Clinical trial NCT00887744: Intermittent Neurogenic Claudication Treatment With APERIUS®
Official title: A Multicenter, Post Marketing Clinical Follow-up Study to Evaluate the Safety and Effectiveness of the Minimally Invasive Device APERIUS® in Degenerative Lumbar Spinal Stenosis With Symptomatic Neurogenic Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Stenosis
Keywords: Degenerative Lumbar Spinal Stenosis
Neurogenic Intermittent Claudication
Interpinous Device
Percutaneous
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 162
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius® device.

Detailed description: The Intermittent Neurogenic Claudication Treatment with Aperius® (INCA) trial was designed as a multicenter single arm post-marketing study to evaluate the safety and effectiveness of the Aperius® in patients with degenerative lumbar stenosis with symptomatic neurogenic intermittent claudication.

One hundred fifty six patients with a history of Degenerative lumbar spinal stenosis (Lumbar level L1 to L5) at one or maximum 2 levels with symptoms of neurogenic intermittent claudication with or without back pain were included. All patients were followed for 12 months with visits at 48 hours, 7 days, 6 weeks, 6 and 12 months.

Primary effectiveness endpoint was assessed as the mean percentage change from baseline in Zurich Claudication Questionnaire for Symptom Severity at 6 weeks. Other effectiveness outcomes were percentage change in Zurich Claudication Questionnaire scores (ZCQ), Quality of laife Questionnaire scores (called EuroQuol 5D or EQ-5D), Visual Analogue Scale (VAS) pain scores (back, leg and buttock groin pain), pain medication and changes in walking distance from baseline to follow-up. Procedure and device related Serious Adverse Events were assessed throughout the complete 12 month follow-up period.

Eligibility criteria: Inclusion Criteria:

* History of Degenerative Lumbar Spinal Stenosis (Lumbar spine level from L1 -L5), confirmed by Magnetic Resonance Imaging (MRI) at one or maximal two levels, with symptoms of intermittent neurogenic claudication.
* Leg / Buttock / Groin pain, with or without back pain, relieved by flexion. If back pain is also present, it must be partially relieved when flexed.
* Able to sit for 50 minutes without pain.
* Able to walk a distance of 20 meters without pain.
* Patient states availability for and willing to perform all follow -up examinations.
* Patient signed informed consent form.
* Adults (minimum 21 years of age).

Exclusion Criteria:

* Previous lumbar surgery.
* Unremitting pain (leg/buttock/groin/back) in any spinal position.
* Axial back pain without leg/buttock/groin pain.
* Significant lumbar instability at the affected level: spondylolisthesis greater than grade 1 on a scale from 1-4.
* Objective motor deficit.
* Significant peripheral neuropathy by nerve conduction velocity tests (peroneal and sural nerves) according to the investigator.
* Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence).
* Spinal Stenosis with clinical symptoms at one or more levels outside the L1-L5 lumbar region.
* Severe symptomatic Spinal Stenosis requiring immediate surgical decompression,according to the investigator or lumbar spinal stenosis at more than 2 levels.
* Lumbar Spinal Stenosis, caused by tumors, metastasis or Paget's disease.
* Vascular claudication and severe peripheral vascular disease. (Diminished dorsalis pedis or tibial pulses) that limits walking.
* History of primary or secondary osteoporosis defined as a DXA scan (=dual energy x-ray absorptiometry) of the hip showing T-score (=the number of standard deviations above or below the mean for the patient's age, sex and ethnicity) of more than 2.5 standard deviation below the mean in the presence of one or more fragility fractures.
* Active systemic infection or local infection at the level to treat.
* Major Depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria.
* Dementia and/or inability to give informed consent.
* Unable to complete the study.
* Pregnancy and breastfeeding.

Primary outcomes:
measure: Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
timeFrame: From baseline up to 6 weeks follow-up
measure: The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
timeFrame: Starting at the surgical procedure till 7 days post-operatively
Secondary outcomes:
measure: Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
timeFrame: From baseline up to 12 months follow up
measure: Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire
timeFrame: From baseline up to 12 months
measure: Mean Change in Quality of Life Score at 12 Months Compared to Baseline
timeFrame: From baseline up to 12 months follow up
measure: Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.
timeFrame: From baseline up to 12 months follow up
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Hospital Campus Middelheim
city: Bruges
country: Belgium
facility: Academic Hospital Sint-Jan Brugge-Oostende AV
city: Brussels
country: Belgium
facility: Park Léopold Hospital
city: Gosselies
country: Belgium
facility: Notre Dame de Grace Hospital
city: La Louvière
country: Belgium
facility: University Hospital Tivoli
city: Mons
country: Belgium
facility: Hospital du Grand Hornu
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis Königsallee (Privat Clinic)
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Köln
country: Germany
facility: Klinik und Poliklinik für Orthopädie (Hospital)
city: Schwandorf
country: Germany
facility: Asklepios Hospital Lindenlohe
city: Schwarzach
country: Germany
facility: Orthopädische Fachklinik Schwarzach (Hospital)
city: Aberdeen
country: United Kingdom
facility: Woodend Hospital
Study officials:
affiliation: Medtronic Spinal & Biologics
name: E. Wuelfert, Pharm.
role: STUDY_DIRECTOR
References: