The Open Orthopaedics Journal




ISSN: 1874-3250 ― Volume 13, 2019
RESEARCH ARTICLE

A Prospective Cohort Study of AIS Patients with 40° and More Treated with a Gensingen Brace (GBW): Preliminary Results



Hans-Rudolf Weiss1, *, Nicos Tournavitis2, Sarah Seibel1, Alexander Kleban3
1 Gesundheitsforum Nahetal, Alzeyer Str. 23, D-55457 Gensingen, Germany
2 Scoliosis Best Practice Rehab Services, Aristotelous 5, GR 54624, Thessaloniki, Greece
3 Lomonosov Moscow State University, 119234, Leninskie Gory 1, Moscow, Russia

Abstract

Introduction:

There is a growing resistance from patients and their families to spinal fusion surgery for scoliosis. Due to inconclusive evidence that surgery has a long-term effect on scoliosis and/or improves the quality of life for patients with scoliosis, there is a need to extend the conservative perspective of treatment to patients with curvatures greater than 40 degrees. For that reason, a prospective cohort study was initiated to determine the effectiveness of the Gensingen brace (a Cheneau-style TLSO) in preventing progression in skeletally immature patients.

Materials and Methods:

Since 2011, fifty-five patients have been enrolled in this prospective cohort study. This report includes the mid-term results of twenty-five of these patients, who have a minimum follow-up of 18 months and an average follow-up of 30.4 months (SD 9.2). The twenty-five patients had the following characteristics at the start of treatment: Cobb angle: 49° (SD 8.4; 40º-71º); 12.4 years old (SD 0.82); Risser: 0.84 (SD 0.94; 0-2). A z-test was used to compare the success rate in this cohort to the success rate in the prospective braced cohort from BrAIST.

Results:

After follow-up, the average Cobb angle was 44.2° (SD 12.9). Two patients progressed, 12 patients were able to achieve halted progression, and eleven patients improved. Angle of trunk rotation (ATR) decreased from 12.2 to 10.1 degrees in the thoracic spine (p = 0.11) while the ATR decreased from 4.7 to 3.6 degrees in the lumbar spine (p = 0.0074). When comparing the success rate of the BrAIST cohort with the success rate of patients in this cohort, the difference was statistically significant (z = -3.041; p = 0.01).

Conclusion:

Conservative brace treatment using the Gensingen brace was successful in 92% of cases of patients with AIS of 40 degrees and higher. This is a significant improvement compared to the results attained in the BrAIST study (72%). Reduction of the ATR shows that postural improvement is also possible.

Keywords: Scoliosis, Brace treatment, BrAIST, Cheneau brace, Gensingen brace, Lumbar spine.


Article Information


Identifiers and Pagination:

Year: 2017
Volume: 11
Issue: Suppl-9, M8
First Page: 1558
Last Page: 1567
Publisher Id: TOORTHJ-11-1558
DOI: 10.2174/1874325001711011558

Article History:

Received Date: 30/07/2017
Revision Received Date: 06/09/2017
Acceptance Date: 11/09/2017
Electronic publication date: 29/12/2017
Collection year: 2017

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© 2017 Weiss et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


* Address correspondence to this author at the Gesundheitsforum Nahetal, Alzeyer Str. 23, D-55457 Gensingen, Germany; E-mail: hr.weiss@skoliose-dr-weiss.com




1. INTRODUCTION

Scoliosis is a three-dimensional deformity of the spine and trunk, which may deteriorate quickly during phases of rapid growth [1Goldberg CJ, Moore DP, Fogarty EE, Dowling FE. Adolescent idiopathic scoliosis: Natural history and prognosis. Stud Health Technol Inform 2002; 91: 59-63.[PMID: 15457694] , 2Asher MA, Burton DC. Adolescent idiopathic scoliosis: Natural history and long term treatment effects. Scoliosis 2006; 1(1): 2.[http://dx.doi.org/10.1186/1748-7161-1-2] [PMID: 16759428] ]. The Cobb angle [3Cobb J. Outline for the study of scoliosis. AAOS. Instr Course Lect 1948; 5: 261-75.] determines the degree of lateral curvature on an x-ray while the angle of trunk rotation (ATR), as measured by Scoliometer TM allows for clinical evaluation and follow-up for patients with scoliosis [4Weiss HR, Lehnert-Schroth C, Moramarco M, Moramarco K. Advancements in conservative scoliosis treatment lambert academic publishing, Saarbruecken 2015.].

