目的:为了评估疗效,为患者量身定制的3D打印支架在治疗青少年特发性脊柱侧凸(AIS)中的安全性,并比较使用两种不同类型支具治疗的患者的健康相关生活质量(HRQoL)。
方法:从2017年9月至2020年8月,前瞻性招募了103名需要非手术治疗的AIS患者。所有患者每6个月随访一次,在每个随访时间评估临床和放射学检查.获得站立姿势下脊柱的全长前后X射线。在最后一次随访中,每位患者均完成了标准化的HRQoL问卷.依从性定义为患者坚持每天佩戴支具≥23h(全时佩戴),每6个月随访直至骨成熟。主曲线Cobb进展速率定义为:主曲线最大Cobb角大于6°,与初始诊断时相比,或加重到45°以上,因此建议在治疗期间进行骨科手术,定义为手术的转化率。通过独立样本t检验和卡方检验分析这两种类型的牙套对主曲线Cobb进展率和HRQoL的影响。
结果:胸腰骶骨矫形器(TLSO)的厚度为4mm,3D打印支架(3DPB)的厚度为3mm。此外,与TLSO中使用的材料相比,具有相同面积的3DPB材料的重量(600-800克)减少约25-30%。55例患者(49.1%)和48例患者(33.1%)分别纳入3DPB队列和TLSO队列。6个月时3DPB队列主曲线最大Cobb角明显低于TLSO队列,12个月及末次随访(p<0.01)。两组末次随访时的胸椎后凸(TK)和腰椎前凸(LL)均低于支具治疗前,此外,随访时,两组TK(p=0.001)和LL(p=0.004)差异显著.身体机能的分数,疼痛,自我形象,3DPB队列中中文版SRS-22的心理健康和治疗满意度高于TLSO队列(分别为p<0.01和p<0.05)。在EuroQol-5D健康描述系统的四个维度(分别为p=0.008、0.013、0.015和0.002)中,3DPB队列的得分显着高于TLSO组,3DPB队列的EuroQol-5D的总体健康状况更高(p<0.001)。在最后一次随访中,3DPB队列中的1例患者和TLSO队列中的10例患者的主要曲线Cobb进展大于6°,3DPB队列的主要曲线Cobb进展率显着低于TLSO队列(OR14.2,95%CI1.7〜115.8,p<0.01)。3DPB中的一名患者和TLSO队列中的七名患者接受了后续手术或被推荐进行手术,手术转阴率明显低于3DPB组(OR9.2,95%CI1.1~77.9,p<0.05)。
结论:患者定制的3D打印支架更轻,更薄,在AIS的治疗中,比传统的牙套更舒适。它可以显著改善患者的HRQoL,并可以显著降低主要曲线Cobb进展和手术转换率。
OBJECTIVE: To evaluate the efficacy and safety of patient-tailored 3D printed brace in the treatment of adolescent idiopathic scoliosis (AIS), and to compare the health-related quality of life (
HRQoL) of patients treated with 2 different types of brace.
METHODS: From September 2017 to August 2020, 103 AIS patients requiring non-operative management were prospectively recruited in this study. All patients were followed up every 6 months, clinical and radiologic examination were assessed at each follow-up time. Full-length anteroposterior radiographs of the spine in the standing position were obtained. At the last follow-up, each patient completed a standardized
HRQoL questionnaire. Compliance is defined as that the patient insists on wearing the brace for ≥23 hours every day (full-time wearing) and follow-up every 6 months until bone maturity. The rate of major curve Cobb progression was defined that maximum Cobb angle of major curve greater than 6° compared with that at the initial diagnosis, or aggravated to more than 45° so that orthopedic surgery was recommended during treatment, which was defined as the rate of conversion to surgery. The effects of these 2 types of braces on the rate of major curve Cobb progression and
HRQoL were analyzed by independent sample t test and χ2 test.
RESULTS: The thickness was 4 mm for thoracolumbosacral orthosis (TLSO) and 3 mm for 3D-printed brace (3DPB). In addition, compared with the material used in TLSO, the weight (600-800 g) of the 3DPB materials with the same area is reduced by about 25% to 30%. In our sample, 55 patients (49.1%) and 48 patients (33.1%) were respectively included in the 3DPB cohort and the TLSO cohort. The maximum Cobb angle of major curve in the 3DPB cohort was significantly lower than those in the TLSO cohort at 6 months, 12 months, and the last follow-up (P < 0.01). The thoracic kyphosis (TK) and lumbar lordosis (LL) of the 2 cohorts at the last follow-up were lower than those before brace treatment, in addition, there was a significant difference in TK (P = 0.001) and LL (P = 0.004) between the 2 cohorts at the follow-up. The scores of physical function, pain, self-image, mental health, and treatment satisfaction in the Chinese version of the 22-item questionnaire of the Scoliosis Research Society in the 3DPB cohort were higher than those in the TLSO cohort (P < 0.01 and P < 0.05, respectively). The scores of the 3DPB cohort were significantly higher than those of the TLSO group in the 4 dimensions (P = 0.008, 0.013, 0.015, and 0.002, respectively) of the EuroQol-5D health description system except for mobility, and the overall health status of EuroQol-5D was higher for the 3DPB cohort (P < 0.001). At the last follow-up, 1 patient in the 3DPB cohort and 10 patients in the TLSO cohort had major curve Cobb progression of greater than 6°, and the rate of major curve Cobb progression in the 3DPB cohort was significantly lower than that in the TLSO cohort (OR 14.2, 95% CI 1.7∼115.8, P < 0.01). One patient in the 3DPB and 7 patients in the TLSO cohorts received subsequent surgery or were recommended for surgery, and the rate of conversion to surgery was significantly lower than in the 3DPB cohort (OR 9.2, 95% CI 1.1∼77.9, P < 0.05).
CONCLUSIONS: A patient-tailored 3D-printed brace is lighter, thinner, and more comfortable than conventional braces in the treatment of AIS. It can substantially improve the
HRQoL of patients and can significantly reduce the progression of major curve Cobb progression and rate of conversion of surgery.