Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.

STUDY DESIGN: Prospective multicenter database post-hoc analysis. OBJECTIVES: Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. METHODS: Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. RESULT: Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. CONCLUSIONS: In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.

Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial.

BACKGROUND: The optimal configuration for spinopelvic fixation during multilevel spine fusion surgery for adult spine deformity remains unclear. Postoperative sacroiliac (SI) joint pain, S2AI screw loosening and implant breakage could be related to continued motion of the SI joint with use of only a single point of fixation across the SI joint. METHODS: Prospective, international, multicenter randomized controlled trial of 222 patients with adult spine deformity scheduled for multilevel (4 or more levels) spine fusion surgery with pelvic fixation. Subjects were randomized to sacroalar (S2) iliac (S2AI) screws alone for pelvic fixation or S2AI + triangular titanium implants placed cephalad to S2AI screws. Quad rod techniques were not allowed or used. Baseline spinal deformity measures were read by an independent radiologist. Site-reported perioperative adverse events were reviewed by a clinical events committee. Quality of life questionnaires and other clinical outcomes are in process with planned 2-year follow-up. RESULTS: One hundred thirteen participants were assigned to S2AI and 109 to S2AI + titanium triangular implants (TTI). 35/222 (16%) of all subjects had a history of SI joint pain or were diagnosed with SI joint pain during preoperative workup. Three-month follow-up was available in all but 4 subjects. TTI placement was successful in 106 of 109 (98%) subjects assigned to TTI. In 2 cases, TTI could not be placed due to anatomical considerations. Three TTI ventral iliac breaches were observed, all of which were managed non-surgically. One TTI subject had a transverse sacral fracture and 1 TTI subject had malposition of the implant requiring removal. CONCLUSIONS: SI joint pain is common in patients with adult spinal deformity who are candidates for multilevel spine fusion surgery. Concurrent placement of TTI parallel to S2AI screws during multilevel spine fusion surgery is feasible and safe. Further follow-up will help to determine the clinical value of this approach to augment pelvic fixation.

Spine surgeon versus AI algorithm full-length radiographic measurements: a validation study of complex adult spinal deformity patients.

INTRODUCTION: Spinal measurements play an integral role in surgical planning for a variety of spine procedures. Full-length imaging eliminates distortions that can occur with stitched images. However, these images take radiologists significantly longer to read than conventional radiographs. Artificial intelligence (AI) image analysis software that can make such measurements quickly and reliably would be advantageous to surgeons, radiologists, and the entire health system. MATERIALS AND METHODS: Institutional Review Board approval was obtained for this study. Preoperative full-length standing anterior-posterior and lateral radiographs of patients that were previously measured by fellowship-trained spine surgeons at our institution were obtained. The measurements included lumbar lordosis (LL), greatest coronal Cobb angle (GCC), pelvic incidence (PI), coronal balance (CB), and T1-pelvic angle (T1PA). Inter-rater intra-class correlation (ICC) values were calculated based on an overlapping sample of 10 patients measured by surgeons. Full-length standing radiographs of an additional 100 patients were provided for AI software training. The AI algorithm then measured the radiographs and ICC values were calculated. RESULTS: ICC values for inter-rater reliability between surgeons were excellent and calculated to 0.97 for LL (95% CI 0.88-0.99), 0.78 (0.33-0.94) for GCC, 0.86 (0.55-0.96) for PI, 0.99 for CB (0.93-0.99), and 0.95 for T1PA (0.82-0.99). The algorithm computed the five selected parameters with ICC values between 0.70 and 0.94, indicating excellent reliability. Exemplary for the comparison of AI and surgeons, the ICC for LL was 0.88 (95% CI 0.83-0.92) and 0.93 for CB (0.90-0.95). GCC, PI, and T1PA could be determined with ICC values of 0.81 (0.69-0.87), 0.70 (0.60-0.78), and 0.94 (0.91-0.96) respectively. CONCLUSIONS: The AI algorithm presented here demonstrates excellent reliability for most of the parameters and good reliability for PI, with ICC values corresponding to measurements conducted by experienced surgeons. In future, it may facilitate the analysis of large data sets and aid physicians in diagnostics, pre-operative planning, and post-operative quality control.