Scoliosis has various etiologies (congenital, neuromuscular, mesenchymal disorders and others) [5Winter R. Classification and terminology.Moe's textbook of scoliosis and other spinal deformities 3rd ed. 3rd ed.1995; 39-44.]. However, Adolescent Idiopathic Scoliosis (AIS) [1Goldberg CJ, Moore DP, Fogarty EE, Dowling FE. Adolescent idiopathic scoliosis: Natural history and prognosis. Stud Health Technol Inform 2002; 91: 59-63.[PMID: 15457694] , 2Asher MA, Burton DC. Adolescent idiopathic scoliosis: Natural history and long term treatment effects. Scoliosis 2006; 1(1): 2.[http://dx.doi.org/10.1186/1748-7161-1-2] [PMID: 16759428] , 6Lonstein J. Idiopathic scoliosis. Moe's textbook of scoliosis and other spinal deformities. 3rd ed. Philadelphia: WB Saunders 1995; pp. 219-56.], the most prevalent form, has an undetermined etiology and affects 80 – 90% of the patient population. Recently, MRI studies show signs of a functional tethering of the spinal cord [7Deng M, Hui SC, Yu FW, et al. MRI-based morphological evidence of spinal cord tethering predicts curve progression in adolescent idiopathic scoliosis. Spine J 2015; 15(6): 1391-401.[http://dx.doi.org/10.1016/j.spinee.2015.02.033] [PMID: 25725365] ], which may, in some cases, explain the thoracic flatback deformity, and ventral overgrowth [8Chu WC, Lam WW, Chan YL, et al. Relative shortening and functional tethering of spinal cord in adolescent idiopathic scoliosis?: study with multiplanar reformat magnetic resonance imaging and somatosensory evoked potential. Spine 2006; 31(1): E19-25.[http://dx.doi.org/10.1097/01.brs.0000193892.20764.51] [PMID: 16395162] ] of the spinal column in this condition.

