Lou Edmond H, Hill Doug L, Donauer Andreas, Tilburn Melissa, Hedden Douglas, Moreau Marc
Department of Surgery, University of Alberta, 6-110F, Clinical Science Building, 8440-112 Street, Edmonton, Alberta T6G 2B7 Canada.
Department of Research and Innovation Development, Glenrose Rehabilitation Hospital, Edmonton, Alberta T5G 0B7 Canada.
Scoliosis Spinal Disord. 2017 Aug 8;12:23. doi: 10.1186/s13013-017-0130-2. eCollection 2017.
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.
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.
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 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 test of the in-brace correction was significantly different between the US and the first follow-up of the control group ( = 0.02), but was not significant after the second brace adjustment ( = 0.22).
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.
NCT02996643, retrospectively registered in 16 December 2016.
据报道，有四个因素会影响支具治疗效果：（1）基于生长或曲线的风险，（2）支具内矫正，（3）支具佩戴量，以及（4）支具佩戴质量。支具设计质量会影响支具内矫正和舒适度，进而间接影响支具佩戴量和质量。本文报告了使用超声（US）辅助矫形师设计用于治疗脊柱侧弯支具的即时益处和结果。
34名青少年特发性脊柱侧弯（AIS）受试者参与了本研究，其中17名（2名男性，15名女性）为对照组，17名（2名男性，15名女性）为干预（US）组。所有参与者均被开具全天佩戴的胸腰骶矫形器（TLSO），由制作脊柱支具的2名矫形师中的任何一人制作。对于对照组，采用普罗维登斯支具设计系统设计全天佩戴的支具。对于干预组，使用定制的站立式普罗维登斯支具设计系统，外加一个医用超声系统、一个定制压力测量系统和一个内部软件来辅助支具塑形。
在对照组中，17名受试者中有8名（47%）在初次制作后总共需要11次支具调整，总共需要28张支具内X光片。3名受试者（18%）需要第二次调整。对于US组，只有1名受试者（6%）需要调整。支具内X光片总数为18张。两组在需要支具调整方面的卡方值为0.006，差异具有统计学意义。在干预组中，X光片测量的即时支具内矫正为48±17%，而在对照组中，第一次和第二次支具内矫正分别为33±19%和40±20%。支具内矫正的非配对双侧t检验在US组和对照组第一次随访之间有显著差异（P=0.02），但在第二次支具调整后无显著差异（P=0.22）。
使用三维超声系统提供了一种无辐射的方法来确定最佳压力水平和位置以辅助支具设计，从而在随访支具评估期间减少辐射暴露，增加支具内矫正，减少患者去支具调整诊所和脊柱侧弯诊所的次数。然而，由于一些患者仍在接受支具治疗，最终结果尚未报告。
NCT02996643，于2016年12月16日进行回顾性注册。
