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"Brace technology" thematic series - the Gensingen brace™ in the treatment of scoliosis.

ABSTRACT: BACKGROUND: Bracing concepts in use today for the treatment of scoliosis include symmetric and asymmetric hard braces usually made of polyethylene (PE) and soft braces. A new asymmetric Chêneau style CAD/CAM derivate has been designed to overcome problems the author experienced with other Chêneau CAD/CAM systems over the recent years. BRACE DESCRIPTION: This CAD/CAM Chêneau derivate has been called Gensingen brace™, a brace available to address all possible curve patterns. Once the patients' trunk is scanned with the help of a whole trunk optical 3D-scan and the patients' data from the clinical measurements are recorded, a model of the brace can be created by (1) modifying the trunk model of the patient 'on screen' to achieve a very individual brace model using the CAD/CAM tools provided or by (2) choosing a brace model from our library and re-size it to the patients' properties 'on screen'. RESULTS: End-result studies have been published on the Chêneau brace as early as 1985. Cohort studies on the Chêneau brace are available as is a prospective controlled study respecting the SRS criteria for bracing studies, demonstrating beneficial outcomes, when compared to the controls using a soft brace. Sufficient in-brace correction effects have been demonstrated to be achievable when the Chêneau principles of correction are used appropriately. As there is a positive correlation between in-brace correction and the final outcome, the Chêneau concept of bracing with sufficient in-brace corrections as published can be regarded as being efficient when applied well. Case reports with high in-brace corrections, as shown within this paper using the Gensingen brace™ promise beneficial outcomes when a good compliance can be achieved. CONCLUSIONS: The use of the Gensingen brace™ leads to sufficient in-brace corrections, when compared to the correction effects achieved with other braces, as described in literature.According to the patients' reports, the Gensingen brace™ is comfortable to wear, when adjusted properly.Further studies are necessary (1) in order to evaluate brace comfort and (2) effectiveness using the SRS inclusion criteria.

SUBMITTER: Weiss HR

PROVIDER: S-EPMC2967515 | biostudies-other | 2010

REPOSITORIES: biostudies-other

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"Brace technology" thematic series - the Gensingen brace™ in the treatment of scoliosis.

Weiss Hans-Rudolf HR

Scoliosis 20101013

<h4>Background</h4>Bracing concepts in use today for the treatment of scoliosis include symmetric and asymmetric hard braces usually made of polyethylene (PE) and soft braces. A new asymmetric Chêneau style CAD/CAM derivate has been designed to overcome problems the author experienced with other Chêneau CAD/CAM systems over the recent years.<h4>Brace description</h4>This CAD/CAM Chêneau derivate has been called Gensingen brace™, a brace available to address all possible curve patterns. Once the ...[more]

PMID: 20942970

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Project description:BACKGROUND: Bracing concepts in use today for the treatment of scoliosis include symmetric and asymmetric hard braces usually made of polyethylene (PE) and soft braces. The plaster cast method worldwide seems to be the most practiced technique for the construction of hard braces at the moment. CAD (Computer Aided Design) systems are available which allow brace adjustments without plaster. Another possibility is the use of the ScoliOlogiC™ off the shelf system enabling the Certified Prosthetist and Orthotist (CPO) to construct a light brace for scoliosis correction from a variety of pattern specific shells to be connected to an anterior and a posterior upright. This Chêneau light™ brace, developed according to the Chêneau principles, promises a reduced impediment of quality of life in the brace. The correction effects of the first 81 patients (main diagnosis Adolescent Idiopathic Scoliosis (AIS) [n = 64] or Early Onset Scoliosis (EOS) [n = 15]), treated according to the principles of the Chêneau light™ brace have shown a satisfactory in-brace correction exceeding 50% of the initial Cobb angle. BRACE DESCRIPTION: The ScoliOlogiC® off the shelf bracing system enables the CPO to construct a light brace for scoliosis correction from a variety of pattern specific shells to be connected to an anterior and a posterior upright. This brace, when finally adjusted is called Chêneau light™ brace. The advantage of this new bracing system is that the brace is available immediately, is easily adjustable and that it can also be easily modified. This avoids construction periods of sometimes more than 6 weeks, where the curve may drastically increase during periods of fast growth. The disadvantage of this bracing system is that there is a wide variability of possibilities to arrange the different shells during adjustment. RESULTS: The Cobb angle in the whole group was reduced by an average of 16,4°, which corresponds to a correction effect of 51%. The differences were highly significant in the T-test (T = 17,4; p < 0,001). The best correction effects achieved with Chêneau braces reported in literature so far are about 40% in two different studies. The correction effect was highest in lumbar and thoracolumbar curve patterns (62%; n = 18). In thoracic scoliosis the correction effect was 36% (n = 41) and in double major curve patterns 50% (n = 22). The correction effect was affected in a slightly negative way due to age (r = -0,24; p = 0,014), negatively with the Risser stage (-0,29; p = 0,0096) and correlated negatively with the Cobb angle measured before treatment (r = -0,43; p < 0,0001). CONCLUSIONS: The use of the Chêneau light™ brace leads to correction effects above average when compared to correction effects of other braces described in literature. The reduction of material seems to increase patient's comfort and reduces the stress patients may suffer from whilst in the brace.80% of the adolescent population of scoliosis patients can be braced with the Chêneau light™ brace. In certain patterns of curvature and in the younger population with an age of less than 11 years, other approaches have to be used, such as plaster based bracing or the application of CAD/CAM based orthoses.

