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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Spinal Stenosis
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 162
- Locations
- 12
- Primary Endpoint
- Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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-
- •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.
Outcomes
Primary Outcomes
Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Time Frame: From baseline up to 6 weeks follow-up
This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
Time Frame: Starting at the surgical procedure till 7 days post-operatively
Adverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed: * Day of the procedure until P+1 (where P refers to the day of the surgical procedure) * P+2 until P+7
Secondary Outcomes
- Mean Change in Quality of Life Score at 12 Months Compared to Baseline(From baseline up to 12 months follow up)
- Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire(From baseline up to 12 months)
- Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.(From baseline up to 12 months follow up)
- Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity(From baseline up to 12 months follow up)