Prospective Follow-up Report on Anterior Vertebral Body Tethering for Idiopathic Scoliosis: Interim Results from an FDA IDE Study.

BACKGROUND: Anterior vertebral body tethering (aVBT) has emerged as a novel treatment option for patients with idiopathic scoliosis. We present the results from the first U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study on aVBT. METHODS: In this prospective review of a retrospective data set, eligible patients underwent aVBT at a single center from August 2011 to July 2015. Inclusion criteria included skeletally immature patients with Lenke type-1A or 1B curves between 30° and 65°. Clinical and radiographic parameters were collected, with the latter measured by an independent reviewer. RESULTS: Fifty-seven patients (49 girls and 8 boys), with a mean age (and standard deviation) of 12.4 ± 1.3 years (range, 10.1 to 15.0 years), were enrolled in the study. The patients had a mean of 7.5 ± 0.6 levels tethered, the mean operative time was 223 ± 79 minutes, and the mean estimated blood loss was 106 ± 86 mL. The patients were followed for an average of 55.2 ± 12.5 months and had a mean Risser grade of 4.2 ± 0.9 at the time of the latest follow-up. The main thoracic Cobb angle was a mean of 40.4° ± 6.8° preoperatively and was corrected to 18.7° ± 13.4° at the most recent follow-up. In the sagittal plane, T5-T12 kyphosis measured 15.5° ± 10.0° preoperatively, 17.0° ± 10.1° postoperatively, and 19.6° ± 12.7° at the most recent follow-up. Eighty percent of patients had curves of <30° at the most recent follow-up. The most recent Scoliosis Research Society (SRS) scores averaged 4.5 ± 0.4, and scores on the self-image questionnaire averaged 4.4 ± 0.7. No major neurologic or pulmonary complications occurred. Seven (12.3%) of 57 patients had a revision: 5 were done for overcorrection and 2, for adding-on. CONCLUSIONS: Anterior VBT is a promising technique that has emerged as a treatment option for patients with immature idiopathic scoliosis. We present the results from the first FDA-approved IDE study on aVBT, which formed the basis for the eventual Humanitarian Device Exemption approval. The findings affirm the safety and efficacy of this technique and suggest opportunities for improvement, particularly with respect to reoperation rates. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Scheuermann's Kyphosis: Diagnosis, Management, and Selecting Fusion Levels.

Scheuermann's kyphosis (SK) is a rigid structural deformity of the thoracic spine defined radiographically as three or more contiguous vertebrae with at least 5° of wedging anteriorly. Prevalence of the disease is thought to be between 0.4% and 10%. The true cause of SK remains unclear; however, various theories include growth irregularities, mechanical factors, genetic factors, and/or poor bone quality as the causes. Patients with mild disease (less than 70°) generally have a favorable prognosis with good clinical outcomes. Most patients with SK are successfully treated nonsurgically with observation, anti-inflammatory medications, and physical therapy. Surgical intervention is indicated in patients with greater than 70° to 75° thoracic curves, greater than 25° to 30° thoracolumbar curves, intractable pain, neurologic deficit, cardiopulmonary compromise, or poor cosmesis. Because of advances in posterior spinal instrumentation, surgery can typically be performed through a posterior-only approach. When surgical treatment is planned, appropriate selection of the upper- and lower-instrumented vertebrae is important to achieve a well-balanced spine, preserve motion segments, and reduce the risk of junctional kyphosis.

Outcomes of patients with syringomyelia undergoing spine deformity surgery: do large syrinxes behave differently from small?

BACKGROUND CONTEXT: A paucity of data exists studying outcomes of patients with syringomyelia undergoing spinal deformity correction. The literature does not stratify patients by syrinx size, which is likely a major contributor to outcomes. PURPOSE: The study aimed to compare differences in outcomes between patients with large (≥4 mm) and small syrinxes (<4 mm) undergoing spinal deformity correction. DESIGN: This is a retrospective review. PATIENT SAMPLE: The sample included 28 patients (11 with large syrinx [LS, >4 mm] and 17 with small syrinx [SS, <4 mm]). OUTCOME MEASURES: The outcome measures were radiographic, operative, and neurophysiological measures. METHODS: We retrospectively reviewed 28 patients with syringomyelia who underwent spine deformity surgery with 2-year follow-up. Demographic, surgical, and radiographic data were collected and compared preoperatively and at 2 years. RESULTS: The LS group (11 patients) trended toward more left-sided thoracic curves (36% vs. 18%, p=.38) and was more likely to have had a Chiari decompression (45% vs. 12%, p=.08). The LS patients had larger preoperative major curves (LS=66° vs. SS=57°, p=.05), more thoracic kyphosis (LS=42°, SS=24°, p<.01), and greater rib prominences (LS=16°, SS=13°, p=.04). The LS patients had more levels fused (LS=12.2, SS=11.2, p=.05), higher estimated blood loss (EBL) (LS=1068 cc, SS=832 cc, p=.04), and a trend toward less percent correction of the major curve (LS=57%, SS=65%, p=.18). Four of 11 LS patients (36%) did not have somatosensory evoked potentials, and one of these also did not have motor evoked potentials. Neuromonitoring changes occurred in 3 of 11 (27%) LS patients and in none of the SS patients, with no postoperative deficits. CONCLUSIONS: Outcomes of patients with syringomyelia undergoing spine deformity surgery are dependent on the size of the syrinx. Those with large syringomyelia are fused longer with more EBL and less correction. Spine surgeons should be aware that these patients are more likely to have less reliable neuromonitoring, with a higher chance of experiencing a change.