Lumbar degenerative spondylolisthesis: role of sagittal alignment.

PURPOSE: To evaluate the sagittal alignment of the lumbar spine in patients with degenerative spondylolisthesis at the L4-5 level. METHODS: Patients with untreated degenerative spondylolisthesis at L4-5 were retrospectively identified from the clinical practice of spine surgeons at an academic medical center. All patients had standing X-rays that were reviewed by the senior surgeon to confirm the presence of degenerative spondylolisthesis at L4-5. Radiographs were analyzed for the following: lumbar lordosis (LL), lower lumbar lordosis (L4-S1; LLL), L5-S1 lordosis, pelvic incidence (PI), and pelvic tilt (PT). From these measurements, lumbar distribution index (LLL/LL × 100; LDI), ideal lumbar lordosis (PI × 0.62 + 29; ILL), PI-LL mismatch, and relative lumbar lordosis (LL-ILL; RLL) were calculated. These parameters were used to evaluate the sagittal alignment of the lumbar spine. Normal alignment was defined based on previous studies and clinical experience. RESULTS: 117 participants met inclusion criteria, with an average age of 67.2 years. The majority of the cohort demonstrated hypolordotic sagittal alignment of the L5-S1 segment when assessed in relation to ILL, PI, and LL (73.5%, 61.5%, and 50.4% respectively). Evaluation of the lower lumbar spine (L4-S1) demonstrated normal sagittal alignment when evaluated via LDI and LLL (65%, 52.1%, respectively), suggesting the presence of compensatory hyperextension at L4-5 in response to the L5-S1 hypolordosis. Consequently, normal sagittal alignment of the regional lumbar spine was maintained when evaluated using LL, PI-LL mismatch, and RLL (51.3%, 47%, and 62.4% respectively). CONCLUSIONS: This study demonstrates that there is a high incidence of relative hypolordosis at the L5-S1 level among patients who present with degenerative spondylolisthesis at L4-5. The L5-S1 hypolordosis is associated with L4-5 hyperlordosis, such that the lower lumbar lordosis (L4-S1; LLL) and regional lumbar lordosis (LL) are still within normal range. It is probable that L5-S1 hypolordosis was the initial pathologic event that incited compensatory L4-5 hyperlordosis, which in turn may have led to facet degeneration and laxity, and eventually to development of spondylolisthesis.

Does A Hinged Operating Table Facilitate Sagittal Correction in Transforaminal Lumbar Interbody Fusion With Smith-Peterson Osteotomy? A Radiographic Analysis.

BACKGROUND: Osteotomies allow the restoration of appropriate sagittal alignment; however, closure of osteotomies can be challenging. Typical closure involves compressing pedicle screw heads across the rods, potentially causing screw loosening and failure. Motorized hinged operating tables are often used to assist with controlled closure of osteotomies without manual compression, but there is no published research quantifying the amount of correction provided solely by changes in the table angle. QUESTION/PURPOSE: What is the incremental amount of correction achieved by change in the table angle versus instrumented manipulation during osteotomy closure in transforaminal lumbar interbody fusion (TLIF) with Smith-Petersen osteotomy? METHODS: Sixty-one patients undergoing Smith-Peterson osteotomy and bilateral TLIF using a motorized hinged table from October 2019 to March 2022 were prospectively enrolled. Two patients did not undergo surgery, two did not have table extension, and seven did not have data collected intraoperatively because of disruptions in research protocols owing to the coronavirus-19 pandemic. Fifty patients (24 male, 26 female) who underwent a total of 73 osteotomies were included in the final analysis. The mean ± standard deviation age was 61 ±11 years, and the mean BMI was 31 ± 6 kg/m2. Patients were positioned prone on the table and flexed to 10° for decompression, Smith-Petersen osteotomy, and TLIF. The table was then extended in 5° increments, and radiographs were taken until 10° of extension was achieved or the osteotomy was fully closed. Changes in segmental lordosis across the operative site for each 5° increment were measured to the nearest degree by two reviewers. Intraclass correlation coefficients for segmental lordosis measurements at each table angle change were calculated as 0.97 to 0.98, with all p values < 0.001, indicating excellent agreement. RESULTS: Table change from 10° to 5° yielded a mean segmental lordosis change of 1.9° ± 1.5° (73 osteotomies), 5° to 0° yielded a change of 1.3° ± 0.9° (73 osteotomies), 0° to -5° yielded a change of 1.3° ± 1.0° (69 osteotomies), and -5° to -10° yielded a change of 1.1° ± 1.3° (61 osteotomies). Rod placement and compression yielded a mean 1.8° ± 2.0° of additional segmental lordosis. CONCLUSION: Using a motorized hinged table facilitated an average of 5.6° of total segmental lordosis correction during controlled Smith-Peterson osteotomy closure without the need for cantilevering forces across spinal instrumentation. Surgeons can use this technique to reduce the compression forces needed to close osteotomies, which could eliminate a potential source of complications.Level of Evidence Level II, therapeutic study.

Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion.

BACKGROUND: Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis. METHODS: A prospective, single-arm, multicenter clinical trial (NCT02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis. RESULTS: Postoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed. CONCLUSIONS: The use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits. TRIAL REGISTRATION: NCT02969616.

Chance Fracture Pattern Presenting in Proximal Junctional Failure.

INTRODUCTION: We present a case series of proximal junctional failure due to a Chance-type fracture. METHODS: This is a retrospective review of patients who developed proximal junctional kyphosis because of Chance-type proximal junctional failure after spinal fusion for adult spinal deformity. RESULTS: Fifteen patients were identified (4M:11F). The average age was 61.4 years (range, 39 to 77). The mean time to fracture identification was 25.4 days (range, 3 to 65). The average number of levels instrumented was 6.7 (range, 2 to 17). No patients had antecedent trauma before fracture onset. In 67% of cases with a lumbar upper instrumented vertebra (UIV), there was overcorrection of lumbar lordosis (LL) and/or lower LL. The five cases with a lower thoracic UIV had undergone notable correction of preoperative thoracolumbar junction kyphosis. 14 of 15 patients were treated with extension of fusion. Pedicle screws at the fracture level were salvaged by changing to an anatomic trajectory. CONCLUSION: Continued pain at 6 to 12 weeks with radiographs showing an increased proximal junctional angle and cephalocaudal pedicle widening at the UIV should raise suspicion for this unique fracture pattern. A CT scan is recommended. Low bone density, LL and/or lower LL overcorrection, and selection of lower thoracic UIV in the setting of notable thoracolumbar junction correction may contribute to fracture risk.

Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.

STUDY DESIGN: Prospective, multicenter, international, observational study. OBJECTIVE: Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery. METHODS: Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively. RESULTS: 171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches. CONCLUSION: In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID.

The Influence of Multilevel Spinal Deformity Surgery on the EuroQol 5 Dimensions' (EQ-5D) Questionnaire and Residential Status in the Elderly: A Prospective, Observational, Multicenter Study.

STUDY DESIGN: Multicenter, international prospective study. OBJECTIVE: This study investigated the clinical outcome up to 2 years after multi-level spinal deformity surgery in the elderly by reporting the minimal clinically important difference (MCID) of EuroQol 5-dimensions (EQ-5D), EQ-VAS, and residential status. METHODS: As an ancillary study of 219 patients ≥60 years with spinal deformity undergoing primary instrumented fusion surgery of ≥5 levels, this study focuses on EQ-5D (3-L) as the primary outcome and EQ-VAS and residential status as secondary outcomes. Data on EQ-5D were compared between pre-operatively and postoperatively at 10 weeks, 12 months, and 24 months. An anchor-based approach was used to calculate the MCID. RESULTS: The EQ-5D index and EQ-VAS, respectively, improved significantly at each time point compared to pre-operatively (from .53 (SD .21) and 55.6 (SD 23.0) pre-operatively to .64 (SD .18) and 65.8 (SD 18.7) at 10 weeks, .74 (SD .18) and 72.7 (SD 18.1) at 12 months, and .73 (SD .20) and 70.4 (SD 20.4) at 24 months). 217 (99.1%) patients lived at home pre-operatively, while 186 (88.6%), 184 (98.4%), and 172 (100%) did so at 10 weeks, 12 months, and 24 months, respectively. Our calculated MCID for the EQ-5D index at 1 year was .22 (95% CI .15-.29). CONCLUSIONS: The EQ-5D index significantly increased at each time point over 24 months after ≥5 level spinal deformity surgery in elderly patients. The MCID of the EQ-5D-3 L was .22. Patients living at home pre-operatively can expect to be able to live at home 2 years postoperatively.

