Symptomatic Cervical Radiculopathy Research Articles

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 CONTEXTVarious 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. PURPOSETo evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGNProspective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLESubjects 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 MEASURESThe 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. METHODSPropensity 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. RESULTSAt 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). CONCLUSIONSSubjects 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.

Multilevel ossification of the posterior longitudinal ligament causing cervical myelopathy: An observational series of North American patients.

Few studies regarding ossification of the posterior longitudinal ligament (OPLL) outside of Asia currently exist in the literature. A set of patients with multilevel cervical OPLL causing symptomatic myelopathy or radiculopathy from a North American sample is analyzed. The objective of this study was to describe the demographics, radiographic findings, and surgical outcomes of a cohort of North American patients with degenerative spondylosis presenting for operative management of multilevel (>3 segments) cervical OPLL. Forty-three patients diagnosed with multilevel cervical OPLL and degenerative spondylosis presenting with symptomatic cervical myelopathy or radiculopathy were surgically treated over a 9-year period at a single tertiary care academic medical center. Radiographic measurements were performed on preoperative computed tomography and magnetic resonance imaging images of the cervical spine. Clinical outcomes included pre- and postoperative Nurick scores, 90-day readmission, complication, and revision surgery rates. The mean age was 66.1 ± 10.9 years with a mean latest follow-up time of 32.7 ± 16.4 months. Most patients had previous diagnoses of obesity (70.7%) and hypertension (55.8%). At least one-quarter of patients were diagnosed with type 2 diabetes (34.9%), hyperlipidemia (41.9%), cardiovascular disease (25.6%), or chronic kidney disease (25.3%). The most common OPLL subtype was segmental (39.5%) and spanned a mean of 3.54 ± 1.48 segments. Myelopathic symptoms were present in 88.4% of patients. All patients experienced significant neurologic improvement at 3-week and latest follow-up (P < 0.001 for both). Obesity, diabetes, and other metabolic derangements in patients with existing cervical spondylosis may be risk factors for a particularly aggressive form of multilevel OPLL. Various operative approaches may be employed to achieve adequate neurologic recovery. Further workup for OPLL in patients with these risk factors may prove beneficial to ensure appropriate operative management.

159. Midterm 4-year outcomes for single-level total disc replacement with a novel viscoelastic artificial cervical disc compared to ACDF

