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3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.

ABSTRACT: Introduction: Adolescent 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 analysis: Patients 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 dissemination: This 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 number: ChiCTR1900027379, pre-results.

SUBMITTER: Zhang Y

PROVIDER: S-EPMC7703428 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.

Zhang Youyu Y Liang Junyang J Xu Nanfang N Zeng Lin L Du Chaojun C Du Yaoxu Y Zeng Yan Y Yu Miao M Liu Zhongjun Z

BMJ open 20201127 11

<h4>Introduction</h4>Adolescent 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 pres ...[more]

PMID: 33247008

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Project description:BackgroundScoliotic braces are the standard of curve for management of moderate spinal deformities in pediatric patients. The effectiveness of this treatment method has been shown; however, the spinal and rib cage parameters, in the three anatomical planes, that are associated with bracing outcome in adolescent idiopathic scoliosis (AIS) are not fully identified.MethodsA total number of 45 right thoracic AIS patients who had received a thoraco-lumbo-scaral brace for the first time were included retrospectively. For each patient, radiographic images at three visits, pre-brace, in-brace, and at least 1 year after the first brace fit were included. Age, sex, Risser sign, and curve type at pre-brace, and thoracic and lumbar frontal and sagittal Cobb angles, thoracic and lumbar apical rotations, sagittal and frontal balances at pre-brace and in-brace were determined. Two sagittal curve types (hypothoracolumbar and normal/hyperthoracolumbar kyphosis), two rib cage types based on the costovertebral joints (drooping and horizontal), and two axial shapes of the spine (S shaped and V shaped) were used to stratify the patients. Feature selection and linear regression with regularization determined the parameters and the interaction terms that predicted the brace effectiveness significantly.ResultsSmaller in-brace thoracic Cobb and larger in-brace lordosis predicted brace effectiveness, p < 0.05. Impact of the out of brace lordosis on the brace success increased as the in brace kyphosis angle decreased, p = 0.046. A larger out of brace lordosis in hypothoracolumbar sagittal profile type patients improved the outcomes, p = 0.031. A smaller out of brace thoracic rotation improved the bracing outcomes in patients with horizontal ribs, p = 0.040.ConclusionBoth 3D patient specific parameters (lordosis, thoracic rotation, shape of the rib cage, and sagittal profile) and brace design (which allows larger in brace lordosis, better in brace Cobb correction) are important predictors of the brace effectiveness in AIS.

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:PurposeBrace treatment for adolescent idiopathic scoliosis (AIS) is usually prescribed for 20-40° curves in patients with growth potential. The aim is to reduce the risk of curve progression during growth and to avoid the curve reaching a surgical threshold. Having as small a curve as possible at skeletal maturity will reduce the risk of curve progression during adult life. While evidence exists for brace treatment in AIS, there is disagreement on how and when to discontinue bracing. The purpose of this review was to investigate what criteria have been reported for initiating brace cessation and published weaning protocols and to look at estimates of the number of patients that may progress > 5 degrees after the end of growth.MethodsThis scoping review summarizes existing knowledge on the best time to stop bracing in AIS patients, how to "wean," and what happens to spinal curves after bracing. Searches were carried out through MEDLINE, EMBASE, and PsycINFO in April 2022. A total of 1936 articles were reduced to 43 by 3 reviewers. Full papers were obtained, and data were extracted.ResultsWeaning was most commonly determined by Risser 4 (girls) and 5 (boys). Other requirements included 2 years post-menarche and no growth in standing/sitting height for 6 months. Skeletal maturity assessed from hand and wrist radiographs, e.g., Sanders' stage; distal radius and ulnar physes, could determine the optimal weaning time to minimize curve progression. Complete discontinuation was the most common option at skeletal maturity; variations on weaning protocols involved gradual reduction of bracing over 6-12 months. Curve progression after weaning is common. The 12 studies reporting early curve progression after brace weaning found a mean Cobb angle progression of 3.8° (n = 1655). From the seven studies reporting early curve progression by > 5 degrees, there were 236/700 (34%) patients. There is limited information on risk factors to predict early curve progression after finishing brace treatment with larger curves, especially those over 40 degrees possibly having more chance of progression.ConclusionCurve progression after bracing cessation is a negative outcome for patients who have tolerated bracing for several years, especially if surgery is required. The literature shows that when to start brace cessation and weaning protocols vary. Approximately 34% of patients progressed by more than 5 degrees at 2-4 years after brace cessation or weaning. Larger curves seem more likely to progress. More research is needed to evaluate the risk factors for curve progression after brace treatment, defining the best time to stop bracing based on the lowest risk of curve progression and whether there is any benefit to weaning.

Project description:PurposeTo 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.MethodA 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 α (ERα), estrogen receptor β (ERβ), 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 χ(2) test. A logistic regression analysis was used to figure out the independent predictors of the outcome of brace treatment.ResultsThere 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 ERα 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 ERβ genes, we found no significant differences of the genotype or allele distribution between the two groups. In the logistic regression analysis, ERα and TPH-1 were demonstrated to be independent factors predictive of bracing effectiveness.ConclusionsERα 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 ERα gene and the A allele at the rs10488682 site of the TPH-1 gene are prone to be resistant to brace treatment.

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.

Dataset Information

3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.

Publications

3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.

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