Sacroiliac joint fusion navigation: how accurate is pin placement?

OBJECTIVE: Sacroiliac joint (SIJ) fusion utilizing intraoperative navigation requires a standard reference frame, which is often placed using a percutaneous pin. Proper placement ensures the correct positioning of SIJ fusion implants. There is currently no grading scheme for evaluation of pin placement into the pelvis. The purpose of this study was to evaluate the occurrence of ideal percutaneous pin placement into the posterior ilium during navigated SIJ fusion. METHODS: After IRB approval was obtained, electronic medical records and intraoperative computed tomography images of patients who underwent navigated SIJ fusion by the senior author between October 2013 and January 2020 were reviewed. A pin placement grading scheme and the definition of "ideal" placement were developed by the authors and deemed acceptable by fellow attending surgeons. Six attending surgeons completed two rounds of pin placement grading, and statistical analysis was conducted. RESULTS: Of 90 eligible patients, 73.3% had ideal pin placement, 17.8% medial/lateral breach, and 8.9% complete miss. Male patients were 3.7 times more likely to have ideal placement than females (p < 0.05). There was no relationship between BMI, SIJ fusion laterality, or pin placement laterality and ideal placement. Interobserver reliability was 0.72 and 0.70 in the first and second rounds, respectively, and defined as "substantial agreement." Intraobserver reliability ranged from 0.74 (substantial agreement) to 0.92 (almost perfect agreement). CONCLUSIONS: Nonideal pin placement occurred in 26.7% of cases, but a true "miss" into the sacrum was rare. Ideal pin placement was more likely in males and was not associated with BMI, SIJ fusion laterality, or pin placement laterality. The grading scheme developed has high intraobserver and interobserver reliability, indicating that it is reproducible and can be used for future studies. When placing percutaneous pins, surgeons must be aware of factors that can decrease placement accuracy, regardless of location.

Odontoid Fracture as Proximal Junctional Failure in Patients With Multilevel Spine Fusions.

STUDY DESIGN: Retrospective study. OBJECTIVE: Proximal junctional failure (PJF) commonly occurs as a recognized potential outcome of fusion surgery. Here we describe a unique series of patients with multilevel spine fusion including the cervical spine, who developed PJF as an odontoid fracture. METHODS: We performed a single site retrospective review of patients with prior fusion that included a cervical component, who presented with an odontoid fracture between 2012 and 2019. Radiographic measurements included C2-C7 SVA, C2-C7 lordosis, T1 slope, Occiput-C2 angle, proximal junctional kyphosis, and cervical mismatch. Associated fractures, medical comorbidities, and treatments were determined via chart review after IRB approval. RESULTS: Nine patients met inclusion criteria. 5 reported trauma with subsequent onset of pain. All patients sustained a Type II odontoid fracture. 5 with associated C1/Jefferson fractures. In all patients, pre-injury Occiput-C2 angle was outside normative range; C2-C7 SVA was greater than 4 cm in 6 patients; T1-slope minus cervical lordosis was greater than 18.5 degrees in 6 patients. 7 patients were treated operatively with extension of fusion to C1 and 2 patients declined operative treatment. CONCLUSION: In this series of 9 patients with multilevel fusion with type II odontoid fractures, all patients demonstrated abnormal pre-fracture sagittal alignment parameters and a greater than normal association of C1 fractures was noted. Further study is needed to establish the role of poor sagittal alignment with compensatory occiput-C2 angulation as a predisposing factor for odontoid fracture as a proximal junctional failure mechanism.

Catastrophic acute failure of pelvic fixation in adult spinal deformity requiring revision surgery: a multicenter review of incidence, failure mechanisms, and risk factors.

