bracing scoliosis: the evolution to cad/cam for improved in … · 2019-09-03 · 2 scoliosis 3dc,...

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Licensee OA Publishing London 2013. Creative Commons Attribution License (CC-BY)

For citation purposes: Weiss HR, Seibel S, Moramarco M, Kleban A. Bracing scoliosis: the evolution to CAD/CAM for improved in-brace corrections. Hard Tissue 2013 Nov 25;2(5):43.

* Corresponding authorEmail: [email protected] Orthopedic Rehabilitation Services ‘Gesund-

heitsforum Nahetal’, Gensingen, Germany2 Scoliosis 3DC, Baldwin Green Common, Woburn,

Massachusetts, USA3 Lomonosov Moscow State University, Faculty of

Mechanics and Mathematics GSP-1, Leninskie Gory, Moscow, Russia

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Bracing scoliosis: the evolution to CAD/CAM for improved in-brace corrections

HR Weiss1*, S Seibel1, M Moramarco2, A Kleban3

AbstractIntroductionThere are a wide variety of brace applications available today with different outcomes and different characteristics. The purpose of this study is to compare in-brace cor-rections of the series applied today to recent Chêneau series braces as presented in literature.methodologyAll patients were registered and fulfil the Scoliosis Research Society inclu-sion criteria for studies on bracing from 2012. A total of 21 female patients matched with the Scoliosis Research Society inclusion criteria. These 21 girls were of an average age of 12.2 years (standard deviation = 1.1). Average Risser stage was 0.38 (stan-dard deviation = 0.68), average Cobb angle was 31.33° (standard devia-tion = 6.58). In-brace correction from this sample has been compared to the in-brace corrections of other Chêneau samples as published in literature using a test for comparison of two different proportions.

Average Cobb angle in the brace was 10.66°; 34% of the initial angle that makes an in-brace correction of 66%. A significant difference is revealed for some samples and the absolute in-brace correction was highest in our sample showing that the application of the actual state of

computer-aided design/computer-aided manufacturing braces leads to better in-brace corrections than many cast-made braces, and also better in-brace corrections when comparing to computer-aided design/ computer-aided manufacturing braces as published.ConclusionSymmetric braces are outdated. Asymmetric braces allow better in-brace correction when compared to symmetric braces. Asymmetric braces according to the actual, Best Practice® computer-aided design/computer-aided manufacturing stan-dard allow for improved in-brace corrections promising the best pos-sible radiological and cosmetic end results. Future studies on in-brace corrections and outcomes on brace treatment should use the Scoliosis Research Society inclusion criteria for bracing to improve comparability.

IntroductionScoliosis is a three-dimensional deformity of the spine and trunk, which may deteriorate quickly dur-ing phases of rapid growth1. Although research is still being conducted on the effects of physiotherapy2 for sco-liosis, bracing is recognized to stop progression3 during the pubertal growth spurt. Now, with the newest Chêneau style computer-aided design/ computer-aided manufacturing (CAD/ CAM) bracing under certain circum-stances the potential exists to improve curvature radiologically and visually4.

With the variety of brace appli-cations available today, there are different characteristics with vary-ing outcomes. Independent studies have shown that soft braces have no advantage over rigid braces5–8.

Rigid braces may be symmetric or asymmetric. Examples of symmetric braces are the Boston brace9 or the symmetric, patient-oriented rigid trunk orthosis (SPORT) brace from Italy10. No in-brace corrections are reported for the latter brace (Figure 1).

Symmetric braces have pad inlays that push on the most prominent areas of the scoliotic trunk. Asym-metric braces are constructed in an attempt for overcorrection with foam pads used for augmentation in the pressure areas but also for providing spaces on the oppos-ing sides of the pressure areas. The most effective asymmetric brace is the Chêneau brace11. The primary advantage of the Chêneau brace over symmetric braces is the higher in-brace correction11. Its unique structure allows for a correction in three dimensions (in the sagittal, frontal and transverse planes) and allows room for corrective breathing; a concept in sync with principles of non-surgical scoliosis management via Best Practice® based upon Schroth Method principles. The newest Chêneau brace is also manufactured using less material making the brace lighter than previously manufactured braces with the goal of improving comfort and wearability offering increased likelihood of improved patient compliance (Figure 2).