Project description:Unlabelled: The Lyon Brace, or adjustable multi-shell brace, has been used for more than 60 years.The use and function of the Lyon Brace includes:- The utilization of one or two corrective plaster casts, which enables a true lengthening of the concave ligaments.- An oriented CAD-CAM moulding in 3D auto correction after the removal of the plaster cast.- A blueprint adapted to Lenke's classification.- A specific physiotherapy program.BackgroundPierre Stagnara created the Lyon Brace in 1947. The brace has the following characteristics:- It adjusts to allow for a child's growth of up to seven centimetres and for an increase in weight of up to seven kilograms.- It is 'active' in that the rigidity of the PMM (polymetacrylate of methyl) structure stimulates the user to auto-correct. The active axial auto-correction decreases the pressures of the brace on the trunk.- It is decompressive in that the effect of extension between the two pelvic and scapular girdles decreases the pressure on the intervertebral disc allowing for more effective pushes in the other planes.- It is symmetrical making it both more aesthetically pleasing and easier to build.- It is stable at both shoulders and pelvic girdle, facilitating the intermediate 3D corrections.- It is transparent. The pressure of the shells on the skin can be directly controlled so "pads" are usually not necessary.Brace descriptionTwo metal bars are fixed vertically, one anterior the other posterior and all shells are attached from the bottom to the top in this order:- Two pelvic shells ensure an optimal stability of the brace.- One lumbar shell T12-L4, which can be either independent or extending, at the abdominal chondrocostal level.- One thoracic shell at the level of the thoracic convexity.- One opposite thoracic shell used as a counter push.- One shoulder balance shell on the side of the thoracic convexity.Long term follow up resultsThis is a retrospective study of 1,338 completed treatments checked a minimum of two years after weaning from the brace.Only 5% of the curves progressed more than 5° from the initial magnitudes. This translates to an effectiveness index of 0.95.A subset of 174 subjects who started treatment at Risser 0 was isolated. The global progressive angular mean curve was superimposed on the statistic general curve and the effectiveness index was calculated at 0.80.The Surgery rate was just 2% of the patients presenting with an initial curve below 45°.ConclusionThe Lyon Brace is the historical reference of bracing AIS. To be fully effective, it requires the patient to wear a plaster cast for at least one month and receive specific physiotherapy training. Although this is a retrospective study, the results are very positive, and clearly indicate a need for a prospective study.

