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

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Medical Conditions
  • Spinal Stenosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00905359
Primary Trial ID Number

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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.
Research Details
  • 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.
Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Procedure : Aperius™ PercLID™ System, Procedure : Standalone Decompressive Surgery

Study Arm Groups : Aperius™ PercLID™ System, Standalone Decompressive Surgery

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
21 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Woodend Hospital - Department of Orthopaedics
Aberdeen
AB15 6ZQ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, France, Germany, Iceland, Italy, Poland, Singapore, Sweden, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CIP 0002 AP
Sponsor(s)
Medtronic Spinal and Biologics
Key Dates

Recruitment Start Date

Jan 2010

Recruitment End Date

Sep 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

18 May 2009

Last Updated

26 Jan 2016