Factors affecting the outcome in appearance of AIS surgery in terms of the minimal clinically important difference.

PURPOSE: The minimal clinically important difference (MCID) of the Appearance domain of the SRS-22 questionnaire is an increase ≥1.0 in surgically treated patients with adolescent idiopathic scoliosis (AIS). However, no study has sought to identify the factors associated with an SRS-22 Appearance score increase greater than the MCID at 2 years. METHODS: A retrospective analysis was performed on a prospectively collected multicenter database of 1020 surgically treated AIS patients with a minimum 2-year follow-up. Patients were divided into two cohorts: "I" = Improved after surgery (Δ Appearance ≥1.0) and "NI" = Not improved after surgery (Δ Appearance <1.0). Univariate regression was used to find a significant difference between the cohorts for individual measures. Multivariate logistic regression was used to find continuous predictors. RESULTS: 663 (65%) patients were improved greater than the MCID, and 357 were not improved (35%). The improved cohort trended toward a greater percentage of underweight patients (p = 0.074) with lower preoperative SRS Appearance scores (p < 0.001) and larger preoperative trunk shifts (p = 0.033). Postoperatively, those patients with greater percent correction of thoracic (p = 0.021) and lumbar (p = 0.003) Cobb angles, smaller apical lumbar translation (p = 0.006), and a greater correction in trunk shift (p = 0.003) were most likely to attain the MCID. CONCLUSION: Several factors influence which patients are most likely to attain the MCID following surgery for AIS. Factors such as preoperative appearance scores and body weight are patient specific; other factors such as percent correction of the thoracic and lumbar Cobb angles, trunk shift, and lumbar apical translation may be influenced by the surgeon. LEVEL OF EVIDENCE: II.

Reversible Intraoperative Neurophysiologic Monitoring Alerts in Patients Undergoing Arthrodesis for Adolescent Idiopathic Scoliosis: What Are the Outcomes of Surgery?

BACKGROUND: Confidence in intraoperative neurophysiologic monitoring (IONM) data can allow scoliosis surgeons to proceed with surgery even after a monitoring alert, assuming the recovery of signals. We sought to determine the outcomes of surgical treatment of adolescent idiopathic scoliosis (AIS) after a notable IONM alert. METHODS: We identified 676 patients who underwent arthrodesis with use of IONM for the treatment of AIS. The patients were divided into 2 cohorts: those who experienced a lower-extremity IONM alert and those who did not. An alert was defined as a notable change in IONM data, specifically, a ≥50% drop in somatosensory evoked potentials (SSEPs) and/or in transcranial motor evoked potentials (tcMEPs). RESULTS: Of the 676 patients, 36 (5.3%) experienced IONM alerts. Those patients had a larger preoperative major Cobb angle (mean of 61° ± 13° compared with 55° ± 12° for the no-alert group; p < 0.01), a greater number of levels fused (mean of 12 ± 2 compared with 11 ± 2; p < 0.01), a longer operative duration (mean of 357 ± 157 minutes compared with 298 ± 117 minutes; p < 0.01), a higher estimated blood loss (1,857 ± 1,323 mL compared with 999 ± 796 mL; p < 0.01), and a greater volume of autologous blood transfused (mean of 527 ± 525 mL compared with 268 ± 327 mL; p < 0.01). Among patients who experienced an alert and had a completed operation (34 of 36 patients), mean postoperative radiographic measurements were similar to those of the no-alert group in terms of the percentage of correction of the major Cobb angle (alert, 66% ± 13%; no alert, 64% ± 19%; p = 0.53) and of rib prominence (alert, 49% ± 36%; no alert, 47% ± 46%; p = 0.83) and measurement of thoracic kyphosis (alert, 23° ± 10°; no alert, 22° ± 2°; p = 0.58). The Scoliosis Research Society (SRS)-22 outcome scores were also similar between the 2 cohorts. CONCLUSIONS: Notable IONM changes occurred in 5.3% of the patients who underwent arthrodesis for AIS. Those patients had larger preoperative deformity, a longer operative duration, a greater number of levels fused, a higher estimated blood loss, and a greater volume of autologous blood transfused. Return of IONM data guided the surgeon to safely complete the procedure in 34 of 36 patients, with correction similar to that of patients who did not experience an alert. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Anterior vertebral body tethering for immature adolescent idiopathic scoliosis: one-year results on the first 32 patients.