OBJECTIVE: There are few prior reports of acute pelvic instrumentation failure in spinal deformity surgery. The objective of this study was to determine if a previously identified mechanism and rate of pelvic fixation failure were present across multiple institutions, and to determine risk factors for these types of failures. METHODS: Thirteen academic medical centers performed a retrospective review of 18 months of consecutive adult spinal fusions extending 3 or more levels, which included new pelvic screws at the time of surgery. Acute pelvic fixation failure was defined as occurring within 6 months of the index surgery and requiring surgical revision. RESULTS: Failure occurred in 37 (5%) of 779 cases and consisted of either slippage of the rods or displacement of the set screws from the screw tulip head (17 cases), screw shaft fracture (9 cases), screw loosening (9 cases), and/or resultant kyphotic fracture of the sacrum (6 cases). Revision strategies involved new pelvic fixation and/or multiple rod constructs. Six patients (16%) who underwent revision with fewer than 4 rods to the pelvis sustained a second acute failure, but no secondary failures occurred when at least 4 rods were used. In the univariate analysis, the magnitude of surgical correction was higher in the failure cohort (higher preoperative T1-pelvic angle [T1PA], presence of a 3-column osteotomy; p < 0.05). Uncorrected postoperative deformity increased failure risk (pelvic incidence-lumbar lordosis mismatch > 10°, higher postoperative T1PA; p < 0.05). Use of pelvic screws less than 8.5 mm in diameter also increased the likelihood of failure (p < 0.05). In the multivariate analysis, a larger preoperative global deformity as measured by T1PA was associated with failure, male patients were more likely to experience failure than female patients, and there was a strong association with implant manufacturer (p < 0.05). Anterior column support with an L5-S1 interbody fusion was protective against failure (p < 0.05). CONCLUSIONS: Acute catastrophic failures involved large-magnitude surgical corrections and likely resulted from high mechanical strain on the pelvic instrumentation. Patients with large corrections may benefit from anterior structural support placed at the most caudal motion segment and multiple rods connecting to more than 2 pelvic fixation points. If failure occurs, salvage with a minimum of 4 rods and 4 pelvic fixation points can be successful.

Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion.

BACKGROUND: While autologous bone grafts remain the gold standard for spinal fusion procedures, harvesting autologous bone is associated with significant complications, including donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allograft (CBA) presents an alternative to autologous bone harvesting, with a favorable efficacy and safety profile. The current study further investigates CBA as an adjunct to lumbar spinal fusion procedures. METHODS: A prospective, multicenter, open-label clinical study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcome measures included the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain. Adverse-event reporting was conducted throughout 12 months of follow-up. Available subject data at 12 months were analyzed. RESULTS: A total of 274 subjects were enrolled into the study, with available data from 201 subjects (73.3%) who completed 12 months of postoperative radiographic and clinical evaluation at the time of analysis. Subjects had a mean age of 60.2 ± 11.5 years. A higher number of women (n = 124, 61.7%) than men (n = 77, 38.3%) were enrolled, with a collective mean BMI of 30.6 + 6.5 kg/m2 (range 18.0-51.4). At month 12, successful fusion was achieved in 90.5% of subjects. A significant (p < 0.001) improvement in ODI, VAS-back, and VAS-leg clinical outcomes was also observed compared to baseline scores. One adverse event related to CBA (postoperative radiculopathy) was reported, with surgical exploration demonstrating interbody extrusion of graft material. This subject reported successful fusion at month 12. CONCLUSIONS: CBA represents a viable substitute for harvesting of autograft alone with a high rate of successful fusion and significant improvements in subject-reported outcomes, such as pain and disability. Positive benefit was observed in subjects reporting single and multiple risk factors for pseudoarthrosis.

Intraoperative stitched fluoroscopic images: effect of parallax on angular measurements of the spine.

