDARY outcome

Timeframe: 14days, 6 week, 6 months, 12 months, 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire At 14 days (n=67, 66)	-34.38 percentage change from baseline Standard Deviation 19.32	-27.92 percentage change from baseline Standard Deviation 19.32
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire At 6 weeks (n=66, 68)	-35.72 percentage change from baseline Standard Deviation 22.08	-36.38 percentage change from baseline Standard Deviation 19.26
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire at 6 months (n=60, 62)	-33.86 percentage change from baseline Standard Deviation 21.70	-34.18 percentage change from baseline Standard Deviation 19.84
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire At 12 months (n=60, 63)	-31.24 percentage change from baseline Standard Deviation 26.85	-36.40 percentage change from baseline Standard Deviation 24.53
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire At 24 months (n=50, 57)	-40.25 percentage change from baseline Standard Deviation 21.91	-32.78 percentage change from baseline Standard Deviation 23.89

SECONDARY outcome

Timeframe: 14 days, 6 weeks, 6 months, 12 months, and 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire PS score at 14 days	1.76 units on a scale Standard Deviation 0.55	1.77 units on a scale Standard Deviation 0.59
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire PS score at 6 weeks	1.71 units on a scale Standard Deviation 0.49	1.64 units on a scale Standard Deviation 0.48
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire PS score at 6 months	1.73 units on a scale Standard Deviation 0.63	1.67 units on a scale Standard Deviation 0.58
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire PS score at 12 months	1.73 units on a scale Standard Deviation 0.66	1.73 units on a scale Standard Deviation 0.70
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire PS score at 24 months	1.68 units on a scale Standard Deviation 0.68	1.72 units on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: 14 days, 6 weeks, 6 months, 12 months, and 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain at 14 days	-67.62 percentage of change from baseline Standard Deviation 35.57	-57.64 percentage of change from baseline Standard Deviation 35.70
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain at 6 weeks	-65.14 percentage of change from baseline Standard Deviation 32.49	-67.65 percentage of change from baseline Standard Deviation 35.54
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain at 6 months	-56.10 percentage of change from baseline Standard Deviation 37.97	-66.75 percentage of change from baseline Standard Deviation 34.62
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain At 12 months	-59.20 percentage of change from baseline Standard Deviation 35.75	-66.41 percentage of change from baseline Standard Deviation 31.98
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain At 24 months	-70.71 percentage of change from baseline Standard Deviation 34.44	-66.55 percentage of change from baseline Standard Deviation 31.11

SECONDARY outcome

Timeframe: 14 days, 6 weeks, 6 months, 12 months, and 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of PCS at 14 days	35.93 percentage of change from baseline Standard Deviation 50.06	27.40 percentage of change from baseline Standard Deviation 38.39
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of PCS at 6 weeks	52.28 percentage of change from baseline Standard Deviation 50.37	46.16 percentage of change from baseline Standard Deviation 42.02
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of PCS at 6 months	53.95 percentage of change from baseline Standard Deviation 53.04	42.52 percentage of change from baseline Standard Deviation 39.00
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of PCS at 12 months	47.83 percentage of change from baseline Standard Deviation 53.69	44.82 percentage of change from baseline Standard Deviation 37.77
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of PCS at 24 months	51.53 percentage of change from baseline Standard Deviation 49.37	39.27 percentage of change from baseline Standard Deviation 37.17
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of MCS at 14 days	18.74 percentage of change from baseline Standard Deviation 31.60	23.42 percentage of change from baseline Standard Deviation 39.98
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of MCS at 6 weeks	25.27 percentage of change from baseline Standard Deviation 35.05	26.57 percentage of change from baseline Standard Deviation 46.69
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of MCS at 6 months	20.21 percentage of change from baseline Standard Deviation 40.35	25.90 percentage of change from baseline Standard Deviation 44.57
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of MCS at 12 months	18.21 percentage of change from baseline Standard Deviation 34.86	23.90 percentage of change from baseline Standard Deviation 40.89
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire percentage change of MCS at 24 months	20.05 percentage of change from baseline Standard Deviation 31.80	21.74 percentage of change from baseline Standard Deviation 40.81

