A Subdural Dissection of Cerebrospinal Fluid Causing Cauda Equina Centralization After Durotomy: A Case Report.

CASE: A 61-year-old woman with recurrent left L5 radiculopathy underwent revision L4-5 decompression complicated by incidental durotomy requiring primary repair. Postoperative course was complicated by wound drainage and headache. Repeat magnetic resonance imaging demonstrated cerebrospinal fluid dissecting a plane deep to the dura mater but superficial to the arachnoid, with the collection compressing the cauda equina in an atypical horizontal and linear fashion. Nonoperative treatment was ineffective, and she required revision decompression and dural repair. CONCLUSION: Spine surgeons should recognize this finding on postoperative imaging as a potential sign of an incomplete dural repair necessitating return to the operating room.

Twenty-Year Radiographic Outcomes Following Single-Level Cervical Disc Arthroplasty: Results From a Prospective Randomized Controlled Trial.

STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: Compare range of motion (ROM) and adjacent segment degeneration (ASD) following cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) at 20-year follow-up. SUMMARY OF BACKGROUND DATA: Anterior cervical discectomy and fusion is the standard of treatment for single-level cervical disc degeneration causing radiculopathy. CDA is claimed to reduce shear strain, and adjacent-level ROM changes are hypothesized to hasten ASD with ACDF. MATERIALS AND METHODS: This study collected data on 47 patients randomized to ACDF or CDA. Lateral cervical spine radiographs were evaluated preoperatively, postoperatively, and at 20 years for alignment, ROM, ASD, and heterotopic ossification. RESULTS: Eighty-two percent (18/22) of CDA patients and 84% (21/25) of ACDF patients followed up at 20 years. At 20 years, total cervical (C2-C7) ROM was statistically different between the CDA and fusion groups (47.8° vs . 33.4°, P =0.005). Total cervical ROM was not significantly different between preoperative and 20-year periods following CDA (45.6° vs . 47.4°, P =0.772) or ACDF (40.6° vs . 33.0°, P =0.192). Differences in postoperative and 20-year index-level ROM following CDA were not significant (10.1° vs . 10.2°, P =0.952). Final ASD grading was statistically lower following CDA versus ACDF at both adjacent levels ( P <0.005). Twenty-year adjacent-level ossification development was increased following ACDF versus CDA ( P <0.001). Polyethylene mean thickness decreased from 9.4 mm immediately postoperatively to 9.1 mm at 20-year follow up ( P =0.013). Differences in adjacent-level ROM from preoperative to 20-year follow-up in both the ACDF and CDA groups did not meet statistical significance ( P >0.05). CONCLUSIONS: Cervical disc arthroplasty maintains index-level and total cervical ROM with very long-term follow-up. Total cervical ROM was higher at 20 years in CDA relative to ACDF. CDA results in lower rates of ASD and adjacent-level ossification development than ACDF.

Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study.

BACKGROUND CONTEXT: Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSE: To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGN: Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLE: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURES: The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODS: Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTS: At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). CONCLUSIONS: Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.

20-year Clinical Outcomes of Cervical Disk Arthroplasty: A Prospective, Randomized, Controlled Trial.

STUDY DESIGN: Prospective, randomized, controlled trial. OBJECTIVE: To compare clinical outcomes of anterior cervical discectomy and fusion (ACDF) and cervical disk arthroplasty (CDA) at 20 years. SUMMARY OF BACKGROUND DATA: Concern for adjacent-level disease after ACDF prompted the development of CDA. MATERIALS AND METHODS: Forty-seven patients with single-level cervical radiculopathy were randomized to either BRYAN CDA or ACDF for a Food and Drug Administration Investigational Device Exemption trial. At 20 years, patient-reported outcomes, including visual analog scales (VAS) for neck and arm pain, neck disability index (NDI), and reoperation rates, were analyzed. RESULTS: Follow-up rate was 91.3%. Both groups showed significantly better NDI, VAS arm pain, and VAS neck pain scores at 20 years versus preoperative scores. Comparing CDA versus ACDF, there was no difference at 20 years in mean scores for NDI [11.1 (SD 14.1) vs. 19.9 (SD 17.2), P =0.087], mean VAS arm pain [0.9 (SD 2.4) vs. 2.3 (SD 2.8), P =0.095], or mean VAS neck pain [1.2 (SD 2.5) vs. 2.9 (3.3), P =0.073]. There was a significant difference between CDA versus ACDF groups in the change in VAS neck pain score between 10 and 20 years [respectively, -0.4 (SD 2.5) vs. 1.5 (SD 2.5), P =0.030]. Reoperations were reported in 41.7% of ACDF patients and 10.0% of CDA patients ( P =0.039). CONCLUSIONS: Both CDA and ACDF are effective in treating cervical radiculopathy with sustained improvement in NDI, VAS neck and VAS arm pain at 20 years. CDA demonstrates lower reoperation rates than ACDF. There were no failures of the arthroplasty device requiring reoperation at the index level. The symptomatic nonunion rate of ACDF was 4.2% at 20 years. Despite a higher reoperation rate in the CDA group versus ACDF group, there was no difference in the 20-year NDI, VAS Neck, and VAS arm pain scores.

