Luhmann Scott J, McCarthy Richard E
*Department of Orthopaedic Surgery, Washington University School of Medicine †St. Louis Children's Hospital ‡St. Louis Shriners Hospital §Arkansas Children's Hospital, St. Louis, MO.
J Pediatr Orthop. 2017 Dec;37(8):e567-e574. doi: 10.1097/BPO.0000000000000751.
The purpose of this study was to compare the outcomes of the SHILLA GROWTH GUIDANCE SYSTEM and "intermittent distraction growing rod" (IDGR) in the treatment of children (less than 10 y of age) with progressive spinal deformity. This was a multicenter retrospective study of the SHILLA used as an alternative treatment to IDGR to support an HDE submission for Food and Drug Administration approval.
Inclusion criteria were progressive scoliosis in a patient less than 10 years of age at index procedure. The study population consisted of 19 SHILLA and 6 IDGR patients whose mean age was 6.1 and 5.8 years, respectively. Group demographics were similar between the 2 groups.
The initial major curve magnitude was 70.3 degrees for SHILLA and 68.3 degrees for IDGR, which decreased postoperatively to 22.4 degrees (68.1% improvement) and 32.2 degrees (52.9% improvement). During the first 4 years the correction for SHILLA varied from 40.5% to 53.4% and for IDGR from 40.9% to 56.9%. At last follow-up, T1-S1 length was 32.9 cm for SHILLA (4.2 increase from preoperation) and 34.0 cm (5.0 cm increase from preoperation) for IDGR. Average growth per month from T1-S1: SHILLA 0.14 cm, IDGR 0.11 cm. Sagittal T2-T12 preoperatively was 36.3 degrees for SHILLA and 30.0 degrees for IDGR. There were 29 reoperations in 12 of the 19 SHILLA patients (63.2%) and 40 reoperations in all 6 of the IDGR patients (100%) related to the index procedure.
The SHILLA GROWTH GUIDANCE SYSTEM compares favorably with traditional IDGR constructs in terms of correction of the major curve, spinal length and growth, and maintenance of sagittal alignment. The >4-fold decrease in additional surgeries makes the SHILLA an attractive alternative to minimize comorbidities associated with additional surgeries.
Level III.
本研究的目的是比较SHILLA生长引导系统与“间歇性撑开生长棒”（IDGR）治疗进展性脊柱畸形儿童（年龄小于10岁）的疗效。这是一项多中心回顾性研究，将SHILLA用作IDGR的替代治疗方法，以支持向美国食品药品监督管理局提交的人道主义器械豁免申请。
纳入标准为初次手术时年龄小于10岁的进行性脊柱侧弯患者。研究人群包括19例使用SHILLA的患者和6例使用IDGR的患者，其平均年龄分别为6.1岁和5.8岁。两组的人口统计学特征相似。
SHILLA组初始主弯角度为70.3度，IDGR组为68.3度，术后分别降至22.4度（改善68.1%）和32.2度（改善52.9%）。在最初4年中，SHILLA组的矫正率在40.5%至53.4%之间，IDGR组在40.9%至56.9%之间。在最后一次随访时，SHILLA组T1-S1长度为32.9 cm（较术前增加4.2 cm），IDGR组为34.0 cm（较术前增加5.0 cm）。T1-S1每月平均生长：SHILLA组0.14 cm，IDGR组0.11 cm。术前矢状面T2-T12角度SHILLA组为36.3度，IDGR组为30.0度。19例SHILLA患者中有12例（63.2%）进行了29次再次手术，6例IDGR患者全部（100%）进行了40次与初次手术相关的再次手术。
SHILLA生长引导系统在主弯矫正、脊柱长度和生长以及矢状面排列维持方面与传统IDGR结构相比具有优势。再次手术减少超过4倍使得SHILLA成为减少与再次手术相关合并症的有吸引力的替代方案。
三级。
