Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial.

PURPOSE: To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis. METHODS: Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data. RESULTS: Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks. CONCLUSION: Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.

The Effect of Patient Resilience on Postoperative Scores After One- and Two-Level Anterior Cervical Discectomy and Fusion.

OBJECTIVE: To investigate the association between resilience and outcomes of pain and neck-related disability after single- and double-level anterior cervical discectomy and fusion (ACDF). METHODS: Patients who underwent single- or double-level ACDF were sent a survey between 6 months and 2 years after surgery. The survey included the Brief Resilience Scale (BRS), visual analogue scale (VAS) for pain, Neck Disability Index (NDI), and Pain Self-Efficacy Questionnaire (PSEQ-2). Patients completed the VAS and NDI twice, once describing preoperative pain and disability and once describing current pain and disability. Respondents were classified as high resilience (HR), medium resilience (MR), or low resilience (LR). Demographics, PSEQ-2 scores, pre- and postoperative VAS and NDI scores, and change in VAS (ΔVAS) and NDI (ΔNDI) scores were compared between groups. RESULTS: Thirty-three patients comprised the HR group, 273 patients comprised the MR group, and 47 patients comprised the LR group. All groups demonstrated postoperative improvement in VAS and NDI scores that exceeded previously established MCID values. The HR group demonstrated greater improvement in pain compared with the LR group (ΔVAS: -5.8 for HR vs. -4.4 for LR, P = 0.05). Compared with the MR group, the LR group demonstrated greater postoperative pain (VAS: 3.2 for LR vs. 2.5 for MR, P = 0.02) and disability (NDI: 11.9 for LR vs. 8.6 for MR, P = 0.02). CONCLUSIONS: Patients demonstrated improvement in pain and neck-related disability after single- and double-level ACDF, regardless of resilience score. Patients with greater resilience may be expected to demonstrate more improvement in pain after ACDF.

Alternate levels versus all levels mini-plate fixation in C3-6 cervical laminoplasty: a retrospective comparative study.

OBJECTIVE: The purpose of this study is to compare radiological and clinical outcomes between alternate levels (C4 and C6) and all levels mini-plate fixation in C3-6 unilateral open-door laminoplasty. METHODS: Ninety-six patients who underwent C3-6 unilateral open-door laminoplasty with alternate levels mini-plate fixation (54 patients in group A) or all levels mini-plate fixation (42 patients in group B) between September 2014 and September 2019 were reviewed in this study. Radiologic and clinical outcomes were assessed. Clinical results included Visual Analogue Scale (VAS) of axial neck pain and Japanese Orthopedic Association (JOA) score. Radiographic results included cervical range of motion (ROM), cervical curvature index (CCI), and the spinal canal expansive parameters including open angle, anteroposterior diameter (APD), and Pavlov`s ratio. RESULTS: There was no significant difference in VAS, JOA score, ROM, and CCI between two groups. There was no significant difference in canal expansion postoperatively between two groups. However, open angle, APD, and Pavlov`s ratio in group A decreased significantly during the follow-up. In group B, APD, Pavlov`s ratio, and open angle were maintained until the final follow-up. There was no hardware failure or lamina reclosure occurred in both groups during the follow-up. The mean cost of group B was higher than that of group A. CONCLUSIONS: Despite the differences in the maintenance of canal expansion, alternate levels mini-plate fixation can achieve similar clinical outcomes as all levels mini-plate fixation in C3-6 unilateral open-door laminoplasty. As evidenced in this study, we believe C3-6 laminoplasty with alternate levels (C4 and C6) mini-plate fixation is an economical, effective, and safe treatment method.

Radiofrequency ablation for the cervical spine.