Technique Pearls for Successful Cervical Disc Arthroplasty From More Than 20 Years of Surgical Experience.

STUDY DESIGN: Surgical technique paper. OBJECTIVE: To describe tips and pearls for cervical disc arthroplasty (CDA). BACKGROUND: CDA has proven to be an effective means of treatment for degenerative cervical disc disease and cervical radiculopathy in properly selected patients who have previously failed non-operative treatment. METHODS: Surgical tips and pearls garnered from more than 20 years of experience with CDA surgery are described. RESULTS: This discussion focuses on pearls for successful procedures, including patient selection, patient positioning, surgical technique, and postoperative protocols. CONCLUSIONS: In correctly selected patients, CDA can be effective in treating cervical degenerative disc disease and radiculopathy. The techniques described here can increase the chance of success and decrease complications.

Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results.

BACKGROUND: Reherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone. OBJECTIVE: The objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States. METHODS: In this post-market study, all patients (N = 55) received discectomy surgery with a bone-anchored ACD. The comparison population was patients enrolled in the RCT study who had discectomy with an ACD (N = 262) or discectomy alone (N = 272). All other eligibility criteria, surgical technique, device characteristics, and follow-up methodology were comparable between studies. Endpoints included rate of symptomatic reherniation or reoperation, SAEs, and patient-reported measures of disability, pain, and quality of life. RESULTS: Fifty-five patients received ACD implants at 12 sites between May 2020 and February 2021. In the previous RCT, 272 control patients had discectomy surgery alone (RCT-Control), and 262 patients had discectomy surgery with an ACD implant (RCT-ACD). Baseline characteristics across groups were typical of the overall population undergoing lumbar discectomy. The proportion of patients who experienced reherniation and/or reoperation was significantly lower in the ACD group compared to RCT-ACD and RCT-Control groups (p < 0.05). In the ACD study, the one-year rate of symptomatic reherniation was 3.7%, compared to 8.5% in the RCT-ACD group and 17.0% in the RCT-Control group. In the ACD group, the risk of reoperation was 5.5%, compared to 6.5% in the RCT-ACD group and 12.5% in the RCT-Control group. There were no device-related SAEs or device integrity failures in the ACD, and there were clinically meaningful improvements in patient-reported measures of disability, pain, and quality of life. CONCLUSION: In this post-market study of bone-anchored ACD in patients with large annular defects, rates of symptomatic reherniation, reoperation, and SAEs were all low. Compared to the RCT, the post-market ACD study demonstrated lower rates of reherniation and/or reoperation and measures of back pain one-year post-surgery.

Clinical Significance of Lateral Pedicle Screw Malposition in Lumbar Spine Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Our objective was to determine whether lateral pedicle screw breach affects fusion rates and patient-reported outcomes in lumbar fusion surgery. SUMMARY OF BACKGROUND DATA: Although lateral pedicle screw malposition is considered relatively benign, few studies have focused specifically on clinical outcomes or fusion rates associated with lateral screw malposition. METHODS: Twelve-month postoperative computed tomography scans were reviewed for lateral breach, severity of breach, and fusion status. Patients with lateral breach were compared with patients with no breach. Outcome measures included Numerical Pain Rating Scale for back and leg pain, Oswestry Disability Index, and SF-36 physical function (SF-36 PF). Multivariable linear and logistic regression and were adjusted for age, procedure, level, and/or baseline pain score. RESULTS: Forty-five patients (31%) demonstrated 1 or more lateral breaches as compared with 99 patients without breach. After adjusting for baseline scores and fusion level, patients with 2 or more screw breaches experienced SF-36 PF score improvements that were 3.43 points less ( P =0.016) than patients with no lateral breach. After adjusting for baseline Numerical Pain Rating Scale, there was also a significant decrease in the odds of achieving minimally clinical important difference in back pain relief in these patients. There was no observed effect of lateral breach on the odds of successful fusion. CONCLUSIONS: The current study did not observe an association between laterally malpositioned pedicle screws and nonunion. However, results are consistent with a negative effect on SF-36 PF scores and self-reported back pain at 12 months.

Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion.

BACKGROUND: Previous analyses of the US Food and Drug Administration (FDA) Investigational Device Exemption study demonstrated the superiority of i-FACTOR compared with local autograft bone in single-level anterior cervical discectomy and fusion (ACDF) at 12 and 24 months postoperatively in a composite end point of overall success. OBJECTIVE: To report the final, 6-year clinical and radiological outcomes of the FDA postapproval study. METHODS: Of the original 319 subjects enrolled in the Investigational Device Exemption study, 220 participated in the postapproval study (106 i-FACTOR and 114 control). RESULTS: The study met statistical noninferiority success for all 4 coprimary end points. Radiographic fusion was achieved in 99% (103/104) and 98.2% (109/111) in i-FACTOR and local autograft subjects, mean Neck Disability Index improvement from baseline was 28.6 (24.8, 32.3) in the i-FACTOR and 29.2 (25.6, 32.9) in the control group, respectively (noninferiority P < .0001). The neurological success rate at 6 years was 95.9% (70/73) in i-FACTOR subjects and 93.7% (70/75) in local autograft subjects (noninferiority P < .0001). Safety outcomes were similar between the 2 groups. Secondary surgery on the same or different cervical levels occurred in 20/106 (18.9%) i-FACTOR subjects and 23/114 (20.2%) local autograft subjects ( P = .866). Secondary outcomes (pain, SF-36 physical component score and mental component score) in i-FACTOR subjects were similar to those in local autograft subjects. CONCLUSION: i-FACTOR met all 4 FDA-mandated noninferiority success criteria and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion for cervical radiculopathy through 6 years postoperatively. Safety outcomes are acceptable, and the clinical and functional outcomes observed at 12 and 24 months remained at 72 months.

Pedicle Screw-Associated Violation of the Adjacent Unfused Facet Joint: Clinical Outcomes and Fusion Rates.

STUDY DESIGN: Retrospective review of a prospective randomized trial. OBJECTIVES: To compare outcome scores and fusion rates in patients with and without pedicle screw-associated facet joint violation (FJV) after a single-level lumbar fusion. METHODS: Clinical outcomes data and computed tomography (CT) imaging were reviewed for 157 patients participating in a multicenter prospective trial. Post-operative CT scans at 12-months follow-up were examined for fusion status and FJV. Patient-reported outcomes (PROs) included Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for leg and low back pain. Chi-square test of independence was used to compare proportions between groups on categorical measures. Two-sample t-test was used to identify differences in mean patient outcome scores. Logistic regression models were performed to determine association between FJV and fusion rates. RESULTS: Of the 157 patients included, there were 18 (11.5%) with FJV (Group A) and 139 (88.5%) without FJV (Group B). Patients with FJV experienced less improvement in ODI (P = .004) and VAS back pain scores (P = .04) vs patients without FJV. There was no difference in mean VAS leg pain (P = .4997). The rate of fusion at 12-months for patients with FJV (27.8%) was lower compared to those without FJV (71.2%) (P = .0002). Patients with FJV were 76% less likely to have a successful fusion at 12-months. CONCLUSION: Pedicle screw-associated violation of the adjacent unfused facet joint during single-level lumbar fusion is associated with less improvement in back pain, back pain-associated disability, and a lower fusion rate at 1-year after surgery.

Comparison of a right versus left sided anterior approach to the thoracic and thoracolumbar spine: A case series.

