Spinal Stenosis
Conditions
Brief summary
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.
Detailed description
The NICE study is a Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication. DLSS patients suffering from NIC that would be candidates for surgical treatment without stabilization and/or fusion can be offered participation in the study. After randomization, patients will be treated with either the Aperius™ PercLID™ System or Standalone Decompressive Surgery (SDS). A sample size recalculation reduced the amount of patients to be enrolled from 280 to 128 in both treatment group. The patient will undergo a study visit at screening / baseline and at 14 days, 6 weeks, 6, 12 and 24 months after surgery. Safety data will be collected during surgery and throughout the 24 months follow up. Procedural details will be collected during surgery and also duration of hospital stay will be collected. At screening / baseline and all follow up visits a physical examination will be performed, the use of pain medication will be documented and the subject will be asked to complete a pain VAS scale (back - leg - buttock / groin pain) and questionnaires (SF36 v2 and Zurich Claudication Questionnaire). Study subjects are required to undergo X-ray, CT and MRI and fluoroscopy procedures at specified time points during the study.
Interventions
PROCEDUREAperius™ PercLID™ System
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
PROCEDUREStandalone Decompressive Surgery
Lumbar decompressive surgery without instrumentation or fusion
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of symptomatic DLSS * Presence of NIC * Patient would be candidate for Standalone Decompressive Surgery * Patient has signed Informed Consent form (ICF) * Patient is 21 years old or older
Exclusion criteria
* Previous lumbar surgery * Patient is candidate for instrumented Decompressive Surgery * Patient has back pain without leg pain * Degenerative Spondylolisthesis greater than grade 1 (Meyerding) * Symptomatic DLSS at more than 2 levels in the lumbar region * Spinal stenosis is present at L5-S1 level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire | 14days, 6 week, 6 months, 12 months, 24 months | 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. |
| Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | 14 days, 6 weeks, 6 months, 12 months, and 24 months | 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. |
| Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain | 14 days, 6 weeks, 6 months, 12 months, and 24 months | 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. |
| Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | 14 days, 6 weeks, 6 months, 12 months, and 24 months | 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. |
| Number of Subjects Requiring Secondary Surgical Intervention | Overall study period, up to 24 months | — |
| Percentage of Subjects With Serious Adverse Device Effects | Overall study period, up to 24 months | — |
| Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire | 14 days, 6 weeks, 6 months, and 24 months | 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 14 days, 6 weeks, 6 months, and 24 months was reported. |
| Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | baseline, 12 months, and 24 months | 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. |
| Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain | 12 months and 24 months | — |
| Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain | 12 months and 24 months | — |
| Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function | 12 months and 24 months | — |
| Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity | 12 months and 24 months | — |
| 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 | 14 days, 6 weeks, 6 months, 12 months, and 24 months | — |
| Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points | baseline, 12 months, and 24 months | 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. |
Countries
Australia, Belgium, France, Germany, Iceland, Italy, Poland, Singapore, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aperius™ PercLID™ System Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System. | 77 |
| Standalone Decompressive Surgery Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion. | 75 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 17 | 10 |
| Overall Study | Withdrawal consent | 5 | 6 |
Baseline characteristics
| Characteristic | Aperius™ PercLID™ System | Standalone Decompressive Surgery | Total |
|---|---|---|---|
| Age, Continuous | 65.29 years STANDARD_DEVIATION 10.91 | 64.59 years STANDARD_DEVIATION 10.22 | 64.94 years STANDARD_DEVIATION 10.55 |
| BMI | 28.54 kg/m^2 STANDARD_DEVIATION 3.5 | 28.07 kg/m^2 STANDARD_DEVIATION 3.54 | 28.31 kg/m^2 STANDARD_DEVIATION 3.51 |
| Gender Female | 41 Participants | 37 Participants | 78 Participants |
| Gender Male | 36 Participants | 38 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 77 | 57 / 75 |
| serious Total, serious adverse events | 26 / 77 | 25 / 75 |
Outcome results
Primary
Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire
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.
Time frame: 1 year
Population: Per-protocol analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire | -37.48 percentage change from baseline | Standard Deviation 22.79 |
p-value: 0.172t-test, 1 sided
Secondary
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points
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.
