AxiaLIF 360 Construct

Size: px

Start display at page:

Download "AxiaLIF 360 Construct"

Buddy Aubrey Shelton
5 years ago
Views:

1 Surgeon Didactic

2 AxiaLIF 360 Construct

3 Least Invasive Surgical Goals Identify Truly Muscle Sparing Access Route to Lumbar Spine Apply Existing MIS Techniques Preserve Supportive Soft Tissue Structures Utilize Existing Fusion Principles Broaden Fusion Treatment Options L4-S1 Pioneer Axial Motion Preservation Therapies

4 Proof of Principle, History and Publications In 2001, AxiaLIF was tested and validated in both porcine and human cadavers. In May 2002, series of three consecutive patients, biopsy of the lumbosacral disc and vertebral body region. In November 2003 a human pilot study was initiated with Pimenta, et al that included 35 patients with very promising results.

5 Proof of Principle, History and Publications Yuan P, Day T, Albert T, Morrison W, Pimenta L, Cragg A, Weinstein M: Anatomy of the Percutaneous Presacral Space for a Novel Fusion Technique, J Spinal Disord Tech, 2006 June; 19 (4): The 1st US AxiaLIF was performed by Levy, et al (University of Buffalo) in January 2005 after US FDA regulatory clearance in late A limited group of 10 US spine surgeons initiated treatment of L5S1 degenerative disc disease patients to corroborate the pilot work of Pimenta, et al, including ~90 patients in 2005

6 Proof of Principle, History and Publications AxiaLIF was fully released to the spine community in the US and Europe in Accumulated over 6,500 procedures to date and generated 17 peer reviewed original articles, scientific journal and textbook publications. AxiaLIF is one of, if not the most validated and studied MIS lumbar fusion operation 19 original articles on anatomy, access, biomechanics, including functional outcomes, arthrodesis rates, complications for degenerative disc disease, instability and adult degenerative scoliosis, in a series of 3 Level II evidence peer reviewed papers.

7 Patient Indications AxiaLIF System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion. Pseudoarthrosis Unsuccessful previous fusion Degenerative Disc Disease Spondylolisthesis (Grade 1 or 2) Usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed pedicle and facet screw systems. See package insert for full labeling.

8 Pre-Op Workup Indications for fusion-standard practice Contraindication-specific Previous bowel surgery, IBD, Pelvic disease, perirectal abscess Age appropriate-osteoporosis Images: MRI & Flexion/Extension films Standard field of view for lumbar MR increased to include coccyx Review for trajectory & anatomy

9 AxiaLIF Contraindications Absolute contra-indications Previous Bowel Surgery Relative contra-indications Previous Rectal Resections History of pelvic radiotherapy (rectal cancer,prostate cancer) Crohn s disease Ulcerative colitis Full-thickness rectal prolapse Coagulopathy Severe scoliosis Sacral agenesis Spondy grade 2 and above Tumor.

10 Pre-Surgery Prep A bowel preparation needs to be performed prior to the AxiaLIF procedure Collaborate with general and or colorectal surgeons regarding choice of bowel prep Two common bowel prep s: 1. Miralax prep (64 oz) Well tolerated / may be mixed with fruit juices 2. Golytely (4 liters) Probably the safest for elderly & or patients with co-morbidities Goal is to facilitate dissection and mobilization of the rectum and to minimize fecal contamination in case of rectal perforation

11 Pre-Op Images Mitigate Complications Not a candidate for AxiaLIF,bowel adhered to sacrum, poor trajectory, prior surgery and vein traversing across midline at L3.

