Masters Technique: MdGRs [Magnet driven Growing Rods] Mr. MH Hilali Noordeen MA, FRCS(Tr & Orth) Consultant Spinal Surgeon Royal National Orthopaedic Hospital and University College of London United Kingdom Magnet driven Growing Rods (MdGR) for Early-onset Scoliosis (EOS) Presenter: MHH Noordeen Co-author: NS Harshavardhana ICEOS annual meeting, Warsaw 20th -21st, Nov 2014 Authors Disclosure Information K2M, Ellipse Tech & Stryker (a, b & c) No relationships a. b. c. d. e. Grants/Research Support Consultant Stock/Shareholder Speakers’ Bureau Other Financial Support Background: What is MdGR? • Novel growing rod with incorporated magnet • A new ‘Game changer’ in surgical management of Early-onset scoliosis (EOS) • Aim: One-off surgery eliminating the need for repetitive anaesthesia every 4-6 months • I share my experience with at least 100 MdGR insertions over past 4½ years Principle behind MdGR The Coil Extension in the shaft Rotating Magnetic Flux The Implant inside patient’s limb An external rotating magnetic field captures a powerful magnet mounted inside the growing rod causing it to rotate in synchronisation generating a small torque. This torque is then amplified through a gearbox driving a power screw that telescopes and lengthens the rod. ---------------26cm ---------------- 47cm PROXIMAL ROD , -- 9c=m ---s , ---- 1 2 c m ---4 J MdGR: Standard and Off-set rod • • • • Available in 4.5 mm and 5.5 mm diameter rods The proximal and distal rods can be bent / contoured to match the desired (natural) curvature of the spine. The MdGR rod is attached to the spine using standard anchors (hooks / screws) which could be either rib or spine based A permanent magnet in the actuator area can be non-invasively lengthened by the External Remote Controller (ERC) S L rod S L R rod The magnet is off-set in the SLR rod: Differential distraction MdGR: Biomechanical Tests Stronger than a standard 5.5mm Ti rod over 5m cyclical loading Withstands up to 270N distraction force ( Eq. to 3mm gap per lengthening) My Practice for EOS (Past) • Up to yrs. ago: Used conventional growing rods for EOS Single & Dual sub-muscular • Repetitive 4-6monthly distractions: ↓ GA • Law of diminishing returns: Force needed doubled by 5th lengthening Growth Rods: In-vivo distractive forces 700 600 500 400 VAR00 004 wt on N e 16 300 200 100 0 1 2 3 4 5 6 7 8 10 number Noordeen MHH et al, Spine 2011 Number of lengthenings The Future of EOS Surgery: MdGR Magic & The Magician = • Embrace new technology • Exclusively using MdGR over past 4.5yrs Why I use MdGR? • Risk of developing learning disabilities Hazard ratio: 2.12 (95% CI: 1.26 - 3.54) • Highest risk: Children aged < 2 yrs. • Repetitive anaesthesia: Independent risk factor after adjusting for health status • Time to ask: Is this preventable or inevitable ? Health Economics: MdGR • Cost-utility analysis with 10 year costs projection • 14 MdGR insertion over 4 years (2009-12) • Initial insertion: MdGR costs £11,000 more than CGRs • 10 year forecast projects saving of £48,000 for MdGRs MdGR: How do I insert them? • Two 2” - 3” incisions to expose T2-T5 (all EOS) L4 – S1 (EOS-NMD) • Prepare the sub-muscular bed • Insertion of anchors Upper (Hybrid: Spine based Hooks & screws) Lower (All screws construct) • Testing the MdGR & appropriate sagittal contouring Tips & Tricks I: Proximal anchors Minarets have 7-120 outward tilt: Intentional In event of earthquake: The central dome is protected (minarets falling outwards) Optical illusion: From distance - appear erect TP Hooks: Apply laterally directed forces In event of screw loosening, they do not migrate medially and compress spinal cord Proximal anchors: Two pair of pedicle screws and one pair of TP Hooks The Taj Mahal construct I - MdGR distal end: Not long enough • Proximal end: 26 cms & Distal end: 12 cms • Magnetic coil / actuator area: 9 cms (should not be bent / contoured) • In severe lumbar hyperlordosis: The actuator should lie in thoracic spine • Distal end: 12 cms may be too short for anchorage (esp. if fusion to pelvis) • My Solution: Deliberate upside-down insertion (make use of 26 cms) • Distraction: By holding in reverse fashion MdGR: Stanmore Experience (2013) • World’s largest published series to this day (English) • My 1st MdGR insertion at GOSH in Mar 2010 • My preferred option for Rx EOS: All cases Case 1: Juvenile IS (single rod) Pre-op Post-op After 3 distractions: 19mm After 9 distractions: 28mm