It is generally agreed that bracing outcomes are determined by the amount of in-brace correction and compliance12. Therefore, the aim of future developments should be improvement of in-brace correction and comfort. A recent study reveals that not all Chêneau braces are of comparable quality or have the ability to achieve the same in-brace correction. Borysov and Borysov

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have demonstrated the capability to attain a high standard with hand-made braces using the plaster tech-nique13, however, the outcomes of Chêneau braces created elsewhere have varied significantly; between

56%14 and >95% successful15 based on in-brace correction.

Chêneau braces made by the cast technique are at a disadvantage because they lack standardization. Even among specialists, there will

always be a wide range of quality. When constructing a brace by cast, the clinician must start anew each time without a baseline standard. With each correction and alteration, the brace is vulnerable to deteriora-tion. These deteriorations can cause the brace’s function to veer from the original intended curve pattern correction (Figure 2).

A solution is CAD/CAM techn ology. For 3 years, brace formulas from a library created by the first author have been used to address specific curvature patterns16. The augmented Lehnert-Schroth (ALS) classification determines which brace formula from the library is best matched to an individual patient (Figure 3). These basic patterns are key patterns. Special patterns are also available for certain presentations, such as double thoracic patterns, kyphotic patterns and adults. Furthermore, each brace (whether made from key patterns or special patterns) from the library are always customized to the individual through adjustments for comfort and function.

The baseline standard of these braces can be improved without generating new problems by adjust-ing unforeseen complications. Any reported problems with the braces created from the library are regis-tered and are easily modified using CAD. After CAD modification, the problem is solved for the entire series. When compared to previously worn braces, patients have reported braces from the library (Figures 3–5) to be more comfortable.

The purpose of this study is to compare in-brace correction of the CAD/CAM series as currently applied to the Chêneau series as presented in literature previously13.

methodologyThe authors have referenced some of their own studies in this review. These referenced studies have been conducted in accordance with the Declaration of Helsinki (1964) and

Figure 2. Left: Chêneau (Gensingen) CAD/CAM brace clearly mirroring the deformity. The type of curve pattern as treated and the corrective movement is clearly visible in the brace (middle). Right: Rigo Chêneau brace made by cast in the US lacking visible correction of the right thoracic deformity and far more material than current Chêneau (Gensingen).

Figure 1. A 7-year-old girl from Italy treated with brace known as SPORT brace. The patient is squeezed as evidenced by the marked impressions on the skin. An example of this type of brace is shown on the right. This brace does not appear to be patient-oriented.

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the protocols of these studies have been approved by the relevant ethics committees related to the institution in which they were performed. All human subjects, in these referenced studies, gave

informed consent to participate in these studies.

In 2011, a prospective trial comme-nced using the referenced CAD/CAM approach. Patients included were from November 2011 to December 2012.

In accordance with Scoliosis Research Society (SRS) inclusion criteria for studies on bracing all patients fulfilled the following criteria17.

The SRS inclusion criteria for bracing studies:

1. Age at bracing = 10 years and older 2. Primary curve = 25–40° 3. Risser sign = 0, 1 or 2 4. No prior treatment 5. Females—premenarchal or one-year

postmenarchal 6. Include all patients regardless of

compliance (‘intent to treat’)

The 21 females who matched the criteria were of an average age of 12.2 years [standard deviation (SD) = 1.1] with the following distri-bution of curve patterns:

Thoracic: n = 11Double major: n = 4Lumbar: n = 4Thoracolumbar: n = 2

Average Risser stage was 0.38 (SD = 0.68) and average Cobb angle was 31.33° (SD = 6.58).

In-brace correction from this sample has been compared to the in-brace correction of other Chêneau samples as published in litera-ture11,13,15,18–21.

ResultsAverage Cobb angle in brace for our sample was 10.66° (SD); 34% of the initial angle resulting in an in-brace correction of 66%.

