Spinal Stenosis
Conditions
Keywords
Degenerative Lumbar Spinal Stenosis, Neurogenic Intermittent Claudication, Interpinous Device, Percutaneous
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.
Interventions
DEVICEAperius® Percutaneous Interspinous Spacer
Implantation of the Aperius® device
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | The Zurich Claudication questionnaire - Symptom Severity 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).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5. The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage. |
| Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire | From baseline up to 12 months | The Zurich Claudication Questionnaire - Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0. The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage. |
| Mean Change in Quality of Life Score at 12 Months Compared to Baseline | From baseline up to 12 months follow up | The quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored. |
| 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 | — |
Countries
Belgium, Germany, United Kingdom
Participant flow
Recruitment details
The first patient entered the study on November 20, 2006 and the last patient's last visit was on May 21, 2009 with a total study duration of 30 months.
Pre-assignment details
Not applicable. Single arm study
Participants by arm
| Arm | Count |
|---|---|
| Aperius® Treatment Arm The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body. | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Various reasons | 9 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Aperius® Treatment Arm |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 11.93 |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 95 / 157 |
| serious Total, serious adverse events | 39 / 157 |
Outcome results
Primary
Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
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.
Time frame: From baseline up to 6 weeks follow-up
Population: Intention-To-Treat: the population of patients who underwent the minimally invasive procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aperius® Treatment Arm | Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity | -29.7 Percent change | Standard Deviation 23.4 |
Primary
The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
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
Time frame: Starting at the surgical procedure till 7 days post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aperius® Treatment Arm | The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure | 3.8 Proportion of patients (%) |
Secondary
Mean Change in Quality of Life Score at 12 Months Compared to Baseline
The quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored.
Time frame: From baseline up to 12 months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aperius® Treatment Arm | Mean Change in Quality of Life Score at 12 Months Compared to Baseline | 30 Scores on a scale (1-100) | Standard Deviation 31 |
Secondary
Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire
The Zurich Claudication Questionnaire - Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0. The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Time frame: From baseline up to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aperius® Treatment Arm | Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire | 25.3 Percent Change | Standard Deviation 27.7 |
Secondary
Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
The Zurich Claudication questionnaire - Symptom Severity 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).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5. The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Time frame: From baseline up to 12 months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aperius® Treatment Arm | Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity | 26.7 Percent Change | Standard Deviation 25.8 |
Secondary
Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.
Time frame: From baseline up to 12 months follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aperius® Treatment Arm | Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period. | 7.6 Proportion of patients (%) |