Arm Pain Scores Research Articles

79. Does facet distraction affect patient outcomes after ACDF?

<h3>BACKGROUND CONTEXT</h3> Intervertebral distraction in anterior cervical discectomy and fusion (ACDF) leads to indirect nerve decompression but has been associated with facet joint over-distraction that may lead to postoperative axial neck pain. <h3>PURPOSE</h3> The aim of this study is to determine if there is a correlation between the amount of facet distraction and postoperative patient-reported outcomes after ACDF. <h3>STUDY DESIGN/SETTING</h3> Retrospective cohort study. <h3>PATIENT SAMPLE</h3> All patients over age 18 who underwent one- to three-level ACDF for cervical spondylosis with associated radiculopathy and/or myelopathy at a single academic institution between 2010- 2015 were retrospectively identified. Patients with a traumatic injury, infection, malignancy, revision procedures or incomplete medical records were excluded. <h3>OUTCOME MEASURES</h3> Postoperative short- and long- term health-related quality of life outcomes: Neck Disability Index (NDI), Short Form-12 (SF-12), VAS Neck pain, and VAS Arm pain scores. Delta outcome, recovery ratio and %MCID achievement. <h3>METHODS</h3> A retrospective cohort analysis of patients undergoing ACDF for degenerative pathologies at a single academic center was performed. Each patient received upright, lateral cervical spine x-rays at the immediate postoperative time point from which interfacet distance (facet distraction) was measured. Patient-reported outcome measures were obtained preoperatively and at short-term (<3 months) and long-term (>1 year) follow-up. Receiver operating curves were generated to evaluate the possibility of a critical interfacet distraction distance. Univariate and multivariate analysis were performed to compare outcomes between groups based on the degree of facet distraction. <h3>RESULTS</h3> A total of 229 patients met the inclusion criteria. Receiver operating curves failed to yield a critical interfacet distraction distance associated with worse post-operative outcomes. Patients were instead grouped based on facet distraction distance below and above the third quartile (0.8mm-2.0mm, 2.0mm-3.7mm), with 173 and 56 patients in each respective group. Univariate analysis did not detect any statistically significant differences in outcome measures, recovery ratio, or % MCID achievement at short- and long-term follow-up between groups. Multivariate analysis also failed to demonstrate any significant differences between the facet distraction groups. <h3>CONCLUSIONS</h3> Increased interfacet distance did not correlate with increased neck pain or disability after an ACDF. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

4. Single-level cervical disc replacement using a PEEK-on-ceramic implant: Results of a multicenter FDA IDE trial with 24-month follow up

<h3>BACKGROUND CONTEXT</h3> Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. PEEK is used increasingly for spinal implants due to its mechanical properties and lack of artifact on imaging. A cervical TDR was designed with commercially pure titanium-coated PEEK endplates and a biconvex zirconia toughened alumina ceramic core. <h3>PURPOSE</h3> The purpose of this study was to compare this PEEK-on-ceramic TDR to anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration. <h3>STUDY DESIGN/SETTING</h3> This was a prospective, nonrandomized, multicenter Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial comparing the investigational group to a propensity-matched historic control group. <h3>PATIENT SAMPLE</h3> Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n=150 patients from 16 sites). The historic control group included 117 propensity-matched ACDF patients from an earlier cervical TDR IDE trial employing the same inclusion/exclusion criteria. All patients were treated for single-level symptomatic cervical disc degeneration. <h3>OUTCOME MEASURES</h3> The primary outcome was a composite 5-point success classification at 24-month follow-up requiring: >15 point (of 100) improvement in Neck Disability Index (NDI) score; 2) maintenance/improvement in neurologic status; 3) no device failure; 4) no reoperation/revision/removal and/or supplemental fixation at the index level, and 5) no major adverse events. Outcome measures included NDI, visual analog scale (VAS) assessing neck and arm pain, neurological status, adverse events and subsequent surgery. Radiographic assessment included flexion/extension range of motion. Facet joints were assessed at 24 months comparing pre- to postoperative MRI images using a published 4-point scale. <h3>METHODS</h3> Evaluations were performed preoperatively and postoperatively within 2 and 6 weeks, and 3, 6, 12 and 24 months. The control was propensity match with ACDF patients from an earlier TDR vs ACDF trial, which used the same inclusion criteria and primary outcome assessments. <h3>RESULTS</h3> The overall composite success rate was significantly greater in the TDR group vs ACDF (93.0% vs 73.6%; p<0.001). 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 all p<0.01). Secondary surgical intervention was undertaken in 4 (2.7%) patients at the index level in the TDR group and 6 (5.1%) in the ACDF group. There were no significant differences in the rates of serious adverse events when comparing the two groups. The mean segmental range of motion of the treated level in the TDR group was 7.3° prior to surgery. This increased to 8.6° at 3-month follow-up and continued to increase to 9.6° at 24 months (p<0.001). Facet joint assessment by MRI at 24-month follow-up in the TDR group showed little change from preoperative. <h3>CONCLUSIONS</h3> The results of this study found that the Simplify® Cervical Artificial Disc produced outcomes similar or superior on some measures, including superiority in the composite success classification, compared with ACDF, for the treatment of single-level symptomatic cervical disc degeneration. ROM at the treated level increased from the preoperative value and was maintained throughout follow-up. Safety of the PEEK-on-ceramic disc was established with no device failures in the series. These results support that the device is a viable alternative to ACDF. <h3>FDA DEVICE/DRUG STATUS</h3> Simplify Cervical Disc Replacement (Approved for this indication)