T1-S1: 360mm Cobb ^le – 620 T1-S1: 375mm Cobb ^le – 470 T1-S1: 400mm Cobb ^le – 360 T1-S1: 435mm Cobb ^le - 320 Case 1: JIS (My 1 s t MdGR graduate) Pre-op 9 distractions: total 28mm 3 years post MdGR insern T1-S1: 360mm Cobb ^le - 620 T1-S1: 435mm Cobb ^le – 320 T1-S1: 446mm Cobb ^le maintained at 320 Case 2: Juvenile IS (dual rod) Pre-op Post-op After 5 distractions: total 19mm T1-S1: 375mm Cobb ^le - 620 T1-S1: 388 mm Cobb ^le – 520 T1-S1: 415 mm Cobb ^le - 420 Case 3 - MdGR for EOS-NMD (SMA II) • 8/FCh with age of onset at 2yrs. Rapid progression to 880 • Index MGR insertion at age 6yrs • Spectacular improvement in Cobb angle from 880 to 500 Case 3 - MdGR for EOS-NMD (SMA II) • • 17mm lengthening at 18months post-op Reduced incidence of chest infections, emergency hospital admissions with improvement in lung function MdGR & Pulmonary Function Noordeen H et al 2014 • Level of Evidence (LoE): Prognostic II • Dramatically reduced the rate of decline in pulmonary function (statistically significant) • Facilitated normal developmental milestones with improvement in quality of life • Fewer complications and high care giver satisfaction MdGR & Pulmonary Function 6 patients with EOS-NMD SMA Type II – 2 Neurofibromatosis - 2 William’s syndrome - 1 Cong muscular dystrophy – 1 MdGR & Pulmonary Function P<0.028 • P<0.027 P<0.028 Box plots (SPSS v17) showing statistically significant: Decrease in Cobb angle Increase in both FEV1 and FVC • Spectacular improvement in PFT in patients with SMA-II • MdGR probably arrest rapid deterioration / decline of PFT and do NOT alter its natural history (γ error!) MdGR: Stanmore Experience (2014) 17 patients (9♂ & 8♀ ) Mean f/u 3.35 yrs. Follow-up range: 2.08-4.25 yrs Single centre / single surgeon One MdGR graduate Etiologies Idiopathic: 3 Neuromuscular: 7 Congenital: 2 Syndromic: 5 AAOS 2015 podium presentation MdGR: Stanmore Experience (2014) Patient demographics (n=17 pts) Complications I - Rod fracture 10 yr & 3 mo old with juvenile idiopathic scoliosis: Broken single rod @ 3yrs post-op Metal fatigue failure – Weak at actuator-rod junction Design modification Dual rods probably protective: Load sharing Complications II - Rod fracture Dual rod fracture at 8th post-op mo with ↓↓ in length Break is no more at the actuator–rod junction Complications III – Loss of distraction Two of my single rod MdGR pts had to wear external magnets Index surgery in 2010 for non-dystrophic NF-1 Faulty actuator / ratchet: This has been addressed / corrected now NICE Evidence (FDA Eq in the UK) ISBN: 978-1-4731-0608-6 • • • • Based on meta-analysis: From fixed and random effects model Reduced infection rate in-comparison to CGR (p=0.03-0.04) Similar improvement in Cobb angle and T1-S1 height gain to CGR MdGR: NOT cost-saving if <3 yrs of remaining growth potential NICE Position Statement (FDA Eq) • Evidence exists to support its use in EOS (≥2 years) • MdGR is cheaper than CGR (LoE Economic II) • MdGR breaks even at 3.25 yrs post-index insertion • At least ₤12,077 cost-savings at 6 yrs post-insertion • Particular advantage in high-risk pts (EOS-NMD) • Unsuitable for pts with severe kyphotic deformities SUMMARY - I • EOS: Growth guided surgery is standard of care (what growth guidance needs re-defining: MdGR vs. CGR vs. VEPTR vs. Shilla vs. Staples) • I do NOT perform definitive spinal fusion for EOS • Understand natural history, pulmonary maturation and life expectancy of different EOS etiologies • MdGR: Promising early results with favourable cost-utility on long-term forecast analysis (10y) SUMMARY - II • A new ‘game-changer’ amongst distraction based devices in surgical treatment of EOS • Eliminates the need for repetitive anaesthesia • Has been around now for at least four years • Approved by NICE-UK (National institute of clinical excellence): FDA equivalent of USA • Associated with improvement in PFT for EOS-NMD My Vision for MdGRs: Research Multi-national collaboration with prospective cases input Creation of MdGR study group LoE II Therapeutic studies evaluating MdGRs & CGRs LoE I Economic studies comparing MdGRs & CGRs LoE I Prognostic studies for MdGRs Serial pre and post-op PFT in EOS-NMD Serial pre and post-op IQ / Cognitive tests Limitation of MdGR Does not address the ‘parasol’ deformity of chest Need for 2nd generation MdGRs that correct chest cage in-addition to correction of spinal deformity Thank You
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