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Quality Control of Idiopathic Scoliosis Treatment in 147 Patients While Using the RSC® Brace

  • InVivo Group

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The objective was to determine the primary correction of the Cobb angles of 147 idiopathic scoliosis subjects wearing the Rigo System Chêneau (RSC) brace. The RSC brace is a scoliosis brace that incorporates expansion and pressure areas to treat all aspects of the 3D scoliotic deformity not only in the frontal plane but also in the sagittal and transverse planes. RSC brace uses specific clinical and radiological classifications to define the most effective principles of correction. The experimental hypothesis predicted that those subjects who are treated with the RSC brace would report a significant primary correction of the major, minor, thoracic, and lumbar Cobb angles for both the main and Society of Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) restrictive criteria groups. The primary correction of main group was 43°, 42°, 48°, and 37° for thoracic, lumbar, major, and minor curve, respectively. The primary correction of SOSORT group was 54°, 59°, 61°, and 52° for thoracic, lumbar, major, and minor curve, respectively. The present experiment focused on the radiographic measurements of idiopathic scoliosis subjects before treatment and the primary correction with the RSC brace. The results are based on a sample size of 147 subjects in the main group and 25 subjects in the SOSORT (restrictive criteria) group. As a result, the RSC brace system had significant primary corrections in both the main and SOSORT groups. Because the initial in-brace radiographs presented with favorable results, it is predicted that the RSC brace prevents curve progression at the end of the treatment.
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... The experimental hypothesis predicted that patients treated with the ARTbrace would report a significant inbrace correction of major, minor, thoracic and lumbar curves for both the main prospective group and SRS & SOSORT restrictive criteria [17][18][19]. Although it is difficult to compare the different braces used around the world, we present the results in the same form as the Rigo System Cheneau (RSC) results [20]. ...
... As an example we choose a scoliotic curve similar to the first subject of the RSC study [20] (Figure 25). Manon, a girl of 12 years of age and Risser 0 was presenting an acute evolutive scoliosis with a progression of the Cobb angle from 15°to 39°in 4 months at the beginning of the treatment. ...
... We can compare results in ARTbrace with the RSC [20]. The initial Cobb angle is 2°less in our series, but the correction is significantly different (Figure 29). ...
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The symmetrical Lyon brace is a brace, usually used to maintain correction after a plaster cast reduction in the Cotrel's EDF (Elongation-Derotation-Flexion) frame. The new Lyon brace or ARTbrace is an immediate corrective brace based on some of the principles of the plaster cast which are improved due to advances in CAD/CAM technology. The aim of this paper is to describe concepts of this new brace to be not only a replacement of the plaster cast, but also a definitive brace. Instead of a plaster cast, three segmental CAD/CAM moulds are made with the instantaneous full 3D raster stereography digitizer (Orten):In self axial elongationIn shift and lumbar lordosisIn shift and thoracic kyphosis A specific software (OrtenShape) makes up the overlay of the three moulds. Mould 1 is used for the pelvis and the shoulders mould 2 for the lumbar segment and mould 3 for the thoracic segment. The mathematical basis of the ARTbrace is the torso column which is a circled helicoid with horizontal circle generator. A torso column is reproduced in the opposite direction of the scoliosis. Like the plaster cast, the ARTbrace is worn for a "total time" of 24 hours 7 days a week without modifying the standard protocol of the Lyon brace reduction. The prospective controlled cohort observational study of the 225 first patients treated since May 2013 is reported below. The in-brace immediate reduction is: 0.7, i.e. 40% better with the ARTbrace than with a plaster cast. The correction of flat back is 9° (from 18°.4 to 28°.5 kyphosis Cobb angle). The improved aesthetic appearance is equal for rib hump and ATR. This first paper is an introduction with very short results and does not prejudge the final outcome. The ARTbrace can be used not only to replace the plaster cast, but also as a definitive brace. The new segmental moulding with final detorsion is even more efficient and to this day the ARTbrace is the most effective to reduce the Cobb angle of scoliosis.
