Objective functional assessment using the "Timed Up and Go" test in patients with lumbar spinal stenosis.

OBJECTIVEPatient-reported outcome measures (PROMs) are standard of care for the assessment of functional impairment. Subjective outcome measures are increasingly complemented by objective ones, such as the "Timed Up and Go" (TUG) test. Currently, only a few studies report pre- and postoperative TUG test assessments in patients with lumbar spinal stenosis (LSS).METHODSA prospective two-center database was reviewed to identify patients with LSS who underwent lumbar decompression with or without fusion. The subjective functional status was estimated using PROMs for pain (visual analog scale [VAS]), disability (Roland-Morris Disability Index [RMDI] and Oswestry Disability Index [ODI]), and health-related quality of life (HRQoL; 12-Item Short-Form Physical Component Summary [SF-12 PCS] and the EQ-5D) preoperatively, as well as on postoperative day 3 (D3) and week 6 (W6). Objective functional impairment (OFI) was measured using age- and sex-standardized TUG test results.RESULTSSixty-four patients (n = 32 [50%] male, mean age 66.8 ± 11.7 years) were included. Preoperatively, they reported a mean VAS back pain score of 4.1 ± 2.7, VAS leg pain score of 5.4 ± 2.7, RMDI of 10.4 ± 5.3, ODI of 41.9 ± 16.2, SF-12 PCS score of 32.7 ± 8.3, and an EQ-5D index of 0.517 ± 0.226. The preoperative rates of severe, moderate, and mild OFI were 4.7% (n = 3), 12.5% (n = 8), and 7.8% (n = 5), respectively, and the mean OFI T-score was 116.3 ± 23.7. At W6, 60 (93.8%) of 64 patients had a TUG test result within the normal population range (no OFI); 3 patients (4.7%) had mild and 1 patient (1.6%) severe OFI. The mean W6 OFI T-score was significantly decreased (103.1 ± 13.6; p < 0.001). Correspondingly, the PROMs showed a decrease in subjective VAS back pain (1.6 ± 1.7, p < 0.001) and leg pain (1.0 ± 1.8, p < 0.001) scores, disability (RMDI 5.3 ± 4.7, p < 0.001; ODI 21.3 ± 16.1, p < 0.001), and increase in HRQoL (SF-12 PCS 40.1 ± 8.3, p < 0.001; EQ-5D 0.737 ± 0.192, p < 0.001) at W6. The W6 responder status (clinically meaningful improvement) ranged between 81.3% (VAS leg pain) and 29.7% (EQ-5D index) of patients.CONCLUSIONSThe TUG test is a quick and easily applicable tool that reliably measures OFI in patients with LSS. Objective tests incorporating longer walking time should be considered if OFI is suspected but fails to be proven by the TUG test, taking into account that neurogenic claudication may not clinically manifest during the brief TUG examination. Objective tests do not replace the subjective PROM-based assessment, but add valuable information to a comprehensive patient evaluation.

Short-term outcomes of lateral lumbar interbody fusion without decompression for the treatment of symptomatic degenerative spondylolisthesis at L4-5.

OBJECTIVE Recently, authors have called into question the utility and complication index of the lateral lumbar interbody fusion procedure at the L4-5 level. Furthermore, the need for direct decompression has also been debated. Here, the authors report the clinical and radiographic outcomes of transpsoas lumbar interbody fusion, relying only on indirect decompression to treat patients with neurogenic claudication secondary to Grade 1 and 2 spondylolisthesis at the L4-5 level. METHODS The authors conducted a retrospective evaluation of 18 consecutive patients with Grade 1 or 2 spondylolisthesis from a prospectively maintained database. All patients underwent a transpsoas approach, followed by posterior percutaneous instrumentation without decompression. The Oswestry Disability Index (ODI) and SF-12 were administered during the clinical evaluations. Radiographic evaluation was also performed. The mean follow-up was 6.2 months. RESULTS Fifteen patients with Grade 1 and 3 patients with Grade 2 spondylolisthesis were identified and underwent fusion at a total of 20 levels. The mean operative time was 165 minutes for the combined anterior and posterior phases of the operation. The estimated blood loss was 113 ml. The most common cage width in the anteroposterior dimension was 22 mm (78%). Anterior thigh dysesthesia was identified on detailed sensory evaluation in 6 of 18 patients (33%); all patients experienced resolution within 6 months postoperatively. No patient had lasting sensory loss or motor deficit. The average ODI score improved 26 points by the 6-month follow-up. At the 6-month follow-up, the SF-12 mean Physical and Mental Component Summary scores improved by 11.9% and 9.6%, respectively. No patient required additional decompression postoperatively. CONCLUSIONS This study offers clinical results to establish lateral lumbar interbody fusion as an effective technique for the treatment of Grade 1 or 2 degenerative spondylolisthesis at L4-5. The use of this surgical approach provides a minimally invasive solution that offers excellent arthrodesis rates as well as favorable clinical and radiological outcomes, with low rates of postoperative complications. However, adhering to the techniques of transpsoas lateral surgery, such as minimal table break, an initial look-and-see approach to the psoas, clear identification of the plexus, minimal cranial caudal expansion of the retractor, mobilization of any traversing sensory nerves, and total psoas dilation times less than 20 minutes, ensures the lowest possible complication profile for both visceral and neural injuries even in the narrow safe zones when accessing the L4-5 disc space in patients with degenerative spondylolisthesis.

