Neurogenic Intermittent Claudication Evaluation Study (NICE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Stenosis |
Procedure: Aperius™ PercLID™ System and Standalone Decompressive Surgery |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
- Mean percentage change from baseline in Physical Function at 1 year follow-up using the patient completed Zurich Claudication Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 280 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Aperius™ PercLID™ System
Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System.
|
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 |
|
Active Comparator: Standalone Decompressive Surgery
Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
|
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 |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: C. Beelen, Study Manager | nice.studyregistration@medtronic.com | |
| Contact: M. Leenders, Study Manager | nice.studyregistration@medtronic.com |
Show 28 Study Locations More Information
No publications provided
| Responsible Party: | Medtronic Spinal & Biologics ECA |
| ClinicalTrials.gov Identifier: | NCT00905359 History of Changes |
| Other Study ID Numbers: | CIP 0002 AP |
| Study First Received: | May 18, 2009 |
| Last Updated: | March 12, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee Belgium: Ethics Committee Belgium: Directorate general for the protection of Public health: Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee France: French Data Protection Authority France: Conseil National de l'Ordre des Médecins Germany: Ethics Commission Germany: Ministry of Health Germany: German Institute of Medical Documentation and Information Germany: Federal Office for Radiation Protection Iceland: Icelandic Radiation Safety Authority, Ethics Committee Italy: Ethics Committee Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Constriction, Pathologic Intermittent Claudication Spinal Stenosis Pathological Conditions, Anatomical Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Signs and Symptoms Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013