Radiofrequency ablation (RFA), a minimally invasive procedure for pain reduction, is increasingly used for managing chronic neck pain and headaches. This article offers a concise overview of cervical spine RFA. In the context of RFA, heat is applied to specific nerve tissues to interrupt pain signals. Wallarian degeneration occurs as a result of the thermal injury to the nerve. The heat generated by the RFA procedure can damage the nerve fibers, initiating the degenerative process. Wallarian degeneration is a process that occurs in a nerve axon due to the thermal injury, leading to the breakdown and eventual degradation of the axon and its myelin sheath. However, nerves have regeneration capacity, especially the peripheral nerves, which are often the target of RFA for pain management. After Wallarian degeneration takes place, the nerve sheath, or the connective tissue surrounding the nerve, can serve as a scaffold for the growth of new nerve fibers. Over time, these new fibers can regenerate and re-establish connections, potentially restoring nerve function. Three common types are traditional thermal, water-cooled, and pulsed radio frequency ablation. Given the regenerative potential of nerves, these procedures are typically effective for 1 to 2 years, with some variability. Despite a 112% increase in Medicare claims for RFA from 2009 to 2018, it's recommended for patients who respond positively to diagnostic medial branch blocks, with recent guidelines suggesting a single block may be sufficient. Although generally effective, the procedure carries risks, including nerve and tissue injury. Notably, the procedure's increased utilization notably surpasses the most commonly reported prevalence rates of conditions it aims to treat. Moreover, diagnostic blocks performed before cervical RFA also have their risks, such as inadvertent vascular injections leading to seizures or paralysis. In summary, the risks and benefits of cervical RFA must be considered with regards to the patient's comorbidities and specific pain issues. The skill and experience of the practitioner plays a significant role in minimizing these risks. Detailed discussions with healthcare providers about the risks, benefits, and alternatives can help in making an informed decision about the procedure.

Comparison of the Outcomes of Anterior Cervical Discectomy and Fusion and Cervical Disc Replacement for Cervical Disc Disease.

OBJECTIVE: To compare the radiological outcome and development of heterotopic ossification (HO) following single-segment anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) for cervical disc herniation and evaluate their impact on surgical success. STUDY DESIGN: Descriptive comparative study. Place and Duration of the Study: Neurosurgery Department at Bozyaka Education and Research Hospital, Izmir, Turkiye, between January 2020 and June 2022. METHODOLOGY: Patients aged 18-70 years with radicular neck pain unresponsive to conventional medical treatment and an MRI-confirmed diagnosis were included. Patients with osteoporosis (OP) were excluded. Patients were randomised into two treatment groups (ACDF and CDR) and stratified by age and symptom severity. Radiographic assessments and HO classification according to McAfee were performed. RESULTS: Among the included patients, 56 underwent ACDF and 45 underwent CDR. The mean patient age was 48.29 ± 9.530 and 41.84 ± 7.239 years in the ACDF and CDR groups, respectively (p <0.001). The postoperative disc height increased in both groups. The T1 slope was significantly higher preoperatively and in the early postoperative period in the CDR group than in the ACDF group (p = 0.001). HO was graded as 1, 2, 3, and 4 in 28 (27.7%), 6 (5.9%), 7 (6.9%), and 4 (3%) patients, respectively. CONCLUSION: ACDF and CDR provided similar improvements in radiological measurements and pain relief. Although both procedures significantly enhanced the patient's quality of life and disability scores, HO was more prevalent following CDR during long-term follow-up. KEY WORDS: Cervical disc replacement, Anterior cervical discectomy and fusion, Spinal surgery techniques, Heterotopic ossification.

Disability and pain after anterior cervical decompression and fusion: A group-based trajectory analysis.

OBJECTIVES: This study aimed to identify the clusters of patients with different developmental trajectories of pain and disability after anterior cervical decompression and fusion (ACDF). METHODS: Group-based trajectory analysis among 318 patients undergoing the ACDF. RESULTS: Three developmental trajectories of disability were identified: "Steadily good functioning," "Improved functioning," and "Steadily poor functioning." Three developmental trajectories of neck pain were identified: "Worsened pain," "Pain relief," and "Steadily severe pain." Two developmental trajectories of arm pain were identified: "Decreased arm pain" and "Severe arm pain with only short-term relief." No associations were found between sex, preoperative pain duration, or body weight and probability to be classified into a particular disability trajectory group. Female sex (relative risk ratio (RRR) 1.78) and longer history of preoperative pain (RRR 2.31-2.68) increased the probability to be classified into a group with steadily severe neck pain. Longer history of preoperative pain increased the probability to be classified into group with severe arm pain with only short-term pain relief (RRR 2.68). CONCLUSION: After the ACDF, dissimilar developmental trajectories of pain and disability were identified between the patient clusters. While sex, preoperative pain duration, and body weight were not associated with differences in improvement in disability level, female sex and longer duration of preoperative pain were correlated with more severe neck and arm pain after surgery.