Cervical Disc Arthroplasty for Axial Neck Pain: Comparison of Outcomes to 2 Other Common Cervical Conditions.

Cervical disc arthroplasty (CDA) is an established treatment for degenerative disc disease with radiculopathy and/or myelopathy. There is, however, little published evidence of its effectiveness to relieve pain and improve function in patients with a primary diagnosis of axial neck pain. Such patients were excluded from all previous Food and Drug Administration clinical trials for CDA. We compare the outcomes of patients who underwent CDA for 3 common cervical conditions from 2003 to 2018. Seven hundred and eighty-two CDA patients at a single site were grouped by primary diagnosis: predominant axial neck pain (ANP) (n = 257), predominant radiculopathy (RAD) (n = 331), or a combination of both (ANP + RAD) (n = 195). Mixed models for repeated measures predicted and analyzed scores at all time points, adjusting for diagnosis group, time point, and, if statistically significant, number of operative levels and demographic characteristics. Outcome measures included the Neck Disability Index, numerical pain scales (intensity plus frequency), the Veterans RAND 12 Item Health Survey (VR-12) Physical Component Score, the Mental Component Score, and reoperations. Patients were assessed preoperatively and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter. At baseline, arm pain scores in the ANP group were statistically lower (P = .0002) than in the RAD and ANP + RAD groups, consistent with preoperative diagnoses. Surgeries included 40.8% 1-level, 41.6% 2-level, 14.7% 3-level, and 2.9% 4-level. For all outcome measures, improvements were statistically significant from baseline to each postoperative time point without statistical difference between the 3 diagnosis groups. In total, 45/782 patients (5.8%) underwent a secondary surgery: 3.5% ANP, 5.8% RAD, and 8.7% ANP + RAD. Days to reoperation did not statistically differ between groups (P = .489). Appropriately selected patients with predominant axial neck pain treated with CDA may achieve clinical and functional outcomes comparable to patients with a primary diagnosis of radiculopathy or of axial neck pain with concomitant radiculopathy. This study provides information that should help clinicians decide whether to offer CDA for patients with a primary diagnosis of axial neck pain and to appropriately counsel such patients about expected outcomes. 4.

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

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. 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. 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. 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. 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. 2.

Comparison between Anterior Cervical Decompression with Fusion and Posterior Cervical Fusion with Wide Facetectomy for Treatment of Severe Bony Foraminal Stenosis.

ObjectiveTo compare the anterior cervical discectomy and fusion (ACDF) and posterior cervical fusion (PCF) with wide facetectomy in the treatment of parallel-shaped bony foraminal stenosis (FS). MethodsThirty-six patients underwent surgery due to one-or-two levels of parallel-shaped cervical FS. ACDF was performed in 16 patients, and PCF using CPS was performed in 20 patients. All patients were followed up at 1, 3, 6, and 12 months postoperatively. Standardized outcome measures such as Numeric rating scale (NRS) score for arm/neck pain and Neck disability index (NDI) were evaluated. Cervical radiographs were used to compare the C2–7 Cobb’s angle, segmental angle, and fusion rates. ResultsThere was an improvement in NRS scores after both approaches for radicular arm pain (mean change -6.78 vs. -8.14, p=0.012), neck pain (mean change -1.67 vs. -4.36, p=0.038), and NDI score (-19.69 vs. -18.15, p=0.794). The segmental angle improvement was greater in the ACDF group than in the posterior group (9.4°±2.7° vs. 3.3°±5.1°, p=0.004). However, there was no significant difference in C2–7 Cobb angle between groups (16.2°±7.9° vs. 14.8°±8.5°, p=0.142). As a complication, dysphagia was observed in one case of the ACDF group. ConclusionIn the treatment of parallel-shaped bony FS up to two surgical levels, segmental angle improvement was more favorable in patients who underwent ACDF. However, PCF with wide facetectomy using CPS should be considered as an alternative treatment option in cases where the anterior approach is burdensome.

