Search

The index 2014 International Society for the Advancement of Spine Surgery Policy Statement—Minimally Invasive Surgical Sacroiliac Joint Fusion—was generated out of necessity to provide an International Classification of Diseases, Ninth Revision (ICD-9)-based background and emphasize tools to ensure correct diagnosis. A timely ICD-10-based 2016 update provided a granular threshold selection with improved level of evidence and a more robust and relevant database (Appendix Table A1). As procedures and treatment options have evolved, this 2020 update reviews and analyzes the expanding evidence base and provides guidance relating to differences between the lateral and dorsal surgical procedures for minimally invasive surgical sacroiliac joint fusion.

Lumbar disc herniation (LDH) is a frequent cause of low back pain and radiculopathy, disability, and diminution in quality of life. While nonsurgical care remains the mainstay of initial treatment, symptoms that persist for prolonged periods of time are well treated with discectomy surgery. A large body of evidence shows that, in patients with unremitting symptoms despite a reasonable period of nonsurgical treatment, discectomy surgery is safe and efficacious. In patients with symptoms lasting greater than 6 weeks, various forms of discectomy (open, microtubular, and endoscopic) are superior to continued nonsurgical treatment. The small but significant proportion of patients with recurrent disc herniation experience less improvement overall than patients who do not experience reherniation after primary discectomy. Lumbar discectomy patients with large annular defects (≥6 mm wide) are at a higher risk for recurrent herniation and revision surgery. Annular closure via a bone-anchored device has been shown to decrease the rate of recurrent disc herniation and associated reoperation in these high-risk patients. After a detailed review of the literature, current clinical evidence supports discectomy (open, microtubular, or endoscopic discectomy) as a medically necessary procedure for the treatment of LDH with radiculopathy in indicated patients. Furthermore, there is new scientific evidence that supports the use of bone-anchored annular closure in patients with large annular defects, who are at greater risk for recurrent disc herniation.

BACKGROUND: This report documents 1-year results of 250 patients enrolled in a prospective, multicenter study of a minimally invasive (MI) sacroiliac joint fusion (SIJF) system that uses decortication, graft placement, and joint fixation. METHODS: The cohort includes all patients enrolled in the EVoluSIon (EVSI) clinical study who had MI SIJF surgery and completed 1-year follow-up. Average age at baseline was 60.5 years, and 70.8% were female. Sacroiliac (SI) joint-related pain duration was ≥2 years in 56% of patients. Visual analog scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life, and opioid use were assessed preoperatively and at 1 year. RESULTS: At 1 year, the mean VAS pain demonstrated a significant reduction of more than 43 points, from 76.4 at baseline to 33.0 (P < 0.0001), with 72.2% of patients attaining the minimal clinically important difference (MCID, ≥20-point improvement). Mean ODI scores also significantly improved from 54.4 at baseline to 30.5 at 1 year (P < 0.0001), with 62.5% of patients achieving the MCID (≥15-point improvement). Prior to surgery, 62.7% (126/201) of patients were taking opioids or other narcotics, but by 1 year postsurgery, only 26.9% (54/201) of patients reported using these medications, representing a significant 57.1% decrease in narcotic/opioid use (P < 0.0001). Fusion of the SI joint was seen in 68.7% of patients. Few procedural complications were reported. In all, there were 8 (8/250) serious procedure-related events, including 1 device malposition observed on the day of surgery that required replacing the superior screw with a shorter screw. CONCLUSIONS: Analysis of patients treated with MI SIJF in the EVSI study demonstrated that the procedure can be performed safely and results in significant improvements in pain, quality of life, and opioid use at 1 year as well as causing fusion in the majority of patients. LEVEL OF EVIDENCE: 2. CLINICAL RELEVANCE: MI SIJF differs from most procedures currently being performed in that it applies true orthopedic principles with decorticating, bone grafting, fusion, and placement of implants perpendicular to the joint for greatest stability. The 12-month data show improvement in functionality, reduction in pain, and, most notably, a reduction in narcotic usage, which is important considering the ongoing opioid epidemic.

