Clinical trial NCT00905359: Neurogenic Intermittent Claudication Evaluation Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Stenosis
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 163
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire
timeFrame: 14 days, 6 weeks, 6 months, and 24 months
measure: Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire
timeFrame: 14days, 6 week, 6 months, 12 months, 24 months
measure: Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire
timeFrame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
measure: Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain
timeFrame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
measure: Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire
timeFrame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
measure: Number of Subjects Requiring Secondary Surgical Intervention
timeFrame: Overall study period, up to 24 months
measure: Percentage of Subjects With Serious Adverse Device Effects
timeFrame: Overall study period, up to 24 months
measure: Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points
timeFrame: baseline, 12 months, and 24 months
measure: Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points
timeFrame: baseline, 12 months, and 24 months
measure: Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain
timeFrame: 12 months and 24 months
measure: Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain
timeFrame: 12 months and 24 months
measure: Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function
timeFrame: 12 months and 24 months
measure: Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity
timeFrame: 12 months and 24 months
measure: 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
timeFrame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Benowa
country: Australia
facility: Pindara Specialist Suite
state: Queensland
city: Brugge
country: Belgium
facility: Ziekenhuis St. Jan - Orthopedie
city: Brussels
country: Belgium
facility: Clinique Parc Leopold - Neurochirurgie
city: La Louviere
country: Belgium
facility: CHU Tivoli - Neurochirurgie
city: Liège
country: Belgium
facility: Clinique Saint Joseph - Neurochirurgie
city: Mons
country: Belgium
facility: Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie
city: Bordeaux
country: France
facility: Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie
city: Lille
country: France
facility: Hôpital Roger Salengro - Clinique de Neurochirurgie
city: Nice
country: France
facility: CHU de Nice Hôpital Pasteur - Neurochirurgie
city: Berlin
country: Germany
facility: Neurochirurgische Klinik - Campus Benjamin Franklin
city: Munchen
country: Germany
facility: Klinikum rechts der Isar der TU München - Neurochirurgie
city: Reykjavik
country: Iceland
facility: Landspitali - National hospital of Iceland
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea - Neurochirurgia
city: Varese
country: Italy
facility: Ospedale di Circolo - Ortopedia e Traumatologia
city: Toruń
country: Poland
facility: Municipal Hospital - Szpital Miejski
city: Warsaw
country: Poland
facility: Szpital Kliniczny Dziecatka Jezus - Orthopaedics
city: Singapore
country: Singapore
facility: Singapore General Hospital - Orthopaedic Surgery
city: Göteborg
country: Sweden
facility: Ortopedmottagningen SU/Sahlgrenska
city: Aberdeen
country: United Kingdom
facility: Woodend Hospital - Department of Orthopaedics
Study officials:
affiliation: CHU Pellegrin Tripode
name: Jean-Charles Le Huec, Prof.
role: PRINCIPAL_INVESTIGATOR
References: