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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
163
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
Lumbar decompressive surgery without instrumentation or fusion
Pindara Specialist Suite
Benowa, Queensland, Australia
Ziekenhuis St. Jan - Orthopedie
Bruges, Belgium
Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.
Time frame: 1 year
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.
Time frame: 14 days, 6 weeks, 6 months, and 24 months
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.
Time frame: 14days, 6 week, 6 months, 12 months, 24 months
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire
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Clinique Parc Leopold - Neurochirurgie
Brussels, Belgium
CHU Tivoli - Neurochirurgie
La Louvière, Belgium
Clinique Saint Joseph - Neurochirurgie
Liège, Belgium
Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie
Mons, Belgium
Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie
Bordeaux, France
Hôpital Roger Salengro - Clinique de Neurochirurgie
Lille, France
CHU de Nice Hôpital Pasteur - Neurochirurgie
Nice, France
Neurochirurgische Klinik - Campus Benjamin Franklin
Berlin, Germany
...and 9 more locations
PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain
Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire
The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Number of Subjects Requiring Secondary Surgical Intervention
Time frame: Overall study period, up to 24 months
Percentage of Subjects With Serious Adverse Device Effects
Time frame: Overall study period, up to 24 months
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points
The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.
Time frame: baseline, 12 months, and 24 months
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points
Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.
Time frame: baseline, 12 months, and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain
Time frame: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain
Time frame: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function
Time frame: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity
Time frame: 12 months and 24 months
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
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months