The results in comparison to others are demonstrated in Table 1. A signifi-cant difference is revealed showing that the application of CAD/CAM braces leads to better in-brace corrections than cast-made braces, and also better in-brace corrections than previous results for CAD/CAM braces as previously published (RSC)19.

DiscussionDuring growth, it is of vast impor-tance that brace treatment is estab-lished immediately and with the most effective brace available. To attempt

Figure 3. ALS classification as used for the selection of the appropriate brace from our Gensingen library. (From left to right) 3CH, 3-curve with hip promi-nence; 3CTL, 3-curve with hip prominence thoracolumbar; 3C, 3-curve bal-anced; 3CL, 3-curve with long lumbar countercurve; 4C, 4-curve double; 4CL, 4-curve single lumbar; 4CTL, 4-curve single thoracolumbar.

Figure 4. Brace from a patient of this series with a full correction of the single thoracic curve pattern. This patient, from New Zealand, was 12 years old with Tanner II–III and therefore still rather flexible.

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for males before voice change. In limited cases, drastic improvements have been achieved when a growth peak occurs in immature patients (Figures 4–6).

Missing the opportunity for treat-ment at the optimal time may result in an increased risk for curve progres-sion. If curve progression occurs to the point when surgery is commonly recommended, usually 45°–50°, a patient’s risk for long-term health complications as a result of scoliosis increases22–24.

These newer developments in CAD/CAM-based standardization make it possible for improved patient out-comes, especially when the pati ent is treated early at an immature phase⁴ (Figures 4 and 7). Curvatures exce-e ding 45° may now be addressed offering the patient the chance for improved trunk appearance and Cobb angles, but in-brace correc-tion may be difficult to achieve (Figure 8). Early treatment (before 45° is reached), combined with this newest bracing standard may at times indicate a short-term wearing schedule: 23 h/day for possibly up to only 6 months25. If a curve has been corrected to less than 20° (out of the brace) as an intermediate result, then part-time brace wear will be sufficient.

Bracing standardization allows consistent and optimal treatment for patients. Nevertheless, there are curves that present challenges (Figures 9 and 10). Fortunately, this applies to a smaller percentage of the population (estimated at 5%). In these cases, correction is not a typical outcome, but the curves presented by this population can usually be kept stable with full compliance.

In a recent retrospective cohort study on Chêneau braces26 from Italy, the authors report high in-brace corr-ections and a success rate of more than 95% as published in 2012 in a series of the first author15. However, the average Cobb angle in the sample of patients from Italy as reported is

Figure 5. Clinical result of a 15-year-old patient with a 42° Cobb angle at the start of treatment with marked progression within a few weeks. Right: Clinical result following 6 months of treatment after outgrowing her first brace. Pelvic width has increased as compared to the photo at far left revealing skel-etal immaturity at the start, age 15, although normally 15-year-old girls are nearly fully grown (to 99%).

Table 1. Papers on the Chêneau brace treatment of patients with Ado-lescent Idiopathic Scoliosis as can be found in PubMed and the journal ‘Scoliosis’ where the average in-brace correction (φ corr) is documented (φ corr and φ Cobb angle have been rounded). Statistical analysis revealed significant differences of the in-brace correction achieved when the results from this sample (Weiss et al., 2013) were compared to previous studies11,18,21 (t = 2.4 and 3.64, respectively, in a statistical test to compare two different proportions)

Authors Year n φ Corr φ Cobb Significance

Hopf and Heine11 1985 52 41% 36° 0.05Rigo et al.18 2002 105 31% 37° 0.01Rigo19 2007 32 42% 33° nsWeiss et al.20 2007 81 51% 36° nsMaruyama et al.21 2012 54 36% 37° 0.05Weiss and Werkmann15 2012 34 59% 31° nsBorysov et al.13 2013 92 56% 29° nsWeiss et al. (this study) 2013 21 66% 31°

an early reduction of the curvature, the earliest onset of treatment with the highest in-brace correction is desirable. When the first signs of maturation appear, immediate treat-ment offers the benefit of the shortest possible length of treatment, allowing for the least impact on the patients’

quality of life and perhaps improving the likelihood of improved patient compliance. With increasing age and curvatures, the possibility for a curve correction via bracing is reduced. Due to growth dynamics, in females, the best chance for correction is before the onset of menarche, and

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rather low. In addition, only selected single patterns of curvature have been included. The average Cobb angle of the subset of patients with thoracic curvatures is only 24°, and thus is not comparable to the other samples in Table 1. Unlike in the other studies, double curvatures obvi ously have been excluded. Despite these lim-itations, the final results, as reported, must be regarded as far above average.