Treatment indications for scoliosis continue to be under debate [9Weiss H-R, Moramarco M. Indication for surgical treatment in patients with adolescent Idiopathic Scoliosis - a critical appraisal. Patient Saf Surg 2013; 7(1): 17.[http://dx.doi.org/10.1186/1754-9493-7-17] [PMID: 23705983] , 10Bess S. Response to Weiss HR, Moramarco M: indication for surgical treatment in patients with adolescent idiopathic scoliosis - A critical appraisal (Patient Saf. Surg. 2013, 7:17). Patient Saf Surg 2013; 7(1): 26.[http://dx.doi.org/10.1186/1754-9493-7-26] [PMID: 23866169] ]. Conservative treatment of scoliosis, both rehabilitative exercise and bracing, are recognized in literature reviews [11Weiss HR, Goodall D. The treatment of adolescent idiopathic scoliosis (AIS) according to present evidence. A systematic review. Eur J Phys Rehabil Med 2008; 44(2): 177-93.[PMID: 18418338] -14Weiss HR, Turnbull D, Tournavitis N, Borysov M. Treatment of scoliosis-evidence and management (review of the literature). Middle East J Rehabil Health 2016; 3(2): e35377.], Cochrane reviews [15Romano M, Minozzi S, Bettany-Saltikov J, et al. Exercises for adolescent idiopathic scoliosis. Cochrane Database Syst Rev 2012; (8): CD007837.[PMID: 22895967] , 16Negrini S, Minozzi S, Bettany-Saltikov J, et al. Braces for idiopathic scoliosis in adolescents. Cochrane Database Syst Rev 2015; (6): CD006850.[PMID: 26086959] ] and randomized controlled studies [17Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J 2014; 23(6): 1204-14.[http://dx.doi.org/10.1007/s00586-014-3241-y] [PMID: 24682356] -19Schreiber S, Parent EC, Moez EK, et al. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: “SOSORT 2015 Award Winner”. Scoliosis 2015; 10: 24.[http://dx.doi.org/10.1186/s13013-015-0048-5] [PMID: 26413145] ]. Often, when a scoliosis reaches 45- 50º, surgery is the typical mode of treatment despite the absence of high-quality evidence [9Weiss H-R, Moramarco M. Indication for surgical treatment in patients with adolescent Idiopathic Scoliosis - a critical appraisal. Patient Saf Surg 2013; 7(1): 17.[http://dx.doi.org/10.1186/1754-9493-7-17] [PMID: 23705983] , 14Weiss HR, Turnbull D, Tournavitis N, Borysov M. Treatment of scoliosis-evidence and management (review of the literature). Middle East J Rehabil Health 2016; 3(2): e35377., 20Hawes M. Impact of spine surgery on signs and symptoms of spinal deformity. Pediatr Rehabil 2006; 9(4): 318-39.[http://dx.doi.org/10.1080/13638490500402264] [PMID: 17111548] -25Bettany-Saltikov J, Weiss HR, Chockalingam N, et al. Surgical versus non-surgical interventions in people with adolescent idiopathic scoliosis. Cochrane Database Syst Rev 2015; 4(4): CD010663.[PMID: 25908428] ]. Comprehensive reviews [11Weiss HR, Goodall D. The treatment of adolescent idiopathic scoliosis (AIS) according to present evidence. A systematic review. Eur J Phys Rehabil Med 2008; 44(2): 177-93.[PMID: 18418338] , 14Weiss HR, Turnbull D, Tournavitis N, Borysov M. Treatment of scoliosis-evidence and management (review of the literature). Middle East J Rehabil Health 2016; 3(2): e35377., 20Hawes M. Impact of spine surgery on signs and symptoms of spinal deformity. Pediatr Rehabil 2006; 9(4): 318-39.[http://dx.doi.org/10.1080/13638490500402264] [PMID: 17111548] , 21Weiss HR. Adolescent idiopathic scoliosis (AIS) - An indication for surgery? A systematic review of the literature. Disabil Rehabil 2008; 30(10): 799-807.[http://dx.doi.org/10.1080/09638280801889717] [PMID: 18432438] , 23Bettany-Saltikov J, Weiss HR, Chockalingam N, Kandasamy G, Arnell T. A comparison of patient-reported outcome measures following different treatment approaches for adolescents with severe idiopathic scoliosis: A systematic review. Asian Spine J 2016; 10(6): 1170-94.[http://dx.doi.org/10.4184/asj.2016.10.6.1170] [PMID: 27994796] ] and two Cochrane reviews [23Bettany-Saltikov J, Weiss HR, Chockalingam N, Kandasamy G, Arnell T. A comparison of patient-reported outcome measures following different treatment approaches for adolescents with severe idiopathic scoliosis: A systematic review. Asian Spine J 2016; 10(6): 1170-94.[http://dx.doi.org/10.4184/asj.2016.10.6.1170] [PMID: 27994796] , 24Cheuk DK, Wong V, Wraige E, Baxter P, Cole A. Surgery for scoliosis in duchenne muscular dystrophy. Cochrane Database Syst Rev 2015; 10(10): CD005375.[PMID: 26423318] ] failed to establish evidence supporting the position that surgery is superior to conservative treatment and/or to natural history [1Goldberg CJ, Moore DP, Fogarty EE, Dowling FE. Adolescent idiopathic scoliosis: Natural history and prognosis. Stud Health Technol Inform 2002; 91: 59-63.[PMID: 15457694] , 2Asher MA, Burton DC. Adolescent idiopathic scoliosis: Natural history and long term treatment effects. Scoliosis 2006; 1(1): 2.[http://dx.doi.org/10.1186/1748-7161-1-2] [PMID: 16759428] ]. Recent comprehensive reviews show that the long-term risks of spinal fusion surgery are significant [14Weiss HR, Turnbull D, Tournavitis N, Borysov M. Treatment of scoliosis-evidence and management (review of the literature). Middle East J Rehabil Health 2016; 3(2): e35377., 20Hawes M. Impact of spine surgery on signs and symptoms of spinal deformity. Pediatr Rehabil 2006; 9(4): 318-39.[http://dx.doi.org/10.1080/13638490500402264] [PMID: 17111548] , 26Weiss HR, Goodall D. Rate of complications in scoliosis surgery - a systematic review of the Pub Med literature. Scoliosis 2008; 3: 9.[http://dx.doi.org/10.1186/1748-7161-3-9] [PMID: 18681956] , 27Weiss HR, Moramarco M, Moramarco K. Risks and long-term complications of adolescent idiopathic scoliosis surgery vs. non-surgical and natural history outcomes. Hard Tissue 2013; 2(3): 27.[http://dx.doi.org/10.13172/2050-2303-2-3-498] ].