Cost-effectiveness of adult spinal deformity surgery in a military healthcare system.

OBJECTIVEAdult spinal deformity surgery is an effective way of treating pain and disability, but little research has been done to evaluate the costs associated with changes in health outcome measures. This study determined the change in quality-adjusted life years (QALYs) and the cost per QALY in patients undergoing spinal deformity surgery in the unique environment of a military healthcare system (MHS).METHODSPatients were enrolled between 2011 and 2017. Patients were eligible to participate if they were undergoing a thoracolumbar spinal fusion spanning more than 6 levels to treat an underlying deformity. Patients completed the 36-Item Short Form Health Survey (SF-36) prior to surgery and 6 and 12 months after surgery. The authors used paired t-tests to compare SF-36 Physical Component Summary (PCS) scores between baseline and postsurgery. To estimate the cost per QALY of complex spine surgery in this population, the authors extended the change in health-related quality of life (HRQOL) between baseline and follow-up over 5 years. Data on the cost of surgery were obtained from the MHS and include all facility and physician costs.RESULTSHRQOL and surgical data were available for 49 of 91 eligible patients. Thirty-one patients met additional criteria allowing for cost-effectiveness analysis. Over 12 months, patients demonstrated significant improvement (p < 0.01) in SF-36 PCS scores. A majority of patients met the minimum clinically important difference (MCID; 83.7%) and substantive clinical benefit threshold (SCBT; 83.7%). The average change in QALY was an increase of 0.08. Extended across 5 years, including the 3.5% discounting per year, study participants increased their QALYs by 0.39, resulting in an average cost per QALY of $181,649.20. Nineteen percent of patients met the < $100,000/QALY threshold with half of the patients meeting the < $100,000/QALY mark by 10 years. A sensitivity analysis showed that patients who scored below 60 on their preoperative SF-36 PCS had an average increase in QALYs of 0.10 per year or 0.47 over 5 years.CONCLUSIONSWith a 5-year extended analysis, patients who receive spinal deformity surgery in the MHS increased their QALYs by 0.39, with 19% of patients meeting the $100,000/QALY threshold. The majority of patients met the threshold for MCID and SCBT at 1 year postoperatively. Consideration of preoperative functional status (SF-36 PCS score < 60) may be an important factor in determining which patients benefit the most from spinal deformity surgery.

Male sex may not be associated with worse outcomes in primary all-posterior adult spinal deformity surgery: a multicenter analysis.

OBJECTIVE Adolescent spine deformity studies have shown that male patients require longer surgery and have greater estimated blood loss (EBL) and complications compared with female patients. No studies exist to support this relationship in adult spinal deformity (ASD). The purpose of this study was to investigate associations between sex and complications, deformity correction, and health-related quality of life (HRQOL) in patients with ASD. It was hypothesized that male ASD patients would have greater EBL, longer surgery, and more complications than female ASD patients. METHODS A multicenter ASD cohort was retrospectively queried for patients who underwent primary posterior-only instrumented fusions with a minimum of 5 levels fused. The minimum follow-up was 2 years. Primary outcomes were EBL, operative time, intra-, peri-, and postoperative complications, radiographic correction, and HRQOL outcomes (Oswestry Disability Index, SF-36, and Scoliosis Research Society-22r Questionnaire). Poisson multivariate regression was used to control for age, comorbidities, and levels fused. RESULTS Ninety male and 319 female patients met the inclusion criteria. Male patients had significantly greater mean EBL (2373 ml vs 1829 ml, p = 0.01). The mean operative time, transfusion requirements, and final radiographic measurements did not differ between sexes. Similarly, changes in HRQOL showed no significant differences. Finally, there were no sex differences in the incidence of complications (total, major, or minor) at any time point after controlling for age, body mass index, comorbidities, and levels fused. CONCLUSIONS Despite higher EBL, male ASD patients did not experience more complications or require less deformity correction at the 2-year follow-up. HRQOL scores similarly showed no sex differences. These findings differ from adolescent deformity studies, and surgeons can counsel patients that sex is unlikely to influence the outcomes and complication rates of primary all-posterior ASD surgery.