<h3>BACKGROUND CONTEXT</h3> The M6-C artificial cervical disc, with a compressible viscoelastic nuclear core and an annular structure, is substantially different from first generation articulating surface designs and has previously demonstrated favorable clinical outcomes out to 2-years post-implantation. <h3>PURPOSE</h3> To evaluate the safety and effectiveness of the M6-C artificial cervical disc compared with ACDF. <h3>STUDY DESIGN/SETTING</h3> A prospective, multicenter, controlled, IDE clinical trial is ongoing. Twelve M6-C sites and 11 ACDF sites are participating in the study, with preoperative assessments followed by assessments at 6 weeks, 3 months, 6 months, 1 year and annually out to 10 years postimplantation. <h3>PATIENT SAMPLE</h3> Study subjects presented with one-level symptomatic degenerative cervical radiculopathy, and received either M6-C or ACDF at a single level. <h3>OUTCOME MEASURES</h3> Neck Disability Index (NDI), neck pain and shoulder/arm pain visual analog scale (VAS) scores. <h3>Methods</h3> The M6-C and ACDF cohorts were propensity matched. Follow-up assessments are ongoing and planned out to 10-years postop. <h3>Results</h3> A total of 160 M6-C and 189 ACDF subjects were enrolled. NDI scores are available for 124 M6-C and 148 ACDF subjects at 3 years, and 116 M6-C and 133 ACDF subjects at 4 years postop. At 3 years postop, M6-C subjects had a mean NDI score of 10.9 - significantly better than the mean of 17.2 observed in the ACDF group. A significant difference was observed at 4 years postop (M6-C mean of 10.3 compared to 19.2 for ACDF.) M6-C subjects experienced a mean improvement from baseline of 43.9 points at 3-years and 45.2 points at 4-years postop, compared to 36.0 and 36.0, respectively, for the ACDF cohort, with the 4-year results being significantly better for the M6-C group. More M6-C subjects experienced a 15-point improvement from baseline (93.6% at 3 years and 95.7% at 4 years,) compared to the ACDF cohort (86.6% and 82.7%, respectively,) with the 4-year results being significantly better for the M6-C group. Neck pain and shoulder/arm pain VAS scores are available for analysis for 124 M6-C and 148 ACDF subjects at 3 years, and 116 M6-C and 134 ACDF subjects at 4 years postop. At 3 years postop, M6-C subjects had a mean neck pain VAS score of 1.1, which was significantly better than the mean of 2.0 observed in the ACDF control group. Similarly, a significant difference was observed at 4 years postop (M6-C mean of 1.0 compared to 2.3 for ACDF.) M6-C subjects experienced a mean improvement from baseline of 6.1 points at 3-years and 6.2 points at 4-years postop, compared to 5.2 and 4.8, respectively, for the ACDF cohort, both significantly better for the M6-C group. Similarly significant results were observed in shoulder/arm pain VAS scores (worst side) at 3-years (0.9 for M6-C and 2.2 for ACDF) and 4-years postop (0.6 for M6-C and 2.7 for ACDF.) One M6-C subject (0.6%) had the device removed in the first 4 postop years (chronic neck pain.) <h3>Conclusions</h3> The significant benefits in NDI and neck pain and shoulder/arm pain VAS scores associated with M6-C in earlier follow-up periods, compared to ACDF controls, appear to be maintained at 3- and 4-years postop, with no concerns for durability of the surgical outcome or the prosthesis at 4 years. Both NDI and neck pain and shoulder/arm pain will continue to be monitored in this cohort via annual assessments out to 10-years postop. <h3>FDA DEVICE/DRUG STATUS</h3> M6 TDR (Approved for this indication)

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 CONTEXTVarious 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. PURPOSETo 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/SETTINGProspective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial. PATIENT SAMPLESubjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF. OUTCOME MEASURESPain 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. METHODSUsing 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). RESULTSBoth 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. CONCLUSIONSM6-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.

Trans-interlamina percutaneous endoscopic cervical discectomy for symptomatic cervical spondylotic radiculopathy using the new Delta system

To describe the rationale and surgical technique and compare the clinical effect of posterior percutaneous endoscopic cervical discectomy (PPECD) using the Delta system versus that of conventional PPECD (key-hole) surgery for the treatment of symptomatic cervical spondylotic radiculopathy (CSR). A retrospective analysis was performed on 106 single-segment CSR patients between February 2016 and February 2017, 50 of whom underwent conventional PPECD (key-hole), and 56 underwent PPECD using the Delta system. The operative time, intraoperative blood loss, intraoperative complications and postoperative hospital stay were recorded, and the clinical effect was evaluated by the indicators of the Neck Disability Index (NDI), arm-visual analog scale (arm-VAS), neck-VAS, EQ-5D and MacNab classification at the last follow-up. All patients underwent the operation successfully, and 106 patients were followed up. The operative time of the Delta group was 60.47 ± 0.71 min, while the operative time of the key-hole group was 75.46 ± 0.41 min. The difference between the two groups was statistically significant (P < 0.05). However, there was no significant difference between the two groups in terms of blood loss and hospital stay (P > 0.05). The VAS, NDI and EQ-5D scores of the neck and upper limbs in the two groups were significantly better than those before surgery at 1 week after surgery and at the last follow-up (P < 0.05). However, there was no significant difference between the two groups at the last follow-up (P > 0.05). At the last follow-up, there was no significant difference between the two surgical methods when evaluated using the modified MacNab criteria. The imaging results showed that the herniated disc was removed completely and the nerve root was decompressed. The complication rate in the Delta group (3/56, 5.35%) was significantly lower than that in the conventional key-hole group (5/50, 10.0%). PPECD using the Delta system for CSR may be a feasible and promising alternative surgical plan. Compared with the traditional key-hole method, this surgical system can not only provide the surgeon with a larger surgical field of vision but also reduces the operation time and complication rates.