BACKGROUND CONTEXT: Intraoperative stitched O-arm images are commonplace during spinal deformity correction surgeries; however, the accuracy of stitched images for measuring angular measures is unknown. PURPOSE: To examine the effect of radiographic parallax effect of stitched O-arm images by assessing the regional curve agreement with measurements from computed tomography (CT). STUDY DESIGN/SETTING: Experimental radiographic study. PATIENT SAMPLE: Four whole body cadavers (age: 81±14, sex: 2M/2F) and two fabricated spine model phantoms from surgical cases, one with extreme scoliosis and one normal spine, were utilized. OUTCOME MEASURES: The limits of agreement for angular measures between CT (gold-standard) and intraoperative stitched fluoroscopic images were calculated. Further, intra- and inter-rater reliability was measured. METHODS: A series of adjacent anterior-posterior and lateral images were acquired cranial to caudal using an O-arm in three table configurations (standard position, off-axis in the coronal plane, and reverse Trendelenburg) and stitched manually. Regional angular measures were extracted, and the limits of agreement were calculated between each table position and CT using a Bland-Altman approach. RESULTS: The observers displayed excellent inter-rater reliability across table positions (range: 0.944-0.989) and intra-rater reliability (0.979-0.995). The limits of agreement results showed a similar and better agreement was observed for the Standard and Reverse Trendelenburg than the Off-Axis position. CONCLUSIONS: This work shows reliable regional curvature measurements can be calculated with good agreement with CT in common table positions, but care should be taken to ensure the patient is perpendicular to the X-rays, particularly in the lateral view.

Bilateral open sacroiliac joint fusion during adult spinal deformity surgery using triangular titanium implants: technique description and presentation of 21 cases.

OBJECTIVE: Pelvic fixation enhances long constructs during deformity surgery. Subsequent loosening of iliac screws and pain at the pelvis occur in as many as 29% of patients. Concomitant sacroiliac (SI) fusion may prevent potential pain and failure. The objective of this study was to describe a novel surgical technique and a single institution's experience using bilateral SI fusion during adult deformity surgery with S2-alar-iliac (S2AI) screws and triangular titanium rods (TTRs) placed with navigation. METHODS: The authors reviewed open SI joint fusions with TTR performed between August 2019 and March 2020. All patients underwent lumbosacral fusion through a midline approach and bilateral S2AI pelvic fixation in the caudal teardrop, followed by TTR placement just proximal and cephalad to the S2AI screws using intraoperative CT imaging guidance. RESULTS: Twenty-one patients were identified who received 42 TTRs, ranging in size from 7.0 × 65 mm to 7.0 × 90 mm. Three TTRs (7%) were malpositioned intraoperatively, and each was successfully repositioned during index surgery without negative sequelae. All breaches occurred in a medial and cephalad direction into the pelvis. Incremental operative time for adding TTR averaged 8 minutes and 33 seconds per implant. CONCLUSIONS: Image-guided open SI joint fusion with TTR during lumbosacral fusion is technically feasible. The bony corridor for implant placement is narrower cephalad, and implants tend to deviate medially into the pelvis. Detection of malpositioned implant is aided with intraoperative CT, but this can be salvaged. A prospective randomized clinical trial is underway that will better inform the impact of this technique on patient outcomes.

Acute failure of S2-alar-iliac screw pelvic fixation in adult spinal deformity: novel failure mechanism, case series, and review of the literature.

OBJECTIVE: Pelvic fixation with S2-alar-iliac (S2AI) screws is an established technique in adult deformity surgery. The authors' objective was to report the incidence and risk factors for an underreported acute failure mechanism of S2AI screws. METHODS: The authors retrospectively reviewed a consecutive series of ambulatory adults with fusions extending 3 or more levels, and which included S2AI screws. Acute failure of S2AI screws was defined as occurring within 6 months of the index surgery and requiring surgical revision. RESULTS: Failure occurred in 6 of 125 patients (5%) and consisted of either slippage of the rods or displacement of the set screws from the S2AI tulip head, with resultant kyphotic fracture. All failures occurred within 6 weeks postoperatively. Revision with a minimum of 4 rods connecting to 4 pelvic fixation points was successful. Two of 3 (66%) patients whose revision had less fixation sustained a second failure. Patients who experienced failure were younger (56.5 years vs 65 years, p = 0.03). The magnitude of surgical correction was higher in the failure cohort (number of levels fused, change in lumbar lordosis, change in T1-pelvic angle, and change in coronal C7 vertical axis, each p < 0.05). In the multivariate analysis, younger patient age and change in lumbar lordosis were independently associated with increased failure risk (p < 0.05 for each). There was a trend toward the presence of a transitional S1-2 disc being a risk factor (OR 8.8, 95% CI 0.93-82.6). Failure incidence was the same across implant manufacturers (p = 0.3). CONCLUSIONS: All failures involved large-magnitude correction and resulted from stresses that exceeded the failure loads of the set plugs in the S2AI tulip, with resultant rod displacement and kyphotic fractures. Patients with large corrections may benefit from 4 total S2AI screws at the time of the index surgery, particularly if a transitional segment is present. Salvage with a minimum of 4 rods and 4 pelvic fixation points can be successful.