Multilevel cervical arthroplasty: current evidence. A systematic review.

OBJECTIVE Cervical disc arthroplasty (CDA) has been demonstrated to be an effective treatment modality for single-level cervical radiculopathy or myelopathy. Its advantages over an anterior cervical discectomy and fusion (ACDF) include motion preservation and decreased reoperations at the index and adjacent segments up to 7 years postoperatively. Considering the fact that many patients have multilevel cervical disc degeneration (CDD), the authors performed a systematic review of the clinical studies evaluating patients who underwent multilevel CDA (2 or more levels). METHODS A systematic review in the MEDLINE database was performed. Clinical studies including patients who had multilevel CDA were selected and included. Case reports and literature reviews were excluded. Articles were then grouped according to their main study objective: 1) studies comparing multilevel CDA versus ACDF; 2) studies comparing single-level CDA versus multilevel CDA; and 3) multilevel CDA after a previous cervical spine surgery. RESULTS Fourteen articles met all inclusion criteria. The general conclusions were that multilevel CDA was at least as safe and effective as ACDF, with preservation of cervical motion when compared with ACDF and potentially with fewer reoperations expected in most of the studies. Multilevel CDAs are clinically effective as single-level surgeries, with good clinical and radiological outcomes. Some studies reported a higher incidence of heterotopic ossification in multilevel CDA when compared with single-level procedures, but without clinical relevance during the follow-up period. A CDA may be indicated even after a previous cervical surgery in selected cases. CONCLUSIONS The current literature supports the use of multilevel CDA. Caution is necessary regarding the more restrictive indications for CDA when compared with ACDF. Further prospective, controlled, multicenter, and randomized studies not sponsored by the device manufactures are desirable to prove the superiority of CDA surgery over ACDF as the treatment of choice for CDD in selected cases.

Early experience with endoscopic foraminotomy in patients with moderate degenerative deformity.

OBJECTIVE Asymmetrical degeneration of the disc is one of the most common causes of primary degenerative scoliosis in adults. Coronal deformity is usually less symptomatic than a sagittal deformity because there is less expenditure of energy and hence less effort to maintain upright posture. However, nerve root compression at the fractional curve or at the concave side of the main curve can give rise to debilitating radiculopathy. METHODS This study was a retrospective analysis of 16 patients with coronal deformity of between 10° and 20°. All patients underwent endoscopic foraminal decompression surgery. The pre- and postoperative Cobb angle, visual analog scale (VAS), 36-Item Short Form Health Survey (SF-36), and Oswestry Disability Index scores were measured. RESULTS The average age of the patients was 70.0 ± 15.5 years (mean ± SD, range 61-86 years), with a mean followup of 7.5 ± 5.3 months (range 2-14 months). The average coronal deformity was 16.8° ± 4.7° (range 10°-41°). In 8 patients the symptomatic foraminal stenosis was at the level of the fractional curve, and in the remaining patients it was at the concave side of the main curve. One of the patients included in the current cohort had to undergo a repeat operation within 1 week for another disc herniation at the adjacent level. One patient had CSF leakage, which was repaired intraoperatively, and no further complications were noted. On average, preoperative VAS and SF-36 scores showed a tendency for improvement, whereas a dramatic reduction of VAS, by 65% (p = 0.003), was observed in radicular leg pain. CONCLUSIONS Patients with mild to moderate spinal deformity are often compensated and have tolerable levels of back pain. However, unilateral radicular pain resulting from foraminal stenosis can be debilitating. In select cases, an endoscopic discectomy or foraminotomy enables the surgeon to decompress the symptomatic foramen with preservation of essential biomechanical structures, delaying the need for a major deformity correction surgery.

A comparison of minimally invasive posterior cervical decompression and open anterior cervical decompression and instrumented fusion in the surgical management of degenerative cervical myelopathy.