Comparing Mid-Term Outcomes Between ACDF and Minimally Invasive Posterior Cervical Foraminotomy in the Treatment of Cervical Radiculopathy.

Retrospective cohort study. To compare minimally invasive posterior cervical foraminotomy (MI-PCF) and anterior cervical discectomy and fusion (ACDF) in the treatment of unilateral cervical radiculopathy. MI-PCF has been shown to be equally effective as ACDF in treating cervical radiculopathy due to foraminal stenosis and similar pathologies. Additionally, it has been hypothesized that preserving motion and avoiding fusion reduces risk for adjacent segment disease, but potentially increases risk for subsequent revision to an ACDF. With similar short-term outcomes and substantial advantages, MI-PCF may be an effective alternative to ACDF for addressing appropriate cervical pathology. A retrospective review was performed to identify patients between 2009 and 2013 who underwent ACDF or MI-PCF with a minimum follow-up of 7 years. Demographic data was recorded. Revision rates and average time to revision between cohorts were compared. Clinical outcomes were assessed at each follow-up visit with Neck Disability Index and Visual Analog Scale for neck and Visual Analog Scale for arm pain scores. All complications were reviewed. Standard binomial and categorical comparative analysis were performed. A total of 251 consecutive patients were included (205 ACDF, 46 MI-PCF). Mean follow-ups for the ACDF and MI-PCF groups were 98.3 and 95.9 months, respectively. Complication rates were 2.9% and 2.2% for the ACDF and MI-PCF cohorts, respectively (P = 0.779). Revision rates were 7.8% for the ACDF cohort and 8.7% for the MI-PCF cohort (P = 0.840). Both cohorts experienced significant improvements in their clinical scores compared with their preoperative values. Final Visual Analog Scale for neck pain (ACDF: 2.6; MI-PCF: 1.6) and Visual Analog Scale for arm pain (ACDF: 1.1; MI-PCF: 0.4) scores differed significantly at final follow-up (P = < 0.001; P = < 0.001). MI-PCF is a safe and effective alternative to ACDF in the treatment of cervical radiculopathy, demonstrating substantial benefit. After final follow-up, MI-PCF demonstrated superior improvements in Visual Analog Scale scores, without increased complication or revision rates.Level of Evidence: 3.

Does Facet Distraction Affect Patient Outcomes After ACDF?

Retrospective cohort study. The aim of this study is to determine if there is a correlation between the amount of facet distraction and postoperative patient-reported outcomes after ACDF. A retrospective cohort analysis of patients undergoing 1 to 3 level ACDF for degenerative pathologies at a single academic center was performed. Each patient received upright, lateral cervical spine x-rays at the immediate postoperative time point from which interfacet distance (facet distraction) was measured. Patient-reported outcome measures including NDI, PCS-12, MCS-12, VAS Neck, and VAS Arm pain scores were obtained preoperatively and at short-term (<3 months) and long-term (>1 year) follow-up. Receiver operating curves were generated to evaluate the possibility of a critical interfacet distraction distance. Univariate and multivariate analysis were performed to compare outcomes between groups based on the degree of facet distraction. A total of 229 patients met the inclusion criteria. Receiver operating curves failed to yield a critical interfacet distraction distance associated with worse post-operative outcomes. Patients were instead grouped based on facet distraction distance below and above the third quartile (0.8mm-2.0mm, 2.0mm-3.7mm), with 173 and 56 patients in each respective group. Univariate analysis did not detect any statistically significant differences in outcome measures, recovery ratio, or % MCID achievement at short- and long-term follow-up between groups. Multivariate analysis also failed to demonstrate any significant differences between the facet distraction groups. Increased interfacet distance did not correlate with increased neck pain or disability after an ACDF.

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.