Multiple Points of Pelvic Fixation: Stacked S2-Alar-Iliac Screws (S2AI) or Concurrent S2AI and Open Sacroiliac Joint Fusion with Triangular Titanium Rod.

Sacropelvic fixation is a continually evolving technique in the treatment of adult spinal deformity. The 2 most widely utilized techniques are iliac screw fixation and S2-alar-iliac (S2AI) screw fixation1-3. The use of these techniques at the base of long fusion constructs, with the goal of providing a solid base to maintain surgical correction, has improved fusion rates and decreased rates of revision4. Description: The procedure is performed with the patient under general anesthesia in the prone position and with use of 3D computer navigation based on intraoperative cone-beam computed tomography (CT) imaging. A standard open posterior approach with a midline incision and subperiosteal exposure of the proximal spine and sacrum is performed. Standard S2AI screw placement is performed. The S2AI starting point is on the dorsal sacrum 2 to 3 mm above the S2 foramen, aiming as caudal as possible in the teardrop. A navigated awl is utilized to establish the screw trajectory, passing through the sacrum, across the sacroiliac (SI) joint, and into the ilium. The track is serially tapped with use of navigated taps, 6.5 mm followed by 9.5 mm, under power. The screw is then placed under power with use of a navigated screwdriver.Proper placement of the caudal implant is vital as it allows for ample room for subsequent instrumentation. The additional point of pelvic fixation can be an S2AI screw or a triangular titanium rod (TTR). This additional implant is placed cephalad to the trajectory of the S2AI screw. A starting point 2 to 3 mm proximal to the S2AI screw tulip head on the sacral ala provides enough clearance and also helps to keep the implant low enough in the teardrop that it is likely to stay within bone. More proximal starting points should be avoided as they will result in a cephalad breach.For procedures with an additional point of pelvic fixation, the cephalad S2AI screw can be placed using the previously described method. For placement of the TTR, the starting point is marked with a burr. A navigated drill guide is utilized to first pass a drill bit to create a pilot hole, followed by a guide pin proximal to the S2AI screw in the teardrop. Drilling the tip of the guide pin into the distal, lateral iliac cortex prevents pin backout during the subsequent steps. A cannulated drill is then passed over the guide pin, traveling from the sacral ala and breaching the SI joint into the pelvis. A navigated broach is then utilized to create a track for the implant. The flat side of the triangular broach is turned toward the S2AI screw in order to help the implant sit as close as possible to the screw and to allow the implant to be as low as possible in the teardrop. The navigation system is utilized to choose the maximum possible implant length. The TTR is then passed over the guide pin and impacted to the appropriate depth. Multiplanar post-placement fluoroscopic images and an additional intraoperative CT scan of the pelvis are obtained to verify instrumentation position. Alternatives: The use of spinopelvic fixation in long constructs is widely accepted, and various techniques have been described in the past1. Alternatives to stacked S2AI screws or S2AI with TTR for SI joint fusion include traditional iliac screw fixation with offset connectors, modified iliac fixation, sacral fixation alone, and single S2AI screw fixation. Rationale: The lumbosacral junction is the foundation of long spinal constructs and is known to be a point of high mechanical strain5-7. Although pelvic instrumentation has been utilized to increase construct stiffness and fusion rates, pelvic fixation failure is frequently reported8,9. At our institution, we identified a 5% acute pelvic fixation failure rate over an 18-month period10. In a subsequent multicenter retrospective series, a similar 5% acute pelvic fixation failure rate was also reported11. In response to these findings, our institution changed its pelvic fixation strategies to incorporate multiple points of pelvic fixation. From our experience, utilization of multiple pelvic fixation points has decreased acute failure. In addition to preventing instrumentation failure, S2AI screws are lower-profile, which decreases the complication of implant prominence associated with traditional iliac screws. S2AI screw heads are also more in line with the pedicle screw heads, which decreases the need for excessive rod bending and connectors.The use of the techniques has been described in case reports and imaging studies12-14, but until now has not been visually represented. Here, we provide technical and visual presentation of the placement of stacked S2AI screws or open SI joint fusion with a TTR above an S2AI screw. Expected Outcomes: Pelvic fixation provides increased construct stiffness compared with sacral fixation alone15-17 and has shown better rates of fusion4. However, failure rates of up to 35%8,9 have been reported, and our own institution identified a 5% acute pelvic fixation failure rate10. In response to this, the multiple pelvic fixation strategy (stacked S2AI screws or S2AI and TTR for SI joint fusion) has been more widely utilized. In our experience utilizing multiple points of pelvic fixation, we have noticed a decreased rate of pelvic fixation failure and are in the process of reporting these findings18,19. Important Tips: The initial trajectory of the caudal S2AI screw needs to be as low as possible within the teardrop, just proximal to the sciatic notch.The starting point for the cephalad implant should be 2 to 3 mm proximal to the S2AI screw tulip head. This placement provides enough clearance and helps to contain the implant in bone.More proximal starting points may result in cephalad breach of the TTR.The use of a reverse-threaded Kirschner wire helps to prevent pin backout while drilling and broaching for TTR placement.If malpositioning of the TTR is found on imaging, removal and redirection is technically feasible. Acronyms and Abbreviations: S2AI = S2-alar-iliacTTR = triangular titanium rodCT = computed tomographyAP = anteroposteriorOR = operating roomSI = sacroiliacDRMAS = dual rod multi-axial screwK-wire = Kirschner wireDVT = deep vein thrombosisPE = pulmonary embolism.