Image guidance (IG) and robotic-assisted (RA) surgery are modern technological advancements that have provided novel ways to perform precise and accurate spinal surgery. These innovations supply real-time, three-dimensional imaging information to aid in instrumentation, decompression, and implant placement. Although nothing can replace the knowledge and expertise of an experienced spine surgeon, these platforms do have the potential to supplement the individual surgeon's capabilities. Specific advantages include more precise pedicle screw placement, minimally invasive surgery with less reliance on intraoperative fluoroscopy, and lower radiation exposure to the surgeon and staff. As these technologies have become more widely adopted over the years, novel uses such as tumor resection have been explored. Disadvantages include the cost of implementing IG and robotics platforms, the initial learning curve for both the surgeon and the staff, and increased patient radiation exposure in scoliosis surgery. Also, given the relatively recent transition of many procedures from inpatient settings to ambulatory surgery centers, access to current devices may be cost prohibitive and not as readily available at some centers. Regarding patient-related outcomes, much further research is warranted. The short-term benefits of minimally invasive surgery often bolster the perioperative and early postoperative outcomes in many retrospective studies on IG and RA surgery. Randomized controlled trials limiting such confounding factors are warranted to definitively show potential independent improvements in patient-related outcomes specifically attributable to IG and RA alone. Nonetheless, irrespective of these current unknowns, it is clear that these technologies have changed the field and the practice of spine surgery. Surgeons should be familiar with the potential benefits and tradeoffs of these platforms when considering adopting IG and robotics in their practices.

Study Design:Systematic review.Objectives:Superiority claims for medical devices are commonly derived from noninferiority trials, but interpretation of such claims can be challenging. This study aimed to ( a) establish the prevalence of noninferiority and superiority designs among spinal device trials, ( b) assess the frequency of post hoc superiority claims from noninferiority studies, and ( c) critically evaluate the risk of bias in claims that could translate to misleading conclusions.Methods:Study bias was assessed using the Cochrane Risk of Bias Tool. The risk of bias for the superiority claim was established based on post hoc hypothesis specification, analysis of the intention-to-treat population, post hoc modification of a priori primary outcomes, and sensitivity analyses.Results:Forty-one studies were identified from 1895 records. Nineteen (46%) were noninferiority trials. Fifteen more (37%) were noninferiority trials with a secondary superiority hypothesis specified a priori. Seven (17%) were superiority trials. Of the 34 noninferiority trials, 14 (41%) made superiority claims. A medium or high risk of bias was related to the superiority claim in 9 of those trials (64%), which was due to the analyzed population, lacking sensitivity analyses, claims not being robust during sensitivity analyses, post hoc hypotheses, or modified endpoints. Only 4 of the 14 (29%) noninferiority studies provided low bias in the superiority claim, compared with 3 of the 5 (60%) superiority trials.Conclusions:Health care decision makers should carefully evaluate the risk of bias in each superiority claim and weigh their conclusions appropriately.

Background Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. Objective To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. Methods This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. Results At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. Conclusion Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

Purpose: This report documents six-month results of the first 50 patients treated in a prospective, multi-center study of a minimally invasive (MI) sacroiliac (SI) joint fusion system. Patients and Methods: This cohort includes 50 patients who had MI SI joint fusion surgery and completed 6 month follow-up. Average age at baseline was 61.5, 58% were female, and SI joint-related pain duration was ≥2yrs in 54.0% of patients. Visual Analog Scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life and opioid use were assessed preoperatively and at 6 months. Results: At 6 months, mean VAS pain demonstrated a significant reduction from 76.2 at baseline to 35.1 (54% reduction, p

Background: Performing an adequate transforaminal lumbar interbody fusion (TLIF) discectomy requires numerous instrument passes, increasing surgical time and the risk of complications. The purpose of this study was to evaluate the efficacy and efficiency of discectomy and endplate preparation during TLIF using traditional manual instrumentation versus a novel suction discectomy curette. The direct economic benefit with use of the suction discectomy curette is calculated. Methods: Three experienced, spine-fellowship-trained surgeons performed TLIF discectomies on 3 cadaveric specimens from T12 to S1 using either traditional manual discectomy instruments or CONCORDE Clear (Xtool) devices supplemented with manual discectomy instruments. For each level in which a discectomy was performed, the following were measured: elapsed time, number of instrument passes and the number of instrument exchanges, and estimated tissue volume. Results: Transforaminal lumbar interbody fusion discectomy times improved on average 11:32 minutes per level, which equates to an estimated procedural time savings of 15:85 minutes, using 1.4 levels per TLIF, the average number of levels in a large series. Usage of the CONCORDE Clear significantly reduced instrument passes compared to traditional, with a mean of 62.0 for traditional versus 7.1 for CONCORDE Clear, an 8.7-fold improvement. Instrument exchanges showed a 5.9-fold improvement, with means of 26.8 and 4.6, respectively. Wet discectomy tissue volume was measured for each discectomy, with a mean of 5.4 cc for traditional versus 12.9 cc for CONCORDE Clear, a 2.4-fold improvement. Conclusions: This study estimates that, in a typical TLIF procedure, over 15 minutes should be saved by using the CONCORDE Clear l device (a quarter of the time of a traditional discectomy), and by considering the direct cost-benefit associated with this time savings as well as reduced sterilization costs, it is estimated that a hospital could save approximately $1300 in operating room time and sterilization cost with the use of the CONCORDE Clear device in a typical 1-level TLIF procedure.

