title: A Comparison of SHILLA GROWTH GUIDANCE SYSTEM and Growing Rods in the Treatment of Spinal Deformity in Children Less Than 10 Years of Age.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  METHODS
  Level III.
authors.affiliation: *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.
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Luhmann
authors.forename: Richard E
authors.initials: RE
authors.lastname: McCarthy
mesh_terms: D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation; D019637:Orthopedic Procedures / Q000295:instrumentation*; D009989:Orthotic Devices; D012189:Retrospective Studies; D012600:Scoliosis / Q000601:surgery*; D013131:Spine / Q000254:growth & development*; D016896:Treatment Outcome