Time frame: baseline, 12 months, and 24 months
Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aperius™ PercLID™ System | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | First level operated at baseline | 3 participants |
| Aperius™ PercLID™ System | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | First level operated at 12 months | 2 participants |
| Aperius™ PercLID™ System | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | First level operated at 24 months | 1 participants |
| Aperius™ PercLID™ System | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | Second level operated at baseline | 3 participants |
| Aperius™ PercLID™ System | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | Second level operated at 12 months | 5 participants |
| Aperius™ PercLID™ System | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | Second level operated at 24 months | 3 participants |
| Standalone Decompressive Surgery | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | Second level operated at 12 months | 13 participants |
| Standalone Decompressive Surgery | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | First level operated at baseline | 1 participants |
| Standalone Decompressive Surgery | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | Second level operated at baseline | 2 participants |
| Standalone Decompressive Surgery | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | First level operated at 12 months | 15 participants |
| Standalone Decompressive Surgery | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | Second level operated at 24 months | 6 participants |
| Standalone Decompressive Surgery | Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points | First level operated at 24 months | 7 participants |
Secondary
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points
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.
Time frame: baseline, 12 months, and 24 months
Population: Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | 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) | 15.21 mm^2 | Standard Deviation 5.52 |
| Standalone Decompressive Surgery | 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) | 8.20 mm^2 | Standard Deviation 2.97 |
| Standalone Decompressive Surgery | 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) | 7.72 mm^2 | Standard Deviation 3.1 |
| Standalone Decompressive Surgery | 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) | 13.40 mm^2 | Standard Deviation 5.41 |
| Standalone Decompressive Surgery | 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) | 16.18 mm^2 | Standard Deviation 5.36 |
| Standalone Decompressive Surgery | 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) | 13.80 mm^2 | Standard Deviation 5.32 |
Secondary
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | 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) | 0.103 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.144 correlation coefficient |
| Standalone Decompressive Surgery | 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) | 0.026 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.229 correlation coefficient |
Secondary
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | 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) | -0.287 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.264 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.050 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.276 correlation coefficient |
Secondary
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | 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) | -0.104 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.242 correlation coefficient |
| Standalone Decompressive Surgery | 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) | 0.145 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.163 correlation coefficient |
Secondary
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | 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) | -0.230 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.196 correlation coefficient |
| Standalone Decompressive Surgery | 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) | 0.020 correlation coefficient |
| Standalone Decompressive Surgery | 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) | -0.367 correlation coefficient |
Secondary
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire
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 14 days, 6 weeks, 6 months, and 24 months was reported.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire | at 24 months | -35.15 percentage change from baseline | Standard Deviation 22.78 |
| Standalone Decompressive Surgery | Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire | at 14 days | -18.52 percentage change from baseline | Standard Deviation 28.07 |
| Standalone Decompressive Surgery | Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire | at 6 months | -38.11 percentage change from baseline | Standard Deviation 21.7 |
| Standalone Decompressive Surgery | Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire | at 6 weeks | -34.60 percentage change from baseline | Standard Deviation 24.19 |
Secondary
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain | At 24 months | -66.55 percentage of change from baseline | Standard Deviation 31.11 |
| Standalone Decompressive Surgery | Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain | at 14 days | -57.64 percentage of change from baseline | Standard Deviation 35.7 |
| Standalone Decompressive Surgery | Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain | at 6 weeks | -67.65 percentage of change from baseline | Standard Deviation 35.54 |
| Standalone Decompressive Surgery | Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain | at 6 months | -66.75 percentage of change from baseline | Standard Deviation 34.62 |
| Standalone Decompressive Surgery | Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain | At 12 months | -66.41 percentage of change from baseline | Standard Deviation 31.98 |
Secondary