SECONDARY outcome

Timeframe: Overall study period, up to 24 months

Population: Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=77 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Number of Subjects Requiring Secondary Surgical Intervention	16 participants	6 participants

SECONDARY outcome

Timeframe: Overall study period, up to 24 months

Population: Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=77 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Percentage of Subjects With Serious Adverse Device Effects	3.9 percentage of subjects	0.0 percentage of subjects

SECONDARY outcome

Timeframe: baseline, 12 months, and 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points First level operated at baseline (n=61, 62)	7.81 mm^2 Standard Deviation 3.33	8.20 mm^2 Standard Deviation 2.97
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points First level operated at 12 months (n=53, 56)	9.55 mm^2 Standard Deviation 3.61	13.40 mm^2 Standard Deviation 5.41
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points First level operated at 24 months (n=48, 49)	10.43 mm^2 Standard Deviation 3.54	13.80 mm^2 Standard Deviation 5.32
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points Second level operated at baseline (n=28, 29)	7.30 mm^2 Standard Deviation 2.91	7.72 mm^2 Standard Deviation 3.10
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points Second level operated at 12 months (n=26, 25)	9.44 mm^2 Standard Deviation 4.45	15.21 mm^2 Standard Deviation 5.52
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points Second level operated at 24 months (n=21, 23)	10.20 mm^2 Standard Deviation 4.94	16.18 mm^2 Standard Deviation 5.36

SECONDARY outcome

Timeframe: baseline, 12 months, and 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points First level operated at baseline	3 participants	1 participants
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points First level operated at 12 months	2 participants	15 participants
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points First level operated at 24 months	1 participants	7 participants
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points Second level operated at baseline	3 participants	2 participants
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points Second level operated at 12 months	5 participants	13 participants
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points Second level operated at 24 months	3 participants	6 participants

SECONDARY outcome

Timeframe: 12 months and 24 months

Population: Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=77 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain First operated level at 12 months (n=49, 52)	-0.222 correlation coefficient	-0.144 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain First operated level at 24 months (n=42, 39)	-0.013 correlation coefficient	-0.229 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain Second operated level at 12 months (n=25, 20)	-0.200 correlation coefficient	0.026 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain Second operated level at 24 months (n=17, 17)	0.029 correlation coefficient	0.103 correlation coefficient

SECONDARY outcome

Timeframe: 12 months and 24 months

Population: Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=77 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain First operated level at 12 months (n=49, 52)	-0.210 correlation coefficient	-0.264 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain First operated level at 24 months (n=42, 39)	0.051 correlation coefficient	-0.276 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain Second operated level at 12 months (n=25, 20)	0.181 correlation coefficient	-0.050 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain Second operated level at 24 months (n=17, 17)	-0.065 correlation coefficient	-0.287 correlation coefficient

SECONDARY outcome

Timeframe: 12 months and 24 months

Population: Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=77 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function First level operated at 12 months (n=48, 50)	-0.179 correlation coefficient	-0.242 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function First level operated at 24 months (n=41, 37)	0.193 correlation coefficient	-0.163 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function Second operated level at 12 months (n=24, 20)	-0.016 correlation coefficient	0.145 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function Second operated level at 24 months (n=17, 17)	0.173 correlation coefficient	-0.104 correlation coefficient

SECONDARY outcome

Timeframe: 12 months and 24 months

Population: Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=77 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity First operated level at 12 months (n=48, 50)	-0.091 correlation coefficient	-0.196 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity First operated level at 24 months (n=40, 37)	0.177 correlation coefficient	-0.367 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity Second operated level at 12 months (n=24, 20)	0.114 correlation coefficient	0.020 correlation coefficient
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity Second operated level at 24 months (n=16, 17)	-0.368 correlation coefficient	-0.230 correlation coefficient

SECONDARY outcome

Timeframe: 14 days, 6 weeks, 6 months, 12 months, and 24 months

Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).