Vietnamese herbal medicine (TD0019) in the treatment of cervical radiculopathy: A double-blind phase-2 randomized controlled trial

IntroductionCervical radiculopathy causes chronic pain and reduces patients’ quality of life. Oral analgesics are commonly used but only after careful consideration due to their complications. TD0019, a Vietnamese herbal medicine, composed of Duhuo Jisheng decoction, nattokinase and an extract of Salix alba cortex has shown evidence of some benefits for these patients in pre-clinical and phase-1 studies. This study aimed to evaluate the efficacy and safety of TD0019 in the treatment of cervical radiculopathy. MethodsIn this double-blind phase-2 trial, 180 patients with symptomatic cervical radiculopathy were randomized to either group 1 with intended dose of TD0019, group 2 with a higher dose (1.5 times the intended dose), or group 3, a placebo. The primary efficacy endpoint was the neck-specific disability score according to the Neck Disability Index (NDI) questionnaire. The safety endpoint included adverse events (AEs) and serious adverse events (SAEs). All patients received the drugs for 30 days and were followed for 60 days. ResultsBaseline characteristics were similar for the three groups. The reduction of NDI score from baseline to the end of study was greatest for group 2 (from 17.6 ± 7.2 to 4.8 ± 5.1), followed by group 1 (from 16.1 ± 6.9 to 5.4 ± 5.1) and placebo group (from 15.6 ± 6.2 to 7.8 ± 6.8), with a significant decrease for both groups compared to placebo. The percentage of AEs was comparable among three groups and no SAEs occurred. ConclusionsTD0019 was superior to placebo for the reduction of symptoms with similar rates of side effects. The higher dose is more beneficial than the intended dose. This herbal medicine may be a potential alternative analgesic in the treatment of cervical radiculopathy.

Microendoscopic anterior cervical foraminotomy: a preliminary series of 76 cases

BackgroundAnterior cervical foraminotomy represents a relatively recent minimally invasive approach that can potentially preserve the intervertebral disc and thus the functional motion segment.ObjectiveThis study aims to evaluate the clinical outcome of microendoscopic anterior cervical foraminotomy (MACF) for patients with cervical unilateral radiculopathy due to single level soft disc herniation or hard disc-osteophyte complex (DOC).MethodsIn the period between August 2009 and March 2015, 76 consecutive patients with symptomatic unilateral cervical radiculopathy were included in this study. There were 40 left-sided cervical radiculopathy cases and 36 right-sided; of those, 42 had soft disc fragment herniation, 18 had DOC, 12 had a migrated disc fragment whether cranial or caudal, and four had far lateral (foraminal) disc herniation. In all cases, MACF with root decompression was performed. Cervical magnetic resonance imaging (MRI), computed tomography (CT) scan, and plain X-rays were performed for all patients and then repeated postoperatively. All patients were followed-up for at least a year. Clinical and functional outcomes were assessed using visual analogue scale (VAS) and Odom’s criteria.ResultsAccording to VAS score, there was an improvement in neck pain from 6.4 (range 5–10) to 1.5 (1–5) and in arm pain from 7.2 (range 6–10) to 1.2 (0–4) at final follow-up (P < 0.05). Functional outcomes according to Odom’s criteria were excellent in 59 (78%) cases, good in ten (13%), fair in six (8%), and poor in one (1%) case. Success of surgery was considered to be achieved in 91% (excellent + good) of cases. Mean operating time was 81 min, and mean intraoperative blood loss was 21 ml. Most significant complications included a dural tear in one case, transient postoperative dysesthesia in six cases, excess bony work resulting in unintended uncinectomy in three cases, fracture of transverse process in one case, unintended near total discectomy in two cases, infective discitis in one case, and persistent radicular pain due to incomplete osteophyte removal in one case.ConclusionsThis preliminary report suggests that MACF yields overall excellent results in selected patients with unilateral cervical radiculopathy. The technique potentially can preserve the functional motion segment, thus patients typically experience immediate postoperative neck mobility and do not need to wear a cervical collar.