Does the Contrast Dispersion Pattern During Fluoroscopically Guided Cervical Transforaminal Epidural Steroid Injection Predict Short-Term Pain and Functional Outcomes? An Exploratory Analysis of Prospective Cohort Data

No study has evaluated the relationship between contrast dispersion patterns and outcomes after fluoroscopically guided cervical transforaminal epidural steroid injection (CTFESI). Determine whether contrast dispersion patterns predict pain and functional outcomes after CTFESI. Secondary analysis of data collected during two prospective studies of CTFESI for the treatment of refractory radicular pain. Contrast dispersion patterns visualized by true anteroposterior (AP) projections during CTFESIs were categorized by flow: 1)completely external to the lateral border of the neuroforamen (zone 1); 2)within the neuroforamen but without entry into the lateral epidural space (zone 2); and 3)with extension into the lateral epidural space (zone 3). At baseline and at 1 month post-CTFESI, neck pain, arm pain, and "dominant index pain" (the greater of arm or neck pain) were evaluated using a numeric rating scale (NRS); physical function was assessed using the Five-Item Version of the Neck Disability Index (NDI-5). One-month post-CTFESI, neck pain, arm pain, and "dominant index pain" reductions of ≥50% were observed in 39.4% (95% confidence interval [CI], 28.2-51.8), 55.6% (95% CI, 43.0-67.5), and 44.1% (95% CI, 32.7-56.2) of participants, respectively. Regarding "dominant index pain," 72.7% (95% CI, 40.8-91.2), 39.4% (95% CI, 24.2-57.0), and 37.5% (95% CI, 20.5-58.2) of participants reported ≥50% pain reduction when zone 1, zone 2, and zone 3 contrast flow patterns were observed. Contrast dispersion zone was not significantly associated with subgroup differences in neck pain, arm pain, or NDI-5 scores (P>0.05). Improvements in pain and function 1 month after treatment with CTFESI did not differ significantly based on the contrast dispersion pattern. Future study is needed to confirm or refute these findings in other procedural settings, in broader patient populations, and with longer-term outcome assessment.

250. Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with Prestige LP™ disc at two contiguous levels

BACKGROUND CONTEXT Evaluation of 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) using the Prestige LP™ disc to treat degenerative cervical spine disease at two adjacent levels has been completed. Occurrence of heterotopic ossification (HO) surrounding the prosthesis following CDA has been reported for other prostheses and found to limit the range of motion and to negatively impact function of the prosthesis. PURPOSE To assess the impact of HO on clinical outcomes and angular range of motion (ROM) after CDA with the Prestige LP™ disc at two levels. STUDY DESIGN/SETTING Multicenter, prospective, randomized, controlled, FDA-approved clinical trial. PATIENT SAMPLE A total of 209 subjects implanted with Prestige LP™ discs at two cervical levels in the clinical trial and participating in a post-approval study. The 10-year follow-up rate was 86% after excluding subjects at sites not participating in the PAS study, deaths, and withdrawals. OUTCOME MEASURES HO assessed on lateral neutral radiographs and graded 0-IV; clinical outcomes of overall success, neurological success, neck disability index (NDI), neck pain, arm pain and SF-36 Physical Component Summary (PCS) score; ROM; implant-related adverse event (AE) rate. METHODS Data were obtained as part of an FDA-approved clinical trial and a separate subgroup analysis was performed for this study. ROM was compared by HO grade, and clinical outcomes were compared between HO subgroups (Grade 0-II vs III/IV) based on HO severity at 2 and 10 years after surgery. RESULTS The Grade III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years and 39.0% (57/146) at 10 years. No statistical difference was found in overall success, neurological success, NDI, neck pain, arm pain, or SF-36 PCS scores between the HO subgroups (Grade 0-II vs III/IV) at either 2 or 10 years. The cumulative rate of possible implant-related AEs was higher in subjects having Grade III/IV HO than those having Grade 0-II HO at 2 years (56.3% vs 24.4%) and 10 years (47.8% vs 17.9%), specifically in two subcategories: spinal events and heterotopic ossifications reported by the investigators. However, no statistical difference was found between HO subgroups in possible implant-related serious AEs or secondary surgeries at index or adjacent levels. The average angular ROMs at index levels were lower in subjects with higher-grade HO at 2 and 10 years. The average ROMs at the superior level were 8.8°, 6.6°, 3.2°, and 0.3°, respectively for HO Grade 0-I, II, III and IV groups at 10 years, and 7.9°, 6.2°, 3.7°, and 0.6°, respectively, at the inferior level. CONCLUSIONS Radiographically severe (Grade III or IV) HO after CDA with the Prestige LP disc at two levels did not significantly affect efficacy or safety (severe AEs or secondary surgeries) outcomes. However, severe HO, particularly Grade IV HO, significantly limited ROM, as expected. FDA DEVICE/DRUG STATUS Prestige LP™ Disc, Approved for 2-level cervical disc arthroplasty in 2016 (Approved for this indication)

MRI Findings in Patients Undergoing Triangular Fibrocartilage Complex Repairs Versus Patients Without Ulnar-Sided Wrist Pain.

