Neurogenic Intermittent Claudication Evaluation Study (NICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT00905359
First received: May 18, 2009
Last updated: June 17, 2016
Last verified: June 2016
  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
Procedure: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • 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 ]
    ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.


Secondary Outcome Measures:
  • Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire [ Time Frame: 14 days, 6 weeks, 6 months, and 24 months ] [ Designated as safety issue: No ]
    ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.

  • Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire [ Time Frame: 14days, 6 week, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.

  • Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire [ Time Frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.

  • Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain [ Time Frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.

  • Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire [ Time Frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.

  • Number of Subjects Requiring Secondary Surgical Intervention [ Time Frame: Overall study period, up to 24 months ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Serious Adverse Device Effects [ Time Frame: Overall study period, up to 24 months ] [ Designated as safety issue: Yes ]
  • Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points [ Time Frame: baseline, 12 months, and 24 months ] [ Designated as safety issue: No ]
    The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.

  • Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points [ Time Frame: baseline, 12 months, and 24 months ] [ Designated as safety issue: No ]
    Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.

  • Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months [ Time Frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: January 2010
Study Completion Date: April 2015
Primary Completion Date: September 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
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
Active Comparator: Standalone Decompressive Surgery
Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Procedure: 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, 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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905359

Locations
Australia, Queensland
Pindara Specialist Suite
Benowa, Queensland, Australia, 4217
Belgium
Ziekenhuis St. Jan - Orthopedie
Brugge, Belgium, 8000
Clinique Parc Leopold - Neurochirurgie
Brussels, Belgium, 1040
CHU Tivoli - Neurochirurgie
La Louviere, Belgium, 7100
Clinique Saint Joseph - Neurochirurgie
Liège, Belgium, 4000
Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie
Mons, Belgium, 7301
France
Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie
Bordeaux, France, 33076
Hôpital Roger Salengro - Clinique de Neurochirurgie
Lille, France, 59037
CHU de Nice Hôpital Pasteur - Neurochirurgie
Nice, France, 06002
Germany
Neurochirurgische Klinik - Campus Benjamin Franklin
Berlin, Germany, 13353
Klinikum rechts der Isar der TU München - Neurochirurgie
Munchen, Germany, 81675
Iceland
Landspitali - National hospital of Iceland
Reykjavik, Iceland, 108
Italy
Azienda Ospedaliera Sant'Andrea - Neurochirurgia
Rome, Italy, 00189
Ospedale di Circolo - Ortopedia e Traumatologia
Varese, Italy, 21100
Poland
Municipal Hospital - Szpital Miejski
Toruń, Poland
Szpital Kliniczny Dziecatka Jezus - Orthopaedics
Warsaw, Poland, 02-005
Singapore
Singapore General Hospital - Orthopaedic Surgery
Singapore, Singapore, 169608
Sweden
Ortopedmottagningen SU/Sahlgrenska
Göteborg, Sweden
United Kingdom
Woodend Hospital - Department of Orthopaedics
Aberdeen, United Kingdom, AB15 6ZQ
Sponsors and Collaborators
Medtronic Spinal and Biologics
Investigators
Principal Investigator: Jean-Charles Le Huec, Prof. CHU Pellegrin Tripode
  More Information

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00905359     History of Changes
Other Study ID Numbers: CIP 0002 AP 
Study First Received: May 18, 2009
Results First Received: April 28, 2016
Last Updated: June 17, 2016
Health Authority: Australia: Human Research Ethics Committee
Belgium: Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP
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
Iceland: Ethics Committee
Italy: Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Intermittent Claudication
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2016