... Treatment with a brace is one of the main modalities of conservative treatment of Adolescent Idiopathic Scoliosis (AIS) and its main objective is to prevent the progression of scoliotic curves. 1 The major obstacles to conservative treatment with braces are low adherence, negative psychosocial impact in the adolescent, and correction of the deformity in a single plane. These adversities are considered significant factors in the failure of conservative treatment and they, in theory, could contribute to the undesirable increase in surgically treated cases. ...
... The mechanism of action of these two orthoses does not act on vertebral rotation and tends to straighten the physiological curves in the sagittal plane with the potential to produce what is known as flatback. 1,4 The Milwaukee brace has the additional disadvantage of the apparent cervical ring of the orthosis, which contributes to the problem of the self-image of the adolescent with all its repercussions for that age group. 5 Braces with a proposal of multiplanar correction emerged in the 1990s with the work of Chêneau. ...
... 6 The treatment principle of the WCR is to create different areas of pressure and expansion in the trunk to generate different degrees of rotation in the vertebrae and multifocal corrective forces, including the axial, sagittal, and coronal planes. 1,7 The application of emerging technologies, such as 3D surface scanning, digital modeling software, 3D printers, and especially high precision robotic technology seem to have the potential to make this brace more effective, as well as more acceptable and lighter. ...
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Objective To evaluate the immediate correction capacity of the Wood-Chêneau-Rigo brace (WCR), produced using digital technological resources and robotic engineering, in primary and secondary curves of adolescent idiopathic scoliosis (AIS). Methods A retrospective study was conducted of 138 patients with a diagnosis of AIS and who received a WCR brace from a laboratory that makes orthoses and orthopedic prostheses between 2019 and 2021. These individuals were submitted to an independent analysis of the radiographic parameters by a single researcher, the main outcome of which was the standardized measurement of the main and secondary curves using the Cobb method. The radiographs analyzed were performed in orthostasis before and immediately after the adaptation of the brace on the patient. The correction capacity was calculated as the ratio of the difference between the pre- and post-brace curves to the pre-brace curve. Results The mean correction with the WCR was 48.4% for the main curve and 41.0% for the secondary curve. The level of correction of the main curve was significantly higher in patients with a main curve with the apex of convexity in the thoracolumbar region (p = 0.004), especially in the left thoracolumbar region (p = 0.010); curves of magnitude between 10º and 24.9º (p <0.001); and curves classified as simple (p <0.001). Conclusion The use of the WCR, which is produced using modern technological resources, was effective in the immediate correction of AIS. Long-term studies on this new modality of conservative scoliosis treatment are necessary. Level of evidence III; Retrospective study.
... Wearing the brace for 12 hours in the non-compliant group resulted in progression of the curvatures. Many Cheneau brace studies do not mention the number of hours the brace was worn [17,54,60,61] but good brace compliance has been shown by a number of studies to have good outcomes [21][22][23][24][62][63][64][65]. Recording the brace wearing hours was one of the challenges of this study. ...
... The compliant group is similar to several studies that show normalisation of kyphosis and lordosis with the Cheneau brace [13,17,60]. In many Cheneau brace studies however, the sagittal profile is not mentioned, [24,56,59,61,65,71]. The RSC brace allows sagittal normalisation because of its physiological profile in the sagittal plane and every trunk section is aligned to allow a normal sagittal profile [17,75]. ...
