Braun et al subsequently demonstrated that vertebral body staples on the convex side of the anterior spine can induce correction of experimentally created scoliosis (Braun). Studies on VBT in animal models have demonstrated dynamic tethering of the immature spine can alter spinal alignment. Added vertebral body tethering to INV/NMN statement. <> Only individuals with a follow-up of at least 2 years were included in this study group. At the final follow-up visit, half of the participants showed curve progression greater than 5° while the other half of the participants either remained stable or corrected over time. The authors reported that of the subjects who had vertebral body stapling of the lumbar curve, 82% were successful, and of the subjects who had vertebral body stapling of the thoracic curve, 74% were successful. The mean Cobb angle at last follow-up was 24.7° (range, 15-38°). It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. Eight of the participants required an additional surgery to fix overcorrections, cord breakage, development of a new curve in another area of the spine, and slippage in the spine unrelated to the tethering. Phone: 414.289.9107 Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. and Ram Mudiyam M.D.,MBA. Limitations to this study include retrospective design and small sample size. Five participants (15%) progressed during follow-up and required spinal fusion. One participant experienced a puncture in a segmental spinal vein secondary to a staple prong and required both transfusion and conversion to an open procedure to control blood loss. h�b```b``�``e``�bd@ A�(�&����y�v /���$�=O) 298 0 obj <>stream Last updated on April 23, 2019. There were no neurological, infectious or hardware-related complications noted. Betz RR, Ranade A, Samdani AF, et al. During the postoperative period, 1 individual developed a pleural effusion on the contralateral side that required drainage. Anterior vertebral body tethering for immature adolescent idiopathic scoliosis: One-year results on the first 32 patients. None of the complications required further intervention. Two of the study participants had pneumothorax, and 1 participant had symptomatic pleural effusion. The procedure has been in use for approximately 10 years and has been used on several hundred patients thus far. Does anybody know? All Rights Reserved Overall, the lumbar curve demonstrated significant spontaneous correction as well, measuring 25º preoperatively, 18º at first erect and 13º at most recent follow-up (P<0.05). Long term data and complication rates are no possible at this time. The concept of growth modulation or arrest has been applied in the lower extremities for decades through epiphyseal stapling (asymmetrical growth arrest) for excessive genu varum and limb lengthening with distraction (Ilizarov technique). This means the application of this tether system to the anterior spine in the U.S. is an off-label use. H190005. Of the 43 participants with a pre-operative Cobb angle of less 45 degrees, 35 (81.4%) achieved a Cobb angle less than 30 degrees; of the 12 participants with a pre-operative Cobb angle of greater or equal to 45 degrees, a Cobb angle less than 30 degrees was achieved in 8 (61.5%). endstream endobj 216 0 obj <. Spine (Phila Pa 1976). Created Date: 7/22/2020 10:17:04 AM Spine 2008;33(7):724-33, Chay E, Patel A, Ungar B, et al. Government Agency, Medical Society, and Other Authoritative Publications: CD Horizon® Spinal System Nitinol Staple OSStaple™ The Tether™ Vertebral Body Tethering System. A retrospective chart review by Trupia and colleagues (2019) reported on 10 skeletally immature participants with adolescent idiopathic scoliosis who underwent vertebral body stapling. The pre-operative lumbar curve of 25.2° ± 7.3° showed correction at first erect 18.0° ± 7.1° and 1-year correction of 12.6° ± 9.4°. Of these 10 individuals, 4 (40%) progressed and 6 (60%) remained stable or improved. Six of the subjects required stapling of a second curve, 3 as part of the primary surgery, and 3 as a second stage because a second untreated curvature progressed. In 2005, Betz and colleagues carried forward their clinical series and presented the retrospective findings of 39 consecutive individuals (52 curves) who received vertebral body stapling as treatment for idiopathic scoliosis or scoliosis associated with other conditions, such as Marfan syndrome or skeletal dysplasia (syndromic scoliosis). 2019; 7(5):720-728. The aim of this study was to evaluate the change in Cobb angle measurements over time in subjects treated with vertebral body stapling. One individual experienced an intraoperative segmental vein bleed which resulted in an estimated blood loss of 1500 cc as compared to the average estimated blood loss of 247 cc for all participants. %PDF-1.5 U.S. Food and Drug Administration (FDA) HDE Notification Summary. There is no FDA market approval of the use of the Nitinol staple in the treatment of adolescent scoliosis. There were no neurological, infectious or hardware-related complications noted. Previous researchers had described consistent reports of a severe ?deep boring pain? Clinically significant atelectasis was experienced by 2 individuals and 2 other participants required prolonged chest tube drainage (greater than 4 days). 