Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
163 participants
INTERVENTIONAL
2010-01-31
2015-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aperius™ PercLID™ System
Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System.
Aperius™ PercLID™ System
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
Standalone Decompressive Surgery
Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Standalone Decompressive Surgery
Lumbar decompressive surgery without instrumentation or fusion
Interventions
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Aperius™ PercLID™ System
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
Standalone Decompressive Surgery
Lumbar decompressive surgery without instrumentation or fusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Charles Le Huec, Prof.
Role: PRINCIPAL_INVESTIGATOR
CHU Pellegrin Tripode
Locations
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Pindara Specialist Suite
Benowa, Queensland, Australia
Ziekenhuis St. Jan - Orthopedie
Bruges, , Belgium
Clinique Parc Leopold - Neurochirurgie
Brussels, , Belgium
CHU Tivoli - Neurochirurgie
La Louvière, , Belgium
Clinique Saint Joseph - Neurochirurgie
Liège, , Belgium
Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie
Mons, , Belgium
Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie
Bordeaux, , France
Hôpital Roger Salengro - Clinique de Neurochirurgie
Lille, , France
CHU de Nice Hôpital Pasteur - Neurochirurgie
Nice, , France
Neurochirurgische Klinik - Campus Benjamin Franklin
Berlin, , Germany
Klinikum rechts der Isar der TU München - Neurochirurgie
München, , Germany
Landspitali - National hospital of Iceland
Reykjavik, , Iceland
Azienda Ospedaliera Sant'Andrea - Neurochirurgia
Rome, , Italy
Ospedale di Circolo - Ortopedia e Traumatologia
Varese, , Italy
Municipal Hospital - Szpital Miejski
Torun, , Poland
Szpital Kliniczny Dziecatka Jezus - Orthopaedics
Warsaw, , Poland
Singapore General Hospital - Orthopaedic Surgery
Singapore, , Singapore
Ortopedmottagningen SU/Sahlgrenska
Gothenburg, , Sweden
Woodend Hospital - Department of Orthopaedics
Aberdeen, , United Kingdom
Countries
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Other Identifiers
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CIP 0002 AP
Identifier Type: -
Identifier Source: org_study_id
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