High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.

BACKGROUND: Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches). METHODS: Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis. RESULTS: A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05). CONCLUSIONS: CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches. CLINICAL RELEVANCE: The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes. TRIAL REGISTRATION: NCT02969616.

Sacropelvic Fixation with Porous Fusion/Fixation Screws: A Technical Note and Retrospective Review.

OBJECTIVE: The goal of this study was to analyze our initial experience using a novel porous fusion/fixation screw (PFFS) for pelvic fixation and determine our rate of screw malposition requiring intraoperative repositioning. METHODS: We reviewed 83 consecutive patients who underwent sacropelvic fixation with PFFS at our institution from June 1, 2022 to June 30, 2023 using intraoperative computed tomography-based computer-assisted navigation via an open posterior approach. Following PFFS insertion, intraoperative computed tomography scans were obtained to assess screw positioning. Demographic data were collected, and operative reports and patient images were reviewed to determine what implants were used and if any PFFS required repositioning. RESULTS: Seventy-four patients (26M:48F) were included, and 57 (77.0%) had a prior sacroiliac joint or lumbar spine surgery. A stacked screw configuration was used in 62/74 cases (83.8%). A total of 235 PFFS were used and six (2.6%) were malpositioned. Of 88 cephalic screws placed in stacked configuration, 4 were malpositioned (4.5%) and 1/123 caudal screws were malpositioned (0.8%). One of 24 sacral-alar-iliac screws placed in a stand-alone configuration was malpositioned (4.2%). Malpositions included 4 medial, 1 lateral, and 1 inferior, and all were revised intraoperatively without major sequela. CONCLUSIONS: Although PFFSs are larger than traditional sacropelvic fixation screws, stacked sacral-alar-iliac instrumentation can be done safely with computer-assisted navigation. We found a low malposition rate in our initial series of patients, the majority being the cephalad screw in a stacked configuration. This isn't surprising, as these are placed after the caudal screws, which reduces the available corridor size and increases the placement difficulty.

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.

Esophageal perforation after anterior cervical spine surgery.

Objective: To report our updated experience in the management of esophageal perforation resulting from anterior cervical spine surgery, and to compare two wound management approaches. Methods: This is a retrospective review of patients managed for esophageal perforations resulting from anterior cervical spine surgery (2007-2020). We examine outcomes based on 2 wound management approaches: closed (closed incision over a drain) versus open (left open to heal by secondary intention). We collected data on demographics, operative management, resolution (resumption of oral intake), time to resolution, number of procedures needed for resolution, microbiology, length of stay, and neck morbidity. Results: A total of 13 patients were included (10 men). Median age was 52 years (range, 24-74 years). All patients underwent surgical drainage, repair, or attempted repair of perforation, hardware removal, and establishment of enteral access. Wounds were managed closed versus open (6 closed, 7 open). There were 2 early postoperative deaths due to acute respiratory distress syndrome and aspiration (open group), and 1 patient was lost to follow-up (closed group). Among the remaining 10 patients: resolution rate was 80% versus 100%, resolution in 30 days was 20% versus 100%, median number of procedures needed for resolution was 3 versus 1, and median hospital stay was 23 versus 14 days, for the closed and open groups, respectively. Conclusions: Esophageal perforation following anterior cervical spine surgery should be managed in a multidisciplinary fashion with surgical neck drainage, primary repair when feasible, hardware removal, and establishment of enteral access. We advocate open neck wound management to decrease the time-to-resolution, number of procedures, and length of stay.

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.

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.

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.

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.

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.

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.

Sagittal radiographic parameters in the presence of lumbosacral transitional vertebra (LSTV): relationships between measurements using the upper vs lower transitional vertebra.