Outcomes and revision rates following multilevel anterior cervical discectomy and fusion.

Anterior cervical discectomy and fusion (ACDF) for cervical degenerative disease is an accepted treatment for symptomatic cervical radiculopathy and myelopathy. One- and two-level fusions are much more common and more widely studied. Outcomes and revision rates for three- and four-level ACDF have not been well described. The purpose of this study is to report on clinical outcomes and revision rates following multilevel ACDF. Patients who underwent three- or four-level anterior cervical discectomy with plate fixation between 2006 and 2011 from a single-center multi-surgeon practice for symptomatic cervical degenerative disease were identified. Improvements in neck disability index (NDI), neck and arm pain scores two years after surgery and revision rates were analyzed. Forty-six patients with a mean age of 55.9 years were included in the analysis. Twenty-one (46%) were male, 10 (22%) were smokers. Forty-one (89%) underwent three-level fusion and 5 (11%) underwent four-level fusion. NDI improved from 34.46 at baseline to 25.47 at 2 years. Neck pain improved from 7.04 at baseline to 3.95 and arm pain improved from 6.24 to 3.09 at 2 year follow up. Sixteen patients (35%) returned to surgery within 2 years with 11 of these patients (24%) returning for non-union. The average number of days to revision surgery was 750.6±570.3 days. Patients undergoing three- and four-level ACDF for multilevel cervical disease demonstrate substantial improvement in outcomes. However, the two-year revision rate is relatively high at 35% with the majority of these patients returning due to non-union.

Length of stay associated with posterior cervical fusion with intervertebral cages: experience from a device registry.

Using a multi-center medical device registry, we prospectively collected a set of perioperative and clinical outcomes among patients treated with tissue-sparing, posteriorly-placed intervertebral cage fusion used in the management of symptomatic, degenerative neural compressive disorders of the cervical spine. Cervical fusion utilizing posteriorly-placed intervertebral cages offers a tissue-sparing alternative to traditional instrumentation for the treatment of symptomatic cervical radiculopathy. A registry was established to prospectively collect perioperative and clinical data in a real-world clinical practice setting for patients treated via this approach. This study evaluated length of stay as well as estimated blood loss and procedural time in 271 registry patients. The median length of stay was 1.1, 1.1 and 1.2 days for patients having a stand-alone arthrodesis, revision of a pseudoarthrosis, and circumferential fusion (360°), respectively, and was not related to number of levels treated. Historical comparison to published literature demonstrated that average lengths of stay associated with open, posterior lateral mass fixation were consistently ≥4 days. Average blood loss (range, 32-75 mL) and procedural time (range, 51-88 min) were also diminished in patients having tissue-sparing, cervical intervertebral cage fusion compared to open posterior lateral mass fixation. Adoption of this tissue-sparing procedure may offer substantial cost-constraining benefits by reducing the length of post-operative hospitalization by, at least, 3 days compared to traditional lateral mass fixation.

Surgical Treatment of Cervical Radiculopathy: Meta-analysis of Randomized Controlled Trials.

Meta-analysis of published randomized controlled trials (RCTs). To determine whether anterior cervical discectomy and fusion (ACDF), cervical disc replacement (CDR), or minimally invasive posterior cervical foraminotomy (MI-PCF) provides the best outcomes for patients with symptomatic single-level, single-side, and cervical radiculopathy. The surgical treatment of cervical radiculopathy is still controversial. ACDF has been widely used as a "gold standard." CDR has evolved and become a motion-preserving alternative with a potentially lower incidence of adjacent segment disease. However, both techniques require anterior neck dissection that carries a potential for serious morbidity. MI-PCF is a motion-preserving technique that can be performed with minimal invasiveness but has not gained universal acceptance. Electronic database search for RCTs comparing the efficacy and effectiveness of ACDF, CDR, and MI-PCF was performed. Meta-analysis was done for secondary surgical procedures and adverse events. A total of 358 studies were retrieved, of which four RCT reports met the inclusion criteria for this study. Three studies present clinical data comparing ACDF and CDR, and one study presents data comparing ACDF and MI-PCF. Available data from the RCTs analyzed concluded that ACDF, CDR, and MI-PCF result in significant improvements in relevant symptoms, clinical, and functional outcomes in patients with single-level, single side cervical radiculopathy refractory to nonoperative treatment. CDR had the lowest percentage of secondary surgical procedures (P = 0.0178) whereas MICPF had the lowest percentage of adverse events (P < 0.0001). All three techniques are effective in treating cervical radicular symptoms. MI-PCF has the lowest rate of adverse events whereas CDR has the lowest rate of secondary procedures. There is insufficient evidence to show which technique is the most effective and provides the longest-lasting symptom relief. 1.