2014; 39(20):1688-1693. Eur Spin J 2015;24:1533-9. August 16, 2019. Investigational and Not Medically Necessary: Vertebral body stapling and vertebral body tethering as treatment of scoliosis in children and adolescents are considered investigational and not medically necessary. A flexible cord, or tether, is attached to the screws and tensioned to attain the desired degree of spine straightening. Treatment of idiopathic scoliosis with vertebral body stapling. h�bbd```b``�"W�H�c �s X|&Xd3X�9�d["YT�d X��. competitive athletics) and increased risk of degenerative changes in the adjacent segments leading to secondary back pain, lower extremity radiculopathy or spinal stenosis symptoms. Email: email@example.com Crawford CH 3rd, Lenke LG. Overcorrection occurred in three participants who the authors note may require an adjustment of the tether. For growth modulation to occur, there needs to be sufficient vertical growth of the spine remaining to create a straighter spine. None of the individuals experienced staple dislodgement or movement during the follow-up period (mean 11 months, range 3-36 months), and no adverse effects specifically related to the staples were identified. At the first postoperative visit, all participants showed curve correction. Therefore, we prefer Anterior Scoliosis Correction (ASC) and not VBT (Vertebral Body Tethering). Vertebral Body Tethering for Scoliosis – Commercial Medical Policy Author: UnitedHealthcare Subject: Effective Date: 03.01.2020 This policy addresses vertebral body tethering for the treatment of scoliosis. Torre-Healy A, Samdani AF. J Laparoendosc Adv Surg Tech A. Fax: 414.276.3349 Preoperative thoracic Cobb angle averaged 44.2 ± 9.0° and corrected to 20.3 ± 11.0° on first erect, and 2-year Cobb angle 13.5 ± 11.6°. Initial document development. Because this procedure avoids fusion of the spine, it is proposed that this treatment will permit a gradual correction of the spinal curvature as the child grows while maintaining movement and flexibility and decreasing the risk for back pain in adulthood. At room temperature the staple is shaped like a clamp. MPTAC review. Applicable Procedure Code: 22899. The authors concluded that vertebral body stapling is an effective method to control curve progression in the high-risk group of children younger than 10 years with idiopathic scoliosis between 30° and 39° in whom bracing may be ineffective. None of the study participants required definitive fusion for curve progression. Hence, preservation of spinal motion, particularly in the lumbar spine, is a highly attractive goal. Guille JT, D'Andrea LP, Betz RR. Spine Deform. The mean preoperative thoracic curve was 42.8° ± 8.0° which corrected to 21.0° ± 8.5° on first erect and 17.9° ± 11.4° at most recent. Limitations include the retrospective design and small sample size. In light of this, the Nitinol (nickel-titanium alloy) staple is being investigated as a surgical device to treat scoliosis. vertebral body Posterior column contains the ... And the CPT codes are 22612Posterior Arthrodesis, lumbar 1; st; level 22614 each additional level 22614 each additional level 22842 post. Yes, we've got it all figured out Almost, we've started training Kind-of, we're going to do training soon Not really, we'll do it at the end of the year The what? Another participant experienced mild pancreatitis. Fusionless scoliosis correction using a shape memory alloy staple in the anterior thoracic spine of the immature goat. Study results once the individuals have reached skeletal maturity are warranted in order to determine the definitive benefit of vertebral body stapling and vertebral body tethering in these individuals at high risk for continued curve progression. Website: www.zimmerbiomet.com/medical-professionals/spine/product/dynesys-dynamic-stabilization-system.html. 2018; 6(1)28-37. The Tether™ Vertebral Body Tethering System. A total of 13 curves were treated with vertebral body stapling (lumbar: n=4, thoracic: n=9). Theologis AA, Cahill P, Auriemma M, et al. 0 At the time of last follow-up, none of the participants required postoperative bracing or spinal fusion. The average preoperative curve magnitude was 33.4° (range, 30-39°) compared to most recent curve magnitude measurement at follow-up of 23.0° (range, 10-34°). No. Following 32 skeletally immature participants with a 1-year follow-up, the participants had tethering of an average of 7.7 levels. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.” This change was approved at the November 29, 2007 MPTAC meeting. FDA. In the cases of thoracic curves, which measured greater than 35 degrees, vertebral body stapling was not considered successful and required alternative treatments. | Spine Deformity Solutions: A Hands-On Course | Nijmegen, the Netherlands | June 17-19, 2020, Awards & Scholarships Applications Open Now, NEWS RELEASE | Scoliosis Research Society Announces 2019-2020 Board of Directors, NEWS RELEASE | Scoliosis Research Society Announces Biedermann Innovation Award, NEWS RELEASE | Scoliosis Research Society Announces New Logo, FDA Approves Minimally Invasive Deformity Correction (MID-C) System, FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis, NEWS RELEASE: SRS Announces New Dates for IMAST, NEWS RELEASE: SRS Announces the Winners of the Thomas E. Whitecloud Awards, SRS Annual Meeting Registration & Housing Now Open, NEWS RELEASE: Scoliosis Research Society Receives ACCME Reaccredidtation, NEWS RELEASE: Scoliosis Research Society Announces the 2018 Winners of the Russell A. Hibbs, John H. Moe & Louis A. Goldstein Awards, NEWS RELEASE: Scoliosis Research Society Announces the 2018 Winners of the Thomas E. Whitecloud Awards, NEWS RELEASE: SRS Collaborates to Complete ASLS II Study, NEW Patient Education Videos Now Online - Frequently Asked Questions & Early Onset Scoliosis, NEWS RELEASE: Scoliosis Research Society Announces the Winners of the Russell A. Hibbs, John H. Moe & Louis A. Goldstein Awards, NEWS RELEASE: Scoliosis Research Society Announces 2017-2018 Board of Directors, NEWS RELEASE: Supermodel Martha Hunt Creates Necklace to Benefit SRS, NEWS RELEASE: Scoliosis Research Society Announces the 2017 Winners of the Thomas E. Whitecloud Awards, www.zimmerbiomet.com/medical-professionals/spine/product/dynesys-dynamic-stabilization-system.html.
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