12 MRI to tip of coccyx Important to assess trajectory, fat pad, evidence of scarring within presacral space Insufficient fat pad & presacral scarring Rule out presence of vascular structures Pre Sacral Vessel

13 Trajectory Planning for AxiaLIF Typical excellent trajectory Infrequent and unsuitable trajectory

IV, Clindamycin & Gentamycin IV, Invanz IV Bi Planar Fluoro (key for facet screws)

14 Patient Prep & OR Set-up Patient Prone on Jackson Table Pads to elevate sacrum Legs apart Gram (-) and anaerobic antibiotics For Example: Cefotoxin IV, Ciprofloxacin IV and Flagyl IV, Clindamycin & Gentamycin IV, Invanz IV Bi Planar Fluoro (key for facet screws) Instruments fit onto Mayo stand Standard skin prep Occlusive drape over anus, mastisol or benzoin to adhere

15 Safety of AxiaLIF Approach MRI with distances to internal iliac vessels CT with measurement from sacrum to rectum

16 Vascular & Neurological Structures Safe Zone via midline approach

17 Presacral Anatomy

& lateral fluoroscopy to accurately verify tip of coccyx

18 Initial Incision Palpate coccyx & ligamentous arch For heavier patients, surgeons may choose to use metal instrument & lateral fluoroscopy to accurately verify tip of coccyx Incision is made 1cm off midline and 1 finger breadth caudal to the arch

19 The Safe Zone Pre-sacral space between parietal and visceral fascia Potential for deviation into visceral structures reduced by advancing trocar along the sacrum

20 Finger Sweep Use finger to bluntly dissect tissue from the face of the sacrum Turn finger over to push the rectum anteriorly, increasing the pre- sacral working space

21 Access (Finger Sweep) 1. Lateral View Air (white) within the bowel assists visualization of presacral space 2. Lateral View Finger bluntly deflects bowel anteriorly to widen the presacral space 3. Lateral View Probe is introduced into widened pre-sacral space with bowel deflected anteriorly

22 Sacral Entry & Guide Pin Trajectory Verify position with A/P and lateral Fluoro Fingertip control on the handle Stay on anterior sacrum to S1/S2

23 Tissue Dilation & Working Channel Sequentially dilate channel with 6, 8 & 10mm dilators. Check positioning & fixation between each step

24 Establish Working Channel Withdraw 10 mm Dilator without Sheath Insert the 9 mm Twist Drill Harvest sacral autograft via twist drill

Discectomy Instrumentation Loop Cutters Tissue Extractors Designed

Remove disc material loosened by the various cutters.

abrade the endplates in disc tight disc spaces (less than 3mm) *Not

25 Discectomy Instrumentation Loop Cutters Tissue Extractors Designed to debulk the nucleus and lightly abrade the endplates. Remove disc material loosened by the various cutters. Tight Disc Cutters* Designed to debulk the nucleus and lightly abrade the endplates in disc tight disc spaces (less than 3mm) *Not recommended for use in L4-5 disc space. Small & Large Radial Down Cutters Small & Large Radial Cutters

26 AxiaLIF Discectomy

27 Discectomy Technique Intra-Op discography post discectomy Intra-Op Fluoro QuickTim e and a decom pres s or are needed to s ee this picture. QuickTim e and a decom pres s or are needed to s ee this picture.

28 Bone Graft Volume 7-10 cc common (Depending on disc space)

directional delivery Recommendation: Flood disc space with saline prior to insertion of graft material QuickTim e and a decom

29 Bone Graft Insertion Surgeon s choice of osteogenic material Load approximately 3 to 5cc of graft into distal end of inserter & slowly push material into disc space and pack with Inserter Rod through Cannula Beveled Cannula tip can be rotated for directional delivery Recommendation: Flood disc space with saline prior to insertion of graft material QuickTim e and a decom pres s or are needed to s ee this picture. Limit posterior discectomy and graft delivery in patients with recent (<1 year) prior discectomy

30 Extent of Discectomy Graft & Rod: CT Axial/Coronal Views

31 Extent of Discectomy Graft & Rod: CT Sagittal / Coronal Views

AxiaLIF Rod Variable Pitch (Distal Thread finer than Proximal Thread) Reverse Herbert Screw Design Variables to amount of distraction Bone quality Laxity of the motion segment Length of rod used &

32 AxiaLIF Rod Variable Pitch (Distal Thread finer than Proximal Thread) Reverse Herbert Screw Design Variables to amount of distraction Bone quality Laxity of the motion segment Length of rod used & depth the rod implanted Thread-pitch differential The average distraction per full turn is: 0.70mm/turn for 9-12 pitch rods or 5-9mm 0.42mm/turn for or 3-6mm 0.23mm/turn for or Neutral-3mm Distal

33 Extend Channel into L5 QuickTim e and a decom pressor are needed to see this picture. Extend channel into L5 by inserting the 7.5 mm Twist Drill - Channel should not be extended past the L5 pedicle, or 2/3 way into the L5 vertebral body Monitor drill advancement with Fluoro Extract Twist Drill counter-clockwise to avoid extracting bone in the flutes.

