EPIMENIO RAMUNDO ORLANDO - formazionesostenibile.it
EPIMENIO RAMUNDO ORLANDO - formazionesostenibile.it
EPIMENIO RAMUNDO ORLANDO - formazionesostenibile.it
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WallisInterspinous DevicesSénégas J. et al.Mechanical supplementation by non-rigid fixation in degenerativeintervertebral lumbar segments: the Wallis system.Eur Spine J. 2002 Oct;11 Suppl 2:S164-9. Epub 2002 Jun 1.PMID: 12384740 [PubMed - indexed for MEDLINE]AperiusX-StopDiamCoflexVikingIn-Space
The Technique
The Trocar Yellow = 8 mm Green = 10 mm Gray= 12 mm Blue= 14 mm
The DeviceHandle of implant holderImplantHandle to releasethe implantHandle forpos<strong>it</strong>ioning theimplant
Local Anesthesia
First Trocar Insertion
Final Pos<strong>it</strong>ioning
Procedure duration andX-Ray Exposure Procedure duration about 15-20 minutes. X-Ray exposure about 60-80 sec w<strong>it</strong>h1500-7000 mGy/cm2 dose.
Personal Data 80 Patients 85 treated levels From year 2006 to 2011 Age range: from 33 to 100 years (85% ofwhich from 65 to 75 years).
Personal DataTreated LevelsL4-L5L1-L20%3%L2-L3L3-L422%75%
Dimentions of Implanted Devices12 mm 14 mm3%8 mm10 mm57%0%40%14 mm2% 2%2006-20088 mm12 mm10 mm2009-2011
ResultsPatient satisfaction at 6M FUUnsatisfiedTotally Satisfied14,7%8,8%76,5%Partially Satisfied
ResultsPatient satisfaction at 24 M FUUnsatisfiedTotally Satisfied14,7%10%75,3%Partially Satisfied
Results VAS Score:109878,66543213,63,2VAS preopVAS 6MVAS VAS 1Y2Y01
Results Foramina Evaluation on TC
3D ReconstructionPre op Post op Pre op Post op
Pre-opPost-op
Right foraminaPre-opPost-op
Left foraminaPre-opPost-op
Pre-opPost-op
Right foraminaPre-opPost-op
ResultsYellow ligaments hypertrophyAxial imagesPre-opPost-op
ResultsYellow ligaments hypertrophySag<strong>it</strong>tal imagesPre-opPost-op
Failure Analysis Presence of a marked discal bulging stenosisassociated: In 2 cases the implant caused a large discalerniation requiring implant removal and a new surgeryfor microdiscectomy.
Failures: Listhesis: one patient out of 4 w<strong>it</strong>h apparently mobiledegenerative listhesis, showed a worsening of theamount of shifting and requested new surgery toremove the device and stabilize the spine.
Failures: Osteoporosis: Risk of spinal process fracture.
Failures: Oversized Device: Risk of spinal processfracture.
Conclusions Surgical duration from 15 to 20 min. Low risk. Osp<strong>it</strong>alization time reduced at 24-48 h. High patient satisfaction since the immediatepostoperative phase.
Effectivness of interspinous implant surgery in patient w<strong>it</strong>hinterm<strong>it</strong>tent neurogenic claudication: a systematic review and metaanalysis.Moojen WA, Arts MP, Bartels RH, Jacobs WC, Peul WC.Eur Spine J. 2011 Oct;20(10): 1596-606.C<strong>it</strong>ation: “ Furthermore, no data is presently availablecomparing interspinous process decompression w<strong>it</strong>h standardbony decompression. We suggest that more studies will bedone on this subject comparing the surgical treatment w<strong>it</strong>hIPD versus bony decompression. Desp<strong>it</strong>e the fact that wecould give a Grade A recommendation, according to theOxford-Centre for Evidence Based Medicine, we suggest thatfurther studies have to be performed before a thoroughtrecommendation can be given regarding the treatment ofINC w<strong>it</strong>h IPDs (82).These studies should also include analysis on complicationrate and device failure rate.
Other ongoingRCT,s• The Felix Trial - Leiden.• Norwegian Univers<strong>it</strong>y of Science and Technology.• NICE.
InclusionExclusion•Symptomatic DLSS on MRI,L1-L5, or maximum 2 levels.•Presence of NIC, relived inflexion.•VAS score legs > 2 VAS scoreback..•Average disc height ≥ 5 mm.•Standalone Decompressivesurgery candidate.•Leg symptoms at least 6weeks.•Previous lumbar surgery at any lumbarlevel.•Unrem<strong>it</strong>ting pain in any spinal pos<strong>it</strong>ion.•Instrumented Decompressive Surgerycandidate.•Spondylolisthesis > Grade 1.•Spinous process fracture.Symptomatic DLSS at more than 2 levels.Symptomatic Spinal stenosis is present atL5-S1 level.•Symptomatic disc herniation causingradiculopaty at any level between T12-S1•BMI of patient equal or higher than 35.•History of one or more osteoporoticfragil<strong>it</strong>y fracture(s) anywhere in the body.
ConclusionsThe NICE RCT, w<strong>it</strong>h one year follow-up and fullsample size, will still address a major gap in thel<strong>it</strong>erature:•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
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