Neurogenic Intermittent Claudication Evaluation Study

Spinal Stenosis Clinical Trial

— NICE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905359
• Other study ID #: CIP 0002 AP
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2009
• Last updated: January 26, 2016
• Start date: January 2010
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeBelgium: Ethics CommitteeBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeFrance: French Data Protection AuthorityFrance: Conseil National de l'Ordre des MédecinsGermany: Ethics CommissionGermany: Ministry of HealthGermany: German Institute of Medical Documentation and InformationGermany: Federal Office for Radiation ProtectionIceland: Icelandic Radiation Safety AuthorityIceland: Ethics CommitteeItaly: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Spinal Stenosis

Intervention

Procedure:
• Aperius™ PercLID™ System
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
• Standalone Decompressive Surgery
Lumbar decompressive surgery without instrumentation or fusion

Locations

Country	Name	City	State
Australia	Pindara Specialist Suite	Benowa	Queensland
Belgium	Ziekenhuis St. Jan - Orthopedie	Brugge
Belgium	Clinique Parc Leopold - Neurochirurgie	Brussels
Belgium	CHU Tivoli - Neurochirurgie	La Louviere
Belgium	Clinique Saint Joseph - Neurochirurgie	Liège
Belgium	Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie	Mons
France	Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie	Bordeaux
France	Hôpital Roger Salengro - Clinique de Neurochirurgie	Lille
France	CHU de Nice Hôpital Pasteur - Neurochirurgie	Nice
Germany	Neurochirurgische Klinik - Campus Benjamin Franklin	Berlin
Germany	Klinikum rechts der Isar der TU München - Neurochirurgie	Munchen
Iceland	Landspitali - National hospital of Iceland	Reykjavik
Italy	Azienda Ospedaliera Sant'Andrea - Neurochirurgia	Rome
Italy	Ospedale di Circolo - Ortopedia e Traumatologia	Varese
Poland	Municipal Hospital - Szpital Miejski	Torun
Poland	Szpital Kliniczny Dziecatka Jezus - Orthopaedics	Warsaw
Singapore	Singapore General Hospital - Orthopaedic Surgery	Singapore
Sweden	Ortopedmottagningen SU/Sahlgrenska	Göteborg
United Kingdom	Woodend Hospital - Department of Orthopaedics	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

Australia,  Belgium,  France,  Germany,  Iceland,  Italy,  Poland,  Singapore,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percentage change from baseline in Physical Function at 1 year follow-up using the patient completed Zurich Claudication Questionnaire		1 year	No
Secondary	Mean percentage change from baseline in Physical Function, using the patient completed Zurich Claudication Questionnaire		14d, 6w, 6, 24m	No
Secondary	Outcomes of the Symptom Severity and Patient Satisfaction domains of the patient completed Zurich Claudication Questionnaire		14d, 6w, 6, 12, 24m	No
Secondary	Mean percentage change from baseline in Leg Pain VAS Scores		14d, 6w, 6, 12, 24 m	No
Secondary	QoL related outcomes using the patient completed SF-36 v2 questionnaire		14d, 6w, 6, 12, 24m	No
Secondary	Proportion of subjects with complications at the secondary surgical intervention		Full follow up period	Yes
Secondary	Proportion of subjects with Serious Adverse Device Effects		Full follow up period	Yes