: Intermittent Neurogenic Claudication Aperius® Percutaneous Interspinous Spacer F. Collignon, P. Fransen, D Morelli, N. Craig, J. Van Meirhaeghe For the INCA-study investigator group Disclosure information Patrick Fransen Study design STUDY DESIGN International, multi-center, single arm trial N° PATIENTS 162 patients consented, 157 patients treated CLINICAL SITES 12 European: 6 in Belgium, 5 in Germany, 1 in United Kingdom FOLLOW-UP 48 hours, 7 days, 6 weeks, 6 months and 12 months ENDPOINTS Primary Safety: procedural or device related SAE < 7 days Effectiveness: ZCQ-Symptom Severity at 6 weeks Secondary Safety: procedural or device related SAE in follow-up Effectiveness: ZCQ Symptom Severity ZCQ Physical Function and EQ-5D Radiological Implant status & positioning, change in lordosis, p-MRI, maintenance of distraction PURPOSE Evaluate safety of the procedure and the safety and effectiveness of Aperius® Percutaneous Interspinous Spacer Patient Demographics & Surgical Procedure Information Sex 50.3% Male 49.7% Female Mean age 64,9 years ± 11,9 Mean complaint duration 40.0 months ± 60,4 Treatment history Pain medication : 85,4 % Physical therapy : 66,2 % Epidural infiltration : 59,2 % N° of stenotic levels 1 level : 69 patients 2 levels : 78 patients 3 levels : 10 patients Treated levels L1-L2 : 0.4 % L2-L3 : 5.9 % L3-L4 : 35.5 % L4-L5 : 58.2 % Device size used (n=250) 8mm : 6.4 % 10mm : 24.8 % 12mm : 39.2 % 14mm : 29.6 % Mean estimated procedure time (skin to skin) One level : 15.5 min ± 9.1 Two levels : 24.6 min ± 8.6 Three levels : 39.1 min ± 8.9 Primary Effectiveness Endpoint Zurich Claudication Questionnaire on Symptom Severity 5 Primary endpoint 4 3 * 2 * * * 3 2.1 2.1 2.2 2.2 7 days (n=156) 6 weeks (n=155) 6 months (n=151) 12 months (n=155) 1 Baseline (n=157) At 6 weeks the mean ZCQ Symptom Severity was reduced by 29.7%. This statistical significant improvement (*p<0.001) was maintained at 6 and 12 months Secondary Effectiveness Endpoints ZCQ-Physical Function VAS Pain Scores 10 4 9 8 * 7 3 * * * 2 * * * 6 5 Leg pain 4 Buttock/groin pain Back pain 3 2,5 2,3 1,8 1 1,9 1,8 2 1 0 BL (n=157) 7d (n=155) 6w (n=155) 6m (n=149) BL 12m (n=153) Max. improvement (0.7 points in ZCQ PF) reached at 6 weeks (*paired t-test p<0.001) 7 days 6 w eeks 6m 12m Immediate significant pain reduction and at all timepoints compared to baseline (*p<0.001) Pain medication Walking distance 100,0% 100% 80% Morphine 80,0% >1000 Central acting (Tramadol) 60% Codeine combinations NSAID 40% 60,0% 500-1000 100-500 40,0% <100 Paracetamol and/or aspirine No pain medication 20% 20,0% 0,0% 0% Screening 7 d ays 6 weeks 6 mo nt hs 12 mo nt hs The use and strenght of pain medication used decreased over time Screening (n=157) 7 days (n=156) 6 weeks (n=156) 6 months (n=153) 12 months (n=156) Walking distance improved overall and was maintained over total follow-up period Safety Primary safety endpoint - First 7 days post-operatively • 6 serious adverse device related effects (SADE) were observed • One patient with a spinous process fracture • Three patients suffering from back pain • One hematoma • One patient experiencing pain in the lower extremities Overall safety assessment - Up to 12 months • 11 patients experienced an SADE, mainly reporting back pain and recurrence of NIC symptoms • 52 patients experienced an ADE of which 26 reported as back pain and 10 recurrent NIC symptoms. • 14 explant procedures were performed while 90.7% of the population had their device still in place • Nine confirmed cases of spinous process fracture were observed during the study, 3 spontaneously reported cases and 6 cases confirmed following central reading of X-rays. The clinical outcome of all nine patients was analysed but no correlation was found. Conclusion 1. 2. The procedure was shown to be generally safe and well tolerated • 11 patients experienced SADEs during the total follow-up period • No unexpected ADEs or SADEs were identified The device was effective for up to 12 months post-operatively when used for the relief of NIC complaints in patients with symptomatic DLSS • 3. Statistical significant improvement from baseline was shown in: • both symptom severity and physical function (ZCQ) • leg, back and buttock/groin pain assessed by VAS • Quality of life assessed by EQ5D • A reduced use of pain medication was reported. • Significant improvement in walking distance was observed. The APERIUS® device offers advantages due to the percutaneous approach • Short operation time • Potential use of local anesthesia • Minimal/negligible blood loss • Short recovery and rehabilitation period