The Effect of Spinal Fusion Stimulators on Outcomes following Fusion Procedures: A Meta-Analysis

The Effect of Spinal Fusion Stimulators on Outcomes following Fusion Procedures: A Meta-Analysis

NASS 32nd Annual Meeting Proceedings / The Spine Journal 17 (2017) S166–S175 were significantly (p0.05). CONCLUSIONS: Non-WC patients who underwent sp...

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NASS 32nd Annual Meeting Proceedings / The Spine Journal 17 (2017) S166–S175 were significantly (p<.005) inferior in patients undergoing revision surgery compared to primary surgery. CONCLUSIONS: Lumbar decompression has impressive efficacy in the improvement of symptoms and QoL for patients with degenerative lumbar stenosis. As expected, the outcomes were inferior in revision surgery. Much of the improvement a patient will experience will be present at 3 months and is sustained for at least 2 years. The number of patients reporting back pain as most troubling doubled at 2-year follow-up. PROMs are an extremely useful method for assessing treatment efficacy and demonstrating excellent patient satisfaction from this surgery and can be used as a tool in counselling prospective patients regarding surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.

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compared to only 0.5% among patients who were not working. Among patients who were positive for preoperative work status, having a medical comorbidity was negatively associated with RTW status (OR: 0.19, 95% CI: 0.04–0.85, p=.03). Age, gender, alcohol use, smoking status, surgery characteristics, and complications were not significant predictors of RTW status (all ps>0.05). CONCLUSIONS: Non-WC patients who underwent spine surgery were highly likely to return to employment if they were working prior to having surgery. Type of surgery including presence of instrumentation or fusion did not appear to affect RTW status, but having a medical co-morbidity reduced the likelihood of returning to work. Randomized trials are needed to fully explore variables affecting RTW status in various populations. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.

https://doi.org/10.1016/j.spinee.2017.07.319 https://doi.org/10.1016/j.spinee.2017.07.320 263. Variables Affecting Return to Work After Spine Surgery in a Non-Workers’ Compensation Population: A Retrospective Cohort Study Yu-Po Lee, MD1, Saifal-Deen B. Farhan, MD2, P.D. Kiester, MD2, Charles D. Rosen, MD1, Arif Pendi, MS1, Nitin N. Bhatia, MD3; 1UC Irvine Medical Center, Orange, CA, US; 2University of California, Irvine, Orange, CA, US; 3Department of Orthopedic Surgery, UC Irvine Medical Center, Orange, CA, US BACKGROUND CONTEXT: Spinal pathologies often induce disability. Patients suffering from spinal disorders may discontinue working, leading to dire consequences for their families and society. As a result, patients may consult with spine surgeons to see if surgery will allow them to return to work (RTW). Alternatively, patients may eschew surgery for fear that they will be unable to resume employment following the operation. Although poor surgical outcome has been associated with workers’ compensation (WC) patients, less is known about the RTW rates of non-WC patients or the factors that affect whether non-WC patients resume employment. PURPOSE: To determine the percentage of non-workers’ compensation patients who returned to employment following spine surgery and investigate variables that affect RTW status. STUDY DESIGN/SETTING: Retrospective study of the electronic medical record at two institutions in California. PATIENT SAMPLE: A total of 326 non-WC patients who underwent spine surgery from August 2010 to July 2014. OUTCOME MEASURES: RTW status. METHODS: For 326 patients, socio-demographic data, medical comorbidities, diagnoses, surgery-related data, complication, and work status (pre- and postoperatively) were collected. Age, gender, alcohol use, and smoking status data were recorded as categorical variables. Age was dichotomized as ≥50 years or <50 years. Gender was recorded as male or female. Alcohol consumption and smoking status were described as binary outcomes. Patients who were employed 3 months prior to surgery were considered positive for preoperative work status; patients who resumed employment within one year following operation and were still working during the final followup were considered positive for RTW status. A patient was considered positive for co-morbidity if at least one co-morbidity was noted in the chart. Diagnoses were also recorded and patients with any diagnosis were included in the study. Surgery data included fusion or non-fusion, instrumentation, location of surgery (eg, cervical), and number of levels fused, which was dichotomized to ≥4 vertebrae or <4 vertebrae. Postoperative complication data included incidence of wound infection, nerve root palsy, instrumentation failure, pseudarthrosis, durotomy, and pulmonary embolus. Variables affecting RTW status were tested using multivariate logistic regression. Results were reported at Odds Ratios (OR) with 95% Confidence Intervals (CI) and p-values with a level of significance of 0.05. RESULTS: Of 326 patients, 130 were employed prior to surgery (39.9%). Compared to those were unemployed, patients who were employed before their surgery more often resumed employment after surgery (OR: 298.6, 95% CI: 85.72–1039.96, p<.001). The RTW rates within this group were 85.4%

