Endovascular stenting of external iliac vein injury during anterior spine exposure.

Anterior lumbar interbody fusion (ALIF) is a standard approach for the surgical management of patients with severe degenerative disease at the L4-L5 and lumbosacral (L5-S1) levels. ALIF is performed through retroperitoneal exposure but harbors a small risk of major vascular injury. In this case, we describe an emergent endovascular repair of an external iliac vein injury that occurred during ALIF with long-term follow-up. We discuss specific strategies in the decision making and technique that led to a successful outcome in this case. Endovascular stent grafting is a potential bailout option for serious iliac vein injury.

Paired Comparison Survey Analysis Utilizing Rasch Methodology of the Relative Difficulty and Estimated Work Relative Value Units of CPT Code 0202T.

BACKGROUND: In anticipation of Food and Drug Administration (FDA) approval of the Total Posterior Spine (TOPS) system, the International Society for the Advancement of Spine Surgery (ISASS) conducted a study to estimate the work relative value units (RVUs) for facet arthroplasty. The purpose of this study was to establish a valuation of work RVU for Current Procedural Terminology (CPT) Code 0202T in the interim until the Relative Value Scale Update Committee (RUC) can determine an appropriate value. The valuation established from this survey will assist surgeons to establish appropriate procedure reimbursement from third-party payers. METHODS: A survey was created and sent to 52 surgeons who had experience implanting the TOPS system during the investigational device exemption clinical trial. The survey included a patient vignette, a description of CPT Code 0202T along with a video of the TOPS system, and a confirmation question about the illustration's effectiveness. Respondents were asked to compare the work involved in CPT Code 0202T to 8 lumbar spine procedures. A Rasch analysis was performed to estimate the relative difficulty of CPT 0202T using the work RVUs of the comparable procedures. RESULTS: Forty-one surgeons responded to the survey. Of all the procedures, CPT Code 0202T received the most responses for equal work compared with posterior osteotomy (46%) followed by transforaminal lumbar interbody fusion (41%). The results of the regression analysis indicate a work RVU for CPT 0202T of 39.47. CONCLUSION: The study found an estimated work RVU of 39.47 for CPT Code 0202T using Rasch analysis. As an alternative to this Rasch methodology, one may consider a crosswalk methodology to the work RVUs for transforaminal lumbar interbody fusion procedurally, not as an alternative code. CLINICAL RELEVANCE: These recommendations are not a substitute for RUC methodology but serve as a reference for physicians and third-party payers to understand work RVU similarities for charge and payment purposes temporarily until RUC methodology provides accurate RVUs for the procedure.

A novel antibacterial compound decreases MRSA biofilm formation without the use of antibiotics in a murine model.

Despite significant advancements in material science, surgical site infection (SSI) rates remain high and prevention is key. This study aimed to demonstrate the in vivo safety and antibacterial efficacy of titanium implants treated with a novel broad-spectrum biocidal compound (DBG21) against methicillin-resistant Staphylococcus aureus (MRSA). Titanium (Ti) discs were covalently bound with DBG21. Untreated Ti discs were used as controls. All discs were implanted either untreated for 44 control mice or DBG21-treated for 44 treated mice. After implantation, 1 × 107 colony forming units (CFU) of MRSA were injected into the operating site. Mice were killed at 7 and 14 days to determine the number of adherent bacteria (biofilm) on implants and in the peri-implant surrounding tissues. Systemic and local toxicity were assessed. At both 7 and 14 days, DBG21-treated implants yielded a significant decrease in MRSA biofilm (3.6 median log10 CFU [99.97%] reduction [p < 0.001] and 1.9 median log10 CFU [98.7%] reduction [p = 0.037], respectively) and peri-implant surrounding tissues (2.7 median log10 CFU/g [99.8%] reduction [p < 0.001] and 5.6 median log10 CFU/g [99.9997%] reduction [p < 0.001], respectively). There were no significant differences between control and treated mice in terms of systemic and local toxicity. DBG-21 demonstrated a significant decrease in the number of biofilm bacteria without associated toxicity in a small animal implant model of SSI. Preventing biofilm formation has been recognized as a key element of preventing implant-related infections.

Implant Surface Technologies to Prevent Surgical Site Infections in Spine Surgery.