Microendoscopic anterior cervical foraminotomy: A preliminary series of 76 cases

Anterior cervical foraminotomy represents a relatively recent minimally invasive approach that can potentially preserve the intervertebral disc and thus the functional motion segment. This study aims to evaluate the clinical outcome of microendoscopic anterior cervical foraminotomy (MACF) for patients with cervical unilateral radiculopathy due to single level soft disc herniation or hard disc-osteophyte complex (DOC). In the period between August 2009 and March 2015, 76 consecutive patients with symptomatic unilateral cervical radiculopathy were included in this study. There were 40 left-sided cervical radiculopathy cases and 36 right-sided; of those, 42 had soft disc fragment herniation, 18 had DOC, 12 had a migrated disc fragment whether cranial or caudal, and four had far lateral (foraminal) disc herniation. In all cases, MACF with root decompression was performed. Cervical magnetic resonance imaging (MRI), computed tomography (CT) scan, and plain X-rays were performed for all patients and then repeated postoperatively. All patients were followed-up for at least a year. Clinical and functional outcomes were assessed using visual analogue scale (VAS) and Odom’s criteria. According to VAS score, there was an improvement in neck pain from 6.4 (range 5–10) to 1.5 (1–5) and in arm pain from 7.2 (range 6–10) to 1.2 (0–4) at final follow-up (P < 0.05). Functional outcomes according to Odom’s criteria were excellent in 59 (78%) cases, good in ten (13%), fair in six (8%), and poor in one (1%) case. Success of surgery was considered to be achieved in 91% (excellent + good) of cases. Mean operating time was 81 min, and mean intraoperative blood loss was 21 ml. Most significant complications included a dural tear in one case, transient postoperative dysesthesia in six cases, excess bony work resulting in unintended uncinectomy in three cases, fracture of transverse process in one case, unintended near total discectomy in two cases, infective discitis in one case, and persistent radicular pain due to incomplete osteophyte removal in one case. This preliminary report suggests that MACF yields overall excellent results in selected patients with unilateral cervical radiculopathy. The technique potentially can preserve the functional motion segment, thus patients typically experience immediate postoperative neck mobility and do not need to wear a cervical collar.

Increased Utilization of Cervical Disk Arthroplasty in University Hospitals with Regional Variation and Socioeconomic Discrepancies.

Treatment of cervical radiculopathy with disk arthroplasty has been approved by the U.S. Food and Drug Administration since 2007. Recently, a significant increase in clinical data including mid- and long-term follow-up has become available, demonstrating the superiority of disk arthroplasty compared with anterior discectomy and fusion. The aim of this project is to assess the nationwide use of cervical disk arthroplasty. The University Healthcare Consortium database was accessed for all elective cases of patients treated for cervical radiculopathy caused by disk herniation (International Classification of Diseases [ICD] 722.0) from the fourth quarter of 2012 to the third quarter of 2015. Within this 3-year window, temporal and socioeconomic trends in the use of cervical disk replacement for this diagnosis were assessed. Three thousand four hundred forty-six cases were identified. A minority of cases (10.7%) were treated with disk arthroplasty. Median hospital charges were comparable for cervical disk replacement ($15,606) and anterior cervical fusion ($15,080). However, utilization was seen to increase by nearly 70% during the timeframe assessed. Disk arthroplasty was performed in 8% of patients in 2012 to 2013, compared with 13% of cases in 2015. Disk replacement use was more common for self-paying patients, patients with private insurance, and patients with military-based insurance. There was widespread variation in the use of cervical disk replacement between regions, with a nadir in northeastern states (8%) and a peak in western states (20%). Over a short, 3 -year period there has been an increase in the treatment of symptomatic cervical radiculopathy with disk arthroplasty. The authors predict a further increase in cervical disk arthroplasty in upcoming years.

