Neurogenic Intermittent Claudication Evaluation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Procedure: Aperius™ PercLID™ System
* Procedure: Standalone Decompressive Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aperius™ PercLID™ System<br>Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System. | Procedure: Aperius™ PercLID™ System<br>* Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.<br>|
| Active Comparator: Standalone Decompressive Surgery<br>Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion. | Procedure: Standalone Decompressive Surgery<br>* Lumbar decompressive surgery without instrumentation or fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days, 6 weeks, 6 months, and 24 months | 
| 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. | 14days, 6 week, 6 months, 12 months, 24 months | 
| 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. | 14 days, 6 weeks, 6 months, 12 months, and 24 months | 
| 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. | 14 days, 6 weeks, 6 months, 12 months, and 24 months | 
| 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. | 14 days, 6 weeks, 6 months, 12 months, and 24 months | 
| 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 | 
| 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. | baseline, 12 months, and 24 months | 
| 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. | baseline, 12 months, and 24 months | 
| 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 |