Spine surgeries are occurring more frequently worldwide. Spinal implant infections are one of the most common complications of spine surgery, with a rate of 0.7% to 11.9%. These implant-related infections are a consequence of surface polymicrobial biofilm formation. New technologies to combat implant-related infections are being developed as their burden increases; however, none have reached the market stage in spine surgery. Conferring antimicrobial properties to biomaterials relies on either surface coating (physical, chemical, or combined) or surface modification (physical, chemical, or combined). Such treatment can also result in toxicity and the progression of antimicrobial resistance. This narrative review will discuss "late-stage" antimicrobial technologies (mostly validated in vivo) that use these techniques and may be incorporated onto spine implants to decrease the burden of implant-related health care-acquired infections (HAIs). Successfully reducing this burden will greatly improve the quality of life in spine surgery. Familiarity with upcoming surface technologies will help spine surgeons understand the anti-infective strategies designed to address the rapidly worsening challenge of implant-related health care-acquired infections.

Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial.

OBJECTIVE: Spinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain study evaluates the effectiveness of SCS compared with conventional medical management (CMM) in the treatment of chronic low back pain in patients who had not undergone and were not candidates for lumbar spine surgery. METHODS AND MATERIALS: Patients were randomized to passive recharge burst therapy (n = 162) or CMM (n = 107). They reported severe pain and disability for more than a decade and had failed a multitude of therapies. Common diagnoses included degenerative disc disease, spondylosis, stenosis, and scoliosis-yet not to a degree amenable to surgery. The six-month primary end point compared responder rates, defined by a 50% reduction in pain. Hierarchical analyses of seven secondary end points were performed in the following order: composite responder rate (numerical rating scale [NRS] or Oswestry Disability Index [ODI]), NRS, ODI, Pain Catastrophizing Scale responder rate, Patient Global Impression of Change (PGIC) responder rate, and Patient-Reported Outcome Measure Information System-29 in pain interference and physical function. RESULTS: Intention-to-treat analysis showed a significant difference in pain responders on NRS between SCS (72.6%) and CMM (7.1%) arms (p < 0.0001). Of note, 85.2% of those who received six months of therapy responded on NRS compared with 6.2% of those with CMM (p < 0.0001). All secondary end points indicated the superiority of burst therapy over CMM. A composite measure on function or pain relief showed 91% of subjects with SCS improved, compared with 16% of subjects with CMM. A substantial improvement of 30 points was observed on ODI compared with a

Burst spinal cord stimulation can attenuate pain and its affective components in chronic pain patients with high psychological distress: results from the prospective, international TRIUMPH study.

BACKGROUND CONTEXT: Psychological characteristics such as catastrophizing and depression have been shown to negatively impact outcome prognosis after spinal interventions. PURPOSE: To evaluate whether high psychological distress, defined as clinically elevated levels of catastrophizing and depression, is associated with poorer outcomes after spinal cord stimulation utilizing a passive recharge burst stimulation design. This proprietary waveform may uniquely attenuate the emotional aspects of chronic pain given its affects on the medial pain pathway projecting to the dorsal anterior cingulate cortex and anterior insula. STUDY DESIGN/SETTINGS: Data were extracted from the prospective, multi-center, single-arm, international TRIUMPH study. The purpose of TRIUMPH was to assess long-term (2 years) safety and effectiveness of spinal cord stimulation for chronic pain in the trunk and/or limbs using a passive recharge enabled burst spinal cord stimulation (B-SCS) system. PATIENT SAMPLE: Two subsets of study patients were identified; those with (n=31) and those without (n=54) high psychological distress. OUTCOME MEASURES: Psychological and functional outcomes as well as pain intensity and impact of pain on life were administered at baseline and all follow intervals. Additionally, patient satisfaction and patient global impression of change were assessed at all follow-up intervals. METHODS: Psychological distress (PD) was defined as a baseline score of ≥ 30 on the Pain Catastrophizing Scale (PCS) and ≥ 10 on the Patient Health Questionnaire Depression scale (PHQ-9). Nondistressed (ND) patients had scores below these thresholds on both scales. All patients were implanted with a B-SCS system and completed data collection for the 24-month follow-up visit. This study was funded by Abbott. JMH is a consultant for Abbott and has received <$20,000 in lifetime consulting fees from Abbott. SMF is a consultant for Abbott and has received >$50,000 in lifetime consulting fees from Abbott. BB is an Abbott employee. RAC is a former Abbott employee. JJY is a consultant for Abbott and has received <$2,500 in lifetime consulting fees from Abbott. RESULTS: Of the 128 participants with 24-month data, 31 (24%) and 54 (35%) met the criteria for PD and ND, respectively. Baseline measures indicated a more severe chronic pain profile and worse quality of life in the PD group. Two years after implant, 71% were no longer clinically catastrophizing and 58% were no longer clinically depressed. Notably, more than half of the PD patients on antidepressants discontinued or decreased their medication. Health-related quality of life was 82% higher in the PD group at 24 months, reaching levels similar to the ND group. Psychological distress did not impact outcomes after SCS therapy; composite multi-responder rates were similar in the 2 groups throughout the follow-up period. Patient reported pain relief (58% PD vs. 61% ND) was equivalent in each group. In both groups, 81% were satisfied or very satisfied with the pain relief provided. CONCLUSIONS: Our results showed that B-SCS appears to be as effective in a chronic pain population with high psychological distress as in those without distress. This may be due to the unique mechanism of action with the stimulation design involving the emotional-affective medial pain pathway in the brain.

Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results.

BACKGROUND: This study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes. METHODS: This was a prospective, multicenter, randomized, controlled investigational device exemption study. Eligible patients with symptomatic, single-level lumbar DDD had failed ≥6 months of nonsurgical management. Patients (N = 283) were randomized to receive activL (n = 218) or ProDisc-L (n = 65). At 7 years, data were available from 206 patients (activL, 160; ProDisc-L, 46). Logistic regression models were fit to predict 7-year outcomes for patients lost to follow-up after 2 years. RESULTS: At 7 years, the activL group was noninferior to the ProDisc-L group on the primary composite endpoint (P = .0369). Both groups showed significant reductions in back/leg pain severity and improvements in disability index and quality-of-life relative to baseline (P < .0001). In both groups, opioid use was significantly reduced at 7 years (0%) relative to baseline (P < .01), and the overall reoperation rates were low (4.6%). activL patients showed a significantly better range of motion (ROM) for flexion-extension rotation than ProDisc-L patients (P = .0334). A significantly higher proportion of activL patients did not report serious adverse events (activL, 62%; ProDisc-L, 43%; P = .011). Predictive modeling indicated that >70% of patients (depending on outcome) lost to follow-up after 2 years would show clinically significant improvement at 7 years if improvements were achieved at 2 years. CONCLUSIONS: The benefits of activL and ProDisc-L are maintained after 7 years, with significant improvements from baseline observed in pain, function, and opioid use. activL is more effective at preserving ROM than ProDisc-L and has a more favorable safety profile. Improvements in other primary and secondary outcomes were similar between both disc designs. LEVEL OF EVIDENCE: 1.

Postoperative Bracing on Pain, Disability, Complications, and Fusion Rate Following 1-3+ Level Lumbar Fusion in Degenerative Conditions: A Meta-Analysis.

OBJECTIVES: Lumbar fusion surgeries in degenerative spinal conditions can be invasive and may challenge the normal biomechanical spine and joint function. Frequently, patients require postoperative rehabilitation management. The purpose of this meta-analysis is to determine if there is an advantage to using a postoperative lumbar orthosis with regard to postoperative function and surgical healing. DATA SOURCES: Articles in the English language were searched in electronic databases including PubMed and Clinicaltrials.gov from January 1, 2004 to January 1, 2019. STUDY SELECTION: Studies were included if they were described as being a prospective randomized trial, utilized a common pain score determinant, reported complications postoperatively, analyzed disability, and were published within a 15-year period. After review of 218 citations by 2 authors, 4 studies were identified as meeting the inclusion criteria. DATA EXTRACTION: Pain scores (Visual Analogue Scale/Dallas Pain Questionnaire), disability (Oswestry Disability Index, Short Form-36, Roland-Morris Disability Questionnaire), postoperative complications and fusion rate outcomes were collected. DATA SYNTHESIS: Four prospective randomized controlled trials were identified and met the inclusion criteria. The outcome disability level showed a combined effect differed from 0 and favored the control [g=0.26, 95% confidence interval (CI): 0.04-0.49, P=0.029]. Visual Analogue Scale pain's combined effect did not differ from 0 and did not favor either the control or brace group (g=0.01, 95% CI: -0.25 to 0.27, P=0.93). The odds ratio (ORs) for complication rates did not differ from 1 (OR=0.88, 95% CI: 0.47-1.65, P=0.69). There was no significant difference in the ORs for fusion rate. Study heterogeneity was measured for all outcomes and there was no excessive variation. CONCLUSIONS: The present meta-analysis indicated no significant difference in pain scores, a decrease in disability level for control (no brace), no significant change in fusion rate, and no significant difference in the odds of complication for the brace group. These conclusions support the theory that there is no significant advantage of postoperative lumbar orthoses.