34 Exchange Cannula QuickTim e and a decom press or are needed to s ee this picture. Choose Exchange Bushing/Cannula System that best matches sacral contact angle 30 Degree 45 Degree Dilate soft tissue up to the face of the sacrum using the chosen Exchange Bushing. Upon contact with the sacrum, simultaneously rotate and advance the Bushing 180 until the angled surface of the Bushing meets the sacral face. QuickTim e and a decom pres s or are needed to s ee this picture.

35 Exchange Cannula Place Exchange Cannula over bushing with the long pointed end facing dorsally. Upon contact with the sacrum, simultaneously rotate and advance the Exchange Cannula forward until the angled surface of the Cannula meets the sacral face Advance the Fixation Wire 1-2cm into the sacrum by using a wire driver

into position Once positioned, insert Plug into cannulation of

36 AxiaLIF Rod Delivery Slowly rotate with forward pressure to engage sacral bone Continue advancing the Rod under Fluoro until into position Once positioned, insert Plug into cannulation of the rod. QuickTim e and a decom pres s or are needed to see this picture.

37 Distraction and Stabilization Variable pitch of AxiaLIF rod results in stabilization & indirect decompression of neural foramen via distraction

38 Distraction and Stabilization Distract & Lock Variable pitch of AxiaLIF rod results in stabilization & indirect decompression of neural foramen via distraction

39 FASK Lab Twin Cities Spine AxiaLIF & Posterior Tension Bands TRANSSACRAL ROD DECREASES ROM IN ALL LOADINGS (P<0.05) ADDITIONAL POSTERIOR FIXATION INCREASE STABILITY. FACET SCREWS DECREASE ROM SIMILAR TO PS-ROD SYSTEM (P>0.05). AVERAGE DISTRACTION: 6mm (88% of intact)

40 Percutaneous Transfacet Screw Fixation Advantages Stability: AxiaLIF 360 provides stability comparable to pedicle fixation. Successful fixation across facet joints Truly Percutaneous: No muscle splitting or stripping Less post-operative pain, less blood loss compared to pedicle screws

Patient Benefits QuickTim e and a YUV420 codec decom pres s or are needed to s ee this picture. QuickTim e and a H.264 decom pres s or are needed to s ee this picture.

41 Patient Benefits QuickTim e and a YUV420 codec decom pres s or are needed to s ee this picture. QuickTim e and a H.264 decom pres s or are needed to s ee this picture. 360 Fusion with AxiaLIF 2 Hours Post-Op 360 Fusion with AxiaLIF 7:30 am O.R. Start Time 11:45 am Ambulation - Discharge Close with Subcuticular Sutures and Dermabond

42 Clinical Data Review February 2009

43 AxiaLIF vs. Historical Controls OR (minutes) Length-of-Stay (days) Blood Loss (cc) Complications (%)

44 20 0 BAK Proximity Single Harms Danek TIBFD InFix Device Branigan PLIF Ray TFC Branigan ALIF Bone Dowel Implant Drilled Axially - No Femoral Ring BAK Axial Fusion Rod Double Harms % of Intact Peer Reviewed Publication Ledet et al, J Biomech Eng, Vol 127, Nov

Peer Reviewed Publications - Aryan HE et al, Minimaly Invasive Neurosurgery, 2008,51:225-230 91% Fusion Rate (35 patients) 3 nonfusions (2 standalones, one combo w/ XLIF)