Combination of Fusion and Motion Preservation in the Surgical Treatment of Degenerative Cervical Disc Disease

Introduction Our clinical study design was prospective, concurrently enrolled, and single-center trial of the combination of fusion (intervertebral cage with or without ventrofixation) and cervical disc prosthesis implantation in the treatment of patients with multiple level degenerative disc disease. The cervical disc arthroplasty become more and more popular in the surgical treatment of the degenerative cervical disc disease. The goals of the cervical disc arthroplasty are to maintain or restore intervertebral height, spinal balance and mobility, and to avoid adjacent segment degeneration. However, in most of the patients with multisegmental degenerative disc disease, the certain segments show different stage of degeneration and instability. The study was designed to investigate the clinical effects of the combination of cervical fusion and arthroplasty and to observe the stability, range of motion, and the cervical spine sagittal balance in the follow-up period. Patients and Methods Since December 2007 to September 2012, 36 patients with symptomatic cervical radiculopathy and/or myelopathy underwent surgery with this combined method. In 14 cases, the surgery involved two level, in 16 cases was three level, and 6 cases was four level. At the follow-up period, the patients' pain, neurologic function, and the radiographic parameters (range of motion at the level of prosthesis and the adjacent segments, the intervertebral disc height of the adjacent segments, lordosis of the whole cervical spine, and heterotopic ossification) were evaluated. Results Early clinical experiences are promising. The segment of the prosthesis ultimately showed preservation of motion when compared with preoperative levels. The pre-op average ROM was 8.2 degrees (flexion/extension), the post-op average ROM 7.6 degrees. The whole cervical spine lordosis was pre-op 1.7 degrees the post-op 16.2 degrees. We have no implant-related failure. Conclusion The most important potential advantages of this method is that we can treat the multisegmental degeneration in each segment with the proper method including motion preservation and fusion, and restore the sagittal balance of the cervical spine. Although early results are promising, long-term follow-up studies required to prove its efficacy in the surgical treatment of the multisegmental degenerative cases.

A meta-analysis of cervical foraminotomy: open versus minimally-invasive techniques

Background contextThe posterior cervical foraminotomy (PCF) may be performed using an open or minimally-invasive (MIS) approach using a tubular retractor. Although there are theoretical advantages such as less blood loss and shorter hospitalizations, there is no consensus in the literature regarding the best approach for treatment. PurposeTo assess clinical outcomes of PCF treated with either an open or an MIS approach using a tubular retractor. Study designSystematic literature review and meta-analysis of English language studies for the treatment of cervical radiculopathy treated with foraminotomy. Patient samplePooled patient results from Level I studies and Level IV retrospective studies. Outcome measuresMeta-analysis for clinical success as determined by Odom and Prolo criteria, and visual analog scale scores for arm and neck pain. MethodsA literature search of three databases was performed to identify investigations performed in the treatment of PCF with an open or MIS approach. The pooled results were performed by calculating the effect size based on the logit event rate. Studies were weighted by the inverse of the variance, which included both within and between-study errors. Confidence intervals (CIs) were reported at 95%. Heterogeneity was assessed using the Q statistic and I-squared, where I-squared is the estimate of the percentage of error due to between-study variation. ResultsThe initial literature search resulted in 195 articles, of which, 20 were determined as relevant on abstract review. An open foraminotomy approach was performed in six; similarly, an MIS approach was performed in three studies. The pooled clinical success rate was 92.7% (CI: 88.9, 95.3) for open foraminotomy and 94.9% (CI: 90.5, 97.4) for MIS foraminotomy, which was not statistically significant (p=.418). The open group demonstrated relative homogeneity with Q value of 7.6 and I2 value of 34.3%; similarly, the MIS group demonstrated moderate study heterogeneity with Q value of 4.44 and I2 value of 54.94%. ConclusionsPatients with symptomatic cervical radiculopathy from foraminal stenosis can be effectively managed with either a traditional open or an MIS foraminotomy. There is no significant difference in the pooled outcomes between the two groups.