Comparing posterior cervical foraminotomy with anterior cervical discectomy and fusion in radiculopathic patients: an analysis from the Quality Outcomes Database.

OBJECTIVE: The objective of this study was to compare clinical and patient-reported outcomes (PROs) between posterior foraminotomy and anterior cervical discectomy and fusion (ACDF) in patients presenting with cervical radiculopathy. METHODS: The Quality Outcomes Database was queried for patients who had undergone ACDF or posterior foraminotomy for radiculopathy. To create two highly homogeneous groups, optimal individual matching was performed at a 5:1 ratio between the two groups on 29 baseline variables (including demographic characteristics, comorbidities, symptoms, patient-reported scores, underlying pathologies, and levels treated). Outcomes of interest were length of stay, reoperations, patient-reported satisfaction, increase in EQ-5D score, and decrease in Neck Disability Index (NDI) scores for arm and neck pain as long as 1 year after surgery. Noninferiority analysis of achieving patient satisfaction and minimal clinically important difference (MCID) in PROs was performed with an accepted risk difference of 5%. RESULTS: A total of 7805 eligible patients were identified: 216 of these underwent posterior foraminotomy and were matched to 1080 patients who underwent ACDF. The patients who underwent ACDF had more underlying pathologies, lower EQ-5D scores, and higher NDI and neck pain scores at baseline. Posterior foraminotomy was associated with shorter hospitalization (0.5 vs 0.9 days, p < 0.001). Reoperations within 12 months were significantly more common among the posterior foraminotomy group (4.2% vs 1.9%, p = 0.04). The two groups performed similarly in PROs, with posterior foraminotomy being noninferior to ACDF in achieving MCID in EQ-5D and neck pain scores but also having lower rates of maximal satisfaction at 12 months (North American Spine Society score of 1 achieved by 65.2% posterior foraminotomy patients vs 74.6% of ACDF patients, p = 0.02). CONCLUSIONS: The two procedures were found to be offered to different populations, with ACDF being selected for patients with more complicated pathologies and symptoms. After individual matching, posterior foraminotomy was associated with a higher reoperation risk within 1 year after surgery compared to ACDF (4.2% vs 1.9%). In terms of 12-month PROs, posterior foraminotomy was noninferior to ACDF in improving quality of life and neck pain. The two procedures also performed similarly in improving NDI scores and arm pain, but ACDF patients had higher maximal satisfaction rates.

Comparison of Laminectomy with Fusion and Laminoplasty Treating Multilevel Cervical Spondylotic Myelopathy: A Single-Center Retrospective Study.

OBJECTIVE: Comparing laminectomy with fusion (LF) and laminoplasty (LP) for treating multilevel cervical spondylotic myelopathy (MCSM) and comparative analysis of neck pain and sagittal cervical parameters. METHODS: This single-center study retrospectively analyzed MCSM patients treated with LF or LP in our department between June 2018 and January 2023, with at least a 12-month follow-up. T-tests were used to identify operation time, hemoglobin, hospital stay, modified Japanese Orthopaedic Association (mJOA) score, C2-C7 Cobb angle, C2-C7 sagittal vertical axis, T1 slope, cervical range of motion (cROM), and C4/5 anterior and posterior spinal canal diameter (A-P diameter) and area. Nonparametric tests were used to identify visual analog scale (VAS) score (assessing neck pain). Pearson correlation analyses were used to identify the neck pain. RESULTS: Of all 67 patients (LF: 24, LP: 43), both groups' mJOA scores significantly improved (P < 0.001). The VAS scores had both significantly decreased, with the LF group exhibiting a more marked reduction (LF: P < 0.001, LP: P = 0.037). Both groups' C4/5 A-P diameters and areas increased significantly (P < 0.001). The cROM had both significantly decreased, with the LF group exhibiting a greater reduction. At the last follow-up, the LF group's T1 slope and C2-C7 Cobb angle considerably increased, and pain VAS scores substantially correlated with the C2-C7 Cobb angle (R = -0.451, P < 0.001). CONCLUSIONS: LF and LP were efficacious for MCSM. LF relieved neck pain better but caused greater reduction in cervical mobility. Cervical lordosis improvement was significantly correlated with neck pain alleviation.

