Neurogenic Intermittent Claudication Evaluation Study

NCT00905359 | Completed Phase 4 Results DMC

• 1 other identifier: CIP 0002 AP
• Study Type: interventional
• Target: 163
• Locations: 10 countries
• Sites: 19

Brief 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.

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire

  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.

  1 year

Secondary Outcomes (14)

• Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire

  14 days, 6 weeks, 6 months, and 24 months

• Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire

  14days, 6 week, 6 months, 12 months, 24 months

• Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire

  14 days, 6 weeks, 6 months, 12 months, and 24 months

• Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain

  14 days, 6 weeks, 6 months, 12 months, and 24 months

• Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire

  14 days, 6 weeks, 6 months, 12 months, and 24 months

Study Arms (2)

Aperius™ PercLID™ System

ACTIVE COMPARATOR

Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System.

Procedure: Aperius™ PercLID™ System

Standalone Decompressive Surgery

ACTIVE COMPARATOR

Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.

Procedure: Standalone Decompressive Surgery

Interventions

Aperius™ PercLID™ System PROCEDURE

Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.

Aperius™ PercLID™ System

Standalone Decompressive Surgery PROCEDURE

Lumbar decompressive surgery without instrumentation or fusion

Standalone Decompressive Surgery

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (19)

Pindara Specialist Suite

Benowa, Queensland, 4217, Australia

Location

Ziekenhuis St. Jan - Orthopedie

Bruges, 8000, Belgium

Location

Clinique Parc Leopold - Neurochirurgie

Brussels, 1040, Belgium

Location

CHU Tivoli - Neurochirurgie

La Louvière, 7100, Belgium

Location

Clinique Saint Joseph - Neurochirurgie

Liège, 4000, Belgium

Location

Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie

Mons, 7301, Belgium

Location

Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie

Bordeaux, 33076, France

Location

Hôpital Roger Salengro - Clinique de Neurochirurgie

Lille, 59037, France

Location

CHU de Nice Hôpital Pasteur - Neurochirurgie

Nice, 06002, France

Location

Neurochirurgische Klinik - Campus Benjamin Franklin

Berlin, 13353, Germany

Location

Klinikum rechts der Isar der TU München - Neurochirurgie

München, 81675, Germany

Location

Landspitali - National hospital of Iceland

Reykjavik, 108, Iceland

Location

Azienda Ospedaliera Sant'Andrea - Neurochirurgia

Rome, 00189, Italy

Location

Ospedale di Circolo - Ortopedia e Traumatologia

Varese, 21100, Italy

Location

Municipal Hospital - Szpital Miejski

Torun, Poland

Location

Szpital Kliniczny Dziecatka Jezus - Orthopaedics

Warsaw, 02-005, Poland

Location

Singapore General Hospital - Orthopaedic Surgery

Singapore, 169608, Singapore

Location

Ortopedmottagningen SU/Sahlgrenska

Gothenburg, Sweden

Location

Woodend Hospital - Department of Orthopaedics

Aberdeen, AB15 6ZQ, United Kingdom

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spinal and Biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Study Officials

• Jean-Charles Le Huec, Prof.

  CHU Pellegrin Tripode

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: April 1, 2015
• Last Updated: February 10, 2017
• Results First Posted: July 29, 2016

Record last verified: 2016-12

Locations

IT (2); IC (1); AU (1); DE (2); PL (2); GB (1); BE (5); SG (1); SE (1); FR (3)