Neurogenic Intermittent Claudication Evaluation Study

Recruiting

• Source

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  Public Title	Neurogenic Intermittent Claudication Evaluation Study
  Acronym	NICE
  Source of Record URL	http://clinicaltrials.gov/show/NCT00905359

• Trial

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  Health Condition(s) or Problem	Spinal Stenosis
  Lay 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. (from ClinicalTrials.gov)
  Who can enter the trial	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
  Who cannot enter the trial	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
  What will happen	Procedure; Aperius™ PercLID™ System and Standalone Decompressive Surgery; Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius. Standalone Decompressive Surgery: lumbar decompressive surgery without instrumentation or fusion; Aperius™ PercLID™ System; Standalone Decompressive Surgery
  Primary aim	Mean percentage change from baseline in Physical Function at 1 year follow-up using the patient completed Zurich Claudication Questionnaire
  Secondary Aim	Mean percentage change from baseline in Physical Function, using the patient completed Zurich Claudication Questionnaire; 14d, 6w, 6, 24, 36, 48m; No; Outcomes of the Symptom Severity and Patient Satisfaction domains of the patient completed Zurich Claudication Questionnaire; 14d, 6w, 6, 12, 24, 36, 48m; No; Mean percentage change from baseline in Leg Pain VAS Scores; 14d, 6w, 6, 12, 24, 36, 48m; No; QoL related outcomes using the patient completed SF-36 v2 questionnaire; 14d, 6w, 6, 12, 24, 36, 48m; No; Assessment of the radiological changes in the stenotic region.; 12, 24, 48 months; No; Percentage of patients requiring surgical intervention at index level; Full follow up period; Yes; Proportion of subjects with complications at the secondary surgical intervention; Full follow up period; Yes; Proportion of subjects with Serious Adverse Device Effects; Full follow up period; Yes; Determining if there is a correlation between sagittal balance or other radiological findings and the clinical outcomes; 12, 24, 48 months; No; Proportion of subjects with improvement of symptoms, symptoms recurrence, decreased therapeutic response, no therapeutic response and treatment failure; 14d, 6w, 6, 12, 24, 36, 48m; Yes
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	Scotland
  Location	Aberdeen

• Contact

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  Contact for Public Queries	C. Beelen, Study Manager nice.studyregistration@medtronic.com
  Contact for Scientific Queries	Sorry, not currently available