OBJECTIVE Minimally invasive posterior cervical decompression (miPCD) has been described in several case series with promising preliminary results. The object of the current study was to compare the clinical outcomes between patients undergoing miPCD with anterior cervical discectomy and instrumented fusion (ACDFi). METHODS A retrospective study of 74 patients undergoing surgery (45 using miPCD and 29 using ACDFi) for myelopathy was performed. Outcomes were categorized into short-term, intermediate, and long-term follow-up, corresponding to averages of 1.7, 7.7, and 30.9 months, respectively. Mean scores for the Neck Disability Index (NDI), neck visual analog scale (VAS) score, SF-12 Physical Component Summary (PCS), and SF-12 Mental Component Summary (MCS) were compared for each follow-up period. The percentage of patients meeting substantial clinical benefit (SCB) was also compared for each outcome measure. RESULTS Baseline patient characteristics were well-matched, with the exception that patients undergoing miPCD were older (mean age 57.6 ± 10.0 years [miPCD] vs 51.1 ± 9.2 years [ACDFi]; p = 0.006) and underwent surgery at more levels (mean 2.8 ± 0.9 levels [miPCD] vs 1.5 ± 0.7 levels [ACDFi]; p < 0.0001) while the ACDFi patients reported higher preoperative neck VAS scores (mean 3.8 ± 3.0 [miPCD] vs 5.4 ± 2.6 [ACDFi]; p = 0.047). The mean PCS, NDI, neck VAS, and MCS scores were not significantly different with the exception of the MCS score at the short-term follow-up period (mean 46.8 ± 10.6 [miPCD] vs 41.3 ± 10.7 [ACDFi]; p = 0.033). The percentage of patients reporting SCB based on thresholds derived for PCS, NDI, neck VAS, and MCS scores were not significantly different, with the exception of the PCS score at the intermediate follow-up period (52% [miPCD] vs 80% [ACDFi]; p = 0.011). CONCLUSIONS The current report suggests that the optimal surgical strategy in patients requiring dorsal surgery may be enhanced by the adoption of a minimally invasive surgical approach that appears to result in similar clinical outcomes when compared with a well-accepted strategy of ventral decompression and instrumented fusion. The current results suggest that future comparative effectiveness studies are warranted as the miPCD technique avoids instrumented fusion.

Endoscopic minimally invasive transforaminal interbody fusion without general anesthesia: initial clinical experience with 1-year follow-up.

OBJECTIVE One of the principal goals of minimally invasive surgery has been to speed postoperative recovery. In this case series, the authors used an endoscopic technique for interbody fusion combined with percutaneous screw fixation to obviate the need for general anesthesia. METHODS The first 10 consecutive patients treated with a minimum of 1 year's follow-up were included in this series. The patients were all treated using endoscopic access through Kambin's triangle to allow for neural decompression, discectomy, endplate preparation, and interbody fusion. This was followed by percutaneous pedicle screw and connecting rod placement using liposomal bupivacaine for long-acting analgesia. No narcotics or regional anesthetics were used during surgery. RESULTS All patients underwent the procedure successfully without conversion to open surgery. The patients' average age was 62.2 ± 9.0 years (range 52-78 years). All patients had severe disc height collapse, and 60% had a Grade I spondylolisthesis. The mean operative time was 113.5 ± 6.3 minutes (range 105-120 minutes), and blood loss was 65 ± 38 ml (range 30-190 ml). The mean length of hospital stay was 1.4 ± 1.3 nights. There were no intraoperative or postoperative complications. Comparison of preoperative and final clinical metrics demonstrated that the Oswestry Disability Index improved from 42 ± 11.8 to 13.3 ± 15.1; the 36-Item Short Form Health Survey (SF-36) Physical Component Summary improved from 47.6 ± 3.8 to 49.7 ± 5.4; the SF-36 Mental Component Summary decreased from 47 ± 3.9 to 46.7 ± 3.4; and the EQ-5D improved from 10.7 ± 9.5 to 14.2 ± 1.6. There were no cases of nonunion identified radiographically on follow-up imaging. CONCLUSIONS Endoscopic fusion under conscious sedation may represent a feasible alternative to traditional lumbar spine fusion in select patients. Larger clinical series are necessary to validate that clinical improvements are sustained and that arthrodesis rates are successful when compared with open surgery. This initial experience demonstrates the possible utility of this procedure.

Psychometric analysis and critical appraisal of the original, revised, and modified versions of the Japanese Orthopaedic Association score in the assessment of patients with cervical spondylotic myelopathy.