While AIS can be a progressive condition and requires monitoring and management, it is a relatively benign disorder, which rarely leads to severe health consequences [28Weinstein SL, Dolan LA, Spratt KF, Peterson KK, Spoonamore MJ, Ponseti IV. Health and function of patients with untreated idiopathic scoliosis: A 50-year natural history study. JAMA 2003; 289(5): 559-67.[http://dx.doi.org/10.1001/jama.289.5.559] [PMID: 12578488] , 29Weiss HR, Karavidas N, Moramarco M, Moramarco K. Long-term effects of untreated adolescent idiopathic scoliosis: A review of the literature. Asian Spine J 2016; 10(6): 1163-9.[http://dx.doi.org/10.4184/asj.2016.10.6.1163] [PMID: 27994795] ]. Recently Ward et al. [30Ward WT, Friel N, Kenkre TS, Brooks MM. SRS 22r Scores in Non-Operated AIS Patients with Curves ≥ 40°. Proceedings of the 50th Annual Meeting Minneapolis Minnesota, US. 2015, September 30th – October 3rd. 2015; , 31Ward WT, Friel NA, Kenkre TS, Brooks MM, Londino JA, Roach JW. SRS-22r scores in non-operated adolescent idiopathic scoliosis patients with curves greater than forty degrees. Spine (Phila Pa 1976) 2017; 42(16): 1233-40.[http://dx.doi.org/10.1097/BRS.0000000000002004] [PMID: 27922579] ] have demonstrated that spinal fusion surgery does not significantly improve Health-Related Quality of Life (HRQoL). They concluded, “This data in conjunction with an absence of long-term evidence of serious medical consequences with non-surgical management of curves ≥ 40° should encourage surgeons to reevaluate the benefits of routine surgical care [31Ward WT, Friel NA, Kenkre TS, Brooks MM, Londino JA, Roach JW. SRS-22r scores in non-operated adolescent idiopathic scoliosis patients with curves greater than forty degrees. Spine (Phila Pa 1976) 2017; 42(16): 1233-40.[http://dx.doi.org/10.1097/BRS.0000000000002004] [PMID: 27922579] ].”

In consideration of these recent findings and the growing number of reviews supporting conservative treatments, the current indications for bracing should be re-evaluated and possibly expanded, when appropriate. Thus, it is important to research the efficacy of bracing for adolescent patients with scoliosis over 40°. With respect to bracing, it has been shown that the percentage of in-brace correction and brace-wearing time can have an effect on the eventual outcome of brace treatment [32Landauer F, Wimmer C, Behensky H. Estimating the final outcome of brace treatment for idiopathic thoracic scoliosis at 6-month follow-up. Pediatr Rehabil 2003; 6(3-4): 201-7.[http://dx.doi.org/10.1080/13638490310001636817] [PMID: 14713586] ]. That being said, each type of brace should be evaluated independently due to disparate results for different types of braces [33Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trial comparing two different concepts. Pediatr Rehabil 2005; 8(3): 199-206.[http://dx.doi.org/10.1080/13638490400022212] [PMID: 16087554] -45Weiss HR. Bracing can lead to a persistent correction in the treatment of Adolescent Idiopathic Scoliosis: A case report. Hard Tissue 2014; 3(1): 8.]. Independent studies do not show evidence in support of soft braces [33Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trial comparing two different concepts. Pediatr Rehabil 2005; 8(3): 199-206.[http://dx.doi.org/10.1080/13638490400022212] [PMID: 16087554] -35Guo J, Lam TP, Wong MS, et al. A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria. Eur Spine J 2014; 23(12): 2650-7.[http://dx.doi.org/10.1007/s00586-013-3146-1] [PMID: 24378629] ], however, strong evidence exists in support of rigid bracing [32Landauer F, Wimmer C, Behensky H. Estimating the final outcome of brace treatment for idiopathic thoracic scoliosis at 6-month follow-up. Pediatr Rehabil 2003; 6(3-4): 201-7.[http://dx.doi.org/10.1080/13638490310001636817] [PMID: 14713586] , 33Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trial comparing two different concepts. Pediatr Rehabil 2005; 8(3): 199-206.[http://dx.doi.org/10.1080/13638490400022212] [PMID: 16087554] , 36Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am 1995; 77(6): 815-22.[http://dx.doi.org/10.2106/00004623-199506000-00001] [PMID: 7782353] , 37Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369(16): 1512-21.[http://dx.doi.org/10.1056/NEJMoa1307337] [PMID: 24047455] ]. In Europe, a prospective study using a cast-based asymmetric Chêneau brace had a success rate of 80% [33Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trial comparing two different concepts. Pediatr Rehabil 2005; 8(3): 199-206.[http://dx.doi.org/10.1080/13638490400022212] [PMID: 16087554] ]. Recent retrospective studies, also on the Chêneau brace, demonstrate success rates of more than 90% [38Weiss HR, Werkmann M. Rate of surgery in a sample of patients fulfilling the SRS inclusion criteria treated with a Chêneau brace of actual standard. Stud Health Technol Inform 2012; 176: 407-10.[PMID: 22744540] , 39De Giorgi S, Piazzolla A, Tafuri S, Borracci C, Martucci A, De Giorgi G. Chêneau brace for adolescent idiopathic scoliosis: long-term results. Can it prevent surgery? Eur Spine J 2013; 22(Suppl. 6): S815-22.[http://dx.doi.org/10.1007/s00586-013-3020-1] [PMID: 24043341] ].

