Correction of severe spinal deformity is a significant challenge for spinal surgeons. Although halo-gravity traction (HGT) has been shown to be well-tolerated and safe, we report here a case of neurologic decline during treatment. A 24-year-old male presents with severe thoracic kyphoscoliosis with > 180° of 3-dimensional deformity. Magnetic resonance imaging showed his thoracic spinal cord draped across his T7-9 apex. His neurologic exam showed lower extremity myelopathy. During week 7 at a goal traction weight of 18.1 kg, his distal lower extremity exam declined from 4+/5 to 2/5. His traction weight was lowered to 11.3 kg. He subsequently sustained a ground-level fall and became paraparetic with a motor exam of 1-2/5. He subsequently underwent a T1-L4 posterior spinal instrumentation and fusion with a T7-9 vertebral column resection. Postoperatively, he was noted to have a complete return to his baseline neurologic exam. At his 4-month postoperative visit, he was now full strength in his lower extremities with complete resolution of his myelopathy. We present here a case of neurologic decline in a patient with severe kyphoscoliosis who underwent HGT and discuss the management decisions associated with this challenging scenario.

Object

The goal in this study was to evaluate the risk factors for complications, including new neurological deficits, in the largest cohort of patients with adult spinal deformity to date.

Methods

The Scoli-RISK-1 inclusion criteria were used to identify eligible patients from 5 centers who were treated between June 1, 2009, and June 1, 2011. Records were reviewed for patient demographic information, surgical data, and reports of perioperative complications. Neurological deficits were recorded as preexisting or as new deficits. Patients who underwent 3-column osteotomies (3COs) were compared with those who did not (posterior spinal fusion [PSF]). Between-group comparisons were performed using independent samples t-tests and chi-square analyses.

Results

Two hundred seven patients were identified-75 who underwent PSF and 132 treated with 3CO. In the latter group, patients were older (58.9 vs 49.4 years, p < 0.001), had a higher body mass index (29.0 vs 25.8, p = 0.029), smaller preoperative coronal Cobb measurements (33.8° vs 56.4°, p < 0.001), more preoperative sagittal malalignment (11.7 cm vs 5.4 cm, p < 0.001), and similar sagittal Cobb measurements (45.8° vs 57.7°, p = 0.113). Operating times were similar (393 vs 423 minutes, p = 0.130), although patients in the 3CO group sustained higher estimated blood loss (2120 vs 1700 ml, p = 0.066). Rates of new neurological deficits were similar (PSF: 6.7% vs 3CO: 9.9%, p = 0.389), and rates of any perioperative medical complication were similar (PSF: 46.7% vs 3CO: 50.8%, p = 0.571). Patients who underwent vertebral column resection (VCR) were more likely to sustain medical complications than those treated with pedicle subtraction osteotomy (73.7% vs 46.9%, p = 0.031), although new neurological deficits were similar (15.8% vs 8.8%, p = 0.348). Regression analysis did not reveal significant predictors of neurological injury or complication from collected data.

Conclusions

Despite higher estimated blood loss, rates of all complications (49.3%) and new neurological deficits (8.7%) did not vary for patients who underwent complex reconstruction, whether or not a 3CO was performed. Patients who underwent VCR sustained more medical complications without an increase in new neurological deficits. Prospective studies of patient factors, provider factors, and refined surgical data are needed to define and optimize risk factors for complication and neurological deficits.

Study design

Retrospective cohort study.

Objective

Determine the indications, complications, and clinical outcomes in patients requiring fusions from the cervical spine to the pelvis. Several investigators have examined fusions from the thoracic spine to the sacrum, but no similar study has been performed for cervical-to-pelvis fusions.

Methods

Patients from 2003 to 2014 with an upper instrumented vertebrae (UIV) in the cervical spine (any level) and a lower instrumented vertebrae (LIV) in the sacrum or pelvis were included in the study. Those with infectious or acute trauma-related deformities were excluded. Patient demographics, medical history, diagnosis, operative procedure, and health-related quality of life measures were analyzed. Student's t test, Kruskal-Wallis test, and χ² test were used as appropriate; significance was set at P < .05 for all tests.

Results

Fifty-five patients met inclusion criteria for the study. Average follow-up was 2.8 years. Proximal junctional kyphosis was the most common indication for cervical-to-pelvis fusions (36%). The most common UIV was C2 (29%) followed by C7 (24%). There was an average 31° correction in maximum kyphosis and a 3.3 cm improvement in sagittal vertical axis. In adults, the rate of complication was 71.4%, with a major complication rate of 39.3% and reoperation rate of 53.6%. There was significant improvement in the Scoliosis Research Society (SRS-22r) score (3.0 to 3.5; P < .01).

Conclusion

Proximal junctional kyphosis is the most common indication for patients requiring fusion to the cervical spine. Adult patients incur a significant risk of major complications and reoperations. However, significant improvement in SRS-22r outcomes are noted in these patients.