Impact of Racial/Ethnic Disparities on Patient-Reported Outcomes Following Cervical Spine Surgery: QOD Analysis.

STUDY DESIGN: Retrospective analysis of data from the cervical module of a National Spine Registry, the Quality Outcomes Database. OBJECTIVE: To examine the association of race and ethnicity with patient-reported outcome measures (PROMs) at one year after cervical spine surgery. SUMMARY OF BACKGROUND DATA: Evidence suggests that Black individuals are 39% to 44% more likely to have postoperative complications and a prolonged length of stay after cervical spine surgery compared with Whites. The long-term recovery assessed with PROMs after cervical spine surgery among Black, Hispanic, and other non-Hispanic groups ( i.e . Asian) remains unclear. MATERIALS AND METHODS: PROMs were used to assess disability (neck disability index) and neck/arm pain preoperatively and one-year postoperative. Primary outcomes were disability and pain, and not being satisfied from preoperative to 12 months after surgery. Multivariable logistic and proportional odds regression analyses were used to determine the association of racial/ethnic groups [Hispanic, non-Hispanic White (NHW), non-Hispanic Black (NHB), and non-Hispanic Asian (NHA)] with outcomes after covariate adjustment and to compute the odds of each racial/ethnic group achieving a minimal clinically important difference one-year postoperatively. RESULTS: On average, the sample of 14,429 participants had significant reductions in pain and disability, and 87% were satisfied at one-year follow-up. Hispanic and NHB patients had higher odds of not being satisfied (40% and 80%) and having worse pain outcomes (30%-70%) compared with NHW. NHB had 50% higher odds of worse disability scores compared with NHW. NHA reported similar disability and neck pain outcomes compared with NHW. CONCLUSIONS: Hispanic and NHB patients had worse patient-reported outcomes one year after cervical spine surgery compared with NHW individuals, even after adjusting for potential confounders, yet there was no difference in disability and neck pain outcomes reported for NHA patients. This study highlights the need to address inherent racial/ethnic disparities in recovery trajectories following cervical spine surgery.

Effect of Baseline Veterans RAND-12 Mental Composite Score on Postoperative Patient-Reported Outcome Measures for Cervical Disk Replacement.

STUDY DESIGN: Retrospective review. OBJECTIVE: To examine the effect of baseline Veterans RAND-12 (VR-12) Mental Composite Score (MCS) on clinical outcomes in patients undergoing cervical disk replacement (CDR) for herniated disk. BACKGROUND: Few studies in spine surgery have evaluated the impact of preoperative VR-12 MCS on postoperative outcomes in patients undergoing CDR. METHODS: Patients undergoing CDR for herniated disk were separated into 2 cohorts based on the VR-12 MCS standardized mean: VR-12 MCS<50 (worse mental health) and VR-12 MCS≥50 (better mental health). Patient-reported outcome measures of VR-12 MCS, VR-12 Physical Composite Score, Short Form-12 (SF-12) MCS, SF-12 Physical Composite Score, Patient-Reported Outcomes Measurement Information System Physical Function, Patient Health Questionnaire-9 (PHQ-9), Visual Analog Scale (VAS) Neck Pain, VAS Arm Pain, and Neck Disability Index were collected at preoperative and up to 2-year postoperative time points. RESULTS: In all, 109 patients were identified, with 50 patients in the worse mental health cohort. The worse mental health cohort reported inferior patient-reported outcome measures in all domains at preoperative, 6-week postoperative, and final postoperative time points. For 6-week postoperative improvement, the worse mental health cohort reported greater improvement for VR-12 MCS, SF-12 MCS, and PHQ-9. For final postoperative improvement, the worse mental health cohort reported greater improvement in VR-12 MCS and SF-12 MCS. Minimum clinically important difference achievement rates were higher in the worse mental health cohort for VR-12 MCS, SF-12 MCS, and PHQ-9. CONCLUSION: Patients undergoing cervical disk replacement for herniated disk with worse baseline mental health reported inferior clinical outcomes in mental health, physical function, pain, and disability outcomes throughout the postoperative period. Patients with worse baseline mental health demonstrated greater clinically meaningful improvement in mental health. In cervical disk replacement patients, those with worse baseline mental health may report inferior postoperative clinical outcomes but experience greater rates of tangible improvement in mental health.