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Background There is controversy as to whether conservative management that includes wearing a brace and exercises is effective in stabilising idiopathic scoliosis curves. A brace only prevents progression of the curve and has been shown to have favourable outcomes when patients are compliant. So the aim of this study was to: determine the effect of compliance to the Rigo System Cheneau (RSC) brace and a specific exercise programme on Idiopathic Scoliosis curvature; and to compare the Quality of Life (QoL) and psychological traits of compliant and non compliant subjects. Methods A pre/post test study design was used with a post study comparison between subjects who complied with the management and those who did not. Fifty one subjects, girls aged 12-16 years, Cobb angles 20-50 degrees participated in the study. Subjects were divided into two groups, according to their compliance, at the end of the study. The compliant group wore the brace 20 or more hours a day and exercised three or more times per week. The non-compliant group wore the brace less than 20 hours a day and exercised less than three times per week. Cobb angles, vertebral rotation, scoliometer readings, peak flow, quality of life and personality traits were compared between groups, using the student’s two sample t-test and an analysis of covariance. Results The compliant group, wore the brace 21.5 hours per day and exercised four times a week, and significantly improved in all measures compared to non compliant subjects, who wore the brace 12 hours per day, exercised 1.7 times a week and significantly deteriorated (p < 0.0001). The major Cobb angles in the compliant group improved 10.19°(±5.5) and deteriorated 5.52°(±4.3) in the non compliant group (p < 0.0001). Compliant subjects had a significantly better QoL than the non compliant subjects (p = 0.001). The compliant group were significantly more emotionally mature, stable and realistic than the non compliant group (p = 0.03). Conclusions Good compliance of the RSC brace and a specific exercise regime resulted in a significant improvement in curvatures, poor compliance resulted in progression/deterioration. A poorer QoL in the non compliant group possibly was caused by personality traits of the group, being more emotionally immature and unstable.
... 2,3 Braces serve to maintain, and, in some cases, reduce the spinal curve to prevent progression of the deformity by applying corrective forces. 2,4 Until recently, the outcome of bracing treatment has been highly debated. Weinstein et al. conducted a 5-year follow-up study (Bracing in Adolescent Idiopathic Scoliosis Trial, BrAIST), providing evidence that braces are effective (72% success rate) at treating scoliosis. ...
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Introduction: Thoracolumbar braces are used to treat Adolescent Idiopathic Scoliosis. The objective of this study was to design and validate a mechanical analog model of the spine to simulate a thoracolumbar, single-curve, scoliotic deformity in order to quantify brace structural properties and corrective force response on the spine. Methods: The Scoliosis Analog Model used a linkage-based system to replicate 3D kinematics of spinal correction observed in the clinic. The Scoliosis Analog Model is used with a robotic testing platform and programmed to simulate Cobb angle and axial rotation correction while equipped with a brace. The 3D force and moment responses generated by the brace in reaction to the simulated deformity were measured by six-axis load cells. Results: Validation of the model's force transmission showed less than 6% loss in the force analysis due to assembly friction. During simulation of 10° Cobb angle and 5° axial rotation correction, the brace applied 101 N upwards and 67 N inwards to the apical connector of the model. Brace stiffness properties were 0.5-0.6 N/° (anteroposterior), 0.5-2.3 N/° (mediolateral), 23.3-26.5 N/° (superoinferior), and 0.6 Nm/° (axial rotational). Conclusions: The Scoliosis Analog Model was developed to provide first time measures of the multidirectional forces applied to the spine by a thoracolumbar brace. This test assembly could be used as a future design and testing tool for scoliosis brace technology.
... The brace serves to maintain and, in some cases, reduce [9] the spinal curve to prevent progression of the deformity by applying corrective forces while being worn [11]. Many braces use a three-point pressure principle as the method of correction, which involves fixation above, below, and at the apex of the curve [12]. ...