PURPOSE: This retrospective chart review evaluates the clinical and radiographic outcomes of anterior vertebral body tethering (VBT) at 1-year follow-up. Anterior VBT offers a fusionless treatment option for skeletally immature patients with adolescent idiopathic scoliosis. It is a growth-modulation technique, which utilizes patients' growth to attain progressive scoliosis correction. Numerous animal models support its promise; however, clinical data remain sparse. METHODS: Clinical and radiographic data were retrospectively analyzed. We reviewed 32 patients who underwent thoracic VBT with a minimum one-year follow-up. Pertinent clinical and radiographic data were collected. ANOVA, Student's t test and Fisher's exact test were utilized to compare different time points. RESULTS: 32 patients with thoracic idiopathic scoliosis (72 % female) with a minimum one-year follow-up were identified; mean age at surgery was 12 years. All patients were considered skeletally immature pre-operatively; mean Risser score 0.42, mean Sanders score 3.2. Patients underwent tethering of an average of 7.7 levels (range 7-11). Median blood loss was 100 cc. The mean pre-operative thoracic curve magnitude was 42.8° ± 8.0° which corrected to 21.0° ± 8.5° on first erect and 17.9° ± 11.4° at most recent. The pre-operative lumbar curve of 25.2° ± 7.3° demonstrated progressive correction (first erect = 18.0° ± 7.1°, 1 year = 12.6° ± 9.4°, p < 0.00001). Thoracic axial rotation measured 13.4° pre-operatively and 7.4° at the most recent measurement (p < 0.00001). One patient experienced prolonged atelectasis which required a bronchoscopy; otherwise, no major complications were observed. CONCLUSIONS: Our early results indicate that anterior VBT is a safe and potentially effective treatment option for skeletally immature patients with idiopathic scoliosis. These patients experienced an improvement of their scoliosis with minimal major complications. However, longer term follow-up of this cohort will reveal the true benefits of this promising technique. LEVEL OF EVIDENCE: IV.

Anterior vertebral body tethering for idiopathic scoliosis: two-year results.

STUDY DESIGN: Retrospective review. OBJECTIVE: To report the 2-year results of the initial cohort undergoing anterior vertebral body tethering (VBT). SUMMARY OF BACKGROUND DATA: Anterior VBT is a promising new technique with abundant preclinical studies but very few clinical results. It is a growth modulation technique, which utilizes patients' growth to attain progressive correction of their scoliosis. We report 2-year results of the initial cohort undergoing this procedure. METHODS: After obtaining institutional review board approval, we retrospectively reviewed our first 11 consecutive patients who underwent anterior VBT with 2-year follow-up. We collected pertinent preoperative, intraoperative, and most recent clinical and radiographical data. Student t test and Fisher exact test were utilized to compare different time points. RESULTS: Eleven patients with thoracic idiopathic scoliosis (8 females) were identified, with a mean age of 12.3 ± 1.6 years. Preoperatively, all were skeletally immature (Sanders mean = 3.4 ± 1.1; Risser mean = 0.6 ± 1.1). All underwent tethering of an average of 7.8 ± 0.9 (range: 7-9) levels, with the most proximal being T5 and the most distal L2. Preoperative thoracic Cobb angle averaged 44.2 ± 9.0° and corrected to 20.3 ± 11.0° on first erect, with progressive improvement at 2 years (Cobb angle = 13.5 ± 11.6°, % correction = 70%; P < 0.00002). Similarly, the preoperative lumbar curve of 25.1 ± 8.7° demonstrated progressive correction (first erect = 14.9 ± 4.9°, 2 yr = 7.2 ± 5.1°, % correction = 71%; P < 0.0002). Thoracic axial rotation as measured by a scoliometer went from 12.4 ± 3.3° preoperatively to 6.9 ± 3.4° at the most recent measurement (P < 0.01). No major complications were observed. As anticipated, 2 patients returned to the operating room at 2 years postoperatively for loosening of the tether to prevent overcorrection. CONCLUSION: Anterior VBT is a promising technique for skeletally immature patients with idiopathic scoliosis. This technique can be performed safely and can result in progressive correction. LEVEL OF EVIDENCE: 4.