264. The Effect of Spinal Fusion Stimulators on Outcomes following Fusion Procedures: A Meta-Analysis Fady Y. Hijji, BS1, Ankur S. Narain, BA2, Krishna Kudaravalli, BS3, Kelly Yom, BA3, Brittany E. Haws, BS4, Kern Singh, MD5; 1Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, US; 2 Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, US; 3Midwest Orthopaedics at Rush, Chicago, IL, US; 4Wake Forest, NC, US; 5Rush University Medical Center, Chicago, IL, US BACKGROUND CONTEXT: Despite the overall success of spinal fusions, pseudarthroses remain a frequently encountered complication, with reported rates ranging from 5%-81%. Electrical stimulation devices have been popularized as an adjunctive tool to improve spinal fusion rates. These devices can be subdivided into 3 different types based upon the type of electrical stimulation provided: direct current (DC), capacitive coupling (CC), and inductive coupling (IC). Multiple studies have attempted to describe the clinical effectiveness of electrical stimulation devices. However, minimal aggregate data from randomized controlled trials (RCT) are available to determine the overall efficacy of stimulators on spinal fusion outcomes. PURPOSE: To perform a meta-analysis of RCTs assessing the effect of spinal fusion stimulators on fusion rates following spinal fusion procedures. STUDY DESIGN/SETTING: Meta-analysis. PATIENT SAMPLE: Six studies. OUTCOME MEASURES: The primary outcome was fusion rate. Study size, average age, number of smokers, type of electrical stimulation, spinal level, number of involved vertebral levels, type of fusion, graft type, instrumentation, and method of fusion assessment for all studies were also recorded. METHODS: This meta-analysis was performed under the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RCTs that compared fusion rates between cohorts receiving either electrical stimulation or a placebo/control following spinal fusion were included. Studies were obtained from literature searches of PubMed and MEDLINE databases. Review of reference lists from obtained studies were also performed for completeness. Articles were excluded if they did not include a minimum follow-up period of 1 year or utilize complete randomization of patient cohorts. A meta-analysis on relative risks for fusion was performed and the summary estimate was derived using Mantel-Haenszel methods. RESULTS: A total of 6 RCTs were included in this analysis. Fusion rates for the stimulation groups ranged from 35.4% to 90.6%, and fusion rates for the control groups ranged from 33.3% to 92.8%. Following pooling of fusion rates for each group, those receiving spinal stimulators were more likely to fuse when compared to controls (RR=1.07; 95% CI=1.00–1.15; p<.001). Studies exhibited a variety of study population characteristics, including a mixture of primary and revision spinal fusions, single- and multilevel procedures, and electrical stimulation types. CONCLUSIONS: The results from the present study suggest that the use of spinal fusion stimulators may increase fusion rates following spinal fusion. However, physicians should use caution when interpreting these studies, as many are outdated and exhibit no standardization of surgical interventions,

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indications, or patient population. Further RCTs demonstrating uniformity in surgical indications, procedure, patient population, and stimulation device are necessary to better understand the effects of electrical stimulators on spinal fusion. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.321

265. In-Vitro Biomechanical Evaluation of a Novel Sacroiliac Joint Fixation Device William W. Cross III, MD1, Sigurd H. Berven, MD2, Nicholas R. Slater3, Jennifer Lehrman, MS4, Anna G. Newcomb, MS5, Brian Kelly, PhD4; 1 Seattle, WA, US; 2Department of Orthopaedic Surgery, UCSF, San Francisco, CA, US; 3CoorsTek Medical, Chandler, AZ, US; 4Barrow Neurological Institute, Phoenix, AZ, US; 5BNI Spinal Biomechanics Lab, Phoenix, AZ, US BACKGROUND CONTEXT: The efficacy of operative management of sacroiliac pain has been variable. High failure rates in some series may be related to incomplete fusion of the sacroiliac joint, and failure of fixation. The principles of arthrodesis require decortication of adjacent bone surfaces, joint compression, and rigid fixation. A system for arthrodesis of the sacroiliac joint, Integrity-SI (CoorsTek Medical, Chandler, AZ, US), was recently developed and comprised of a large “lag” type screw with hollowed shank for graft placement, a variable angle washer with large footprint, and smaller anti-rotation screw. PURPOSE: The objective of the current study was to evaluate the biomechanical stability of initial SI joint fixation with a lag screw type design in an in-vitro human cadaveric SI joint model. STUDY DESIGN/SETTING: In-vitro biomechanical testing in a human cadaveric sacroiliac joint model. PATIENT SAMPLE: Not applicable. OUTCOME MEASURES: SI joint range of motion (ROM) data were compared using a one-way analysis of variance, followed by repeated-measures Holm-Šidák tests (p<.05). METHODS: Six human SI-joints from three donors (mean age 46.7±7.5 years) were studied. Specimens were transected rostrally at L4 and included the lower lumbar spine, sacrum, and pelvis. Using a previously published single leg stance model, left and right sides of each specimen were tested sequentially in (a) intact, (b) destabilized and (c) instrumented conditions. Destabilization was achieved by sectioning of the pubic symphysis, and posterior SI joint capsule and ligaments. Loads of 7.5 Nm were applied to induce flexion-extension, lateral bending, and axial rotation. RESULTS: Intact SI ROM was in very good agreement with published physiologic in-vivo SI joint motion. Following destabilization, mean intact ROM significantly increased for all directions (p<.004) with greater than a twofold increase in flexion-extension and lateral bending, and greater than a threefold increase in axial rotation to values of 6.2°, 2.6°, and 5.4° respectively. Compared to the destabilized condition, the SI instrumented condition significantly decreased mobility (p<.001) by greater than two thirds in all directions to mean values of 1.8°, 0.6°, and 1.2° for the same directions respectively. Mean SI instrumented joint ROM was equivalent to the intact condition during axial rotation (p=.848), less than intact in flexion-extension without significance (p=.144), and significantly less than intact during lateral bending (p<.010). CONCLUSIONS: Overall, instrumented SI joint stability was restored to a level equal to or less than that for the intact condition. The compressive effect of the lag screw design likely contributed to the observed stability. Limitations of the study include assessment of immediate stability only and absence of muscle forces. Further studies are warranted to clarify performance of this fixation system in the setting of clinical practice. FDA DEVICE/DRUG STATUS: Integrity SI Joint Fixation System (Approved for this indication)