Is the Implant in Bone? The Accuracy of CT and Fluoroscopic Imaging for Detecting Malpositioned Pelvic Screw and SI Fusion Implants.

BACKGROUND: Spine fusions to the pelvis have been associated with increased strain to the sacroiliac joint (SI) and possibly continued postoperative low back pain. To minimize this, concomitant SI joint fusion at the time of lumbopelvic fixation has been advocated. This requires concomitant placement of sacral alar iliac screws (S2AI) for lumbopelvic fixation and triangular titanium rods (TTR) for the SI joint fusion. Traditionally, surgeons have mostly relied on fluoroscopic images to confirm final implant position and patient safety after pelvic instrumentation, although computer tomography (CT) has also been used. METHODS: We wanted to know which imaging modality, if any, was superior in helping to identify malpositioned implants during concomitant lumbopelvic fixation and SI joint fusion. We instrumented pelvic sawbones models with S2AI screws, TTR's, or both in the correct anatomic positions or malpositioned variants that led to known cortical breaches. Pelvic models were then imaged with fluoroscopy and CT, and the images assessed by blinded reviewers (spine surgeons and a musculoskeletal radiologist) for the presence of cortical breaches, the identity of the breached implant, and its direction. The responses of the blinded reviewers were then compared to the known position of the implants and Kappa coefficient calculated to determine agreement. RESULTS: We found that thorough evaluation of implant position with multiple fluoroscopic views (kappa 0.641) or CT imaging (kappa 0.906) allowed reviewers to assess implant position, identity, and breach direction. CONCLUSION: These findings suggest that intraoperative CT imaging allows surgeons to make the best decision regarding implant position prior to leaving the operating room, thus potentially improving patient safety and unplanned returns to the operating room.Level of Evidence: V.

Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS).

BACKGROUND CONTEXT: Patients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements. PURPOSE: The purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery. STUDY DESIGN: Prospective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLE: Patients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity. OUTCOME MEASURES: Oswestry Disability Index (ODI) METHODS: : Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10-<20%) or no change (within 10%). RESULTS: Two-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling. CONCLUSIONS: In this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group.