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 31.6 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 31.8 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of MCS at 6 months | 25.90 percentage of change from baseline | Standard Deviation 44.57 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of PCS at 14 days | 27.40 percentage of change from baseline | Standard Deviation 38.39 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of MCS at 14 days | 23.42 percentage of change from baseline | Standard Deviation 39.98 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of PCS at 6 weeks | 46.16 percentage of change from baseline | Standard Deviation 42.02 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of MCS at 24 months | 21.74 percentage of change from baseline | Standard Deviation 40.81 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of PCS at 6 months | 42.52 percentage of change from baseline | Standard Deviation 39 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of MCS at 6 weeks | 26.57 percentage of change from baseline | Standard Deviation 46.69 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of PCS at 12 months | 44.82 percentage of change from baseline | Standard Deviation 37.77 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of MCS at 12 months | 23.90 percentage of change from baseline | Standard Deviation 40.89 |
| Standalone Decompressive Surgery | Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire | percentage change of PCS at 24 months | 39.27 percentage of change from baseline | Standard Deviation 37.17 |
Secondary
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 21.7 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire | At 24 months (n=50, 57) | -32.78 percentage change from baseline | Standard Deviation 23.89 |
| Standalone Decompressive Surgery | Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire | At 14 days (n=67, 66) | -27.92 percentage change from baseline | Standard Deviation 19.32 |
| Standalone Decompressive Surgery | Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire | At 6 weeks (n=66, 68) | -36.38 percentage change from baseline | Standard Deviation 19.26 |
| Standalone Decompressive Surgery | Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire | at 6 months (n=60, 62) | -34.18 percentage change from baseline | Standard Deviation 19.84 |
| Standalone Decompressive Surgery | Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire | At 12 months (n=60, 63) | -36.40 percentage change from baseline | Standard Deviation 24.53 |
Secondary
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
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Aperius™ PercLID™ System | 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 |
| Standalone Decompressive Surgery | 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 | 1 participants |
| Standalone Decompressive Surgery | 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 | 30 participants |
| Standalone Decompressive Surgery | 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 | 49 participants |
| Standalone Decompressive Surgery | 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 | 46 participants |
| Standalone Decompressive Surgery | 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 | 43 participants |
| Standalone Decompressive Surgery | 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 | 42 participants |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 | 3 participants |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 | 13 participants |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 | 5 participants |
| Standalone Decompressive Surgery | 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 | 14 participants |
| Standalone Decompressive Surgery | 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 | 12 participants |
| Standalone Decompressive Surgery | 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 | 11 participants |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 | 12 participants |
| Standalone Decompressive Surgery | 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 | 7 participants |
| Standalone Decompressive Surgery | 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 | 6 participants |
| Standalone Decompressive Surgery | 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 | 7 participants |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 |
| Standalone Decompressive Surgery | 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 | 1 participants |
Secondary
Number of Subjects Requiring Secondary Surgical Intervention
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aperius™ PercLID™ System | Number of Subjects Requiring Secondary Surgical Intervention | 16 participants |
| Standalone Decompressive Surgery | Number of Subjects Requiring Secondary Surgical Intervention | 6 participants |
Secondary
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aperius™ PercLID™ System | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 6 weeks | 1.71 units on a scale | Standard Deviation 0.49 |
| Aperius™ PercLID™ System | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 12 months | 1.73 units on a scale | Standard Deviation 0.66 |
| Aperius™ PercLID™ System | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 6 months | 1.73 units on a scale | Standard Deviation 0.63 |
| Aperius™ PercLID™ System | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 24 months | 1.68 units on a scale | Standard Deviation 0.68 |
| Aperius™ PercLID™ System | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 14 days | 1.76 units on a scale | Standard Deviation 0.55 |
| Standalone Decompressive Surgery | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 24 months | 1.72 units on a scale | Standard Deviation 0.69 |
| Standalone Decompressive Surgery | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 14 days | 1.77 units on a scale | Standard Deviation 0.59 |
| Standalone Decompressive Surgery | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 6 weeks | 1.64 units on a scale | Standard Deviation 0.48 |
| Standalone Decompressive Surgery | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 6 months | 1.67 units on a scale | Standard Deviation 0.58 |
| Standalone Decompressive Surgery | Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire | PS score at 12 months | 1.73 units on a scale | Standard Deviation 0.7 |
Secondary
Percentage of Subjects With Serious Adverse Device Effects
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aperius™ PercLID™ System | Percentage of Subjects With Serious Adverse Device Effects | 3.9 percentage of subjects |
| Standalone Decompressive Surgery | Percentage of Subjects With Serious Adverse Device Effects | 0.0 percentage of subjects |