International Society for the Advancement of Spine Surgery Policy 2019-Surgical Treatment of Lumbar Disc Herniation with Radiculopathy.

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.

Full Percutaneous Transforaminal Lumbar Interbody Fusion Using the Facet-sparing, Trans-Kambin Approach.

STUDY DESIGN: This was a prospective, multicenter, consecutive case series' study. OBJECTIVE: The objective of this study was to evaluate a novel facet-sparing, percutaneous transforaminal lumbar interbody fusion (pTLIF) technique consisting of percutaneous insertion of an expandable interbody cage through an endoscopic cannula with the trans-Kambin approach and complemented with percutaneous transpedicular screws and rods. SUMMARY OF BACKGROUND DATA: Lumbar interbody fusion by open or minimally invasive surgery is the usual treatment for degenerative disk disease but requires a relatively long recovery period. The transforaminal trans-Kambin approach is a standard in endoscopic spine surgery for safe intradiscal access without facet resection. METHODS: Preoperative and postoperative Visual Analogue Scale (VAS) and Oswestry Disability Index scores were quantitatively assessed at 1, 3, 6, and 12 months after surgery and then every 12 months for patients treated with pTLIF between 2009 and 2018 in 2 health care centers. An immediate postoperative control computed tomography scan was performed, whereas conventional postoperative x-ray controls were performed at 1 month and 1 year. Statistical evaluation was performed with the Student t test. RESULTS: A total of 51 patients (mean age, 59.3 y) were evaluated. The overall mean VAS score for axial lumbar pain improved from 6.6 to 1.8 (P<0.01), mean VAS score for leg pain from 5.5 to 1.2 (P<0.01), and mean Oswestry Disability Index scores from 30.3 to 11.8 (P<0.01) postoperatively with a mean follow-up of 27.9 months (range, 1-77.8 mo). Median estimated blood loss was 103.6 mL. Postoperative complications included 12 (22%) cases with transitory ipsilateral dysesthesia, 2 (4%) cases with transitory ipsilateral muscle weakness, and 3 (6%) clinically asymptomatic cases with radiologic cage subsidence. Median hospital stay was 1.4 days (range, 1-3.2 d). CONCLUSIONS: Postoperative scores for pTLIF significantly improved with minimal blood loss and no long-term complications. On the basis of this experience, the facet-sparing pTLIF is a reliable and safe technique with early hospital discharge, opening the way to outpatient instrumented spine surgery. LEVEL OF EVIDENCE: Level III.

Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease.

STUDY DESIGN: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial. OBJECTIVE: The aim of this study was to compare the 5-year safety and effectiveness of the activL Artificial Disc with Control Total Disc Replacement (TDR) systems (ProDisc-L or Charité) in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD). SUMMARY OF BACKGROUND DATA: The activL Artificial Disc received Food and Drug Administration approval in 2015 based on 2-year follow-up data. METHODS: Eligible patients presented with symptomatic, single-level, lumbar DDD who failed ≥6 months of nonsurgical management. At entry, 324 patients were randomly allocated (2 : 1) to treatment with activL (n = 218) or Control (n = 106, including n = 65 ProDisc-L and n = 41 Charité) TDR. At 5-year follow up, a total of 261 patients (176 activL patients and 85 Control patients) were available for analysis. RESULTS: The primary composite endpoint at 5 years for activL patients was noninferior to Control TDR. Relative to baseline, reductions in back pain severity and improvements in Oswestry Disability Index (ODI) were maintained for both the activL and Control TDR groups through 5 years. The activL group showed significantly better range of motion for flexion-extension rotation, flexion-extension translation, and disc angle, compared with Control TDR. Freedom from a serious adverse event through 5 years was 64% in activL patients, 47% in Control patients (log-rank P = 0.0068). Freedom from index-level and adjacent-level reoperation was high for TDR patients, ranging between 94% and 99%, respectively. CONCLUSION: Long-term evidence supports lumbar total disc replacement as safe. The next-generation activL Artificial Disc is more effective at preserving range of motion than first-generation lumbar TDRs (ProDisc-L and Charité) and offers a higher safety profile. Other primary and secondary outcomes are similar between disc designs. LEVEL OF EVIDENCE: 2.