The purpose of this study is to evaluate a sample of patients with Cobb angles of 40 degrees treated with the Gensingen Brace (a Cheneau-style TLSO) (Fig. 1), and to determine whether brace treatment in curvatures of 40 degrees can be successful. The cohort of this prospective study complies with all the SRS inclusion criteria for bracing [46Thompson GH, Richards Iii BS. Inclusion and assessment criteria for conservative scoliosis treatment. Stud Health Technol Inform 2008; 135: 157-63.[PMID: 18401088] ] with the one exception. The degree of Cobb angle is larger in this population, but includes immature patients at high risk of progression, so that our results can be compared to the results of BrAIST [37Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369(16): 1512-21.[http://dx.doi.org/10.1056/NEJMoa1307337] [PMID: 24047455] ]. For patients who decline surgery, studies such as ours will help establish the benefits and/or disadvantages of bracing severe scoliosis and help patients make informed decisions about how to proceed with treatment options.

Ethical considerations: There is no high-level evidence indicating that spinal fusion surgery is superior to natural history [9Weiss H-R, Moramarco M. Indication for surgical treatment in patients with adolescent Idiopathic Scoliosis - a critical appraisal. Patient Saf Surg 2013; 7(1): 17.[http://dx.doi.org/10.1186/1754-9493-7-17] [PMID: 23705983] , 14Weiss HR, Turnbull D, Tournavitis N, Borysov M. Treatment of scoliosis-evidence and management (review of the literature). Middle East J Rehabil Health 2016; 3(2): e35377., 20Hawes M. Impact of spine surgery on signs and symptoms of spinal deformity. Pediatr Rehabil 2006; 9(4): 318-39.[http://dx.doi.org/10.1080/13638490500402264] [PMID: 17111548] -25Bettany-Saltikov J, Weiss HR, Chockalingam N, et al. Surgical versus non-surgical interventions in people with adolescent idiopathic scoliosis. Cochrane Database Syst Rev 2015; 4(4): CD010663.[PMID: 25908428] ]. Therefore, per the recent suggestions made by Ward and colleagues [30Ward WT, Friel N, Kenkre TS, Brooks MM. SRS 22r Scores in Non-Operated AIS Patients with Curves ≥ 40°. Proceedings of the 50th Annual Meeting Minneapolis Minnesota, US. 2015, September 30th – October 3rd. 2015; , 31Ward WT, Friel NA, Kenkre TS, Brooks MM, Londino JA, Roach JW. SRS-22r scores in non-operated adolescent idiopathic scoliosis patients with curves greater than forty degrees. Spine (Phila Pa 1976) 2017; 42(16): 1233-40.[http://dx.doi.org/10.1097/BRS.0000000000002004] [PMID: 27922579] ], other treatment options for patients with curvatures 40° should be investigated.

2. MATERIALS AND METHODS

2.1. Patient Population

Twenty-five female patients (Risser 0-2) were included in this report. With the exception of having a 40° Cobb angle, all patients satisfied the SRS inclusion criteria. Patients were fit with the Gensingen brace (GBW) at a bracing facility affiliated with the first author’s clinic. All patients were followed prospectively for a minimum of 18 months, with an average follow-up time of 30.4 months (SD 9.2) and with an average x-ray follow-up of 20 months (SD 9.4). The average curvature at the start of treatment was 49 degrees (SD 8.4; 40 – 71º) (12 double and 13 single patterns of curvature). The average age was 12.4 years (SD 0.82), average Risser was 0.84 (SD 0.94), and fourteen out of the twenty-five females were pre-menarcheal.

