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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

This study is currently Recruiting

August 2011 By Medtronic Spinal & Biologics ECA

First Recieved on May 18, 2009

Last Updated on August 17, 2011

Sponsor: Medtronic Spinal & Biologics ECA
Collaborators:
Information provided by: Medtronic Spinal & Biologics ECA
Identifier: NCT00905359

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:21 Years
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

Investigators

Locations

  • Pindara Specialist Suite

    Benowa, Queensland 4217 Australia

  • Healthscope - Allamanda Private Hospital - Neurosurgery

    Southport, QLD 4215 Australia

  • Ziekenhuis St. Jan - Orthopedie

    Brugge, 8000 Belgium

  • Clinique Parc Leopold - Neurochirurgie

    Brussels, 1040 Belgium

  • CHU Tivoli - Neurochirurgie

    La Louviere, 7100 Belgium

  • Clinique Saint Joseph - Neurochirurgie

    Li?ge, 4000 Belgium

  • Centre hospitalier du Grand Hornu - Orthop?die / Traumatologie

    Mons, 7301 Belgium

  • Centre Universitaire Pellegrin Tripode -Orthop?die-Traumatologie

    Bordeaux, 33076 France

  • H?pital Roger Salengro - Clinique de Neurochirurgie

    Lille, 59037 France

  • CHU de Nice H?pital Pasteur - Neurochirurgie

    Nice, 06002 France

  • Neurochirurgische Klinik - Campus Benjamin Franklin

    Berlin, 13353 Germany

  • Universit?tsklinikum Freiburg - Neurochirurgie

    Freiburg, 79106 Germany

  • Otto-von-Guericke-Universit?t - Orthop?dische Universit?tsklinik

    Magdeburg, 39120 Germany

  • Klinikum rechts der Isar der TU M?nchen - Neurochirurgie

    Munchen, 81675 Germany

  • Katharinenhospital - Neurochirurgische Klinik

    Stuttgart, 70174 Germany

  • Landspitali - National hospital of Iceland

    Reykjavik, 108 Iceland

  • Ospedale Fatebenefratelli - Neurochirurgia

    Milano, 20121 Italy

  • Azienda Ospedaliera Sant'Andrea - Neurochirurgia

    Rome, 00189 Italy

  • Ospedale di Circolo - Ortopedia e Traumatologia

    Varese, 21100 Italy

  • Szpital Kliniczny Dziecatka Jezus - Orthopaedics

    Warsaw, 02-005 Poland

  • Singapore General Hospital - Orthopaedic Surgery

    Singapore, 169608 Singapore

  • Woodend Hospital - Department of Orthopaedics

    Aberdeen, AB15 6ZQ United Kingdom

Conditions related to this trial:

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