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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Implantation of the Aperius® device
Hospital Campus Middelheim
Antwerp, Belgium
Academic Hospital Sint-Jan Brugge-Oostende AV
Bruges, Belgium
Park Léopold Hospital
Brussels, Belgium
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
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
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
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Notre Dame de Grace Hospital
Gosselies, Belgium
University Hospital Tivoli
La Louvière, Belgium
Hospital du Grand Hornu
Mons, Belgium
Klinik und Poliklinik für Orthopädie (Hospital)
Cologne, Germany
Gemeinschaftspraxis Königsallee (Privat Clinic)
Düsseldorf, Germany
University Hospital Erlangen
Erlangen, Germany
Asklepios Hospital Lindenlohe
Schwandorf in Bayern, Germany
...and 2 more locations
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
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
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