Foreword: Proceedings From the First Annual Lumbar Total Disc Replacement Summit.

: This publication focuses on proceedings from the First Annual Lumbar Total Disc Replacement Summit, held October 25, 2016 in Boston, MA. The Summit brought together 17 thought leading surgeons who employed a modified-Delphi method to determine where consensus existed pertaining to the utilization of lumbar total disc replacement as a standard of care for a subpopulation of patients suffering from degenerative disc disease.

Defining the Ideal Lumbar Total Disc Replacement Patient and Standard of Care.

: Lumbar total disc replacement, now in use since 2004, was determined by the panel to be a standard of care for the treatment of symptomatic single-level lumbar degenerative disc disease in the active patient subpopulation as outlined by the investigational device exemption study criteria. The large body of evidence supporting this statement, including surgeons' experiences, was presented and discussed. Consensus statements focusing on decision-making criteria reflected that efficacy, long-term safety, clinical outcomes with validated measures, and cost-effectiveness should form the basis of decision-making by payers. Diagnostic challenges with lumbar degenerative disc disease patients were discussed among the panel, and it was concluded that although variably used among surgeons, reliable tools exist to appropriately diagnose discogenic back pain.

Generation and Development of Paravertebral Ossification in Cervical Artificial Disk Replacement: A Detailed Analytic Report Using Coronal Reconstruction CT.

STUDY DESIGN: A retrospective follow-up study and review of images in published papers. OBJECTIVE: To determine whether true heterotopic ossification (HO) occurs in artificial disk replacement (ADR); to evaluate the incidence of paravertebral ossification (PO) and its influence on ADR. SUMMARY OF BACKGROUND DATA: HO is typically defined as the abnormal formation of true bone within extraskeletal soft tissues. However, HO in ADR does not fit this definition precisely, as it originates from vertebral body, making it hard to distinguish radiologically from preexisting osteophytes. In this study, the term used for bone formation around ADR is PO. METHODS: First, all images in the published papers were evaluated as to whether the presented PO in ADR fit the classic definition of HO or osteophytes. Second, we studied 37 consecutive patients who underwent ADR and follow-up for minimum 24 months. The preoperative and follow-up incidence of PO and its influence on range of motion were evaluated using x-ray and computed tomography. RESULTS: All 52 images of PO were found adjacent to the disk in 1 segment rather than entire cervical spine. Fifty (96.2%) of the POs were found to originate from the vertebral body rather than in the soft tissue. A total of 31 patients were included in the follow-up study. No significant difference was found in the incidence of PO between the follow-up and preoperation (61.29% vs. 48.39%, P>0.05). The range of motion of the ADR segment in patients with progressed PO (7.44±4.64 degrees) was significantly lower than that of patients with stable PO grade (12.13±4.42 degrees, P<0.01) at last follow-up. CONCLUSIONS: A proportion of HO might in fact be the natural development of preoperative osteophytes, which is unrelated to ADR; the remaining HO might be due to changes in biomechanical environment after surgery, which promotes the grade of osteophytes and affects the segment motion.

Venous hypertensive myelopathy associated with cervical spondylosis.

BACKGROUND CONTEXT: Venous hypertensive myelopathy (VHM) results from spinal vascular malformations of arteriovenous shunting that increases spinal venous pressure, leading to congestive edema and neurologic dysfunction. There has been no report of VHM associated with cervical spondylotic myelopathy (CSM). PURPOSE: The aim of this study was to report an extremely rare case of VHM likely due to CSM. STUDY DESIGN: This study is a case report and review of the literature. PATIENT SAMPLE: The patient was a 51-year-old man with CSM exhibiting relatively rapid neurologic deterioration with an abnormal expansion of a centromedullary hyperintense lesion on T2-weighted magnetic resonance imaging (MRI) in the absence of traumatic injury. METHODS: Neurologic examination and radiologic imaging were taken by various means. RESULTS: The patient developed a cervical radiculopathy, followed by gait disturbance and motor weakness. The MRI of the cervical spine demonstrated spinal canal stenosis due to disc bulging and flavum hypertrophy at the C5/C6 and C6/C7 levels as well as hyperintense area over the C5-C7 levels on T2-weighted images. Although decompression surgery was planned, an acute inflammatory process such as transverse myelitis or demyelinating disease other than cord compression was also considered, and the patient received intravenous steroids. His walking improved for several days. However, his symptoms then became significantly worse, and he had difficulty walking. Subsequent MRI demonstrated marked progression of the T2 hyperintense lesion over the C4-T1 vertebral levels. Flow voids were also noted on the dorsal surface of the upper cervical cord on T2-weighted MRI. His lab work, medical history, and the local enhancement on contrast-enhanced MRI indicated low probability of spinal inflammatory diseases. Therefore, the decision was made to perform anterior cervical discectomy and fusion surgery on two levels. Following surgery, his symptoms improved promptly. CONCLUSIONS: Our case indicates that VHM could be caused by spondylotic cord compression in the absence of spinal vascular malformations. The diagnostic features for VHM are progressive deterioration of myelopathy, easing/worsening of symptoms associated with postural changes, and centromedullary hyperintensity over multiple segments and the flow voids on dorsal surface of the spinal cord on T2-weighted MRI.