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Velcro fastening straps are commonly used to secure a scoliosis brace around the upper body and apply corrective forces to the spine. However, strap loosening and tension loss have been reported that reduce spinal correction and treatment efficacy. A novel fastening device, or controlled tension unit (CTU), was designed to overcome these limitations. A scoliosis analog model (SAM) was used to biomechanically compare the CTU fasteners and posterior Velcro straps on a conventional brace (CB) as well as on a modified brace (MB) that included a dynamic cantilever apical pad section. Brace configurations tested were (1) CB with posterior Velcro straps, (2) CB with posterior CTU fasteners, (3) MB with posterior Velcro straps, and (4) MB with posterior CTU fasteners. MB configurations were tested with 0 N, 35.6 N, and 71.2 N CTU fasteners applied across the apical pad flap. Three-dimensional forces and moments were measured at both ends of the SAM. The CTU fasteners provided the same corrective spinal loads as Velcro straps when tensioned to the same level on the CB configuration and can be used as an alternative fastening system. Dynamically loading the apical flap increased the distractive forces applied to the spine without affecting tension in the fastening straps.
... However, 53% is significantly higher than our first in-brace correction of 34% reported in 1995. The in-brace correction achieved with the CAD CAM version has been independently reported as 43,42,48, and 37% for thoracic, lumbar, major, and minor curves, respectively, in a group of 147 patients; a sub-group of patients fulfilling the more restrictive SOSORT criteria reportedly achieved corrections of 54, 59, 61, and 52% for thoracic, lumbar, major, and minor curves, respectively [58]. Notwithstanding, as discussed previously, the Chêneau-type brace is not just an orthopedic product but also a brace concept that is permanently evolving in pursuit of the highest possible standard. ...
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Background Chêneau and Matthias introduced in 1979 a brace concept inspired in casting. The brace was initially named “CTM” from Chêneau-Toulouse-Münster. The name “CTM” is still popular in France but “Chêneau-type brace” is its common name in the rest of the world. Principles to construct this brace were originally based on anatomical descriptions rather than biomechanics, and its standard is poor. Methods This paper follows the format of the “Brace technology thematic series.” The Chêneau-type brace has been versioned by many authors. The contribution of the present authors is about to the description of the principles based on biomechanics and a specific classification created to help to standardize the brace design and construction. The classification also correlates with specific exercises (PSSE) according to the Barcelona School, using Schroth principles (BSPTS). This current authors’ version has been named “3D Rigo Chêneau-type brace.” The 3D principles are related to a detorsional mechanism created by forces and counterforces to bring the trunk into the best possible correction: (1) three-point system; (2) regional derotation; (3) sagittal alignment and balance. A custom-made TLS brace (thoracolumbosacral) is built in order to provide highly defined contact areas, which are located, shaped, and oriented in the space to generate the necessary vectors of force to correct in 3D. Expansion areas are also essential for tissue migration, growth, and breathing movements, although body reactions depend basically on how well designed are the contact areas. The brace is open in front and can be considered rigid and dynamic at the same time. ResultsBlueprints for construction of the brace according to the revisited Rigo classification are fully described in this paper. Conclusions Different independent teams have published comparable outcomes by using Chêneau-type braces and versions in combination with specific exercises and following a similar scoliosis comprehensive care model. This present version is also supported by scientific results from several independent teams.
... In the literature, studies on improvement to the sagittal plane due to brace effect do not exist. Instead, many authors report accentuating brace effect on the flat back, probably related to axial stretching due to the overcorrection in the frontal plane [36,37]. Analysing the effect of a brace on 38 patients treated with Chêneau using MR animation, shows a significant reduction of the mean Cobb angle of thoracic curves in-brace in MR animation coronal 0°projection (simulating A-P view in X-ray) but in -90°projection, simulating a lateral X-ray view, reported a reduction Kyphosis Cobb angle in 33/ 38 patients. ...