Background: The clinical picture of ulnar-sided wrist pain is oftentimes confusing because various pathologies may be coexistent. In this study, we aimed: (1) to compare the prevalence of potential causes of ulnar-sided wrist pain on magnetic resonance imaging (MRI) in patients who underwent triangular fibrocartilage complex (TFCC) repair and control subjects: and (2) to evaluate whether inferior clinical results were associated with specific patient characteristics or other potential causes of ulnar-sided wrist pain. Methods: We included 67 patients who underwent a TFCC repair and 67 control subjects. The MRI scans were examined for sources of ulnar-sided wrist pain. After TFCC repair, 42 patients (63%) completed surveys, including Quick Disabilities of the Arm, Shoulder and Hand and pain scores. Bivariate analysis was performed to compare our groups and to identify factors associated with our outcomes. Results: We found significantly higher rates of distal radioulnar joint (DRUJ) arthritis (P = .033), extensor carpi ulnaris (ECU) pathology (P = .028), and ulnar styloid fractures (P = .028) in patients with TFCC repairs. With increasing age, increasing pathology in the pisotriquetral joint (P = .040), more ulnocarpal abutment (P = .0081), and more degenerative tears (P < .001) were seen in both groups. No demographic characteristics or MRI findings were significantly associated with our outcomes. Conclusions: We observed higher rates of DRUJ arthritis and ECU pathology in patients with TFCC tears undergoing repair compared with age- and sex-matched controls. This may be due to damage to the TFCC itself altering relationships of the DRUJ and the ECU subsheath, or it may reflect various pathologies that cause ulnar-sided wrist pain and drive patients toward surgery.

Impact of preoperative weakness and duration of symptoms on health-related quality-of-life outcomes following anterior cervical discectomy and fusion

BACKGROUND CONTEXTThe majority of patients with preoperative upper extremity weakness show improvements in motor function after anterior cervical discectomy and fusion (ACDF). Although numerous studies have examined both the extent and time course to which motor function can be expected to improve, few have shown that these improvements in motor function translate to improved health related quality of life (HRQOL) outcomes. PURPOSEThe purpose of this study was to examine the effect of preoperative weakness and duration of symptoms on HRQOL outcomes in patients who underwent ACDF. STUDY DESIGNRetrospective cohort study. PATIENT SAMPLEAdult patients who underwent an ACDF procedure at an academic hospital from January 2015 to December 2016 by a fellowship-trained spine surgeon. OUTCOME MEASURESThe primary outcomes of interest were HRQOL outcomes: Short Form-12 Physical/Mental Component Scores (SF-12 PCS/MCS), Neck Disability Index (NDI), and Visual Analog Scale Arm/Neck scores (VAS Arm/Neck). METHODSPatient demographics, surgical case characteristics, and motor strength exams were collected in patients who underwent ACDF over a 2-year period. Preoperative weakness was defined by a strength grade ≤3 (on a scale from 0 to 5) in at least one upper extremity muscle group. Multivariate linear regression analysis was performed to determine the effect of the preoperative weakness on HRQOL outcomes. RESULTSOf the 276 patients identified, 45 (16.3%) showed evidence of preoperative weakness, 44 (97.8%) of which showed subsequent postoperative motor improvements after ACDF. All patients reported significant improvements in all HRQOL outcome measures. Patients with preoperative weakness reported significantly worse preoperative VAS Arm (6.9 vs. 5.2; p=.01) and VAS Neck (6.1 vs. 4.8; p=.02) pain scores. Compared with patients without preoperative weakness, those with preoperative weakness reported significantly more improvement in NDI (β: −10.9; p=.001). Patients with symptoms greater than or equal to 12 months and preoperative weakness showed significantly less improvement in NDI (β: 14.8; p=.03). CONCLUSIONSPatients with preoperative weakness generally exhibited worse pain and HRQOL measures preoperatively, and showed greater potential for improvement after ACDF. Patients with a shorter duration of preoperative weakness had greater potential for improvement in HRQOL measures after ACDF compared with those with longer duration of symptoms. ACDF is an effective procedure to improve strength and HRQOL measures across all patient groups under appropriate indications.

Employment Status for the First Decade Following Randomization to Cervical Disc Arthroplasty Versus Fusion.