PURPOSE: Optimization of spinopelvic sagittal parameters in spinal deformity surgery have been shown to correlate with surgical outcomes. Commonly used parameters include pelvic incidence (PI), lumbar lordosis (LL) and PI-LL mismatch. Presence of lumbosacral transitional vertebra (LSTV) introduces variability regarding which endplate is considered the sacral endplate. This study aimed to determine the mathematical relationships between measurements using the upper transitional vertebra (UTV) versus the lower transitional vertebra (LTV). METHODS: The property that internal angles of a triangle sum to 180° was used to create a system of equations to resolve the relationship between the PI-LL mismatch of the UTV and of the LTV. The ultimate relationship was employed on a lateral radiograph of a patient with LSTV for validation. RESULTS: It is possible to compute the PI-LL mismatch using either UTV or LTV and convert to the corresponding PI-LL when using the other vertebra simply by measuring one additional angle (PI-LL)L = (PI-LL)U + X. This angle X is defined by segments connecting the center of the femoral head to the midpoints of the superior endplates of the UTV and LTV. Using the LTV yields a larger PI-LL mismatch value. CONCLUSION: In patients with LSTV, it is controversial whether the UTV or LTV should be used as the sacral endplate for sagittal measurements. With this mathematical relationship, rather than completing two sets of measurements, the surgeon would only need to measure one set and the additional angle X to determine the resultant PI-LL mismatch for the other transitional vertebra.

Identifying biopsychosocial factors that impact decompressive laminectomy outcomes in veterans with lumbar spinal stenosis: a prospective cohort study.

ABSTRACT: One in 3 patients with lumbar spinal stenosis undergoing decompressive laminectomy (DL) to alleviate neurogenic claudication do not experience substantial improvement. This prospective cohort study conducted in 193 Veterans aimed to identify key spinal and extraspinal factors that may contribute to a favorable DL outcome. Biopsychosocial factors evaluated pre-DL and 1 year post-DL were hip osteoarthritis, imaging-rated severity of spinal stenosis, scoliosis/kyphosis, leg length discrepancy, comorbidity, fibromyalgia, depression, anxiety, pain coping, social support, pain self-efficacy, sleep, opioid and nonopioid pain medications, smoking, and other substance use. The Brigham Spinal Stenosis (BSS) questionnaire was the main outcome. Brigham Spinal Stenosis scales (symptom severity, physical function [PF], and satisfaction [SAT]) were dichotomized as SAT < 2.42, symptom severity improvement ≥ 0.46, and PF improvement ≥ 0.42, and analyzed using logistic regression. Sixty-two percent improved in 2 of 3 BSS scales (ie, success). Baseline characteristics associated with an increased odds of success were-worse BSS PF (odds ratio [OR] 1.24 [1.08-1.42]), greater self-efficacy for PF (OR 1.30 [1.08-1.58]), lower self-efficacy for pain management (OR 0.80 [0.68-0.94]), less apparent leg length discrepancy (OR 0.71 [0.56-0.91]), greater self-reported alcohol problems (OR 1.53 [1.07-2.18]), greater treatment credibility (OR 1.31 [1.07-1.59]), and moderate or severe magnetic resonance imaging-identified central canal stenosis (OR 3.52 [1.06-11.6]) moderate, OR 5.76 [1.83-18.1] severe). Using opioids was associated with lower odds of significant functional improvement (OR 0.46 [0.23-0.93]). All P < 0.05. Key modifiable factors associated with DL success-self-efficacy, apparent leg length inequality, and opioids-require further investigation and evaluation of the impact of their treatment on DL outcomes.

The effectiveness of a free-standing lead-shield in reducing spine surgeon radiation exposure during intraoperative 3-dimensional imaging.