The posterior pedicle screw construct: 5-year results for thoracolumbar and lumbar curves.

OBJECT: Several studies of the outcomes of patients with adolescent idiopathic scoliosis (AIS) with thoracolumbar and lumbar curves after treatment with posterior pedicle screws have been reported, but most of these studies reported only 2-year follow-up. The authors analyzed the radiographic and clinical outcomes of patients with thoracolumbar and lumbar curves treated with posterior pedicle screws after 5 years of follow-up. METHODS: A multicenter database was retrospectively queried to identify patients with AIS who underwent spinal fusion for Lenke 3C, 5C, and 6C curves. Radiographs from the following times were compared: preoperative, first follow-up visit, 1-year follow-up visit, 2-year follow-up visit, and 5-year follow-up visit. Chart review included scoliometer measurements, Scoliosis Research Society (SRS)-22 questionnaires, and complications requiring return to the operating room. RESULTS: Among 26 patients with Lenke 3C, 5C, and 6C curves, the mean (± SD) age was 14.6 ± 2.1 years. From the time of the preoperative radiographs to the 5-year follow-up radiographs, there was a statistically significant improvement in the mean coronal lumbar Cobb angles (p < 0.0001), and from the time of the first postoperative radiographs to the 5-year follow-up radiographs, the lumbar curve remained stable (p = 0.14). From the time of the preoperative radiographs to the 5-year follow-up radiographs, there was a statistically significant improvement in the mean coronal thoracic Cobb angles (p < 0.0001), and from the time of the first postoperative radiographs to the 5-year follow-up radiographs, the thoracic curve remained stable (p = 0.10). From the first postoperative visit to the 5-year follow-up visit, the thoracic kyphosis (T5-12) remained stable (p = 0.10), and from the time of the preoperative radiographs to the 5-year follow-up radiographs, the lumbar lordosis (T-12 to top of sacrum) remained stable (p = 0.44). From the preoperative visit to the 5-year follow-up visit, the coronal balance improved significantly (p < 0.05) and remained stable from the first postoperative visit to the 5-year follow-up visit (p = 0.20). The SRS-22 total scores improved significantly from before surgery to 5 years after surgery (p < 0.0001). No patients required reoperation because of complications. CONCLUSIONS: Correction of the coronal, sagittal, and axial planes in this cohort of patients was maintained from the first follow-up measurements to 5 years after surgery. In addition, at 5 years after surgery total SRS-22 scores and inclinometer readings were improved from preoperative scores and measurements.

Comparison of 5-year outcomes between pedicle screw and hybrid constructs in adolescent idiopathic scoliosis.

OBJECT: Pedicle screw fixation has been theorized to provide better correction of scoliotic deformity, but controversy over the benefits of pedicle screw-only constructs remains, and the longer-term impact of pedicle screw fixation as compared with hybrid constructs is unclear. In this study, a retrospective review of a prospectively collected database was conducted to determine the longer-term impact of pedicle screw fixation as compared with hybrid constructs in patients with adolescent idiopathic scoliosis (AIS). METHODS: The authors retrospectively reviewed a multicenter database of pediatric patients (ages ≤ 18) from 1995 to 2006 and identified 127 patients with Lenke Type 1-4 AIS curves with a minimum 5 years of follow-up. Patients were divided into 2 cohorts based on whether they had undergone pedicle screw fixation or fixation with hybrid constructs. RESULTS: The mean main thoracic curvature of 56.1° ± 13.0°, which corrected to 14.9° ± 9.3°, translated into a mean correction of 73% (p < 0.01). The curve was 19.4° ± 10.6° at 2-year follow-up and 20.5° ± 10.4° at 5 years. When comparing preoperative parameters between the groups, differences were noted in the magnitude of the main thoracic curve (p = 0.04), flexibility of the main thoracic curve (p = 0.02), coronal balance (p = 0.04), T2-12 kyphosis (p = 0.02), and sex (p = 0.02). The pedicle screw cohort had fewer spinal segments instrumented (p < 0.01), fewer anterior releases performed (p = 0.02), and fewer thoracoplasties performed (p < 0.01). By 5 years of follow-up, significant differences were apparent between the two cohorts with respect to upper thoracic curvature (p = 0.01), T2-12 (p = 0.02) and T5-12 (p = 0.02) kyphosis, lumbar lordosis (p < 0.01), and sagittal balance (p = 0.01). CONCLUSIONS: Although some preoperative differences did exist, outcomes were comparable between hybrid and screw constructs at 2 and 5 years. However, hybrid constructs required more concurrent anterior releases and thoracoplasties to achieve similar results.