Project description:PURPOSE: To investigate whether the predisposition genes previously reported to be associated with the occurrence or curve severity of adolescent idiopathic scoliosis (AIS) play a role in the effectiveness of brace treatment. METHOD: A total of 312 AIS patients treated with bracing were enrolled in this study. The Cobb angle of the main curve was recorded at the beginning of brace treatment as well as at each follow-up. The patients were divided into two groups according to the outcome of brace treatment (success/failure). The failure of brace treatment was defined as a curve progression of more than 5° compared to the initial Cobb angle or surgical intervention because of curve progression. Single nucleotide polymorphism (SNP) sites in the genes for estrogen receptor ? (ER?), estrogen receptor ? (ER?), tryptophan hydroxylase 1 (TPH-1), melatonin receptor 1B (MTNR1B) and matrillin-1 (MATN1), which were previously identified to be predisposition genes for AIS, were selected for genotyping by the PCR-RFLP method. Differences of genotype and allele distribution between the two groups were compared by the ?(2) test. A logistic regression analysis was used to figure out the independent predictors of the outcome of brace treatment. RESULTS: There were 90 cases (28.8%) in the failure group and 222 cases (71.2%) in the success group. Patients in the failure group were associated with the genotype GA (50.9 vs. 17.9% p < 0.001) and the G allele (27.1 vs. 12.0%, p < 0.001) at SNP rs9340799 of the ER? gene. Similarly, they were also associated with the genotype AT (33.3 vs. 13.0%, p = 0.002) and the A allele (16.7 vs. 9.6%, p = 0.033) at SNP rs10488682 of the TPH-1 gene. For MTNR1B, the difference of genotype distribution between the two groups was found to be statistically significant, while the difference of allele distribution between the two groups was found to be marginally statistically significant; for the MATN1 and ER? genes, we found no significant differences of the genotype or allele distribution between the two groups. In the logistic regression analysis, ER? and TPH-1 were demonstrated to be independent factors predictive of bracing effectiveness. CONCLUSIONS: ER? and TPH-1 might be potential genetic markers that could predict the outcome of brace treatment. Patients with the G allele at the rs9340799 site of the ER? gene and the A allele at the rs10488682 site of the TPH-1 gene are prone to be resistant to brace treatment.

Project description:BACKGROUND:Four factors have been reported to affect brace treatment outcome: (1) growth or curve based risk, (2) the in-brace correction, (3) the brace wear quantity, and (4) the brace wear quality. The quality of brace design affects the in-brace correction and comfort which indirectly affects the brace wear quantity and quality. This paper reported the immediate benefits and results on using ultrasound (US) to aid orthotists to design braces for the treatment of scoliosis. METHODS:Thirty-four AIS subjects participated in this study with 17 (2 males, 15 females) in the control group and 17 (2 males, 15 females) in the intervention (US) group. All participants were prescribed full time TLSO, constructed by either of the 2 orthotists in fabrication of spinal braces. For the control group, the Providence brace design system was adopted to design full time braces. For the intervention group, the custom standing Providence brace design system, plus a medical ultrasound system, a custom pressure measurement system and an in-house software were used to assist brace casting. RESULTS:In the control group, 8 of 17 (47%) subjects needed a total of 11 brace adjustments after initial fabrication requiring a total of 28 in-brace radiographs. Three subjects (18%) required a second adjustment. For the US group, only 1 subject (6%) required adjustment. The total number of in-brace radiographs was 18. The p value of the chi-square for requiring brace adjustment was 0.006 which was a statistically significant difference between the two groups. In the intervention group, the immediate in-brace correction as measured from radiographs was 48?±?17%, and in the control group the first and second in-brace correction was 33?±?19% and 40?±?20%, respectively. The unpaired 2 sided Student's t test of the in-brace correction was significantly different between the US and the first follow-up of the control group (p?=?0.02), but was not significant after the second brace adjustment (p?=?0.22). CONCLUSIONS:The use of the 3D ultrasound system provided a radiation-free method to determine the optimum pressure level and location to assist brace design, resulting in decreased radiation exposure during follow-up brace evaluation, increased the in-brace correction, reduced the patients' visits to both brace adjustment and scoliosis clinics. However, the final outcomes could not be reported yet as some of patients are still under brace treatment. TRIAL REGISTRATION:NCT02996643, retrospectively registered in 16 December 2016.