45 Peer Reviewed Publications - Aryan HE et al, Minimaly Invasive Neurosurgery, 2008,51: % Fusion Rate (35 patients) 3 nonfusions (2 standalones, one combo w/ XLIF) OP-1 used as bone graft 1 supplemented w/ Pedicle Screws 1 continued observation 1 AxiaLIF explanted 42 Minute OR Time 0% Surgical Complications 1 incision site infection

46 Peer Reviewed Publications - Anand N, et al, Journal of Spinal Disorders and Techniques, Vol 21, Num 7, Oct 08 Prospective Evaluation of 12 patients w/ Degen. Scoli Avg. segments treated 3.64 Avg. anterior procedures blood loss 163 ml Avg. anterior procedure time 4.01 hours Preop VAS 7.1 Postop 4.8

47 Peer Reviewed Publications - Anand N, et al, Neurosurg Focus 28 (3):E6, consecutive patients, MIS Deformity patients Mean follow up 22 months All patients fused on CT evaluation Blood loss and morbidity significantly less than open deformity procedures

48 Peer Reviewed Publications Stippler, Turka, Gerszten, The Internet Journal of Neurosurgery 2008 : Vol 5 N 1 36 consecutive patients 40% complete resolution of low back pain 54% significant improvement of low back pain

49 Peer Reviewed Publications Rodgers, SAS Journal 4 (2010) 3740 Cost evaluation MIS vs. Open 101 Open patients 109 MIS patients XLIF/AxiaLIF/MIS TLIF Approx. $2500 cost savings w/ MIS group

50 Peer Reviewed Publications Bohinski, Tobler, et al., SAS Journal 4 (2010) consecutive patients 88% solid fusion CT 10% bridging bone CT ODI/VAS improvement 50% 1 bowel injury

51 Peer Reviewed Publications Tobler et al SPINE accepted for publication 156 Patients Multi-center 96% fusion rate

52 Peer Reviewed Publications Patil et al Orthopedics Dec 2010, pg st 50 patients University of Colorado 96% fusion rate 22% complication rate 2% bowel, 10% wound infection, 4% psuedo, 4% Hematoma, 2% nerve irratation PS) VAS 8.1 to 3.6 ODI 46 to 22

53 Peer Reviewed Publications Gundana SAS Journal accepted for publication 9152 patients 1.3% overall complication rate 0.6% bowel injury 0.2% transient hypotension

54 Society Posters Deformity, Elderly, Obese, Spondy, Degenerative, Safety, and many others

55 FDA Maude Data Base Source All bowel injuries captured National % >1300 cases Los Angeles 1 in last 325 cases Injury Reports from 1/01/2005 to 5/28/2010 Summary approximately cases completed by 6/30/ total MDR injuries 2005 Incidents Reported 2 Broken Cutter 2006 MDR injuries (11 Total) 2006 Incident Reports 5 Infections 3 Broken Cutter 6 Bowel/Temp Colostomy 1 Vascular/Repaired 2007 MDR injuries (9 total) 4 Bowel/Temp Colostomy 3 Bowel/Antibiotics 2007 Incident Reports 4 Broken Cutter 8 Blood Pressure Decrease 1 Vascular Injury 1 Vascular Bleeding 1 Ureter Injury 1 Infection treated w/ antibiotics 1 Discitis 1 Broken plug implant 2008 MDR injuries (17 total) 10 Bowel/Temp Colostomy 4 Bowel/Antibiotics 1 Possible Bowel Injury 1 Infection 1 Injury 2009 MDR injuries (24 total) 10 Bowel/Temp Colostomy 2009 Incident Reports 1 Sacral fracture 6 Possible Bowel 5 Bowel/Antibiotics 1 Sacral fracture/more robust posterior implants added 1 Posterior Foramen Breach w/ implant 1 Infected rod/removed 2010 MDR injuries (3 total) 2 Bowel 1 Bowel/Temp colostomy

56 THANK YOU B 05/6/2009

Corporate Medical Policy

Corporate Medical Policy Axial Lumbosacral Interbody Fusion File Name: Origination: Last CAP Review: Next CAP Review: Last Review: axial_lumbosacral_interbody_fusion 6/2009 10/2017 10/2018 10/2017 Description