In-brace correction is more easily and more safely achieved with braces from the standardized CAD library developed by the first author. In com-parison, cast braces do not offer the same basis of standardization that can allow the patient the potential for improved in-brace corrections and outcomes. Unfortunately, there are a few individuals skilled enough to reproduce the standard of CAD technology via casting13.

Since November 2011 when the prospective study was started, we have applied more than 600 CAD/CAM Chêneau braces in Gensingen. Many of these patients before the study start have been treated else-where or in first author’s clinic; many patients’ age exceeded the limits of the SRS inclusion criteria. Many patients had curvature angles exceeding 40°. Therefore, we were able to include only this small number (21 patients) into the current study.

This exactly is the problem that many patients come late to be braced, at an age and with a Cobb angle that no longer fit within the margins of the SRS inclusion criteria.

Many patients with scoliosis, therefore, are needed to start such an endeavour of a prospective cohort complying with these criteria.

Cobb angle, on the other hand, certainly cannot be regarded as the most important outcome measure for the patient. As has been demon-strated, our new series of CAD/CAM Chêneau braces is able to improve trunk asymmetry significantly even in curves exceeding 40° Cobb angle. Maybe in the future we will be able

Figure 6. Rib hump of the patient from Figure 5 left at the start and right after 6 months of brace treatment.

Figure 7. Immature patient initially treated for a curve of more than 30° at the age of 8 (left). During the growth spurt, part-time treatment is enough as the curve is below 20° as illustrated in the intermediate result ( far right). The 2nd, 4th and 6th x-rays from the left are in-brace x-rays showing that there was no further improvement possible with respect to in-brace correction25.

Figure 8. A 14-year-old girl from the US with a 53° curve thoracic to the right. As she is still skeletally immature (Risser 2), the first author decided to brace her pattern specifically with a 3CL Chêneau brace from the Gensingen CAD/CAM library. In the end, the curve corrected minimally in the thoracic area (to 40°) and the apical area in the x-ray seems quite stiff. Nevertheless, a slight cor-rection can be expected upon outgrowing the brace. The next brace will be of the 3CH model (see Figure 5) shifting the decompensated trunk even more to achieve an improved good cosmetic outcome.

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to change the measure for outcome from the Cobb angle to cosmetic issues, which might be more impor-tant for the patients themselves.

Symmetric braces will not allow the best possible in-brace correction and therefore are outdated today and should no longer be used as these do not promise the best possible per-centage of beneficial outcomes and final corrections especially in curves exceeding 45° have never been dem-onstrated using symmetric braces27.

Conclusion• Symmetric braces are not of the same

standard as asymmetric braces.• Asymmetric braces allow better

in-brace correction.• Asymmetric braces according to

the Best Practice® CAD/CAM stan-dard allow for optimal in-brace correction that in turn yields the best possible end result.

Competing interestsHR Weiss is advisor of Koob GmbH & Co KG

Conflict of interestsHR Weiss is advisor of Koob GmbH & Co KG, M Moramarco is a US provider of the Chêneau Gensingen Brace™.

Abbreviations listALS, augmented Lehnert-Schroth; CAD, computer-aided design; CAM, computer-aided manufacturing; SD, standard deviation; SPORT, sym-metric, patient-oriented rigid trunk orthosis; SRS, Scoliosis Research Society.

AcknowledgementAll patients visible on the pictures and their parents have kindly agreed to the publication of their photos within this article. The authors are thankful to Kathy Moramarco for copyediting the manuscript and for her precious suggestions.