The activL(®) Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain.

Degeneration of the lumbar intervertebral discs is a leading cause of chronic low back pain in adults. Treatment options for patients with chronic lumbar discogenic pain unresponsive to conservative management include total disc replacement (TDR) or lumbar fusion. Until recently, only two lumbar TDRs had been approved by the US Food and Drug Administration - the Charité Artificial Disc in 2004 and the ProDisc-L Total Disc Replacement in 2006. In June 2015, a next-generation lumbar TDR received Food and Drug Administration approval - the activL(®) Artificial Disc (Aesculap Implant Systems). Compared to previous-generation lumbar TDRs, the activL(®) Artificial Disc incorporates specific design enhancements that result in a more precise anatomical match and allow a range of motion that better mimics the healthy spine. The results of mechanical and clinical studies demonstrate that the activL(®) Artificial Disc results in improved mechanical and clinical outcomes versus earlier-generation artificial discs and compares favorably to lumbar fusion. The purpose of this report is to describe the activL(®) Artificial Disc including implant characteristics, intended use, surgical technique, postoperative care, mechanical testing, and clinical experience to date.

Teardrop fracture following head-first impact in an ice hockey player: Case report and analysis of injury mechanisms.

BACKGROUND: We report a case of a young male athlete who sustained a three column displaced teardrop fracture of the C5 vertebra due to a head-first impact in hockey, suffered neurapraxia, yet made full neurological recovery. This full recovery was in sharp contrast to multiple case series which reported permanent quadriplegia in the vast majority of teardrop fracture patients. We investigate the etiology and biomechanical mechanisms of injury. METHODS: Admission imaging revealed the teardrop fracture which consisted of: a frontal plane fracture which separated an anterior quadrilateral-shaped fragment from the posterior vertebral body; a vertical fracture of the posterior vertebral body in the sagittal plane; and incomplete fractures of the neural arch that initiated superiorly at the anterior aspect of the spinous process and left lamina adjacent to the superior facet. Epidural hematoma in the region of the C5 vertebra was observed in addition to disc and ligamentous disruptions at C4-5 and C5-6. Our patient was ultimately treated surgically with anterior fusion from C4 through C6 and subsequently with bilateral posterior fusion at C5-6. RESULTS: The injuries were caused by high-energy axial compression with the neck in a pre-flexed posture. The first fracture event consisted of the anterior vertebral body fragment being sheared off of the posterior fragment under the compression load due in part to the sagittal plane concavity of the C5 inferior endplate. The etiology of the vertical fracture of the posterior vertebral body fragment in the sagittal plane was consistent with a previously described hypothesis of the mechanistic injury events. First, the C4-5 disc height decreased under load which increased its hoop stress. Next, this increased hoop stress transferred lateral forces to the C5 uncinate processes which caused their outward expansion. Finally, the outward expansion of the uncinate processes caused the left and right sides of the vertebral body to split and spread. Evidence in support of this mechanistic event sequence was provided by the neural arch fractures which initiated superiorly, average angulation of the C5 uncinate processes, and similar well-established mechanisms causing vertical fractures at other spinal regions. CONCLUSIONS: Our case study and analyses provide insight into the etiology of the specific teardrop fracture patterns observed clinically.

Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial.