Saturday, October 28, 2017 9:00 AM–10:00 AM Spine Tumors 266. Multi-Disciplinary Management of Spinal Metastasis and Vertebral Instability: A Systematic Review Dylan Greif1, Alex D. Ghasem, MD2, Sheila A. Conway, MD3, Motasem Al Maaieh, MD3; 1Miami, FL, USA; 2Jackson Memorial Hospital, Miami, FL, USA; 3Univeristy of Miami Hospital, Miami, FL, USA Background Context: Vertebral metastasis affects a large volume of cancer patients. Currently, a variety of palliative treatments are available for tumor ablation, but such treatments alone may be associated with an increased risk of vertebral collapse. Percutaneous kyphoplasty (PKP) and vertebroplasty are solutions for restoring vertebral stability. However, a standardized multidisciplinary approach combining tumor treatment with vertebral stabilization has not yet been defined. Purpose: The aim of this systematic literature review is to evaluate recent attempts in creating a standardized multi-disciplinary approach combining tumor treatment with current vertebral stabilization techniques for palliative treatment of vertebral metastases. Study Design/Setting: Not applicable. Patient Sample: Not applicable. Outcome Measures: Not applicable. Methods: We performed a systematic literature search for studies using a tumor modality in conjunction with PKP or vertebroplasty. Among the initial search terms that were applied in PubMed included: “Vertebral Kyphoplasty Metastatic Cancer,” “Radiation Vertebroplasty Metastasis,” and “Radiation Vertebral Metastatic Cancer.” Additionally, the bibliographies of selected articles were examined for additional studies not viewed in database searches, and led to additional search terms used to broaden the scope of analysis: “Vertebroplasty Metastases 125,” “Cementoplasty Radiation Metastasis,” “Vertebroplasty Radiofrequency Ablation Metastasis,” and “Kyphoplasty Radiofrequency Ablation Metastasis.” Inclusion criteria included: original English speaking randomized control trials (RCTs) and retrospective studies using a multidisciplinary approach of tumor treatment and vertebral stabilization. Non-human studies, case reports, clinical reports without technical outcomes, studies involving patients with osteoporotic or traumatic vertebral compression fractures, and narrative reviews were excluded. Results: Our database search yielded 451 papers. A total of 16 studies fulfilled our inclusion criteria. Articles were then divided into categories based on combinations of tumor modality such as radiofrequency ablation (RFA) vs radiotherapy (includes radiosurgery, external beam radiation therapy, Iodine125 and samarium seeding), PKP or vertebroplasty, and what order. The final categories included: RFA followed by PKP (4), RFA followed by vertebroplasty (3), radiotherapy followed by PKP (1), radiotherapy followed by vertebroplasty (3), PKP followed by radiotherapy (3), and vertebroplasty followed by radiotherapy (2). Multiple studies reported significant decreases in VAS scores after combined procedures with very low rates of symptomatic complications. Studies that compared their combination to control treatment groups demonstrated greater clinical efficacy. Conclusions: While multidisciplinary management of spinal metastases using a combination of tumor ablation techniques with vertebral stabilization has been recommended in previous literature, this review demonstrates that there is no consensus in the literature about what method is most appropriate. Additionally, there is no consensus on standardized variables used to evaluate efficacy of treatment, limiting the conclusions that may be drawn from these studies. Therefore further research is needed to create a standardized protocol combining approaches that provide maximal effect. FDA Device/Drug Status: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.324

https://doi.org/10.1016/j.spinee.2017.07.322