Figure 9. Patient with a double major curvature (high lumbar, low thoracic) treated with a Chêneau brace of the early CAD standard 10 years ago. Curvature correction was limited. A switch to the Chêneau light did not result in a better radiological correction either. However, the curve stayed stable even without a significant in-brace correction.

Figure 10. Clinical outcome of the patient from Figure 7. Even without any radiological correction, the trunk deformity in this patient has been improved significantly over the treatment period leading to patient satisfaction in the end.

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treatment in late-onset juvenile and adolescent idiopathic scoliosis. Scoliosis. 2011 Aug;6:18.10. Zaina F, Donzelli S, Negrini A, Romano M, Negrini S. SpineCor, exer-cise and SPoRT rigid brace: what is the best for Adolescent Idiopathic Scoliosis? Short term results from 2 retrospective studies. Stud Health Technol Inform. 2012;176:361–4.11. Hopf C, Heine J. Long-term results of the conservative treatment of scoliosis using the Cheneau brace. Z Orthop Ihre Grenzgeb. 1985 May–Jun;123(3):312–22. German.12. Landauer F, Wimmer C, Behensky H. Estimating the final outcome of brace treatment for idiopathic thoracic scoliosis at 6-month follow-up. Pediatr Rehabil. 2003 Jul–Dec;6(3–4):201–7.13. Borysov M, Borysov A, Kleban A, Weiss HR. Bracing according to b̒est practice’ standards - are the results repeatable? OA Musculoskelet Med. 2013 Apr;1(1):6.14. Bullmann V, Halm HF, Lerner T. Pro-spective evaluation of braces as treat-ment in idiopathic scoliosis. Z Orthop Ihre Grenzgeb. 2004 Jul–Aug;142(4):403–9. German.15. Weiss 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: 407–10.16. Weiss HR. “Brace technology” thematic series - the Gensingen brace™ in the treatment of scoliosis. Scoliosis. 2010 Oct;5:22. 17. Richards BS, Bernstein RM, D’Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). 2005 Sep;30(18):2068–75.18. Rigo M, Quera-Salvá G, Puigdevall N, Martínez M. Retrospective results

in immature idiopathic scoliotic patients treated with a Chêneau brace. Stud Health Technol Inform. 2002;88: 241–5.19. Rigo M. A series of patients with adolescent idiopathic scoliosis treated with a Rigo System Chêneau (RSC) brace. Primary correction in brace improved by technical evolution. Scoliosis. 2007 Oct;2(Suppl 1):S11. 20. Weiss HR, Werkmann M, Stephan C. Correction effects of the ScoliOlogiC® “Chêneau light” brace in patients with scoliosis. Scoliosis. 2007 Jan;2:1.21. Maruyama T, Nakao Y, Yamada H. Early results of Rigo-Chêneau type brace treatment. Scoliosis. 2012 Jan;7(Suppl 1):O33.22. Hawes M. Impact of spine surgery on signs and symptoms of spinal defor-mity. Pediatr Rehabil. 2006 Oct–Dec; 9(4):318–39.23. Weiss HR, Goodall D. Rate of compli-cations in scoliosis surgery – a systematic review of the Pub Med literature. Scoliosis. 2008 Aug;3:9.24. Weiss HR, Moramarco M, Mora-marco K. Risks and long-term complica-tions of adolescent idiopathic scoliosis surgery vs. non-surgical and natural history outcomes. Hard Tissue. 2013 Apr;2(3):27.25. Weiss HR. Patients guide to scoliosis. 9th ed. Munich: Pflaum; 2013.26. De Giorgi S, Piazzolla A, Tafuri S, Borracci C, Martucci A, De Giorgi G. Chêneau brace for adolescent idio-pathic scoliosis: long-term results. Can it prevent surgery? Eur Spine J. 2013 Nov;22(Suppl 6):S815–22.27. Weiss HR, Moramarco M. Remod-elling of trunk and backshape defor-mities in patients with scoliosis using standardized asymmetric computer-aided design/computer-aided manu-facturing braces. Hard Tissue. 2013 Feb;2(2):14.

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