Study design

Prospective cohort.

Objective

To prospectively evaluate PROs up to 5-years after complex ASD surgery.

Methods

The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures.

Results

Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, P < 0.001), SF36-PCS (31.5 vs. 38.8, P < 0.001), SF36-MCS (44.9 vs. 49.1, P = 0.009), SRS-22-total (2.78 vs. 3.61, P < 0.001), NRS-back pain (5.70 vs. 2.95, P < 0.001) and NRS leg pain (3.64 vs. 2.62, P = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values (P > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without.

Conclusions

After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.

Background

The Global Alignment and Proportion (GAP) score, based on pelvic incidence-based proportional parameters, was recently developed to predict mechanical complications after surgery for spinal deformities in adults. However, this score has not been validated in an independent external dataset.

Questions/purposes

After adult spinal deformity surgery, is a higher GAP score associated with (1) an increased risk of mechanical complications, defined as rod fractures, implant-related complications, proximal or distal junctional kyphosis or failure; (2) a higher likelihood of undergoing revision surgery to treat a mechanical complication; and (3) is a lower (more proportioned) GAP score category associated with better validated outcomes scores using the Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22) and the Short Form-36 questionnaires?

Methods

A total of 272 patients who had undergone corrective surgeries for complex spinal deformities were enrolled in the Scoli-RISK-1 prospective trial. Patients were included in this secondary analysis if they fulfilled the original inclusion criteria by Yilgor et al. From the original 272 patients, 14% (39) did not satisfy the radiographic inclusion criteria, the GAP score could not be calculated in 14% (37), and 24% (64) did not have radiographic assessment at postoperative 2 years, leaving 59% (159) for analysis in this review of data from the original trial. A total of 159 patients were included in this study,with a mean age of 58 ± 14 years at the time of surgery. Most patients were female (72%, 115 of 159), the mean number of levels involved in surgery was 12 ± 4, and three-column osteotomy was performed in 76% (120 of 159) of patients. The GAP score was calculated using parameters from early postoperative radiographs (between 3 and 12 weeks) including pelvic incidence, sacral slope, lumbar lordosis, lower arc lordosis and global tilt, which were independently obtained from a computer software based on centralized patient radiographs. The GAP score was categorized as proportional (scores of 0 to 2), moderately disproportional (scores of 3 to 6), or severely disproportional (scores higher than 7 to 13). Receiver operating characteristic area under curve (AUC) was used to assess associations between GAP score and risk of mechanical complications and risk of revision surgery. An AUC of 0.5 to 0.7 was classified as "no or low associative power", 0.7 to 0.9 as "moderate" and greater than 0.9 as "high". We analyzed differences in validated outcome scores between the GAP categories using Wilcoxon rank sum test.

Results

At a minimum of 2 years' follow-up, a higher GAP score was not associated with increased risks of mechanical complications (AUC = 0.60 [95% CI 0.50 to 0.70]). A higher GAP score was not associated with a higher likelihood of undergoing a revision surgery to treat a mechanical complication (AUC = 0.66 [95% 0.53 to 0.78]). However, a moderately disproportioned GAP score category was associated with better SF-36 physical component summary score (36 ± 10 versus 40 ± 11; p = 0.047), better SF-36 mental component summary score (46 ± 13 versus 51 ± 12; p = 0.01), better SRS-22 total score (3.4 ± 0.8 versus 3.7 ± 0.7, p = 0.02) and better ODI score (35 ± 21 versus 25 ± 20; p = 0.003) than severely disproportioned GAP score category.

Conclusion

Based on the findings of this external validation study, we found that alignment targets based on the GAP score alone were not associated with increased risks of mechanical complications and mechanical revisions in patients with complex adult spinal disorders. Parameters not included in the original GAP score needed to be considered to reduce the likelihood of mechanical complications.

Level of evidence

Level III, diagnostic study.

Study design

International, multicenter, prospective, longitudinal observational cohort.

Objective

To assess how new motor deficits affect patient reported quality of life scores after adult deformity surgery.

Summary of background data

Adult spinal deformity surgery is associated with high morbidity, including risk of new postoperative motor deficit. It is unclear what effect new motor deficit has on Health-related Quality of Life scores (HRQOL) scores.

Methods

Adult spinal deformity patients were enrolled prospectively at 15 sites worldwide. Other inclusion criteria included major Cobb more than 80°, C7-L2 curve apex, and any patient undergoing three column osteotomy. American Spinal Injury Association (ASIA) scores and standard HRQOL scores were recorded pre-op, 6 weeks, 6 months, and 2 years.