C-arm CT guided percutaneous vertebroplasty for pain release in cancer patient with cervical 1 vertebral metastases: A case report.

OBJECTIVE: To evaluate the efficacy and treatment outcome of C-arm CT percutaneous vertebroplasty in the treatment of cervical 1 (C1) vertebral metastases. METHODS: This report recruited a male patient diagnosed with hepatocellular carcinoma and C1 vertebral metastases, who had suffered from severe neck pain symptoms and the analgesic showed little soothing effect. Under the guidance of C-arm CT, an 18G coaxial needle was used to puncture the left lateral mass of C1 vertebral metastases from lateral space between thyroid cartilage and the left carotid sheath, with 2 ml bone cement injected. RESULTS: Postoperative C-arm CT three-dimensional reconstruction scan showed that the bone cement was well filled and distributed in the left lateral mass of C1 vertebral body, and no leakage of bone cement was observed. The neck pain of the patients was significantly relieved one week after the operation. CONCLUSION: Under the guidance of C-arm CT, cement augmentation using percutaneous vertebroplasty in an anterior cervical direction could serve as a safe and effective pain relief approach for patients with C1 vertebral metastases.

Does the number of social factors affect long-term patient-reported outcomes and satisfaction in those with cervical myelopathy? A QOD study.

OBJECTIVE: It is not clear whether there is an additive effect of social factors in keeping patients with cervical spondylotic myelopathy (CSM) from achieving both a minimum clinically important difference (MCID) in outcomes and satisfaction after surgery. The aim of this study was to explore the effect of multiple social factors on postoperative outcomes and satisfaction. METHODS: This was a multiinstitutional, retrospective study of the prospective Quality Outcomes Database (QOD) CSM cohort, which included patients aged 18 years or older who were diagnosed with primary CSM and underwent operative management. Social factors included race (White vs non-White), education (high school or below vs above), employment (employed vs not), and insurance (private vs nonprivate). Patients were considered to have improved from surgery if the following criteria were met: 1) they reported a score of 1 or 2 on the North American Spine Society index, and 2) they met the MCID in patient-reported outcomes (i.e., visual analog scale [VAS] neck and arm pain, Neck Disability Index [NDI], and EuroQol-5D [EQ-5D]). RESULTS: Of the 1141 patients included in the study, 205 (18.0%) had 0, 347 (30.4%) had 1, 334 (29.3%) had 2, and 255 (22.3%) had 3 social factors. The 24-month follow-up rate was > 80% for all patient-reported outcomes. After adjusting for all relevant covariates (p < 0.02), patients with 1 or more social factors were less likely to improve from surgery in all measured outcomes including VAS neck pain (OR 0.90, 95% CI 0.83-0.99) and arm pain (OR 0.88, 95% CI 0.80-0.96); NDI (OR 0.90, 95% CI 0.83-0.98); and EQ-5D (OR 0.90, 95% CI 0.83-0.97) (all p < 0.05) compared to those without any social factors. Patients with 2 social factors (outcomes: neck pain OR 0.86, arm pain OR 0.81, NDI OR 0.84, EQ-5D OR 0.81; all p < 0.05) or 3 social factors (outcomes: neck pain OR 0.84, arm pain OR 0.84, NDI OR 0.84, EQ-5D OR 0.84; all p < 0.05) were more likely to fare worse in all outcomes compared to those with only 1 social factor. CONCLUSIONS: Compared to those without any social factors, patients who had at least 1 social factor were less likely to achieve MCID and feel satisfied after surgery. The effect of social factors is additive in that patients with a higher number of factors are less likely to improve compared to those with only 1 social factor.

Is neck pain treatable with surgery?

INTRODUCTION: Neck pain is one of the most common complaints in clinical practice and can be caused by a wide variety of conditions. While cervical spine surgery is a well-accepted option for radicular pain and myelopathy, surgery for isolated neck pain is controversial. The identification of the source of pain is challenging and subtle, and misdiagnosis can lead to inappropriate treatment. MATERIALS AND METHODS AND RESULTS: We conducted a thorough literature review to discuss and compare different causes of neck pain. We then supplemented the literature with our senior author's expert analysis of treating cervical spine pathology. CONCLUSIONS: This study provides an in-depth discussion of neck pain and its various presentations, as well as providing insight into treatment strategies and diagnostic pearls that may prevent mistreatment of cervical spine pathology.