Outcomes following cervical disc arthroplasty: A retrospective review

Cervical disc arthroplasty has emerged as a viable technique for the treatment of cervical radiculopathy and myelopathy, with the proposed benefit of maintenance of segmental range of motion. There are relatively few, non-industry sponsored studies examining the outcomes and complications of cervical disc arthroplasty. Therefore, we set out to perform a single center evaluation of the outcomes and complications of cervical disc arthroplasty. We performed a retrospective review of all patients from a single military tertiary medical center undergoing cervical disc arthroplasty from August 2008 to August 2012. The clinical outcomes and complications associated with the procedure were evaluated. A total of 219 consecutive patients were included in the review, with an average follow-up of 11.2 (±11.0)months. Relief of pre-operative symptoms was noted in 88.7% of patients, and 92.2% of patients were able to return to full pre-operative activity. There was a low rate of complications related to the anterior cervical approach (3.2% with recurrent laryngeal nerve injury, 8.9% with dysphagia), with no device/implant related complications. Symptomatic cervical radiculopathy is a common problem in both the civilian and active duty military populations and can cause significant disability leading to loss of work and decreased operational readiness. There exist several surgical treatment options for appropriately indicated patients. Based on our findings, cervical disc arthroplasty is a safe and effective treatment for symptomatic cervical radiculopathy and myelopathy, with a low incidence of complications and high rate of symptom relief.

Comparison between Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion of 1-2 Levels from 2002-2009

Cervical total disc replacement (TDR) and anterior cervical discectomy and fusion (ACDF) are both indicated for the treatment of a symptomatic cervical radiculopathy and myelopathy. Epidemiology, complication rates and cost differences based upon these two surgical approaches are not well known.

Outcomes Following Cervical Disc Arthroplasty in an Active Duty Military Population

Symptomatic cervical radiculopathy is a common problem in the active duty military population and can cause significant disability leading to limited duty status and loss of operational readiness and strength. Based on their increasing experience with cervical disc arthroplasty (CDA) in this unique patient population, the authors set out to further evaluate the outcomes and complications of CDA in active duty military patients. A retrospective review of a single military tertiary medical center was performed between August 2008 and August 2012 and the clinical outcomes of patients who underwent cervical disc arthroplasty were evaluated. There were 37 active duty military patients, with a total of 41 CDA. The study found good relief of preoperative symptoms (92%) and the ability to maintain operational readiness with a high rate of return to full unrestricted duty (95%) with an average follow-up of 6 months. There was a low rate of complications related to the anterior cervical approach (5%-8%), with no device- or implant-related complications.

Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration–regulated feasibility study with 24-month follow-up

BackgroundAnterior cervical fusion, an established procedure to treat cervical radiculopathy, sacrifices the natural function of the disc, while placing increased stresses on adjacent spinal levels. In contrast, the cervical total disc replacement (cTDR) maintains motion and decreases adjacent-level stresses. The purpose of this study was to investigate the safety and effectiveness of a next-generation cTDR device in patients with symptomatic cervical radiculopathy. MethodsThis is a multicenter Food and Drug Administration–regulated feasibility study to evaluate safety and effectiveness of the M6-C Artificial Cervical Disc for the treatment of patients with symptomatic cervical radiculopathy at 1 or 2 levels from C3 to C7. Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form 36 Health Survey (SF-36), safety, and radiographic outcomes were assessed preoperatively, at 6 weeks and 3, 6, 12, and 24 months postoperatively. ResultsThirty patients were enrolled at 3 clinical sites. Patients were implanted at either 1 or 2 levels. Mean NDI improved from 67.8 to 20.8 (P < .0001) at 24 months. Significant improvement was also observed through 24-month follow-up in neck and arm pain VAS (P < .0001) and in physical (P < .005) and mental component scores of the SF-36 at 3, 6, and 12 months (P < .008). There were no serious adverse events related to the device or procedure as adjudicated by an independent clinical events committee. Radiographically, disc space height increased more than 50% with a correlative increase in the postoperative disc angle. Range of motion decreased slightly from baseline during early follow-up but increased slightly and were maintained throughout the follow-up period. ConclusionsThe M6-C cervical artificial disc represents a new generation of cTDR design. Results of this study found the M6-C device to produce positive clinical and radiographic outcomes similar to other cTDRs, warranting further investigation.

