PROF. EPIMENIO RAMUNDO ORLANDO

Transcription

1 PROF. EPIMENIO RAMUNDO ORLANDO

2 Lumbar Spinal Stenosis - Definition N.I.C. caused by lumbar stenosis was firstly described by Verbiest (1954)*1 and is characterized by contemporary single or multiple factors: Legaments calcification. Osteophytes formation. Spondilolisthesis. Thickening of bone walls and articulations. *1 A radicular syndrome from developmental narrowing of the lumbae vertebral canal. Verbiest H (1954)J Bone Joint Surg 36B:

3 Treatment Conservative Treatment: Physiotheraphy, medical treatment, osteopathy, etc... Surgical Decompression: Spinous process spinosectomy and bilateral laminectomy, bilateral laminectomy with monolateral approach. Dura Interspinous devices: open surgery removing supra and interspinous legament. Minimally invasive surgery and percutaneal surgery.

4 Interspinous Devices Sénégas J. et al. Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments: the Wallis system. Eur Spine J Oct;11 Suppl 2:S Epub 2002 Jun 1. PMID: [PubMed - indexed for MEDLINE] Wallis Aperius X-Stop Coflex Diam Viking In-Space

5 Indication for interspinous devices given by producers Indicated in patients with simptomatic degenerative lumbar spinal stenosis with or without an Intermittent Neurogenic Claudication (NIC). Indicated for interspinous levels from L1 to S1. Other indications: Degenerative lumbar discal pathology and discal bulging..

6 The Technique

7 The Trocar Yellow = 8 mm Green = 10 mm Gray = 12 mm Blue = 14 mm

8 The Device Handle of implant holder Implant Handle to release the implant Handle for positioning the implant

9 Local Anesthesia

10 First Trocar Insertion

11 Final Positioning

12 Procedure duration and X-Ray Exposure Procedure duration about minutes. X-Ray exposure about sec with mgy/cm2 dose.

13 Personal Data 80 Patients 85 treated levels From year 2006 to 2011 Age range: from 33 to 100 years (85% of which from 65 to 75 years).

14 Personal Data Treated Levels L1-L2 L4-L5 L2-L3 0% L3-L4 3% 22% 75%

15 Dimentions of Implanted Devices 12 mm 8 mm 14 mm 10 mm 3% 0% 40% 57% mm 2% 2% 8 mm 10 mm 12 mm

16 Results Patient satisfaction at 6M FU Unsatisfied Totally Satisfied 14,7% 8,8% 76,5% Partially Satisfied

17 Results Patient satisfaction at 24 M FU Patient satisfaction at 24 M FU Unsatisfied Totally Satisfied 14,7% 10% 75,3% Partially Satisfied

18 Results VAS Score: ,6 6 VAS preop 5 VAS 6M 4 VAS VAS1Y2Y 3, ,2

19 Results Foramina Evaluation on TC

20 3D Reconstruction Pre op Post op Pre op Post op

21 Pre-op Post-op

22 Right foramina Pre-op Post-op

23 Left foramina Pre-op Post-op

24 Pre-op Post-op

25 Right foramina Pre-op Post-op

26 Results Yellow ligaments hypertrophy Axial images Pre-op Post-op

27 Results Yellow ligaments hypertrophy Sagittal images Pre-op Post-op

28 Failure Analysis Presence of a marked discal bulging stenosis associated: In 2 cases the implant caused a large discal erniation requiring implant removal and a new surgery for microdiscectomy.

29 Failures: Listhesis: one patient out of 4 with apparently mobile degenerative listhesis, showed a worsening of the amount of shifting and requested new surgery to remove the device and stabilize the spine.

30 Failures: Osteoporosis: Risk of spinal process fracture.

31 Failures: Oversized Device: Risk of spinal process fracture.

32 Conclusions Surgical duration from 15 to 20 min. Low risk. Ospitalization time reduced at h. High patient satisfaction since the immediate postoperative phase.

33 Effectivness of interspinous implant surgery in patient with intermittent neurogenic claudication: a systematic review and metaanalysis. Moojen WA, Arts MP, Bartels RH, Jacobs WC, Peul WC. Eur Spine J Oct;20(10): Citation: Furthermore, no data is presently available comparing interspinous process decompression with standard bony decompression. We suggest that more studies will be done on this subject comparing the surgical treatment with IPD versus bony decompression. Despite the fact that we could give a Grade A recommendation, according to the Oxford-Centre for Evidence Based Medicine, we suggest that further studies have to be performed before a thorought recommendation can be given regarding the treatment of INC with IPDs (82). These studies should also include analysis on complication rate and device failure rate.

34 Other ongoing RCT,s The Felix Trial - Leiden. Norwegian University of Science and Technology. NICE.

35 Inclusion Symptomatic DLSS on MRI, L1-L5, or maximum 2 levels. Presence of NIC, relived in flexion. VAS score legs > 2 VAS score back.. Average disc height 5 mm. Standalone Decompressive surgery candidate. Leg symptoms at least 6 weeks. Exclusion Previous lumbar surgery at any lumbar level. Unremitting pain in any spinal position. Instrumented Decompressive Surgery candidate. Spondylolisthesis > Grade 1. Spinous process fracture. Symptomatic DLSS at more than 2 levels. Symptomatic Spinal stenosis is present at L5-S1 level. Symptomatic disc herniation causing radiculopaty at any level between T12-S1 BMI of patient equal or higher than 35. History of one or more osteoporotic fragility fracture(s) anywhere in the body.

36 Conclusions The NICE RCT, with one year follow-up and full sample size, will still address a major gap in the literature: Fact based comparison of Aperius vs SDS in NIC, including safety and efficacy up to 1 year. In a well defined population. Level 1 evidence