What predicts the best 24-month outcomes following surgery for cervical spondylotic myelopathy? A QOD prospective registry study.

OBJECTIVE: The aim of this study was to identify predictors of the best 24-month improvements in patients undergoing surgery for cervical spondylotic myelopathy (CSM). For this purpose, the authors leveraged a large prospective cohort of surgically treated patients with CSM to identify factors predicting the best outcomes for disability, quality of life, and functional status following surgery. METHODS: This was a retrospective analysis of prospectively collected data. The Quality Outcomes Database (QOD) CSM dataset (1141 patients) at 14 top enrolling sites was used. Baseline and surgical characteristics were compared for those reporting the top and bottom 20th percentile 24-month Neck Disability Index (NDI), EuroQol-5D (EQ-5D), and modified Japanese Orthopaedic Association (mJOA) change scores. A multivariable logistic model was constructed and included candidate variables reaching p ≤ 0.20 on univariate analyses. Least important variables were removed in a stepwise manner to determine the significant predictors of the best outcomes (top 20th percentile) for 24-month NDI, EQ-5D, and mJOA change. RESULTS: A total of 948 (83.1%) patients with 24-month follow-up were included in this study. For NDI, 204 (17.9%) had the best NDI outcome and 200 (17.5%) had the worst NDI outcome. Factors predicting the best NDI outcomes included symptom duration less than 12 months (OR 1.5, 95% CI 1.1-1.9; p = 0.01); procedure other than posterior fusion (OR 1.5, 95% CI 1.03-2.1; p = 0.03); higher preoperative visual analog scale neck pain score (OR 1.2, 95% CI 1.1-1.3; p < 0.001); and higher baseline NDI (OR 1.06, 95% CI 1.05-1.07; p < 0.001). For EQ-5D, 163 (14.3%) had the best EQ-5D outcome and 169 (14.8%) had the worst EQ-5D outcome. Factors predicting the best EQ-5D outcomes included arm pain-only complaints (compared to neck pain) (OR 1.9, 95% CI 1.3-2.9; p = 0.002) and lower baseline EQ-5D (OR 167.7 per unit lower, 95% CI 85.0-339.4; p < 0.001). For mJOA, 222 (19.5%) had the best mJOA outcome and 238 (20.9%) had the worst mJOA outcome. Factors predicting the best mJOA outcomes included lower BMI (OR 1.03 per unit lower, 95% CI 1.004-1.05; p = 0.02; cutoff value of ≤ 29.5 kg/m2); arm pain-only complaints (compared to neck pain) (OR 1.7, 95% CI 1.1-2.5; p = 0.02); and lower baseline mJOA (OR 1.6 per unit lower, 95% CI 1.5-1.7; p < 0.001). CONCLUSIONS: Compared to the worst outcomes for EQ-5D, the best outcomes were associated with patients with arm pain-only complaints. For mJOA, lower BMI and arm pain-only complaints portended the best outcomes. For NDI, those with the best outcomes had shorter symptom durations, higher preoperative neck pain scores, and less often underwent posterior spinal fusions. Given the positive impact of shorter symptom duration on outcomes, these data suggest that early surgery may be beneficial for patients with CSM.

Craniocervical instability in patients with Ehlers-Danlos syndromes: outcomes analysis following occipito-cervical fusion.