An analysis of employment status data up to 10 years following the Federal Drug Administration (FDA) Investigational Device Exemption (IDE) randomized trial and extension as post-approval study comparing BRYAN cervical disc (Medtronic, Minneapolis, MN) arthroplasty (CDA) versus single-level anterior cervical discectomy and fusion (ACDF) was performed. Ten-year experience with the BRYAN disc arthroplasty trial provides opportunity to report patient employment data. The long-term consequences of arthroplasty remain incomplete, including the occurrence of occupational compromise. Patients' employment status were measured at regular intervals in both groups up to 10 years. The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups. In the investigational group, 49.2% returned to work at 6 weeks compared with 39.4% of the control group (P = 0.046). At 6 months and 2 years postoperatively, there was a similar likelihood of active employment in both groups. After 2 years at all time points, 10% drop-off seen in control group employment, but not in investigational group. At 10 years, 76.2% CDA patients were employed to 64.1% ACDF patients (P = 0.057). Preoperative variables influencing work status at 10 years following CDA included: preoperative work status, age, and SF-36 Mental Component Score (SF-36 MCS); whereas, no significant preoperative factor identified with ACDF. Time to return to work was influenced in both groups by preoperative work status; and in the ACDF group: reaching age 65 at 10-year visit, preoperative arm pain and NDI score had significant influences. More patients returned to work at 6 weeks after CDA compared with ACDF, although there was no difference by 6 months. After 2 years, a nonsignificant trend toward higher employment rates in the arthroplasty group was evident, but this difference could not be validated due to the very high rate of loss of patients to the follow-up. 2.

Comparison of the use of opioids only and pregabalin add-on for the treatment of neuropathic pain in cervical myelopathy patients: a pilot trial

Among patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants were randomly assigned to one of the two study groups. The participants in one study group received opioids only, while those in the other group received opioids and pregabalin. Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group). The LANSS, neck pain, and arm pain scores in the pregabalin add-on group improved significantly compared with those in the opioid-only group after the first 4 weeks (p = 0.005, 0.001 and 0.035, respectively), but there was no significant difference between the two groups during the next 4 weeks (p = 0.615, 0.377 and 0.716, respectively). There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up. Adverse events were reported by four patients (20.0%) in the opioid-only group and five patients (26.3%) in the pregabalin add-on group (p = 0.716). However, over time, the occurrence of side effects and dropouts increased in the pregabalin add-on group. This exploratory pilot study suggests that pregabalin add-on treatment is more efficient than the use of opioids alone at the beginning of NP treatment in cervical myelopathy patients. However, prescribing pregabalin add-on treatment for more than four weeks should be done cautiously.

Mid-Term to Long-Term Outcomes After Total Cervical Disk Arthroplasty Compared With Anterior Diskectomy and Fusion: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

This study was a meta-analysis of published randomized controlled trials (RCTs). We investigated the mid-term to long-term outcomes of cervical disk arthroplasty (CDA) versus anterior cervical diskectomy and fusion (ACDF) for the surgical treatment of symptomatic cervical disk degenerative disease. ACDF has been widely performed for the surgical treatment of symptomatic cervical disk degenerative disease. However, the loss of motion at the operated level has been hypothesized to accelerate adjacent-level disk degeneration. CDA was designed to preserve motion segments and decrease the risk/rate of adjacent segment degeneration. However, it is still uncertain whether mid-term to long-term outcomes after CDA is more effective and safer than those observed after ACDF. Two independent reviewers conducted a search of PubMed, Embase, and the Cochrane Library databases for RCTs with a minimum of 48 months of follow-up. For dichotomous variables, the risk ratio and 95% confidence intervals were calculated. For continuous variables, the standardized mean difference and 95% confidence intervals were calculated. Eleven RCTs, finally, were included. The rate of neurological success in the CDA group was not significantly different from that in the ACDF group. The pooled results show that patients who underwent CDA had a significantly greater improvement in Neck Disability Index (NDI) and Short Form 36 Health Survey physical component (SF-36 HSPC) than did those who underwent ACDF. No significant difference was found when comparing the neck and arm pain scores between the CDA and ACDF groups. The overall rate of secondary surgical procedures was significantly lower in patients who underwent CDA than in those who underwent ACDF. We observed similar overall rates of adverse events and adjacent segment degeneration when comparing the CDA group with the ACDF group. This meta-analysis provides evidence suggesting that CDA was superior to ACDF in terms of NDI score, SF-36 HSPC score, and low rate of secondary surgical procedures. Furthermore, no significant differences existed between the CDA group and the ACDF group in the neck pain visual analog scale score, arm pain visual analog scale score, the rate of neurological success, adjacent segment degeneration, and adverse events. Level 1.

Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels.

The authors sought to assess the impact of heterotopic ossification (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP disc) at 2 levels. HO was assessed and graded from 0 to IV for increasing severity on lateral neutral radiographs at each visit in 209 patients who underwent implantation of Prestige LP discs at 2 cervical levels in a clinical trial with extended 10-year follow-up. ROM was compared by using HO grade, and clinical outcomes were compared between HO subgroups (grade 0-II vs III/IV) based on HO severity at 2 and 10 years after surgery. The grade III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years and 39.0% (57/146) at 10 years. No statistical difference was found in overall success; neurological success; or Neck Disability Index (NDI), neck pain, arm pain, or SF-36 Physical Component Summary (PCS) scores between the HO subgroups (grade 0-II vs III/IV) at either 2 or 10 years. The cumulative rate of possible implant-related adverse events (AEs) was higher in patients having grade III/IV HO at 2 years (56.3%) and 10 years (47.8%) compared with those having grade 0-II HO at 2 years (24.4%) and 10 years (17.9%), specifically in 2 subcategories: spinal events and HOs reported by the investigators. No statistical difference was found between the HO subgroups in possible implant-related serious AEs or secondary surgeries at the index or adjacent levels. The average angular ROMs at index levels were lower in subjects with higher-grade HO at 2 and 10 years. The average ROMs at the superior level were 8.8°, 6.6°, 3.2°, and 0.3°, respectively, for the HO grade 0/I, II, III, and IV groups at 10 years, and 7.9°, 6.2°, 3.7°, and 0.6°, respectively, at the inferior level. Radiographically severe (grade III or IV) HO after CDA with the Prestige LP disc at 2 levels did not significantly affect efficacy or safety outcomes (severe AEs or secondary surgeries). However, severe HO, particularly grade IV HO, significantly limited ROM, as expected.

The Impact of Multiple Comorbid Mental Health Disorders on Health-related Quality of Life Following ACDF

Retrospective comparative study. The goal was to determine whether comorbid depression and/or anxiety influence outcomes after anterior cervical discectomy and fusion (ACDF) for patients with degenerative cervical pathology. The role preoperative mental health has on patient reported outcomes after ACDF surgery is not well understood. Patients undergoing elective ACDF for degenerative cervical pathology were identified. Patients were grouped based on their preoperative mental health comorbidities, including patients with no history, depression, anxiety, and those with both depression and anxiety. All preoperative medical treatment for depression and/or anxiety was identified. Outcomes including Physical Component Score (PCS-12), Mental Component Score (MCS-12), Neck Disability Index (NDI), Visual Analogue Scale neck pain score (VAS Neck ), and Visual Analogue Scale arm pain score (VAS Arm) were compared between groups from baseline to postoperative measurements using multiple linear regression analysis-controlling for factors such as age, sex, and body mass index, etc. A P-value <0.05 was considered statistically significant. A total of 264 patients were included in the analysis, with an average age of 53 years and mean follow-up of 19.8 months (19.0-20.6). All patients with a diagnosis of depression or anxiety also reported medical treatment for the disease. The group with no depression or anxiety had significantly less baseline disability than the group with 2 mental health diagnoses, in MCS-12 (P=0.009), NDI (P<0.004), VAS Neck (P=0.003), and VAS Arm (P=0.001) scores. Linear regression analysis demonstrated that increasing occurrence of mental health disorders was not a significant predictor of change over time for any of the outcome measures included in the analysis. Despite more severe preoperative symptoms, patients with a preoperative mental health disorder(s) demonstrated significant improvement in postoperative outcomes after ACDF. No differences were identified in postoperative outcomes between each of the groups. Level III.

Are Outcomes of Anterior Cervical Discectomy and Fusion Influenced by Presurgical Depression Symptoms on the Mental Component Score of the Short Form-12 Survey?