2.2. Brace Development Process

The Gensingen brace is the result of the recent advancements of Chêneau principles [42Weiss HR, Kleban A. Development of CAD/CAM based brace models for the treatment of patients with scoliosis-classification based approach versus finite element modelling. Asian Spine J 2015; 9(5): 661-7.[http://dx.doi.org/10.4184/asj.2015.9.5.661] [PMID: 26435781] ] and was first described in 2010 [41Weiss HR. “Brace technology” thematic series - the Gensingen brace™ in the treatment of scoliosis. Scoliosis 2010; 5: 22.[http://dx.doi.org/10.1186/1748-7161-5-22] [PMID: 20942970] ]. Each orthosis is made via computer-aided-design (CAD) (Fig. 2). Each GBW is based on the augmented Lehnert-Schroth (ALS) classification system [4Weiss HR, Lehnert-Schroth C, Moramarco M, Moramarco K. Advancements in conservative scoliosis treatment lambert academic publishing, Saarbruecken 2015., 42Weiss HR, Kleban A. Development of CAD/CAM based brace models for the treatment of patients with scoliosis-classification based approach versus finite element modelling. Asian Spine J 2015; 9(5): 661-7.[http://dx.doi.org/10.4184/asj.2015.9.5.661] [PMID: 26435781] ] and is pattern-specific based on a patient’s 3D scan, x-ray, scoliometer measurements, and postural assessment. There are seven basic brace models corresponding to the ALS classification pattern and two additional models for larger curves [42Weiss HR, Kleban A. Development of CAD/CAM based brace models for the treatment of patients with scoliosis-classification based approach versus finite element modelling. Asian Spine J 2015; 9(5): 661-7.[http://dx.doi.org/10.4184/asj.2015.9.5.661] [PMID: 26435781] ]. The additional brace models for single thoracic curves exceeding 60° have been developed (Fig. 3) because of an increasing number of patients with higher Cobb angles who are seeking conservative treatment.

Fig. (1)
In-brace correction of a double curve pattern. More than 60% correction can be achieved in the Gensingen brace (GBW) when the curve is still flexible.


Fig. (2)
CAD modeling of a GBW for a single thoracic curve. Mirroring of the deformity (patient’s scan on the right) in the brace model (left) is clearly visible.


Fig. (3)
In-brace correction of a single thoracic curve pattern exceeding 70° in the GBW. The follow-up (right) shows the curve is rebalanced and that postural improvement has been achieved, despite the severity of the initial Cobb angle and noticeable asymmetries.


2.3. X-rays and Follow-Up

X-rays were done prior to the start of treatment, in the brace, before and after each subsequent brace and at skeletal maturity (after brace weaning). If there were clinical signs of deterioration, additional x-rays were taken as well. For local patients, in-brace x-rays were taken 6 weeks after the start of brace-wear. For patients visiting from a distance, in-brace x-rays were taken the following day after fitting. The average in-brace Cobb angle measured 28.5° (SD 14.7; 42% correction). It was recommended that patients wear their brace for 20 hours per day or more; however, the braces did not include any sensors to monitor wear-time. It should be noted that there is a potential for bias as all Cobb angle measurements were done by the senior author.

2.4. Statistical Analysis

A z-test to compare cohorts of different sizes, as proposed by Goldberg [43Goldberg CJ, Moore DP, Fogarty EE, Dowling FE. Adolescent idiopathic scoliosis: The effect of brace treatment on the incidence of surgery. Spine 2001; 26(1): 42-7.[http://dx.doi.org/10.1097/00007632-200101010-00009] [PMID: 11148644] ], was performed to compare the success rate of this cohort to the success rate of patients from the BrAIST cohort, a study which predominately used the Boston-type brace (68% of braced patients) [37Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369(16): 1512-21.[http://dx.doi.org/10.1056/NEJMoa1307337] [PMID: 24047455] ]. In the BrAIST study, 146 patients were braced and followed through skeletal maturity, while in our sample 25 patients have been treated and followed prospectively for a minimum of 18 months. In our study, halted progression and curve improvement (decrease of 6 degrees or more) were considered treatment success, while curve progression was considered treatment failure (increase of 6 degrees or more). The first author also measured each patient’s thoracic and lumbar Angle of Trunk Rotation (ATR) before treatment and at last follow-up. A paired sample t-test was then performed to determine if the differences were statistically significant.

3. RESULTS

The average Cobb angle after follow-up was 44.2 degrees (SD 12.9). Two of the twenty-five patients progressed (curve increased 6 degrees or more) while eleven patients improved (curve decreased 6 degrees or more) and twelve patients were able to halt progression (curve remained within 5 degree margin of error). When comparing the BrAIST cohort to this GBW cohort, the differences in the success rate (72% and 92%, respectively) were statistically significant in the z-test (z = -3.041; p = 0.01). Additionally, in the thoracic spine, average ATR decreased from 12.2 to 10.1 degrees (p = 0.11) and in the lumbar spine, average ATR decreased from 4.7 to 3.6 degrees (p = 0.0074).

The average clinical follow-up time was 30.4 months (SD 9.2) and the average radiological follow-up was 20 months (SD 9.5). Patients in the cohort reported an average brace-wearing time of 21 hours per day, before the weaning-off phase when they were instructed to reduce their wearing hours. By the end of the current study, six patients had completely weaned off the brace, with four of the six having shown improvements of 6°, and the other two being stable (+/-5 degrees).