STUDY DESIGN: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial. OBJECTIVE: The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy. SUMMARY OF BACKGROUND DATA: Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability. There is a paucity of data available regarding the comparative performance of lumbar TDR. METHODS: Patients presenting with symptomatic single-level lumbar DDD who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational TDR device (activL, n = 218) or FDA-approved control TDR devices (ProDisc-L or Charité, n = 106). The hypothesis of this study was that a composite effectiveness outcome at 2 years in patients treated with activL would be noninferior (15% delta) to that in controls. RESULTS: The primary composite endpoint of this study was met, which demonstrated that the activL TDR was noninferior to control TDR (P < 0.001). A protocol-defined analysis of the primary composite endpoint also confirmed that activL was superior to controls (P = 0.02). Radiographic success was higher with activL versus controls (59% vs. 43%; P < 0.01). Mean back pain severity improved by 74% with activL and 68% with controls. Oswestry Disability Index scores decreased by 67% and 61% with activL and controls, respectively. Patient satisfaction with treatment was over 90% in both groups at 2 years. Return to work was approximately 1 month shorter (P = 0.08) with activL versus controls. The rate of device-related serious adverse events was lower in patients treated with activL versus controls (12% vs. 19%; P = 0.13). Surgical reintervention rates at the index level were comparable (activL 2.3%, control 1.9%). CONCLUSION: The single-level activL TDR is safe and effective for the treatment of symptomatic lumbar DDD through 2 years. LEVEL OF EVIDENCE: 2.

Full Endoscopic Spinal Surgery Techniques: Advancements, Indications, and Outcomes.

Advancements in both surgical instrumentation and full endoscopic spine techniques have resulted in positive clinical outcomes in the treatment of cervical, thoracic, and lumbar spine pathologies. Endoscopic techniques impart minimal approach related disruption of non-pathologic spinal anatomy and function while concurrently maximizing functional visualization and correction of pathological tissues. An advanced understanding of the applicable functional neuroanatomy, in particular the neuroforamen, is essential for successful outcomes. Additionally, an understanding of the varying types of disc prolapse pathology in relation to the neuroforamen will result in more optimal surgical outcomes. Indications for lumbar endoscopic spine surgery include disc herniations, spinal stenosis, infections, medial branch rhizotomy, and interbody fusion. Limitations are based on both non spine and spine related findings. A high riding iliac wing, a more posteriorly located retroperitoneal cavity, an overly distal or proximally migrated herniated disc are all relative contra-indications to lumbar endoscopic spinal surgery techniques. Modifications in scope size and visual field of view angulation have enabled both anterior and posterior cervical decompression. Endoscopic burrs, electrocautery, and focused laser technology allow for the least invasive spinal surgical techniques in all age groups and across varying body habitus. Complications include among others, dural tears, dysesthsia, nerve injury, and infection.

Lumbar nerve rootlet entrapment by an iatrogenically spliced percutaneous intra-thecal lumbar cerebrospinal fluid catheter.

BACKGROUND: Complications associated with the use of percutaneous intra-thecal lumbar indwelling spinal catheters include infection, hematoma, neurologic dysfunction, and persistent undesired retention among others. A case of iatrogenic splicing associated with neurologic dysfunction with the use of a percutaneous intra-thecal indwelling spinal catheter is presented in this study. METHOD: Single case study review. RESULTS: Review of case materials indicate Y pattern splicing/fragmentation of an indwelling intra-thecal catheter causing neurologic dysfunction and resistance to removal during attempted removal. Pain and weakness were evident soon after insertion of the catheter and were amplified with attempted catheter removal. Computed tomography revealed a double dot sign on axial view and a Y appearance on sagittal view. Surgical findings revealed entrapment of nerve rootlets in the axilla of the spliced catheter. CONCLUSIONS: Splicing/fragmentation causing neurologic dysfunction as well as catheter retention is described as a potential complication of intra-thecal indwelling cerebrospinal fluid catheters. A symptom of fragmentation of a catheter may include neurologic dysfunction including pain and weakness of a lumbar nerve root. If resistance is experienced upon attempted catheter removal, with or without associated neurologic dysfunction, further attempts at removal should not be attempted. In those cases in which pain and/or lumbar weakness are evident post catheter placement and/or following attempted removal, computed tomography should be performed. If fragmentation of a catheter is evident on CT scan, spinal surgical consultation should be obtained. Recommended spinal surgical intervention includes an open durotomy and visualization of catheter fragments and nerve rootlets and removal of catheter fragments.