Retrospective comparative study. The purpose of this study was to investigate whether preoperative depressive symptoms, measured by mental component score of the Short Form-12 survey (MCS-12), influence patient-reported outcome measurements (PROMs) following an anterior cervical discectomy and fusion (ACDF) surgery for cervical degeneration. There is a paucity of literature regarding preoperative depression and PROMs following ACDF surgery for cervical degenerative disease. Patients who underwent an ACDF for degenerative cervical pathology were identified. A score of 45.6 on the MCS-12 was used as the threshold for depression symptoms, and patients were divided into two groups based on this value: depression (MCS-12 ≤45.6) and nondepression (MCS-12 >45.6) groups. Outcomes including Neck Disability Index (NDI), physical component score of the Short Form-12 survey (PCS-12), and Visual Analogue Scale Neck (VAS Neck), and Arm (VAS Arm) pain scores were evaluated using independent sample t test, recovery ratios, percentage of patients reaching the minimum clinically important difference, and multiple linear regression - controlling for factors such as age, sex, and BMI. The depression group was found to have significantly worse baseline pain and disability than the nondepression group in NDI (P < 0.001), VAS Neck pain (P < 0.001), and VAS Arm pain (P < 0.001) scores. Postoperatively, both groups improved to a similar amount with surgery based on the recovery ratio analysis. The depression group continued to have worse scores than the nondepression group in NDI (P = 0.010), PCS-12 (P = 0.026), and VAS Arm pain (P = 0.001) scores. Depression was not a significant predictor of change in any PROMs based on regression analysis. Patients who presented with preoperative depression reported more pain and disability symptoms preoperatively and postoperatively; however, both groups achieved similar degrees of improvement. 3.

A prospective study on outcome of function after proximal row carpectomy

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Proximal row carpectomy (PRC) is a procedure with varied indications. The purpose of this study was to evaluate functional outcomes with PRC in wrist flexion deformities, neuromuscular disorders and also post-traumatic wrist arthritis.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; A prospective study was performed on all patients who underwent PRC between April 2015 and December 2017, in BIRRD (T) hospital, Tirupati, Andhra Pradesh with a minimum follow up of 6 months. Outcome was assessed in terms of range of motion (ROM), grip strength, quick disabilities of the arm, shoulder, and hand (QDASH) score and pain score. Data was analyzed using the Student t-test.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; Thirty-two patients underwent PRC of which 12 are neuromuscular disorders, 10 are wrist flexion deformities, 10 are post-traumatic wrist arthritis. On the final follow-up, significant improvement in ROM was observed in wrist flexion deformities and neuromuscular disorders, whereas grip strength and QDASH scores showed a significant difference in post-traumatic wrist arthritis. Pain was studied only in post-traumatic wrist arthritis, all were very much pleased with pain reduction.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; PRC is fairly a reliable procedure for all the indications in our study. We consider that PRC is a promising procedure in correcting wrist flexion deformities. Though there has been significant improvement in all the parameters for all the cases, we consider this procedure is best suited for post-traumatic arthritis group.&lt;/p&gt;

Severity of Preoperative Myelopathy Symptoms Affects Patient-reported Outcomes, Satisfaction, and Return to Work After Anterior Cervical Discectomy and Fusion for Degenerative Cervical Myelopathy.

Retrospective review of prospectively-collected registry data. To compare the patient-reported outcomes, satisfaction, and return to work among a large cohort of patients stratified by preoperative myelopathy severity undergoing Anterior Cervical Discectomy and Fusion (ACDF) for Degenerative Cervical Myelopathy. Recent clinical practice guidelines noted a lack of studies stratifying their sample based on preoperative disease severity. The benefits of early surgical intervention for patients with mild myelopathy remain uncertain. A prospectively-maintained registry was retrospectively reviewed for all patients who underwent primary ACDF for Degenerative Cervical Myelopathy. Patients were stratified based on severity of preoperative myelopathy symptoms according to the Japanese Orthopaedic Association (JOA) scale: mild (>13), moderate (9-13), or severe (<9). Patients were prospectively followed for at least 2 years. In total, 219 patients were included: 74 mild, 94 moderate, and 51 severe cases. The mild group had significantly better Neurogenic Symptoms (NS), Neck Disability Index (NDI), SF-36 Physical (PCS), and Mental Component Summary at baseline (P < 0.05). Neck and arm pain scores were similar at all time points. At 2 years, the severe group still had significantly worse patient-reported outcomes and lower rates of satisfaction, expectation fulfilment and return to work. However, they had significantly greater improvement in JOA, Neurogenic Symptoms, NDI, PCS, and Mental Component Summary, and a larger proportion attained minimal clinically important difference (MCID) for NDI and PCS. All three groups had similar proportions attaining MCID for JOA. Patients with severe myelopathy experienced a greater improvement after ACDF. Although fewer patients attained MCID, early surgical intervention for patients with mild myelopathy should also be considered, as this may allow patients to maintain their higher functional status. They also had high rates of postoperative satisfaction and return to work. The clinical trajectory outlined in this study may provide valuable prognostic information for patients. 3.