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NS Harshavardhana, TJ Guillaume, MHH Noordeen, JH Perra What is Magical about Magnet driven Growth Rods (MdGR) Used for Early- onset Scoliosis (EOS)?

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Presentation on theme: "NS Harshavardhana, TJ Guillaume, MHH Noordeen, JH Perra What is Magical about Magnet driven Growth Rods (MdGR) Used for Early- onset Scoliosis (EOS)?"— Presentation transcript:

1 NS Harshavardhana, TJ Guillaume, MHH Noordeen, JH Perra What is Magical about Magnet driven Growth Rods (MdGR) Used for Early- onset Scoliosis (EOS)?

2 Presenter: Presenter: NS HarshavardhanaNo Relationships Co-Authors: TJ GuillaumeNo Relationships MHH Noordeen K2M(c), Ellipse Tech(b,c), Stryker spine (b,c) JH PerraMedtronic(b,c) a.Grants / Research Support b.Consultant / Royalties c.Stock / Shareholder d.Speakers’ Bureau e.Other Financial Support What is Magical about Magnet driven Growth Rods (MdGR) Used for Early- onset Scoliosis (EOS) ICEOS 2015 Boston - MA; USA 19-20 th Nov 2015 Authors Disclosure Information

3 Background: MdGRs Novel implant used in the surgical treatment of EOS Considered to be a game-changer in EOS Rx Recently approved by US-FDA for EOS: Two years Europe using it over the past Five years Substitutes the need for repetitive anaesthesia and invasive lengthening by office-based expansion

4 Aims and Objectives  To undertake comprehensive systematic review with meta-analysis of all published MdGRs  Prospective, Retrospective or / & Case series  At least 4 patients & a minimum of 3 distractions  Report surgical results of MdGRs  Compare single rods vs. dual rods  Sagittal profile and complications  Pulmonary function and cost-utility aspects

5 Materials and Methods All published full-text articles in English: 2012-2015 (up to 1 st June 2015) Inclusion criteria:  Should have used MdGRs  More than 3 patients (JBJS-Am Case-Connector)  At least 3 distractions (follow-up) Exclusions:  Any study which did NOT meet the above criteria i.e.:-  That was not published as full-text article (i.e. abstracts)  In language other than English

6 Included Studies in Meta-analysis Clinical studies 1. Cheung KM, Cheung JP, Samartzis D, Mak KC, Wong YW, Cheung WY, et al. Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet. 2012; 379(9830): 1967-74. 2. Akbarnia BA, Cheung K, Noordeen H, Elsebaie H, Yazici M, Dannawi Z, et al. Next generation of growth-sparing techniques: preliminary clinical results of a magnetically controlled growing rod in 14 patients with early-onset scoliosis. Spine. 2013; 38(8): 665-70. 3. Dannawi Z, Altaf F, Harshavardhana NS, El Sebaie H, Noordeen H. Early results of a remotely-operated magnetic growth rod in early-onset scoliosis. The Bone & Joint Journal. 2013; 95-b(1): 75-80. 4. Akbarnia BA, Pawelek JB, Cheung KMC, Demirkiran G, Elsebaie H, Emans JB, et al. Traditional Growing Rods Versus Magnetically Controlled Growing Rods for the Surgical Treatment of Early-Onset Scoliosis: A Case-Matched 2- Year Study. Spine Deformity. 2014; 2(6): 493-7. 5.Hickey BA, Towriss C, Baxter G, Yasso S, James S, Jones A, et al. Early experience of MAGEC magnetic growing rods in the treatment of early onset scoliosis. European spine journal 2014; 23 Suppl 1: S61-5. USG guided measurement of distraction gained 6. Stokes OM, O'Donovan EJ, Samartzis D, Bow CH, Luk KD, Cheung KM. Reducing radiation exposure in early-onset scoliosis surgery patients: novel use of ultrasonography to measure lengthening in magnetically-controlled growing rods. The spine journal 2014; 14(10): 2397-404. 7.Yoon WW, Chang AC, Tyler P, Butt S, Raniga S, Noordeen H. The use of ultrasound in comparison to radiography in magnetically controlled growth rod lengthening measurement: a prospective study. European spine journal 2014 [Epub ahead of print]. Cost-utility analysis 8. Charroin C, Abelin-Genevois K, Cunin V, Berthiller J, Constant H, Kohler R, et al. Direct costs associated with the management of progressive early onset scoliosis: Estimations based on gold standard technique or with magnetically controlled growing rods. Orthopaedics & Traumatology: Surg & Research. 2014; 100(5): 469-74. 9.Rolton D, Richards J, Nnadi C. Magnetic controlled growth rods versus conventional growing rod systems in the treatment of early onset scoliosis: a cost comparison. European spine journal 2014 [Epub ahead of print]. Pulmonary function 10. Yoon WW, Sedra F, Shah S, Wallis C, Muntoni F, Noordeen H. Improvement of pulmonary function in children with early- onset scoliosis using magnetic growth rods. Spine. 2014;39(15):1196-202.

7 Results  73 children operated for EOS & with a minimum follow-up of 9 months (mean: 1.6 yrs)  Five clinical studies: 3 single center (Hong Kong / London / Cardiff) and 2 multi-centric studies  33♂ & 40♀ (1 st Jan 2010 – 15 th May 2015)  23 single rods(SR) vs. 50 dual rods(DR)  Etiology: 1. Idiopathic (29) 3. Congenital(7) 2. Neuromuscular(20) 4. Syndromic(12) 5. Neurofibromatosis(5)

8 Demographics & Radiological parameters

9 Forest plots: Cobb ^le & T 1 -S 1 Length All five clinical studies reported a statistically significant improvement with scoliosis correction and T 1 -S 1 length gain Complications: 1. Wound infections: 4 superficial (none deep) 2. Rod fractures: 3 (2 SR & 1 DR) 3. Loss of distraction achieved: 10 pts 4. Anchor pull-out: 3 pts (2 proximal & 1 distal) 5. Proximal junctional kyphosis: 2 pts.

10 Forest plots for single vs. dual Rods Cobb angle correction p=0.76 (53 pts & 3 studies) T1-S1 Length gain p=0.83 (48 pts & 2 studies) Dual rods reduced the incidence of rod breakages No difference in curve correction or T 1 -S 1 length gain

11 Sagittal profile and thoracic height Contrary to commonly held belief, MdGRs do NOT cause hypokyphosis: Mean 4.5 0 ↑↑ in Thoracic Kyphosis (n=4 studies)

12 Pulmonary function 6 patients with EOS-NMD  SMA Type II – 2  Neurofibromatosis – 2  William’s syndrome – 1  Cong muscular dystrophy – 1 Impressive 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!)

13 USG measurement & Cost-utility analysis Validated against x-rays: 19 patients NO Meta-analysis possible Estimated cost-savings with MdGR in comparison to CGR at Four & Five years (n=2 studies) Both Studies assume NO MdGR breakage

14 Conclusion  MdGR is a promising novel Rx option  Existing LoE is LOW and WEAK (short follow-up)  Improves pulmonary function in EOS-NMD (γ error!)  Long-term studies with follow-up until graduation from MdGR program are desired  Robust cost-sensitivity analysis studies accounting for rod breakages and complications are needed.

15 Thank You

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