Aims & objectives: Traditionally, a left sided anterior approach has been considered the safest way to access the thoracic and thoracolumbar spine due to avoidance of the inferior vena cava (IVC). We challenge this 'go from the left' dogma by presenting a series of patients who underwent a right sided approach to the thoracic and thoracolumbar spine. Materials & methods: 71 anterior thoracic fusion procedures treated with either a left or right sided approach were identified and retrospectively studied. Demographic information, indication for surgery, intra-operative time, estimated blood loss (EBL), hospital length of stay (LOS), and complications were collected. Patients were further sub divided into groups according to indication for surgery. Results: 57 cases with a right sided approach and 14 cases with a left sided approach were investigated. Four mortalities occurred, all within the right sided approach group among patients who were being for osteomyelitis/discitis. There were statistically significant differences between right and left sided approach groups for operative time and EBL when patients were analysed together favoring the left sided approach. However once subgroup analysis was performed, there were no statistically significant differences between right and left sided approach groups aside from operative time in the HNP group and LOS in the fracture group. Neither group had catastrophic intra-operative vascular injury. Perioperative complications occurred in 22.8% of right sided approach patients and 14% of left sided approach patients. Conclusions: Our results reinforce the fact that anterior thoracic fusion is a major surgical endeavor that is not without risk. Although there were differences in operative time and EBL between right and left sided approach groups when all patients were analysed together, these were no longer significant with subgroup analysis according to indication for surgery with two exceptions. This may be in part due to low sample size or confounding variables related to indication.

Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up.

BACKGROUND: Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core. The purpose of this study was to compare this TDR with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration. METHODS: This was a prospective, nonrandomized, historically controlled, multicenter US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n = 150). The historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial. The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analog scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI. RESULTS: The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; P < .001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points. There were no significant differences in the rates of serious adverse events. The range of motion of the TDR level had increased significantly by 3 months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from preoperation. CONCLUSIONS: The TDR had an acceptable safety profile and a significantly greater composite success rate than ACDF. These results support that the PEEK-on-ceramic TDR is a viable alternative to ACDF for single-level symptomatic disc degeneration. CLINICAL RELEVANCE: This study found that the PEEK-on-ceramic TDR is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion. LEVEL OF EVIDENCE: 2.

Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. OBJECTIVE: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. METHODS: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. RESULTS: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline (P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. CONCLUSIONS: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD.

Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study.

Background Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited.  Methods This was a post-market study to determine the real-world outcomes of the Barricaid device when used in addition to primary lumbar discectomy in patients with large annular defects. Main outcomes included leg pain severity, Oswestry Disability Index (ODI), adverse events, symptomatic reherniation, and reoperation. Imaging studies were read by an independent imaging core laboratory. This paper reports the initial three-month primary endpoint results from the trial; one-year patient follow-up is ongoing. Results Among 55 patients (mean age 41±13 years, 60% male), the mean percent reduction in leg pain severity was 92%, and the mean percent reduction in ODI score was 79%. The three-month rate of symptomatic reherniation was 3.6% and the rate of reoperation was 1.8%. The serious adverse event rate was 5.5%; no device migrations or fractures were observed.  Conclusion Among patients with large annular defects following lumbar discectomy treated with the Barricaid device in real-world conditions, early results demonstrated clinically meaningful improvements in patient symptoms and low rates of symptomatic reherniation, reoperation, and complications, which were comparable to those observed with the device in an FDA-regulated trial.

Far Lateral/Extraforaminal Approaches for Microdiscectomy and Foraminal Decompression in the Lumbar Spine.

Far lateral approaches to the lumbar spine are uncommon procedures but are essential techniques for spine surgeons to understand and master for the treatment of extraforaminal disk herniations and foraminal stenosis. We present our preferred approaches for open and minimally invasive techniques to perform extraforaminal decompressions and/or discectomies in the lumbar spine.

Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study.

BACKGROUND CONTEXT: Various designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series. PURPOSE: To evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy. STUDY DESIGN/SETTING: Prospective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial. PATIENT SAMPLE: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF. OUTCOME MEASURES: Pain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months. METHODS: Using propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls). RESULTS: Both ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups. CONCLUSIONS: M6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline.

Two-Level Anterior Cervical Discectomy and Fusion Versus Cervical Disc Arthroplasty-Long-Term Evidence Update.