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Adolescent idiopathic scoliosis (AIS) is a four dimensionaldeformity of the spine arising in otherwise healthy childrenduring puberty. The fourth dimension is time. This dimensionis the characteristic of our database created in 1998with systematic reconvening of our patients at regular intervalswhich increases the level of scientific evidence [1]. Theuse of a brace in the conservative treatment for AIS playsan important role and has the aim to stop the evolution ofthe deformity in immature adolescents in order to preventproblems during adulthood [2, 3]. Long-term follow-ups indicatethat patients with scoliosis may have a higher prevalenceof back pain and of worsening pulmonary function ifthe curve becomes extremely severe [4]. A randomized controltrial BRAIST study conducted byWeinstein showed thatbracing is significantly effective in reducing the progressionof AIS [5]. Previously, a Cochrane review [6] also demonstratedthe effectiveness of bracing in the treatment of AIS.To measure the effectiveness of a brace two main factorscan be involved: 1. the immediate in-brace reductiondepending how to get the three-dimensional correctionand its reproducibility; 2. the patient's adherence whichdepends on aesthetics and tolerance [7, 8]. Different typesof braces are used in the treatment of AIS but almost allare created on the multiple three points system principleof applying external corrective forces across the curve inorder to stop deformity progression, produce an acceptablesagittal and coronal contour, and delay or avoidsurgical treatment [9-12]. The main biomechanical conceptsare based on: elongation along the vertical axis, lateralinflexion in the frontal plane and derotation of thespine in order to obtain a correction of the scoliotic curve.Derotation is the main movement along the vertical axis.The correction in the sagittal plane is problematic becausemany scoliosis are accompanied by a change in the sagittalplane with a flat back in half of the cases. All of the abovemechanisms are going in the direction of accentuation ofthe flat back and require significant and uncertain changesduring the manufacture of the brace. This problem hasnow been finally solved thanks to segmental moulding
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Conference Paper
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Meeting abstracts from the 10th Annual SOSORT Conference in Chicago, May 2013.
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Spinal classification systems for scoliosis which were developed to correlate with surgical treatment historically have been used in brace treatment as well. Previously, there had not been a scoliosis classification system developed specifically to correlate with brace design and treatment. The purpose of this study is to show the intra- and inter- observer reliability of a new scoliosis classification system correlating with brace treatment. An original classification system ("Rigo Classification") was developed in order to define specific principles of correction required for efficacious brace design and fabrication. The classification includes radiological as well as clinical criteria. The radiological criteria are utilized to differentiate five basic types of curvatures including: (I) imbalanced thoracic (or three curves pattern), (II) true double (or four curve pattern), (III) balanced thoracic and false double (non 3 non 4), (IV) single lumbar and (V) single thoracolumbar. In addition to the radiological criteria, the Rigo Classification incorporates the curve pattern according to SRS terminology, the balance/imbalance at the transitional point, and L4-5 counter-tilting. To test the intra-and inter-observer reliability of the Rigo Classification, three observers (1 MD, 1 PT and 1 CPO) measured (and one of them, the MD, re-measured) 51 AP radiographs including all curvature types. The intra-observer Kappa value was 0.87 (acceptance >0.70). The inter-observer Kappa values fluctuated from 0.61 to 0.81 with an average of 0.71 (acceptance > 0.70). A specific scoliosis classification which correlates with brace treatment has been proposed with an acceptable intra-and inter-observer reliability.
Current concept of bracing must take in consideration both the three-dimensional (3D) nature of Adolescent Idiopathic Scoliosis (AIS) and its pathomechanism of progression. A modern brace should be able to correct in 3D in order to break the so called 'vicious cycle' model. Generally speaking, it is necessary to create detorsional forces to derotate in the transversal plane, to correct the lateral deviation in the frontal plane and to normalize the sagittal profile of the spine. Breathing mechanics can be used to fight against the thoracic structural flat back. The original Chêneau brace was introduced at the end of the 70's and its principles were based more in anatomical observations rather than in biomechanics. A further evolution , enunciating new principles, has allowed a higher standard, improving in brace corrections and trunk modelling. This biomechanical principles have been developed under the name of Rigo-Chêneau-System (RSC) and used later in latest brace models like the Chêneau light with reduced material, and similar in brace corrections. Experience is also important to improve the end results. The blueprints to built the brace according to the anatomorradiological pattern are very helpful.
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