Results

Two hundred seventy two complex adult spinal deformity (ASD) patients enrolled. HRQOL scores were worse for patients with lower extremity motor score (LEMS). Mean HRQOL changes at 6 weeks and 2 years compared with pre-op for patients with motor worsening were: ODI (+12.4 at 6 weeks and -4.7 at 2 years), SF-36v2 physical (-4.5 at 6 weeks and +2.3 at 2 years), SRS-22r (0.0 at 6 weeks and +0.4 at 2 years). Mean HRQOL changes for motor-neutral patients were: ODI (+0.6 at 6 weeks and -12.1 at 2 years), SF-36v2 physical (-1.6 at 6 weeks and +5.9 at 2 years), and SRS-22r (+0.4 at 6 weeks and +0.7 at 2 years). For patients with LEMS improvement, mean HRQOL changes were: ODI (-0.6 at 6 weeks and -16.3 at 2 years), SF-36v2 physical (+1.0 at 6 weeks and +7.0 at 2 years), and SRS-22r (+0.5 at 6 weeks and +0.9 at 2 years).

Conclusion

In the subgroup of deformity patients who developed a new motor deficit, total HRQOLs and HRQOL changes were negatively impacted. Patients with more than 2 points of LEMS worsening had the worst changes, but still showed overall HRQOL improvement at 6 months and 2 years compared with pre-op baseline.Level of Evidence: 3.

Background

The reported neurologic complication rate following surgery for complex adult spinal deformity (ASD) is variable due to several factors. Most series have been retrospective with heterogeneous patient populations and use of nonuniform neurologic assessments. The aim of this study was to prospectively document lower extremity motor function by means of the American Spinal Injury Association (ASIA) lower extremity motor score (LEMS) before and through 2 years after surgical correction of complex ASD.

Methods

The Scoli-RISK-1 study enrolled 272 patients with ASD, from 15 centers, who had undergone primary or revision surgery for a major Cobb angle of ≥80°, corrective osteotomy for congenital spinal deformity or as a revision procedure for any type of deformity, and/or a complex 3-column osteotomy.

Results

One of 272 patients lacked preoperative data and was excluded from the analysis, and 62 (22.9%) of the remaining 271 patients, who were included, lacked a 2-year postoperative assessment. Patients with no preoperative motor impairment (normal LEMS group; n = 203) had a small but significant decline from the mean preoperative LEMS value (50) to that at 2 years postoperatively (49.66 [95% confidence interval = 49.46 to 49.85]; p = 0.002). Patients who did have a motor deficit preoperatively (n = 68; mean LEMS, 43.79) had significant LEMS improvement at 6 months (47.21, p < 0.001) and 2 years (46.12, p = 0.003) postoperatively. The overall percentage of patients (in both groups combined) who had a postoperative LEMS decline, compared with the preoperative value, was 23.0% at discharge, 17.1% at 6 weeks, 9.9% at 6 months, and 10.0% at 2 years.

Conclusions

The percentage of patients who had a LEMS decline (compared with the preoperative score) after undergoing complex spinal reconstructive surgery for ASD was 23.0% at discharge, which improved to 10.0% at 2 years postoperatively. These rates are higher than previously reported, which we concluded was due to the prospective, strict nature of the LEMS testing of patients with these challenging deformities.

Level of evidence

Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Study design

Secondary analysis of prospective multicenter cohort.

Objective

To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).

Summary of background data

Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.

Methods

The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.

Results

Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).

Conclusion

Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.

Level of evidence

2.

Study design

Expert consensus study.

Objective

This expert panel was created to establish best practice guidelines to identify and treat patients with poor bone health prior to elective spinal reconstruction.

Summary of background data

Currently, no guidelines exist for the management of osteoporosis and osteopenia in patients undergoing spinal reconstructive surgery. Untreated osteoporosis in spine reconstruction surgery is associated with higher complications and worse outcomes.

Methods

A multidisciplinary panel with 18 experts was assembled including orthopedic and neurological surgeons, endocrinologists, and rheumatologists. Surveys and discussions regarding the current literature were held according to Delphi method until a final set of guidelines was created with over 70% consensus.

Results

Panelists agreed that bone health should be considered in every patient prior to elective spinal reconstruction. All patients above 65 and those under 65 with particular risk factors (chronic glucocorticoid use, high fracture risk or previous fracture, limited mobility, and eight other key factors) should have a formal bone health evaluation prior to undergoing surgery. DXA scans of the hip are preferable due to their wide availability. Opportunistic CT Hounsfield Units of the vertebrae can be useful in identifying poor bone health. In the absence of contraindications, anabolic agents are considered first line therapy due to their bone building properties as compared with antiresorptive medications. Medications should be administered preoperatively for at least 2 months and postoperatively for minimum 8 months.

Conclusion

Based on the consensus of a multidisciplinary panel of experts, we propose best practice guidelines for assessment and treatment of poor bone health prior to elective spinal reconstructive surgery. Patients above age 65 and those with particular risk factors under 65 should undergo formal bone health evaluation. We also established guidelines on perioperative optimization, utility of various diagnostic modalities, and the optimal medical management of bone health in this population.Level of Evidence: 5.

Objective

Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.

Methods

The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22.

Results

The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD.

Conclusions

The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.