Outcome measures

Outcome measures
Measure	Aperius™ PercLID™ System n=72 Participants Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=73 Participants Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Improvement of symptoms at 14 days	34 participants	30 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Improvement of symptoms at 6 weeks	46 participants	49 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Improvement of symptoms at 6 months	43 participants	46 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Improvement of symptoms at 12 months	41 participants	43 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Improvement of symptoms at 24 months	38 participants	42 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Symptom recurrence at 14 days	0 participants	0 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Symptom recurrence at 6 weeks	2 participants	3 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Symptom recurrence at 6 months	9 participants	9 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Symptom recurrence at 12 months	11 participants	13 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Symptom recurrence at 24 months	8 participants	8 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Decreased therapeutic response at 14 days	0 participants	0 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Decreased therapeutic response at 6 weeks	12 participants	5 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Decreased therapeutic response at 6 months	15 participants	14 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Decreased therapeutic response at 12 months	10 participants	12 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Decreased therapeutic response at 24 months	10 participants	11 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months No therapeutic response at 14 days	0 participants	0 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months No therapeutic response at 6 weeks	18 participants	12 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months No therapeutic response at 6 months	9 participants	7 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months No therapeutic response at 12 months	7 participants	6 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months No therapeutic response at 24 months	5 participants	7 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Treatment failure at 14 days	0 participants	0 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Treatment failure at 6 weeks	0 participants	0 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Treatment failure at 6 months	0 participants	0 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Treatment failure at 12 months	0 participants	1 participants
Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months Treatment failure at 24 months	0 participants	1 participants

Adverse Events

Aperius™ PercLID™ System

Serious events: 26 serious events

Other events: 53 other events

Deaths: 0 deaths

Standalone Decompressive Surgery

Serious events: 25 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Department

Medtronic Spinal and Biologics

Phone: 1800-876-3133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Aperius™ PercLID™ System n=77 participants at risk Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.	Standalone Decompressive Surgery n=75 participants at risk Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Blood and lymphatic system disorders Anemia	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Cardiac disorders Bradycardia	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Cardiac disorders Chest pain	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Cardiac disorders Sick sinus syndrome	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Ear and labyrinth disorders Vertigo	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Gastrointestinal disorders Gastric ulcer	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Gastrointestinal disorders Gastritis	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
General disorders Hernia	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
General disorders Non-cardiac chest pain	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Infections and infestations Implant site infection	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Infections and infestations Orchitis	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Infections and infestations Parotitis	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Infections and infestations Pharyngotonsillitis	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Injury, poisoning and procedural complications Confusion postoperative	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Injury, poisoning and procedural complications Dural tear	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/77 • Overall study period, up to 24 months	2.7% 2/75 • Number of events 2 • Overall study period, up to 24 months
Injury, poisoning and procedural complications Foot fracture	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Injury, poisoning and procedural complications Lumbar vertebral fracture	2.6% 2/77 • Number of events 2 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Injury, poisoning and procedural complications Neurological and psychiatric procedural complications	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Metabolism and nutrition disorders Gout	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Arthritis	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	5.2% 4/77 • Number of events 4 • Overall study period, up to 24 months	2.7% 2/75 • Number of events 2 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Osteoarthritis	6.5% 5/77 • Number of events 5 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 2/77 • Number of events 2 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Nervous system disorders Facet joint syndrome	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Nervous system disorders Ischaemic stroke	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Nervous system disorders Peroneal nerve palsy	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Nervous system disorders Radiculitis lumbosacral	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Nervous system disorders Sciatica	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Nervous system disorders Spinal claudication	7.8% 6/77 • Number of events 6 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Nervous system disorders Subdural haematoma	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Nervous system disorders Vertebral foraminal stenosis	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Renal and urinary disorders Cystocele	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Renal and urinary disorders Urinary retention	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Surgical and medical procedures Coronary arterial stent insertion	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Surgical and medical procedures Gastric banding reversal	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Vascular disorders Cerebrovascular accident	1.3% 1/77 • Number of events 1 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Vascular disorders Femoral artery occlusion	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months
Vascular disorders Peripheral artery stenosis	1.3% 1/77 • Number of events 2 • Overall study period, up to 24 months	0.00% 0/75 • Overall study period, up to 24 months
Vascular disorders Thrombosis	0.00% 0/77 • Overall study period, up to 24 months	1.3% 1/75 • Number of events 1 • Overall study period, up to 24 months