One of the four patients who experienced curve improvement was a girl from New Zealand. She initially began treatment at age 12, with a 43° Cobb angle (Risser 0, Tanner II, premenarcheal). At skeletal maturity (Risser 5, age 16), her Cobb angle measured 20°. During the course of treatment she regularly followed up at the office of the first author, in Germany, and after three years of treatment, she was successfully weaned off her second Gensingen brace in summer 2014 (Figs. 4, 5 and 6). The patient plans to have a new x-ray taken when she completes high school, however this >2-year post-weaning x-ray is not yet available.

Fig. (4)
A 12-year old skeletally immature girl from New Zealand with a single thoracic curve of 43° and an overcorrection in the GBW (model 2012) to -8° [42Weiss HR, Kleban A. Development of CAD/CAM based brace models for the treatment of patients with scoliosis-classification based approach versus finite element modelling. Asian Spine J 2015; 9(5): 661-7.[http://dx.doi.org/10.4184/asj.2015.9.5.661] [PMID: 26435781] ].


Fig. (5)
Intermediate result of the girl from Fig. (4) after 6 months of full-time treatment. At that time, she had outgrown her first brace and a second brace was made. As shown in the x-ray on the right, she achieved overcorrection in her second brace as well.


Fig. (6)
The patient weaned off the brace in the summer of 2014. At skeletal maturity, her Cobb angle measured 20° and she had a more compensated posture in comparison to her initial posture (left).


One patient dropped out and was not included in this cohort. This patient presented with a double major curve pattern of >50°. Over the course of 2 years, she was fit with two Gensingen braces at the facility of the first author and her curves were stable. When the patient needed a third brace, her mother decided to try an orthotist closer to their home for an alternative Chêneau-style brace. The patient’s curves eventually progressed to more than 75° and she returned to the first author for another Gensingen brace, since she had declined surgery. At that point, we were unable to improve her curve, but cosmetically the deformity was not very obvious.

4. DISCUSSION

Different brace types lead to different outcomes. It has been determined that symmetric braces (with asymmetric pads only) are effective in 70-72% of the cases when the SRS inclusion criteria are respected [36Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am 1995; 77(6): 815-22.[http://dx.doi.org/10.2106/00004623-199506000-00001] [PMID: 7782353] , 37Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369(16): 1512-21.[http://dx.doi.org/10.1056/NEJMoa1307337] [PMID: 24047455] ]. Asymmetric scoliosis braces differ in several ways and have demonstrated an even higher rate of success [32Landauer F, Wimmer C, Behensky H. Estimating the final outcome of brace treatment for idiopathic thoracic scoliosis at 6-month follow-up. Pediatr Rehabil 2003; 6(3-4): 201-7.[http://dx.doi.org/10.1080/13638490310001636817] [PMID: 14713586] , 33Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trial comparing two different concepts. Pediatr Rehabil 2005; 8(3): 199-206.[http://dx.doi.org/10.1080/13638490400022212] [PMID: 16087554] , 38Weiss HR, Werkmann M. Rate of surgery in a sample of patients fulfilling the SRS inclusion criteria treated with a Chêneau brace of actual standard. Stud Health Technol Inform 2012; 176: 407-10.[PMID: 22744540] -40Weiss HR, Tournavitis N, Seibel S. Preliminary results of a prospective AIS cohort treated with a Gensingen brace (GBW). 10th Hellenic Spine Congress 2016, October 26th - 29th; Thessaloniki, Greece. ].

Although the success rate of asymmetric braces can vary significantly, this is likely attributable to how the brace is designed, manufactured and fitted. When manufactured by hand, on the basis of a plaster cast, success rates are between 48% [44Zaborowska-Sapeta K, Kowalski IM, Kotwicki T, Protasiewicz-Fałdowska H, Kiebzak W. Effectiveness of chêneau brace treatment for idiopathic scoliosis: Prospective study in 79 patients followed to skeletal maturity. Scoliosis 2011; 6(1): 2.[http://dx.doi.org/10.1186/1748-7161-6-2] [PMID: 21266084] ] and 80% [33Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trial comparing two different concepts. Pediatr Rehabil 2005; 8(3): 199-206.[http://dx.doi.org/10.1080/13638490400022212] [PMID: 16087554] ] among comparable groups. This large discrepancy suggests that the success of scoliosis bracing is at least partially influenced by the experience and skills of the brace technician.

The Gensingen brace used in this study was produced with CAD/CAM technology, which allows for standardization [42Weiss HR, Kleban A. Development of CAD/CAM based brace models for the treatment of patients with scoliosis-classification based approach versus finite element modelling. Asian Spine J 2015; 9(5): 661-7.[http://dx.doi.org/10.4184/asj.2015.9.5.661] [PMID: 26435781] ]. For any given curve pattern, the basic brace model is the same, which reduces the risk for human error. While the brace can be created with measurements of the patient’s trunk at certain anatomical landmarks, most Gensingen braces currently made worldwide are designed from a patient’s 3D scan. Using the scan, the virtual brace model is further individualized with the addition of correction forces in all three planes. A final STL-file is then sent for manufacturing.