OBJECTIVE This purpose of this study was to objectively evaluate and assess the efficacy and efficiency of discectomy and endplate preparation during transforaminal lumbar interbody fusion (TLIF) using traditional manual instrumentation versus a novel suction discectomy curette. Transforaminal lumbar interbody fusion is the most widely used approach for lumbar arthrodesis, and its success depends on the ability to achieve fusion. Complete preparation of intervertebral disc space (removal of the nucleus, endplate cartilage, and margin of inner annulus) is the surgical goal. Performing an adequate discectomy requires numerous instrument passes, increasing surgical time and the risk of complications. METHODS Four experienced spinal surgeons performed transforaminal discectomies from T-12 to S-1 on 5 whole-body cadavers. Each level (n = 26) was randomly assigned to either a control group using traditional instruments (12 levels) or to a suction curette group (14 levels). The time required to perform the discectomy and the number of passes through the annulus were recorded. Motion segments were dissected and analyzed by digital photogrammetric analysis. The intervertebral disc and the discectomy cross-sectional areas were measured on both superior and inferior images of each dissected surgical level. Areas were divided into 4 quadrants based on a midsagittal and midcoronal axis and analyzed for regional efficiency. In addition, a cross-sectional area of bony endplate (the area still covered with cartilage) and an area of endplate perforation were evaluated. RESULTS There was no significant difference in surgical time between the techniques (7:51 ± 2:43 minutes in the manual discectomy [MD] group and 7:06 ± 3:33 minutes in the suction curette discectomy [SD] group). There were significantly fewer (p < 0.01) instrument passes in the SD group (13 passes) compared with the MD group (43 passes). For both techniques, the amount of disc removed depended upon the anatomical region, with the posterior-contralateral side having the least amount of disc material removed. There was significantly less (p < 0.01) disc material removed in the MD group (38%) compared with the SD group (48%). The amount of disc material removed was significantly more (p < 0.05) in each quadrant when comparing the SD and MD groups, with the anterior regions showing the largest difference. For both techniques, the preparation of the endplate within the discectomy area resulted in a mostly cartilaginous interface (50% MD, 48% SD); a smaller amount of bony interface area (31% MD, 38% SD); and a smaller amount of perforation to the interface area (19% MD, 13% SD). There were no significant differences between the groups in terms of endplate preparation. CONCLUSIONS The improved discectomy observed with the suction curette device could potentially improve the clinical fusion rate.

Study design Prospective, multicenter, single-blind, randomized, controlled clinical study. Objective To investigate outcomes associated with repairing the anulus fibrosus after lumbar discectomy for the surgical management of herniated nucleus pulposus. Summary of background data In patients undergoing discectomy, the incidence of reherniation ranges from 10% to 15%. Repair of the anulus fibrosus defect after lumbar discectomy may decrease the incidence of recurrent herniation for these patients. Methods A total of 750 patients were treated for herniated lumbar discs and randomly assigned in a 2:1 ratio to discectomy with the Xclose Tissue Repair System (Anulex Technologies, Minnetonka, MN) for anular repair (n = 500) or discectomy without anular repair (n = 250). Patient self-reported measures included visual analogue scales for leg and back pain, Oswestry Disability Index, and Short Form-12 Health Survey. Adverse events and subsequent reherniation surgical procedures were documented. Preoperative outcome measures were compared with follow-up visits at 2 weeks, 6 months, 1 year, and 2 years. Results Patient symptoms were improved after surgery in an equivalent manner in both study groups. In the overall study analysis, the rate of reherniation surgery was lower for Xclose patients at all follow-up time points, but these differences were not statistically significant. In patients with predominant leg pain, there was a significant reduction in reherniation risk at 3 and 6 months postoperation for patients receiving Xclose. A positive reduction was maintained through 2 years, with a clinically relevant risk reduction of 45%, although not statistically significant. Safety was demonstrated with similar improvements in patient outcomes and no difference in reported adverse events. Conclusion Without a safe and effective method for closing the anulus fibrosus after discectomy, current practice has been to leave the anulus in a compromised state. This multicenter randomized study demonstrated that, while not statistically significant, anular repair reduced the need for subsequent reherniation surgery while retaining the benefits of discectomy with no increased risk for patients. Level of evidence 1.

