Novel Hemi-Staple for the Fusionless Correction of Pediatric Scoliosis Influence on Intervertebral Disks and Growth Plates in a Porcine Model

Study Design: In vivo porcine model utilized to evaluate the influence of an intravertebral fusionless growth modulating device (hemi-staple) on intervertebral disks and growth plates. Objective: To evaluate the radiographic and histologic changes in disks and growth plates with the purpose of measuring influence of the explored hemi-staple. Summary of Background Data: Fusionless growth modulation for the early treatment of scoliosis should insure the long-term viability of the intervertebral disk and successfully reduce or arrest local growth. A novel hemi-staple that proved effective in the control of coronal spinal alignment warranted further analyses of its influence on the disk health and growth-plate morphology. Methods: A hemi-staple that inhibited local vertebral growth exclusive of the disk was introduced over T5-T8 in 4 immature pigs (16 vertebrae; experimental), whereas 3 underwent surgery without instrumentation (sham) and 2 had no intervention (control). Three-month follow-up before animal euthanasia provided radiographic (disk height and health) and histologic (growth plate morphology, disk health, and type X collagen distribution) analyses. Results: No postoperative complications were experienced. Radiographic data returned inverse disk wedging (greater disk height adjacent to device, 2.6 +/- 0.7 mm compared with the noninstrumented side, 1.8 +/- 0.5 mm) in experimental segments and suggested disk viability. Histologic data confirmed device growth modulation through significant local reduction of growth plate hypertrophic zone (125.64 +/- 16.61 mu m and 61.16 +/- 8.25 mu m in noninstrumented and instrumented sections, respectively) and cell height (16.14 +/- 1.87 mu m and 9.22 +/- 1.57 mu m in noninstrumented and instrumented sections, respectively). A variability of disk health, dependant of device insertion location, was observed. Type X collagen was consistently identified in experimental growth plates and absent from intervertebral disks. Conclusions: Hemi-staples decreased growth plate hypertrophic zone and cell height, and, depending on device insertion site, showed positive signs of disk health sustainability. Spinal growth modulation achieved exclusive of disk compression, as practiced by this method, offers unique advantages over other fusionless techniques. This technique may provide a suitable and attractive alternative for the early treatment of idiopathic scoliosis.