Additionally, while many brace models work by pushing against the prominences and convexities of the curvature(s), the objective of the Gensingen brace is to implement a corrective movement as well [42Weiss HR, Kleban A. Development of CAD/CAM based brace models for the treatment of patients with scoliosis-classification based approach versus finite element modelling. Asian Spine J 2015; 9(5): 661-7.[http://dx.doi.org/10.4184/asj.2015.9.5.661] [PMID: 26435781] ]. In order to avoid compression of the trunk, voids are implemented opposite the pressure zones so that curve improvement is only limited by the stiffness of the patient’s spine. These distinctions are integral to the design of the Gensingen brace and for that reason the results of this study cannot be extrapolated to other braces.

When comparing the results from this study (92% success rate) to the results achieved with the Boston brace (72% success rate), it is important to note that the two studies had a different definition of treatment success and failure. In the study by Weinstein and colleagues, patients started with a Cobb angle of 25°-40° and treatment was considered successful when the curve did not exceed 49° [37Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369(16): 1512-21.[http://dx.doi.org/10.1056/NEJMoa1307337] [PMID: 24047455] ]. This means that their scoliosis could progress significantly, but still be labeled a success as long as it did not reach 50°. In our study, patients whose Cobb angle progressed 6° or more were labeled as treatment failure, regardless of their initial Cobb angle. All things being equal, if the BrAIST study had used these stricter parameters, it is likely that their reported success rate would have been adversely affected.

Our initial results are encouraging, especially when considering the fact that the patients included in our sample were at high risk for progression with respect to maturity and severity of scoliosis [47Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg Am 1984; 66(7): 1061-71.[http://dx.doi.org/10.2106/00004623-198466070-00013] [PMID: 6480635] ]. According to Lonstein and Carlson [47Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg Am 1984; 66(7): 1061-71.[http://dx.doi.org/10.2106/00004623-198466070-00013] [PMID: 6480635] ], the average progression factor for this cohort was 4 – meaning that the risk of progression for the average patient was 100%. At the start of the study, the average patient age was 12.4 years – an age during which an adolescent typically starts to enter the descendent phase of the pubertal growth spurt (Fig. 7). Though some patients were still wearing or weaning off the brace at the end of the study, after the average 30.4 month-long follow-up period their growth spurt was nearly complete, corresponding to a lower risk of progression (Fig. 7).

Fig. (7)
The average starting age for patients in the study was 12.4 years. After an average follow-up time of 30.4 months (see red frame), the patients are more mature, their growth rate is decreased and the risk of further progression is significantly reduced.


While the results presented in this paper can only be regarded as preliminary, as our cohort continues to mature, the risk for progression is far less than at the start of the observation period. We will continue to monitor the results of the study participants until all twenty-five have completed treatment and have discontinued brace-wear. Additional studies are needed to validate the use of highly corrective asymmetric braces as a viable non-surgical alternative for skeletally immature patients who are willing to comply with conservative treatment.

CONCLUSION

Conservative brace treatment using the Gensingen brace was successful in 92% of cases of patients with AIS of 40 degrees and higher. This is a significant improvement compared to the results attained in the BrAIST study (72%). Reduction of the ATR shows that postural improvement is also possible.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE

Not applicable.

HUMAN AND ANIMAL RIGHTS

No Animals/Humans were used for studies that are base of this research.

CONSENT FOR PUBLICATION

Written informed consent for publication of the patient's information (x-rays, photos, records, etc.) has been obtained from the patient and her parent as well.

CONFLICT OF INTEREST

HRW is receiving financial support for attending symposia and receives royalties from Koob GmbH & Co KG. The company is held by the spouse of HR Weiss.

NT Is applying the Gensingen brace in his offices in Greece and Cyprus.

None of the other authors report any competing interest or potential conflict of interest.

ACKNOWLEDGEMENTS

HRW provided the first draft and made the literature review. NT contributed to the improvement of the first draft and provided some pictures. SS is responsible for the database and provided the XLS sheet in preparation of the statistical tests. AK (PhD in Mathematics) was in charge of statistical testing.

Parts of this study have already been presented at the 10th. Hellenic Spine Congress, Thessaloniki, October 26th. – 29th. Thessaloniki, Greece, 2016.

The authors would like to thank Maja Fadzan and Kathryn Moramarco for copyediting this paper.

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