Project description:It is recommended that research in patients with idiopathic scoliosis should focus on short- and long-term patient-centred outcome. The aim of the present study was to evaluate outcome in patients with late-onset juvenile or adolescent idiopathic scoliosis 16 years or more after Boston brace treatment.272 (78%) of 360 patients, 251 (92%) women, responded to follow-up examination at a mean of 24.7 (range 16 - 32) years after Boston brace treatment. Fifty-eight (21%) patients had late-onset juvenile and 214 had adolescent idiopathic scoliosis. All patients had clinical and radiological examination and answered a standardised questionnaire including work status, demographics, General Function Score (GFS) (100 - worst possible) and Oswestry Disability Index (ODI) (100 - worst possible), EuroQol (EQ-5D) (1 - best possible), EQ-VAS (100 - best possible), and Scoliosis Research Society - 22 (SRS - 22) (5 - best possible).The mean age at follow-up was 40.4 (31-48) years. The prebrace major curve was in average 33.2 (20 - 57)°. At weaning and at the last follow-up the corresponding values were 28.3 (1 - 58)° and 32.5 (7 - 80)°, respectively. Curve development was similar in patients with late-onset juvenile and adolescent start. The prebrace curve increased > 5° in 31% and decreased > 5° in 26%. Twenty-five patients had surgery. Those who did not attend follow-up (n = 88) had a lower mean curve at weaning: 25.4 (6-53)°. Work status was 76% full-time and 10% part-time. Eighty-seven percent had delivered a baby, 50% had pain in pregnancy. The mean (SD) GFS was 7.4 (10.8), ODI 9.3 (11.0), EQ-5D 0.82 (0.2), EQ-VAS 77.6 (17.8), SRS-22: pain 4.1 (0.8), mental health 4.1 (0.6), self-image 3.7 (0.7), function 4.0 (0.6), satisfaction with treatment 3.7 (1.0). Surgical patients had significantly reduced scores for SRS-physical function and self-image, and patients with curves ? 45° had reduced self-image.Long-term results were satisfactory in most braced patients and similar in late-onset juvenile and idiopathic adolescent scoliosis.

Project description:Over the last years, evidence has accumulated in support of bracing as an effective treatment option in patients with idiopathic scoliosis. Yet, little information is available on the impact of compliance on the outcome of conservative treatment in scoliotic subjects. The aim of the present study was to prospectively evaluate the association between compliance to brace treatment and the progression of scoliotic curve in patients with idiopathic adolescent (AIS) or juvenile scoliosis (JIS).Among 1.424 patients treated for idiopathic scoliosis, 645 were eligible for inclusion criteria. Three outcomes were distinguished in agreement with the SRS criteria: curve correction, curve stabilization and curve progression. Brace wearing was assessed by one orthopaedic surgeon (LA) and scored on a standardized form. Compliance to treatment was categorized as complete (brace worn as prescribed), incomplete A (brace removed for 1 month), incomplete B (brace removed for 2 months), incomplete C (brace removed during school hours), and incomplete D (brace worn overnight only). Chi square test, T test or ANOVA and ANOVA for repeated measures tests were used as statistical tests.The results from our study showed that at follow-up the compliance was: Complete 61.1%; Incomplete A 5.2%; Incomplete B 10.7%; Incomplete C 14.2%; Incomplete D 8.8%. Curve correction was accomplished in 301/319 of Complete, 19/27 Incomplete A, 25/56 Incomplete B, 52/74 Incomplete C, 27/46 Incomplete D. Cobb mean value was 29.8?±?7.5 SD at beginning and 17.1?±?10.9 SD at follow-up. Both Cobb and Perdriolle degree amelioration was significantly higher in patients with complete compliance over all other groups, both in juvenile, both in adolescent scoliosis. In the intention-to-treat analysis, the rate of surgical treatment was 2.1% among patients with definite outcome and 12.1% among those with drop-out. Treatment compliance showed significant interactions with time.Curve progression and referral to surgery are lower in patients with high brace compliance. Bracing discontinuation up to 1 month does not impact on the treatment outcome. Conversely, wearing the brace only overnight is associated with a high rate of curve progression.

Project description:IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10-16 years) with Risser sign 0-II, Cobb angle of main curve of 20°-40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen's design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.

Dataset Information

"Brace technology" thematic series - the Gensingen brace™ in the treatment of scoliosis.

Publications

"Brace technology" thematic series - the Gensingen brace™ in the treatment of scoliosis.

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