Craniocervical instability (CCI) is increasingly recognized in hereditary disorders of connective tissue and in some patients following suboccipital decompression for Chiari malformation (CMI) or low-lying cerebellar tonsils (LLCT). CCI is characterized by severe headache and neck pain, cervical medullary syndrome, lower cranial nerve deficits, myelopathy, and radiological metrics, for which occipital cervical fusion (OCF) has been advocated. We conducted a retrospective analysis of patients with CCI and Ehlers-Danlos syndrome (EDS) to determine whether the surgical outcomes supported the criteria by which patients were selected for OCF. Fifty-three consecutive subjects diagnosed with EDS, who presented with severe head and neck pain, lower cranial nerve deficits, cervical medullary syndrome, myelopathy, and radiologic findings of CCI, underwent open reduction, stabilization, and OCF. Thirty-two of these patients underwent suboccipital decompression for obstruction of cerebral spinal fluid flow. Questionnaire data and clinical findings were abstracted by a research nurse. Follow-up questionnaires were administered at 5-28 months (mean 15.1). The study group demonstrated significant improvement in headache and neck pain (p < 0.001), decreased use of pain medication (p < 0.0001), and improved Karnofsky Performance Status score (p < 0.001). Statistically significant improvement was also demonstrated for nausea, syncope (p < 0.001), speech difficulties, concentration, vertigo, dizziness, numbness, arm weakness, and fatigue (p = 0.001). The mental fatigue score and orthostatic grading score were improved (p < 0.01). There was no difference in pain improvement between patients with CMI/LLCT and those without. This outcomes analysis of patients with disabling CCI in the setting of EDS demonstrated significant benefits of OCF. The results support the reasonableness of the selection criteria for OCF. We advocate for a multi-center, prospective clinical trial of OCF in this population.

Management Considerations for Total Intervertebral Disc Replacement.

The burden of disease regarding lumbar and cervical spine pain is a long-standing, pervasive problem within medicine that has yet to be resolved. Specifically, neck and back pain are associated with chronic pain, disability, and exorbitant health care use worldwide, which have only been exacerbated by the increase in overall life years and chronic disease. Traditionally, patients with significant pain and disability secondary to disease of either the cervical or lumbar spine are treated via fusion or discectomy. Although these interventions have proved curative in the short-term, numerous longitudinal studies evaluating the efficacy of traditional management have reported severe impairment of normal spinal range of motion, as well as postoperative complications, including neurologic injury, radiculopathy, osteolysis, subsidence, and infection, paired with less than desirable reoperation rates. Consequently, there is a call for innovation and improvement in the treatment of lumbar and cervical spine pain, which may be answered by a modern technique known as intervertebral disc arthroplasty, or total disc replacement (TDR). Thus, this review aims to describe the management strategy of TDR and to explore updated considerations for its use in practice, both to help guide clinical decision making.

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.

Anterior Cervical Discectomy and Fusion Versus Cervical Disc Replacement for a Workers' Compensation Population in an Ambulatory Surgical Center.

STUDY DESIGN: Retrospective Cohort. OBJECTIVE: To evaluate patient-reported outcome measures (PROM) and minimal clinically important difference (MCID) achievement outcomes between anterior cervical discectomy and fusion (ACDF) and cervical disk replacement (CDR) in the Workers' Compensation (WC) population. SUMMARY OF BACKGROUND DATA: No studies to our knowledge have compared PROMs and MCID attainment between ACDF and CDR among patients with WC insurance undergoing surgery in an outpatient ambulatory surgical center (ASC). METHODS: WC insurance patients undergoing primary, single/double-level ACDF/CDR in an ASC were identified. Patients were divided into ACDF versus CDR. PROMs were collected at preoperative/6-week/12-week/6-month/1-year timepoints, including PROMIS-PF, SF-12 PCS/MCS, VAS neck/arm, and NDI. RESULTS: Seventy-nine patients were included, 51 ACDF/28 CDR. While operative time (56.4 vs. 54.4 min), estimated blood loss (29.2 vs. 25.9 mL), POD0 pain (4.9 vs. 3.8), and POD0 narcotic consumption (21.2 vs. 14.5 oral morphine equivalents) were higher in ACDF patients, none reached statistical significance ( P >0.050, all). One-year arthrodesis rate was 100.0% among ACDF recipients with available imaging (n=36). ACDF cohort improved from preoperative for PROMIS-PF from 12 weeks to 1 year, SF-12 PCS at 6 months, all timepoints for VAS neck/arm, and 12 weeks/6 months for NDI ( P ≤0.044, all). CDR cohort improved from preoperative for PROMIS-PF at 6 months, VAS neck/arm from 12 weeks to 1 year, and NDI at 12 weeks/6 months ( P ≤0.049, all). CDR cohort reported significantly lower VAS neck at 12 weeks/1 year and VAS arm at 12 weeks ( P ≤0.039, all). MCID achievement rates did not differ. CONCLUSION: While operative duration/estimated blood loss/acute postoperative pain/narcotic consumption were, on average, higher among ACDF recipients, these were not statistically significant, possibly due to the limited sample size. ACDF and CDR ASC patients generally demonstrated comparable arm pain/disability/physical function/mental health, though neck pain was significantly lower at multiple timepoints among CDR patients. Clinically meaningful PROM improvements were comparable. Larger, multicentered studies are required to confirm our results.

