Janicki Joseph A, Poe-Kochert Connie, Armstrong Douglas G, Thompson George H
Division of Pediatric Orthopaedics, Rainbow Babies and Children's Hospital, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH 44106, USA.
J Pediatr Orthop. 2007 Jun;27(4):369-74. doi: 10.1097/01.bpb.0000271331.71857.9a.
This is a retrospective cohort study comparing the effectiveness of the thoracolumbosacral orthosis (TLSO) and the Providence orthosis in the treatment of adolescent idiopathic scoliosis (AIS) using the new Scoliosis Research Society (SRS) Committee on Bracing and Nonoperative Management inclusion and assessment criteria for bracing studies. These new criteria will make future studies comparable and more valid and accurate.
We have used a custom TLSO (duration, 22 hours/day) and the Providence orthosis (duration, 8-10 hours/night) to control progressive AIS curves. Only 83 of 160 patients met the new SRS inclusion criteria: age of 10 years and older at initiation of bracing; initial curve of 25 to 40 degrees; Risser sign 0 to 2; female; premenarcheal or less than 1 year past menarche; and no previous treatment. There were 48 patients in the TLSO group and 35 in the Providence group. The new SRS assessment criteria of effectiveness included the percentage of patients who had 5 degrees or less and 6 degrees or more of curve progression at maturity, the percentage of patients whose curve progressed beyond 45 degrees, the percentage of patients who had surgery recommended or undertaken, and a minimum of 2 years of follow-up beyond maturity in those patients who were thought to have been successfully treated. All patients are evaluated regardless of compliance (intent to treat).
There were no significant differences in age at brace initiation, initial primary curve magnitude, sex, or initial Risser sign between the 2 groups. In the TLSO group, only 7 patients (15%) did not progress (<or=5 degrees), whereas 41 patients (85%) progressed by 6 degrees or more, including the 30 patients whose curves exceeded 45 degrees. Thirty-eight patients (79%) required surgery. In the Providence group, 11 patients (31%) did not progress, whereas 24 patients (69%) progressed by 6 degrees or more, including 15 patients whose curves exceeded 45 degrees. Twenty-one patients (60%) required surgery. However, when the initial curve at initiation of bracing was 25 to 35 degrees, the results improved. Five (15%) of 34 patients in the TLSO group and 10 (42%) of 24 patients in the Providence group did not progress, whereas 29 patients (85%) and 14 patients (58%), respectively, progressed by 6 degrees or more, and 26 patients (76%) and 11 patients (46%), respectively, required surgery.
Using the new SRS bracing criteria, the Providence orthosis was more effective for avoiding surgery and preventing curve progression when the primary initial curves at bracing was 35 degrees or less. However, the overall success of orthotic management for AIS in both groups was inferior to previous studies. Our results raise the question of the effectiveness of orthotic management in AIS and support the need for a multicenter, randomized study using these new criteria.
这是一项回顾性队列研究,采用脊柱侧弯研究学会(SRS)支具与非手术治疗委员会制定的支具研究新纳入及评估标准,比较胸腰骶矫形器(TLSO)和普罗维登斯矫形器治疗青少年特发性脊柱侧弯(AIS)的有效性。这些新标准将使未来的研究具有可比性,且更有效、准确。
我们使用定制的TLSO(佩戴时间,每天22小时)和普罗维登斯矫形器(佩戴时间,每晚8 - 10小时)来控制进展性AIS曲线。160例患者中只有83例符合SRS新纳入标准:开始支具治疗时年龄10岁及以上;初始侧弯角度25至40度;Risser征0至2级;女性;月经初潮前或月经初潮后不到1年;且未曾接受过治疗。TLSO组有48例患者,普罗维登斯组有35例患者。SRS新的有效性评估标准包括成熟时侧弯进展5度及以下和6度及以上的患者百分比、侧弯进展超过45度的患者百分比、建议或接受手术的患者百分比,以及那些被认为成功治疗的患者在成熟后至少2年的随访情况。所有患者无论依从性如何均进行评估(意向性治疗)。
两组在开始使用支具时的年龄、初始主侧弯角度、性别或初始Risser征方面无显著差异。在TLSO组,只有7例患者(15%)侧弯未进展(≤5度),而41例患者(85%)侧弯进展6度或以上,其中30例患者的侧弯超过45度。38例患者(79%)需要手术。在普罗维登斯组,11例患者(31%)侧弯未进展,而24例患者(69%)侧弯进展6度或以上,其中15例患者的侧弯超过45度。21例患者(60%)需要手术。然而,当开始支具治疗时的初始侧弯为25至35度时,结果有所改善。TLSO组34例患者中有5例(15%)未进展,普罗维登斯组24例患者中有10例(42%)未进展,而分别有29例患者(85%)和14例患者(58%)侧弯进展6度或以上,分别有26例患者(76%)和11例患者(46%)需要手术。
采用SRS新的支具标准,当开始支具治疗时的初始主侧弯为35度及以下时,普罗维登斯矫形器在避免手术和防止侧弯进展方面更有效。然而,两组中AIS矫形治疗的总体成功率均低于先前研究。我们的结果引发了关于AIS矫形治疗有效性的问题,并支持采用这些新标准进行多中心随机研究的必要性。