Cheng et al[1][1] have discussed using a dynamic posterior stabilization device to treat asymmetric collapse of an artificial disc in the coronal plane. Although this may correct the radiographic coronal-plane abnormality, there are significant biomechanical considerations to be kept in mind. When

Study design A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. Objective To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Summary of background data Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Methods Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases.Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. Results Preoperative characteristics were statistically similar for the 1- and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1- and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. Conclusion A 4-year post hoc comparison of 1- and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates. Level of evidence 1.

Background Minimally invasive percutaneous pedicle screw instrumentation methods may increase the need for intraoperative fluoroscopy, resulting in excessive radiation exposure for the patient, surgeon, and support staff. Electromagnetic field (EMF)-based navigation may aid more accurate placement of percutaneous pedicle screws while reducing fluoroscopic exposure. We compared the accuracy, time of insertion, and radiation exposure of EMF with traditional fluoroscopic percutaneous pedicle screw placement. Methods Minimally invasive pedicle screw placement in T8 to S1 pedicles of eight fresh-frozen human cadaveric torsos was guided with EMF or standard fluoroscopy. Set-up, insertion, and fluoroscopic times and radiation exposure and accuracy (measured with post-procedural computed tomography) were analyzed in each group. Results Sixty-two pedicle screws were placed under fluoroscopic guidance and 60 under EMF guidance. Ideal trajectories were achieved more frequently with EMF over all segments (62.7% vs. 40%; p = 0.01). Greatest EMF accuracy was achieved in the lumbar spine, with significant improvements in both ideal trajectory and reduction of pedicle breaches over fluoroscopically guided placement (64.9% vs. 40%, p = 0.03, and 16.2% vs. 42.5%, p = 0.01, respectively). Fluoroscopy time was reduced 77% with the use of EMF (22 s vs. 5 s per level; p

Blood pressure measurements frequently guide management in critical care. Direct readings, commonly from a major artery, are considered to be the gold standard. Because arterial cannulation is associated with risks, alternative noninvasive blood pressure (NIBP) measurements are routinely used. However, the accuracy of NIBP determinations in overweight patients in the outpatient setting is variable, and little is known about critically ill patients. This prospective, observational study was performed to compare direct intra-arterial blood pressure (IABP) with NIBP measurements obtained using auscultatory and oscillometric methods in overweight patients admitted to our medical intensive care unit. Adult critically ill patients with a body mass index (BMI) of 25 kg/m2 or greater and a functional arterial line (assessed using the rapid flush test) were enrolled in the study. IABP measurements were compared with those obtained noninvasively. A calibrated aneroid manometer (auscultatory technique) with arm cuffs compatible with arm sizes and a NIBP monitor (oscillometric technique) were used for NIBP measurements. Agreement between methods was assessed using Bland-Altman analysis. Fifty-four patients (23 males) with a mean (± standard error) age of 57 ± 3 years were studied. The mean BMI was 34.0 ± 1.4 kg/m2. Mean arm circumference was 32 ± 0.6 cm. IABP readings were obtained from the radial artery in all patients. Only eight patients were receiving vasoactive medications. Mean overall biases for the auscultatory and oscillometric techniques were 4.1 ± 1.9 and -8.0 ± 1.7 mmHg, respectively (P < 0.0001), with wide limits of agreement. The overestimation of blood pressure using the auscultatory technique was more important in patients with a BMI of 30 kg/m2 or greater. In hypertensive patients both NIBP methods underestimated blood pressure as determined using direct IABP measurement. Oscillometric blood pressure measurements underestimated IABP readings regardless of patient BMI. Auscultatory measurements were also inaccurate, tending to underestimate systolic blood pressure and overestimate mean arterial and diastolic blood pressure. NIBP can be inaccurate among overweight critically ill patients and lead to erroneous interpretations of blood pressure.