Cervical epidural steroid injections for symptomatic disc herniations

Cervical radiculopathy is widespread in society, and the methods used in the treatment cover a wide range from conservative treatment to surgical treatment. There is not yet a full consensus on the use of invasive approaches for the optimal treatment of radicular pain. However, cervical epidural steroid injection (CESI) has been used in patients with symptoms of cervical discopathy. Results of the six-month period of treatment of 58 patients, diagnosed as symptomatic cervical radiculopathy with application of CESI within a one-year period, were evaluated retrospectively. With the patients in a sitting position and with the head flexed, the epidural space was accessed from the C7-T1 aperture using the median approach and the hanging drop technique, and a pre- prepared 6 ml solution consisting of 80 mg triamcinolone with 10 mg levobupivacaine was injected following standard sterilization. The post-CESI treatment VAS values of the patients were significantly lower than pretreatment VAS values. The treatment success rates for CESI application were 93% in the 1st month, 86% in the 3rd month, and 72% in the 6th month, respectively. The CESI application is an effective method in the treatment of cervical radiculopathy and reduces the rate of patients needing surgery.

Lower Incidence of Dysphagia With Cervical Arthroplasty Compared With ACDF in a Prospective Randomized Clinical Trial

The current study of 251 consecutive 1-level anterior cervical reconstructions was undertaken to compare the incidence of dysphagia between cervical disk replacement and conventional anterior cervical fusion and instrumentation. This is a report of 251 patients from 5 investigational centers in the Food and drug Administration's prospective, randomized porous-coated motion (PCM) trial using a validated dysphagia outcomes instrument. The dysphagia data for both PCM and anterior cervical diskectomy and fusion (ACDF) patients were reviewed from 5 centers to (1) compare the severity of dysphagia, (2) compare the postoperative incidence of dysphagia, and (3) to compare the resolution of perioperative dysphagia. Dysphagia and dysphonia after anterior surgical approaches to the cervical spine have been previously reported. The current prospective, randomized investigation quantifies clinical dysphagia based on 3 criteria-severity, incidence, and resolution-in a time-course evaluation. Patients between 18 and 65 years with 1-level symptomatic cervical radiculopathy and/or myelopathy for progressive neurologic symptoms, were randomized to undergo anterior decompression and PCM arthroplasty (N=151) or ACDF (control) (N=100). Patients self-reported dysphagia severity using the Bazaz scale preoperatively and at follow-up. The Bazaz scale has 4 classes of severity based upon the problems with swallowing that the patient has with both liquids and solids. The Bazaz results demonstrate that although both the PCM and ACDF groups exhibited an initial postoperative problem with swallowing, the PCM group continued to improve with increasing time after implantation, whereas the ACDF only improved minimally. The PCM treatments indicated significantly lower incidence of dysphagia at 3 and 12 months postoperatively compared with ACDF controls (P<0.05). An increase in dysphagia severity at either the 6-week or 3-month follow-up visit was reported in 35 (42%) PCM and 29 (64%) ACDF subjects. Long-term resolution of these symptoms was noted in 74% (26/35) of the PCM subjects as compared with 41.4% (12/29) of the ACDF subjects (P=0.015). In a prospective randomized clinical study the incidence of postoperative dysphagia and the long-term resolution of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group.