BACKGROUND: Multiple studies have highlighted the motion-sparing benefits of single-level cervical disc arthroplasty (CDA) compared with anterior cervical discectomy and fusion (ACDF). However, few studies have reviewed multilevel ACDF versus CDA. Several recent studies have midterm and even long-term data available comparing 2-level ACDF versus CDA. METHODS: We reviewed 3 reports from 2 large randomized, prospective Food and Drug Administration investigational drug exemption trials looking at 2-level CDA versus ACDF, which provide the bulk of the available midterm to long-term, high-level evidence for the topic. We also present several smaller and/or shorter-term studies. RESULTS: One 5-year study showed that, while both CDA and ACDF showed significant improvement in patient-reported outcome scores, CDA demonstrated greater improvement in Neck Disability Index (NDI) scores than ACDF (mean = -37 versus mean = -28, P = .0003), were more likely to be satisfied (96.4% versus 89.5%, P = .04), had fewer secondary surgeries (4% versus 16.2%, P = .0003), had fewer adjacent level reoperations (3.1% versus 11.4%), and developed less adjacent segment degeneration (50.7% versus 90.5%, P < .0001). Adverse events occurred more frequently with ACDF (8.6% versus 4.4%).Similarly, Lanman et al [Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD. Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. 2017;27(1):7-19] showed that, at 7 years, while both groups demonstrated improvement in patient-reported outcomes, CDA had greater improvement in regard to NDI, neck pain, and Short Form (36) Physical Component Summary scores (each P < .001), had higher rates of satisfaction (94.8% versus 92.6%), had lower rate of secondary surgery at treated levels (4.2% versus 14.7%), and had a lower, albeit not statistically significant, rate of secondary surgeries at adjacent levels (6.5% versus 12.5%). Adverse events were more common with ACDF (7.2% versus 3.2%).More recently, Gornet et al [Gornet MF, Lanman TH, Burkus JK, et al. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019;31:508-518.] in 2019 reported 10-year data from the same clinical trial as the Lanman et al report comparing 2-level CDA (209 patients) versus ACDF (188 patients). With >84% follow-up for both groups at 10 years, they found that CDA demonstrated a statistically significantly improved rate of overall success (84% versus 62%) as compared with ACDF. Greater improvements were seen in several other outcome measures for CDA, including NDI, neurological success, and neck pain scores. The CDA group had a lower rate of serious implant-related adverse events and demonstrated a lower rate of needing a secondary surgery at an adjacent level, 9% versus 18% in the ACDF group. CONCLUSIONS: Results of 2 large randomized trials suggest similar-to-improved patient reported outcomes for multilevel CDA versus ACDF maintained out to midterm to long-term follow-up of 5-10 years, with lower rates of revision surgery at index and adjacent levels and lower rates of serious adverse device-related events. LEVEL OF EVIDENCE: 5. CLINICAL RELEVANCE: Comparison of the safety and efficacy of multi-level cervical disc arthroplasty and cervical discectomy and fusion.

Remote Virtual Spinal Evaluation in the Era of COVID-19.

BACKGROUND: With the COVID-19 pandemic disrupting many facets of our society, physicians and patients have begun using telemedicine as a platform for the delivery of health care. One of the challenges in implementing telemedicine for the spine care provider is completing a comprehensive spinal examination. Currently, there is no standardized methodology to complete a full spinal examination through telemedicine. METHODS: We propose a novel, remote spinal examination methodology that is easily implemented through telemedicine, where the patient is an active participant in the successful completion of his or her examination. This type of examination has been validated in a neurology setting. To facilitate the telemedicine visit, we propose that video instruction be shared with the patient prior to the telemedicine visit to increase the efficacy of the examination. RESULTS: Since the issuance of stay-at-home order across the states, many spine practices around the country have rapidly adopted and increased their telemedicine program to continue provide care for patients during COVID-19 pandemic. At a tertiary academic center in a busy metropolitan area, nearly 700 telemedicine visits were successfully conducted during a 4-week period. There were no remote visits being done prior to the shutdown. CONCLUSIONS: Implementation of our proposed remote spinal examination has the potential to serve as a guideline for the spine care provider to efficiently assess patients with spine disease using telemedicine. Because these are only suggestions, providers should tailor examination to each individual patient's needs. LEVEL OF EVIDENCE: V. CLINICAL RELEVANCE: It is likely that physicians will incorporate telemedicine into health care delivery services even after the COVID-19 pandemic subsides because of telemedicine's efficiency in meeting patient needs. Using the standard maneuvers provided in our study, spine care providers can perform a nearly comprehensive spine examination through telemedicine. Further studies will be needed to validate the reproducibility and reliability of our methodology.