BACKGROUND: CONTEXT Intraoperative three-dimensional (3D) computed tomography (CT) imaging has become increasingly popular in spine surgery. Previous spine surgeon radiation exposure research has focused largely on procedures using fluoroscopy, however, few studies have been performed on the subject since the introduction of the 3D imaging systems. As a result, concerns have re-emerged over surgeon radiation exposure and the effectiveness of operating room (OR) protocols for decreasing workplace radiation. Current radiation safety guidelines require surgeons wear full body protective lead while any type of radiation is being administered during surgery. As a result, local institutions do not allow for the use of free-standing lead shields for sole radiation protection in the operating room. However, there is no data available to demonstrate whether the additional personal lead is required, or if in fact the lead shield alone is sufficient. PURPOSE: This study investigated the effectiveness of a free-standing lead shield in reducing spine surgeon radiation exposure in the operating room during intraoperative imaging. STUDY DESIGN/SETTING: A prospective clinical research study at a large, tertiary care center. PATIENT SAMPLE: Twenty-seven patients undergoing instrumented spinal procedures between June and August 2019. OUTCOME MEASURES: Fluoroscopy time, total fluoroscopy dose delivered, 3D dose delivered, total 3D spins, number of HD spins, number of standard spins, number of fluoroscopic images, number of spine levels operated on, patient size setting, shield distance from patient, radiation dose in front of shield, radiation dose behind shield. METHODS: Twenty-seven instrumented spinal procedures using the O-Arm Imaging System (Medtronic, Minneapolis, MN) were observed to determine radiation exposure to a spine surgeon standing behind a lead shield in the OR. Two thermoluminescent dosimeters were used to measure scatter radiation in front of and behind lead shields. Both fluoroscopy and intraoperative CT based radiation exposure was recorded. The dosimeter readings were compared to determine the degree of radiation attenuation by the lead shield. Regression analysis of the exposure values from behind the shield, shield distance from the patient, and radiation dose delivered by the imaging system was utilized to estimate the number of cases required to surpass annual exposure limits. Case numbers were calculated for the highest "worst case" and "average case" exposure values. The safe annual occupation exposure limit determined by the National Council on Radiation Protection is five roentgen equivalent man (rem) or 50,000 microsieverts (µSv). RESULTS: Average surgeon radiation exposure per case was 0.694 µSv (SD: 0.501, Range: 0.105-2.167) behind the lead shield compared to 14.577 µSv (SD: 9.864, Range: 2.185-44.492) in front of the lead shield. The average radiation dose reduction by the lead shield was 13.962 µSv (SD: 9.49, Range: 2.08-42.72) per case, which is equivalent to an average of 95.65% (SD: 1.71) radiation attenuation by lead shielding. If surgeons stand behind lead shields in the OR, the annual number of 3D image-guided spinal procedures required to surpass exposure limits is 15,479 and 67,060 based on "worst case" and "average case" analyses, respectively. CONCLUSIONS: Our study demonstrates standing behind intraoperative lead shields is very effective at decreasing radiation exposure to surgeons. Additionally, surgeon radiation doses behind lead shielding fall far below annual exposure limits. Surgeons should not need additional protective equipment when a lead shield is used.

Sacral Dysmorphism and Lumbosacral Transitional Vertebrae (LSTV) Review.

BACKGROUND: Anatomic variation in the relationship between the lumbar spine and sacrum was first described in the literature nearly a century ago and continues to play an important role in spine deformity, low back pain (LBP), and pelvic trauma. This review will focus on the clinical and surgical implications of abnormal lumbosacral anatomy in the context of sacroiliac joint (SIJ) disease, spine deformity, and pelvic trauma. METHODS: A PubMed search using the keywords "lumbosacral transitional vertebrae," "LSTV," "transitional lumbosacral vertebrae," "TLSV," and "sacral dysmorphism" was performed. The articles presented here were evaluated by the authors. CLINICAL SIGNIFICANCE: The prevalence of LSTV varies widely in the literature from 3.9-% to 35.6% in the spine literature, and sacral dysmorphism is described in upwards of 50% of the population in the trauma literature. The relationship between LSTV and LBP is well established. While there is no agreed-on etiology, the source of pain is multifactorial and may be related to abnormal biomechanics and alignment, disc degeneration, and arthritic changes. SURGICAL IMPLICATIONS: Understanding abnormal lumbosacral anatomy is crucial for preoperative planning of SIJ fusion, spine deformity, and pelvic trauma surgery. LSTV can alter spinopelvic parameters crucial in planning spine deformity correction. Traditional safe zones for sacroiliac screw placement do not apply in the first sacral segment in sacral dysmorphism and risk iatrogenic nerve injury. CONCLUSIONS: LSTV and sacral dysmorphism are common anatomic variants found in the general population. Abnormal lumbosacral anatomy plays a significant role in clinical evaluation of LBP and surgical planning in SIJ fusion, spine deformity, and pelvic trauma. Further studies evaluating the influence of abnormal lumbosacral anatomy on LBP and surgical technique would help guide treatment for these patients.

Otospondylomegaepiphyseal Dysplasia: A Case Report of Clinical and Radiographic Findings.

CASE: We present a long-term follow-up on a woman with otospondylomegaepiphyseal dysplasia (OSMED). At the age of 46 years, she is one of the oldest patients with the syndrome in the literature to date. We focus on the musculoskeletal anatomy and orthopaedic interventions over her lifetime. CONCLUSION: OSMED is a very rare syndrome. Arthritis and joint pains presented in her early adolescence and progressed to the point of requiring joint replacements by her 20s. Early intervention and monitoring improved the quality of life for this patient.