Radiofrequency ablation of the occipital nerves for treatment of neuralgias and headache.

OBJECTIVE: The purpose of this study was to retrospectively assess the efficacy of radiofrequency ablation (RFA) therapy as a treatment for occipital neuralgias and headaches at health clinics in the United States between January 1, 2015 and June 20, 2022. We hypothesize that RFA is a minimally invasive treatment that provides significant pain relief long-term for occipital neuralgias and associated headaches. METHODS: This retrospective analysis studies data collected from 277 occipital nerve RFA patients who had adequate pre-procedure and post-procedure follow-up for data analysis. Data collected includes the patient's age, biological sex, BMI, headache diagnosis, pre-procedure, and post-procedure pain score using the visual analog scale (VAS), subjective percent improvement in symptom(s), and duration of symptom relief. Statistical analysis used SPSS software, version 26 (IBM), using a paired t-test to assess the significance between pre and post-occipital RFA therapy pain scores. p-values were significant if found to be ≤0.05. RESULTS: The mean pre-procedure pain score before RFA therapy for patients who completed at least 6 months of follow-up was 5.57 (SD = 1.87) and the mean post-procedure pain score after RFA therapy was 2.39 (SD = 2.42). The improvement in pain scores between pre-procedure and post-procedure was statistically significant with a p-value < 0.001. The mean patient-reported percent improvement in pain following RFA therapy was 63.53% (SD = 36.37). The mean duration of pain improvement was 253.9 days after the initiation of therapy (SD = 300.5). When excluding patients who did not have any relief following their RFA procedure, the average pre-procedure pain score was 5.54 (SD = 1.81) and post-procedure pain score was 1.71 (SD = 1.81) with a p-value < 0.001. CONCLUSION: This study demonstrates the minimally invasive, safe, and effective treatment of RFA in patients with refractory occipital neuralgias and headaches. Additional studies are necessary to illuminate ideal patient characteristics for RFA treatment and the potential for procedural complications and long-term side effects associated with occipital nerve RFA therapy.

Long-Term (>24 Months) Duration of Symptoms Negatively Impacts Patient-Reported Outcomes Following Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To investigate the impact of long symptom duration (>24 mo) on patient self-reported outcomes for pain, function, and quality of life following anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. SUMMARY OF BACKGROUND DATA: ACDF is an effective treatment to relieve the symptoms of cervical radiculopathy. However, there is no consensus on whether prolonged preoperative length of symptoms negatively impacts postoperative outcomes. METHODS: This study included consecutive patients who underwent ACDF for cervical radiculopathy from May 1, 2012 to Dec 1, 2019 by a single surgeon. Patients were stratified by short (<24 mo) and long (>24 mo) duration of symptoms. Outcomes including visual analog scale (VAS) neck and arm, neck disability index (NDI), EuroQol-5D (EQ-5D), and overall state of health (EQ-VAS) were compared between cohort both for absolute values and percentage of patients achieving minimal clinically important difference. RESULTS: A total of 111 consecutive patients were included in our study, including 59 patients in the short symptom duration group and 52 patients in the long symptom duration group. The mean age of the patients was 51.4±9.4 and 41 (36.9%) were female. The baseline VAS neck and arm, NDI, EQ-5D, and EQ-VAS were similar between groups. Patients in both long and short symptom duration groups had clinical improvement following surgery. However, patients with short symptom duration had better VAS Neck and EQ-5D outcomes, and were more likely to meet minimal clinically important difference for NDI, EQ-5D, or any outcome. Multivariate analysis confirmed symptom duration <24 months as an independent predictor for better patient-reported outcomes. CONCLUSION: We appreciated better clinical outcomes in patients with shorter symptom duration who received ACDF for cervical radiculopathy. On the basis of this data, we advocate for prompt treatment of cervical radiculopathy to avoid the potential for long-term impairment. LEVEL OF EVIDENCE: Level 3.