Crawford, Charles H.

Background: Severe adolescent idiopathic scoliosis (AIS) can be treated with instrumented fusion, but the number of anchors needed for optimal correction is controversial. Methods: We conducted a multicenter, randomized study that included patients undergoing spinal fusion for single thoracic curves between 45° and 65°, the most common form of operatively treated AIS. Of the 211 patients randomized, 108 were assigned to a high-density screw pattern and 103, to a low-density screw pattern. Surgeons were instructed to use ≥1.8 implants per spinal level fused for patients in the high-implant-density group or ≤1.4 implants per spinal level fused for patients in the low-implant-density group. The primary outcome measure was the percent correction of the coronal curve at the 2-year follow-up. The power analysis for this trial required 174 patients to show equivalence, defined as a 95% confidence interval (CI) within a ±10% correction margin with a probability of 90%. Results: In the intention-to-treat analysis, the mean percent correction of the coronal curve was equivalent between the high-density and low-density groups at the 2-year follow-up (67.6% versus 65.7%; difference, −1.9% [95% CI: −6.1%, 2.2%]). In the per-protocol cohorts, the mean percent correction of the coronal curve was also equivalent between the 2 groups at the 2-year follow-up (65.0% versus 66.1%; difference, 1.1% [95% CI: −3.0%, 5.2%]). A total of 6 patients in the low-density group and 5 patients in the high-density group required reoperation (p = 1.0). Conclusions: In the setting of spinal fusion for primary thoracic AIS curves between 45° and 65°, the percent coronal curve correction obtained with use of a low-implant-density construct and that obtained with use of a high-implant-density construct were equivalent. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Background: Up to 10% of free-hand pedicle screws are malpositioned, and 1 in 300 patients may undergo return to surgery for revision of malpositioned screws. The indications for revision of asymptomatic malpositioned screws have not been carefully examined in the literature. We sought to evaluate the threshold among spinal deformity surgeons for revision of malpositioned screws. Methods: Twelve experienced spine surgeons reviewed x-ray and computed tomographic images of 32 malpositioned pedicle screws with variable degrees of anterior, medial, and lateral breeches. The surgeons were asked whether based on the image they would revise the screw: (1) intraoperatively before rod placement; (2) intraoperatively after rod placement; (3) in clinic with an asymptomatic patient. For each scenario, we assumed stable neuromonitoring and no neurological changes. Agreement and multirater κ was calculated. Results: There was good agreement as to which screws were malpositioned (80% agreement, κ=0.703). After the rod was placed or postoperatively (scenarios 2 and 3), surgeons less frequently recommended screw revision, and there was greater variability among the surgeons’ recommendations. For return to surgery from clinic for asymptomatic screw revision, % agreement was only 65% (κ=0.477). The majority recommended revision surgery for screws which approached the dura (10/12) or the aorta (7/12 surgeons). Half of the surgeons recommended revision surgery for an asymptomatic screw if the entire screw diameter was in the canal. Revision surgery was not recommended for asymptomatic patients with screws partially violating the canal (<½ the screw diameter), malpositioned laterally in the rib head, or with small anterior cortical violations remote from a vascular structure. Conclusions: There is significant variability of opinion among surgeons regarding which malpositioned screws can be safely observed in an asymptomatic patient. Given the frequency of malpositioned screws and morbidity of surgical return to surgery, more long-term data are needed to develop practice guidelines for determining which screws require revision surgery. Level of Evidence: Level III—retrospective comparative study.