Neurogenic Intermittent Claudication Evaluation Study (NICE)

• Mean percentage change from baseline in Physical Function, using the patient completed Zurich Claudication Questionnaire [ Time Frame: 14d, 6w, 6, 24, 36, 48m ] [ Designated as safety issue: No ]
• Outcomes of the Symptom Severity and Patient Satisfaction domains of the patient completed Zurich Claudication Questionnaire [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: No ]
• Mean percentage change from baseline in Leg Pain VAS Scores [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: No ]
• QoL related outcomes using the patient completed SF-36 v2 questionnaire [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: No ]
• Assessment of the radiological changes in the stenotic region. [ Time Frame: 12, 24, 48 months ] [ Designated as safety issue: No ]
• Percentage of patients requiring surgical intervention at index level [ Time Frame: Full follow up period ] [ Designated as safety issue: Yes ]
• Proportion of subjects with complications at the secondary surgical intervention [ Time Frame: Full follow up period ] [ Designated as safety issue: Yes ]
• Proportion of subjects with Serious Adverse Device Effects [ Time Frame: Full follow up period ] [ Designated as safety issue: Yes ]
• Determining if there is a correlation between sagittal balance or other radiological findings and the clinical outcomes [ Time Frame: 12, 24, 48 months ] [ Designated as safety issue: No ]
• Proportion of subjects with improvement of symptoms, symptoms recurrence, decreased therapeutic response, no therapeutic response and treatment failure [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: Yes ]

• Mean percentage change from baseline in Physical Function, using the patient completed Zurich Claudication Questionnaire [ Time Frame: 14d, 6w, 6, 24, 36, 48m ] [ Designated as safety issue: No ]
• Mean percentage change from baseline in Symptom Severity, using the patient completed Zurich Claudication Questionnaire [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: No ]
• Percentage of patients being satisfied with the treatment assessed using the patient completed Zurich Claudication Questionnaire [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: No ]
• Mean percentage change from baseline in Leg Pain VAS Scores [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: No ]
• Mean percentage change from baseline in Quality of Life using the patient completed SF-36 v2 questionnaire [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: No ]
• Changes is stenosis of the spinal canal assessed by MRI. [ Time Frame: 12, 24, 48 months ] [ Designated as safety issue: No ]
• Changes in bony structures assessed by CT [ Time Frame: 12, 24, 48 months ] [ Designated as safety issue: No ]
• Percentage of patients requiring surgical intervention at index level [ Time Frame: Full follow up period ] [ Designated as safety issue: Yes ]
• Proportion of subjects with complications at the secondary surgical intervention [ Time Frame: Full follow up period ] [ Designated as safety issue: Yes ]
• Proportion of subjects with Serious Adverse Device Effects [ Time Frame: Full follow up period ] [ Designated as safety issue: Yes ]
• Determining if there is a correlation between sagittal balance or other radiological findings and the clinical outcomes [ Time Frame: 12, 24, 48 months ] [ Designated as safety issue: No ]
• Proportion of subjects with improvement of symptoms, symptoms recurrence, decreased therapeutic response, no therapeutic response and treatment failure [ Time Frame: 14d, 6w, 6, 12, 24, 36, 48m ] [ Designated as safety issue: Yes ]

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.

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, a total of up to 280 patients will be treated with either the Aperius™ PercLID™ System or Standalone Decompressive Surgery (SDS).

The patient will undergo a study visit at screening / baseline and at 14 days, 6 weeks, 6, 12, 24, 36 and 48 months after surgery. Safety data will be collected during surgery and throughout the 48 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.

• Active Comparator: Aperius™ PercLID™ System
  Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System.
  Intervention: Procedure: Aperius™ PercLID™ System and Standalone Decompressive Surgery
• Active Comparator: Standalone Decompressive Surgery
  Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
  Intervention: Procedure: Aperius™ PercLID™ System and Standalone Decompressive Surgery

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