Neurogenic Intermittent Claudication Evaluation Study | Completed
Neurogenic Intermittent Claudication Evaluation Study
NICE
Trial Source

Health Conditions
  • Spinal Stenosis
Completed
Recruitment Status
NCT00905359
Primary Trial ID Number
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.
Primary Outcome Measures
  • Mean percentage change from baseline in Physical Function at 1 year follow-up using the patient completed Zurich Claudication Questionnaire; 1 year
Secondary Outcome Measures
  • Mean percentage change from baseline in Physical Function, using the patient completed Zurich Claudication Questionnaire; 14d, 6w, 6, 24m; Outcomes of the Symptom Severity and Patient Satisfaction domains of the patient completed Zurich Claudication Questionnaire; 14d, 6w, 6, 12, 24m; Mean percentage change from baseline in Leg Pain VAS Scores; 14d, 6w, 6, 12, 24 m; QoL related outcomes using the patient completed SF-36 v2 questionnaire; 14d, 6w, 6, 12, 24m; Proportion of subjects with complications at the secondary surgical intervention; Full follow up period; Proportion of subjects with Serious Adverse Device Effects; Full follow up period
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Australia; Belgium; Denmark; France; Germany; Iceland; Italy; Poland; Singapore; Sweden; United Kingdom
Participant Sex
Both
Participant Age Range
21 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Procedure; Aperius™ PercLID™ System; Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.; [Aperius™ PercLID™ System]; Procedure; Standalone Decompressive Surgery; Lumbar decompressive surgery without instrumentation or fusion; [Standalone Decompressive Surgery]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
NICE
Scientific Title
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
Secondary Trial Identifying Number
Sorry, this information is not available
Website
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Study Funded By
Medtronic Spinal & Biologics ECA
Funder Type
Sorry, this information is not available
Study Sponsored By
Medtronic Spinal & Biologics ECA
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

18 May 2009

Last Updated

05 Jun 2015

Date Record Refreshed on UKCTG

01 Aug 2015