OBJECTIVE Cervical spondylotic myelopathy (CSM) is the most common cause of nontraumatic spinal cord impairment and disability in the world. Given that the Japanese Orthopaedic Association (JOA) score is the most frequently used outcome measure in clinical research and practice for treating patients with CSM, this review was undertaken to comprehensively and critically evaluate the psychometric properties of the JOA score. METHODS The authors identified studies (published in the period of January 1975 to November 2015) on the psychometric properties of the original, revised, and modified versions of the JOA score in Medline, PsycINFO, Excerpta Medica dataBASE (EMBASE), American College of Physicians Journal Club, and Cochrane Database of Systematic Reviews. Additional publications were captured in a secondary search of the bibliographies in both original research articles and literature reviews identified in the original search. The JOA scores were evaluated for item generation and reduction, internal consistency, reliability, validity, and responsiveness. This review included all those versions of the JOA score whose psychometric properties had been reported in at least 2 published studies. RESULTS The primary search strategy identified 59 studies, of which 9 fulfilled the inclusion and exclusion criteria. An additional 18 publications were captured in the secondary search and included in the analysis. The key findings from the 27 studies analyzed indicated the following: 1) the original JOA score (1975) was the source for the revised JOA score (1994) and 3 modified versions (1991, 1993, and 1999 JOA scores) reported or used in at least 2 published studies; 2) the revised and modified versions of the JOA score are markedly different from each other; 3) only the revised JOA score (1994) was validated with the original JOA score; and 4) the 1975 JOA score is the most appropriate instrument for assessing patients in Asian populations (especially from Japan) because of its psychometric attributes, and the 1991 JOA score is the most appropriate version for use in Western populations. CONCLUSIONS The authors' results indicate that the original (1975), revised (1994), and modified (1991, 1993, and 1999) versions of the JOA score are substantially different from each other in terms of their content and have been incompletely examined for their psychometric properties and cultural sensitivity. Whereas the 1975 JOA score is the most appropriate version for assessing individuals from Asian populations (particularly those eating with chopsticks), the 1991 JOA score is most suitable for evaluating patients in Western populations. Nonetheless, further investigation of the psychometric properties of the 1975 and 1991 JOA scores is recommended because of a paucity of studies reporting on the responsiveness of these 2 scoring instruments.

Effect of complications within 90 days on patient-reported outcomes 3 months and 12 months following elective surgery for lumbar degenerative disease.

OBJECT There is a paradigm shift toward rewarding providers for quality rather than volume. Complications appear to occur at a fairly consistent frequency in large aggregate data sets. Understanding how complications affect long-term patient-reported outcomes (PROs) following degenerative lumbar surgery is vital. The authors hypothesized that 90-day complications would adversely affect long-term PROs. METHODS Nine hundred six consecutive patients undergoing elective surgery for degenerative lumbar disease over a period of 4 years were enrolled into a prospective longitudinal registry. The following PROs were recorded at baseline and 12-month follow-up: Oswestry Disability Index (ODI) score, numeric rating scales for back and leg pain, quality of life (EQ-5D scores), general physical and mental health (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS] scores) and responses to the North American Spine Society (NASS) satisfaction questionnaire. Previously published minimum clinically important difference (MCID) threshold were used to define meaningful improvement. Complications were divided into major (surgicalsite infection, hardware failure, new neurological deficit, pulmonary embolism, hematoma and myocardial infarction) and minor (urinary tract infection, pneumonia, and deep venous thrombosis). RESULTS Complications developed within 90 days of surgery in 13% (118) of the patients (major in 12% [108] and minor in 8% [68]). The mean improvement in ODI scores, EQ-5D scores, SF-12 PCS scores, and satisfaction at 3 months after surgery was significantly less in the patients with complications than in those who did not have major complications (ODI: 13.5 ± 21.2 vs 21.7 ± 19, < 0.0001; EQ-5D: 0.17 ± 0.25 vs 0.23 ± 0.23, p = 0.04; SF-12 PCS: 8.6 ± 13.3 vs 13.0 ± 11.9, 0.001; and satisfaction: 76% vs 90%, p = 0.002). At 12 months after surgery, the patients with major complications had higher ODI scores than those without complications (29.1 ± 17.7 vs 25.3 ± 18.3, p = 0.02). However, there was no difference in the change scores in ODI and absolute scores across all other PROs between the 2 groups. In multivariable linear regression analysis, after controlling for an array of preoperative variables, the occurrence of a major complication was not associated with worsening ODI scores 12 months after surgery. There was no difference in the percentage of patients achieving the MCID for disability (66% vs 64%), back pain (55% vs 56%), leg pain (62% vs 59%), or quality of life (19% vs 14%) or in patient satisfaction rates (82% vs 80%) between those without and with major complications. CONCLUSIONS Major complications within 90 days following lumbar spine surgery have significant impact on the short-term PROs. Patients with complications, however, do eventually achieve clinically meaningful outcomes and report satisfaction equivalent to those without major complications. This information allows a physician to counsel patients on the fact that a complication creates frustration, cost, and inconvenience; however, it does not appear to adversely affect clinically meaningful long-term outcomes and satisfaction.

Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts.

OBJECTIVE: Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS. METHODS: Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7). RESULTS: Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes. CONCLUSIONS: Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.

Multimodal outcome assessment after surgery for brainstem cavernous malformations.

OBJECTIVE: The object of this study was to assess outcome after surgery for brainstem cavernous malformations (BSCMs) using functional, health-related quality of life (HRQOL), and psychological surveys to analyze the interrelation of these measurements, and to compare HRQOL and anxiety and depression scores with those in a healthy population. METHODS: The authors performed a cross-sectional outcome study of all patients surgically treated for BSCM in their department between January 1, 2003, and December 31, 2019. They assessed functional outcome via the modified Rankin Scale (mRS), health-related quality of life (HRQOL) via the SF-36 and 9-item Life Satisfaction Questionnaire (LISAT-9), cranial nerve and brainstem function using a questionnaire, symptom-based psychological outcome via the Hospital Anxiety and Depression Scale (HADS), and timepoint of a return to previous employment. They analyzed the correlation between absolute (mRS score ≤ 2) and relative (postoperative deterioration in initial mRS score) outcome endpoints and the interrelation of the outcome measures and performed a comparison of HRQOL and HADS scores with findings in a healthy population. RESULTS: Seventy-four patients were eligible for inclusion in the study. HRQOL was impaired after surgery for BSCM compared to that in a healthy population. This impairment was substantial in patients with an unfavorable functional outcome (mRS > 2) but was also present in those with a favorable outcome (mRS ≤ 2) in selected domains. Psychological impairment was negligible in patients with a favorable outcome and grave in those with an unfavorable outcome. LISAT-9 results revealed that brainstem and cranial nerve symptoms reduce satisfaction mainly in self-care abilities for both unfavorable and favorable outcome patients. Among the brainstem and cranial nerve symptoms, balance impairment showed the most significant impact on HRQOL. Absolute outcome endpoints were superior to relative outcome endpoints in reflecting impairment in HRQOL after surgery. CONCLUSIONS: The study data can improve patient counseling and decision-making in BSCM treatment and may function as a benchmark. The authors report outcomes after BSCM surgery in high detail, emphasizing the specific impact of cranial nerve and brainstem symptoms on HRQOL. When reporting BSCM surgery outcome, absolute outcome endpoints should be applied.

Factors associated with chronic opioid use after cervical spine surgery for degenerative conditions.

OBJECTIVE: Opioids are commonly prescribed after surgery for painful spinal conditions, yet little is known about postoperative opioid use. The relationship between chronic opioid use and patient-reported outcomes and satisfaction with surgery is also unclear. The purpose of this study was to evaluate factors associated with opioid use 1 year after elective cervical spine surgery for degenerative conditions causing radiculopathy and myelopathy. The authors hypothesized that patients with preoperative opioid use would be more likely to report postoperative opioid use at 1 year, and that postoperative opioid use would be associated with patient-reported outcomes and dissatisfaction with surgery. METHODS: The authors performed a retrospective study of a prospective cohort of adult patients who underwent elective cervical spine surgery for degenerative changes causing radiculopathy or myelopathy. Patients were prospectively and consecutively enrolled from a single academic center after the decision for surgery had been made. Postoperative in-hospital pain management was conducted using a standardized protocol. The primary outcome was any opioid use 1 year after surgery. Secondary outcomes were the Neck Disability Index (NDI); 36-Item Short-Form Health Survey (SF-36) physical function (PF), bodily pain (BP), and mental component summary (MCS) scores; the modified Japanese Orthopaedic Association (mJOA) score among myelopathy patients; and patient expectations surveys. Patients with and without preoperative opioid use were compared using the chi-square and Student t-tests, and multiple logistic regression was used to study the associations between patient and surgical characteristics and postoperative opioid use 1 year after surgery. RESULTS: Two hundred eleven patients were prospectively and consecutively enrolled, of whom 39 were lost to follow-up for the primary outcome; 43.6% reported preoperative opioid use. Preoperative NDI and SF-36 PF and BP scores were significantly worse in the preoperative opioid cohort. More than 94% of both cohorts rated expectations of pain relief as extremely or somewhat important. At 1 year after surgery, 50.7% of the preoperative-opioid-use cohort reported ongoing opioid use, and 17.5% of patients in the no-preoperative-opioid-use cohort reported ongoing opioid use. Despite this, both cohorts reported similar improvements in NDI as well as SF-36 PF, BP, and MCS scores. More than 70% of both cohorts also reported being extremely or somewhat satisfied with pain relief after surgery. Predictors of 1-year opioid use included preoperative opioid use, duration of symptoms for more than 9 months before surgery, tobacco use, and higher comorbidity index. CONCLUSIONS: One year after elective cervical spine surgery, patients with preoperative opioid use were significantly more likely to report ongoing opioid use. However, patients in both groups reported similar improvements in patient-reported outcomes and satisfaction with pain relief. Interventions targeted at decreasing opioid use may need to focus on patient factors such as preoperative opioid use or duration of symptoms before surgery.

Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study.

OBJECTIVE: Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics' Maverick total disc replacement. METHODS: Patients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement ≥ 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure. RESULTS: Compared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 years, and 5.9% (11/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years. CONCLUSIONS: Lumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.Clinical trial registration no.: NCT00635843 (clinicaltrials.gov).

The utility of radionucleotide imaging in the surgical management of axial neck pain from cervical facet joint arthropathy.

OBJECTIVE: Axial neck pain is common and often debilitating. Diagnosis of the specific pain source can be a challenge, and this confounds effective treatment. Cervical facet arthropathy is implicated in many of these cases. The diagnosis is readily made on conventional cross-sectional imaging modalities, particularly CT imaging. However, this modality falls short in determining if an osteoarthritic facet joint is truly the source of symptoms. Radionucleotide imaging presents a noninvasive radiological adjunct to conventional cross-sectional imaging in the workup of patients with suspected facetogenic pain. Herein, the authors present the patient-reported outcomes (PROs) following posterior instrumented arthrodesis of the subaxial cervical spine from a consecutive case series of patients with a diagnosis of cervical facet joint arthropathy and a concordant positive radionucleotide tracer uptake. METHODS: The clinical case series of patients treated by the senior author at a single tertiary care institution between September 2014 and April 2018 was reviewed. Patients were selected for inclusion if their primary symptom at presentation was axial neck pain without neurological deficits and if CT imaging revealed facet arthropathy of the cervical spine. These patients underwent radionucleotide imaging in the form of a planar 99mTc methylene diphosphonate (99mTc MDP) bone scintigraphy study. Those with a finding of radionucleotide tracer uptake at a location concordant with the facet arthropathy were selected to undergo posterior cervical instrumented arthrodesis of the affected levels. PROs were recorded at the time of surgical consultation (i.e., after nonoperative treatment) and at 6 weeks, 3 months, 6 months, and 1 year following surgery. These included neck and arm pain, the Neck Disability Index (NDI) and the 12-Item Short Form Health Survey responses. RESULTS: A total of 11 patients were included in this retrospective case series. The average reported neck pain and NDI scores were high at baseline; 7.6 ± 2.3 and 37.1 ± 13.9 respectively. Twelve months after surgical intervention, a significant decrease in reported neck pain of -4.5 (95% CI -6.9, -2.1; p = 0.015) and a significant decrease in NDI of -20.0 (95% CI -29.4, -10.6; p = 0.014) was observed. CONCLUSIONS: This case series represents the largest to date of patients undergoing surgical arthrodesis following a finding of facet arthropathy with a concordant positive radioisotope image study. These observations add support to a growing body of evidence that suggests the utility of radioisotope imaging for identification of a facetogenic pain generator in patients with primary axial neck pain and a finding of cervical facet arthropathy. These preliminary data should serve to promote future prospective, controlled studies on the incorporation of radionucleotide imaging into the workup of patients with suspected facetogenic pain of the cervical spine.

The Patient-Reported Outcomes Measurement Information System in spine surgery: a systematic review.

OBJECTIVEThe Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to provide a standardized measure of clinical outcomes that is valid and reliable across a variety of patient populations. PROMIS has exhibited strong correlations with many legacy patient-reported outcome (PRO) measures. However, it is unclear to what extent PROMIS has been used within the spine literature. In this context, the purpose of this systematic review was to provide a comprehensive overview of the PROMIS literature for spine-specific populations that can be used to inform clinicians and guide future work. Specifically, the authors aimed to 1) evaluate publication trends of PROMIS in the spine literature, 2) assess how studies have used PROMIS, and 3) determine the correlations of PROMIS domains with legacy PROs as reported for spine populations.METHODSStudies reporting PROMIS scores among spine populations were identified from PubMed/MEDLINE and a review of reference lists from obtained studies. Articles were excluded if they did not report original results, or if the study population was not evaluated or treated for spine-related complaints. Characteristics of each study and journal in which it was published were recorded. Correlation of PROMIS to legacy PROs was reported with 0.1 ≤ |r| < 0.3, 0.3 ≤ |r| < 0.5, and |r| ≥ 0.5 indicating weak, moderate, and strong correlations, respectively.RESULTSTwenty-one articles were included in this analysis. Twelve studies assessed the validity of PROMIS whereas 9 used PROMIS as an outcome measure. The first study discussing PROMIS in patients with spine disorders was published in 2012, whereas the majority were published in 2017. The most common PROMIS domain used was Pain Interference. Assessments of PROMIS validity were most frequently performed with the Neck Disability Index. PROMIS domains demonstrated moderate to strong correlations with the legacy PROs that were evaluated. Studies assessing the validity of PROMIS exhibited substantial variability in PROMIS domains and legacy PROs used for comparisons.CONCLUSIONSThere has been a recent increase in the use of PROMIS within the spine literature. However, only a minority of studies have incorporated PROMIS for its intended use as an outcomes measure. Overall, PROMIS has exhibited moderate to strong correlations with a majority of legacy PROs used in the spine literature. These results suggest that PROMIS can be effective in the assessment and tracking of PROs among spine populations.

The relevant psychological burden of having a benign brain tumor: a prospective study of patients undergoing surgical treatment of cranial meningiomas.

OBJECTIVE: Meningiomas are the most common intracranial neoplasm. Evidence concerning surgical management and outcome is abundant, while the implications for the quality of life (QOL) of a patient confronted with the diagnosis and undergoing surgery are unclear. The authors conducted a prospective study to evaluate QOL in relation to psychological comorbidities comorbidities. METHODS: A prospective study of patients undergoing elective surgery for the removal of an intracranial meningioma was performed. The authors evaluated depression (Allgemeine Depressionsskala K score) and anxiety (Post-Traumatic Stress Scale-10 [PTSS-10]; State Trait Anxiety Inventory-State Anxiety and -Trait Anxiety [STAI-S and STAI-T]; and Anxiety Sensitivity Index-3 [ASI-3]) scores before surgery and at 3 and 12 months after surgery. The correlation between preoperative psychological burden and postoperative QOL as measured by the 36-Item Short Form Health Survey and EQ-5L questionnaires was analyzed. Incidence and influence of these psychiatric comorbidities on clinical outcome were examined. RESULTS: A total of 78 patients undergoing resection of a meningioma between January 2013 and September 2017 participated in the preoperative psychological screening and 71 patients fully completed postoperative follow-up examination after 1 year of follow-up. At presentation, 48 patients (67.7%) had abnormal anxiety scores, which decreased to 29.6% (p = 0.003). On follow-up at 12 months, mean EQ-5L visual analog scale scores were significantly lower in patients with pathological scores on the PTSS-10 (0.84 vs 0.69; p = 0.004), STAI-S (0.86 vs 0.68; p = 0.001), and STAI-T (0.85 vs 0.71; p = 0.011). Neurological status (modified Rankin Scale) improved slightly and showed some correlation with psychological comorbidities QOL scores (p = 0.167). There was a nonsignificant increase of EQ-5L scores over the period of follow-up (p = 0.174) in the repeated-measures analysis. In the regression analysis, impaired QOL and physical disability on follow-up correlated with elevated preoperative anxiety and depression levels. CONCLUSIONS: The QOL and physical disability of patients undergoing resection of an intracranial meningioma highly depend on preoperative anxiety and depression levels. Stress and anxiety scores generally decrease after the resection, which leads us to conclude that there is a tremendous emotional burden caused by an upcoming surgery, necessitating close psychooncological support in order to uphold functional outcome and health-related QOL in the postoperative course.

Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level.

OBJECTIVE: Food and Drug Administration-approved investigational device exemption (IDE) studies have provided level I evidence supporting cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion (ACDF). Long-term CDA outcomes continue to be evaluated. Here, the authors present outcomes at 10 years postoperatively for the single-level CDA arm of an IDE study (postapproval study). METHODS: The primary endpoint was overall success, a composite variable composed of five criteria: 1) Neck Disability Index score improvement ≥ 15 points; 2) maintenance or improvement in neurological status; 3) no decline in anterior or posterior functional spinal unit (FSU) height of more than 2 mm compared to 6 weeks postoperatively; 4) no serious adverse event (AE) caused by the implant or the implant and the surgical procedure; and 5) no additional surgery classified as a failure. Additional safety and effectiveness measures included numeric rating scales for neck pain and arm pain, SF-36 quality-of-life physical and mental components, patient satisfaction, range of motion, and AEs. RESULTS: From the reported assessments at 7 years postoperatively to the 10-year postoperative follow-up, the scores for all patient-reported outcomes, rate of overall success (without FSU), and proportion of patients at least maintaining their neurological function remained stable for the CDA group. Nine patients had secondary surgery at the index level, increasing the secondary surgery cumulative rate from 6.6% to 10.3%. In that same time frame, four patients experienced a serious implant or implant/surgical procedure-related AE, for a 10-year cumulative rate of 7.8%. Seven patients had any second surgery at adjacent levels, for a 10-year cumulative rate of 13.8%. Average angular motion at both the index and adjacent levels was well maintained without creating hypermobility. Class IV heterotopic ossification increased from 1.2% at 2 years to 4.6% at 7 years and 9.0% at 10 years. Patient satisfaction was > 90% at 10 years. CONCLUSIONS: CDA remained safe and effective out to 10 years postoperatively, with results comparable to 7-year outcomes and with high patient satisfaction.Clinical trial registration no.: NCT00667459 (clinicaltrials.gov).

Effect of depression and anxiety on health-related quality of life outcomes and patient satisfaction after surgery for cervical compressive myelopathy.

OBJECTIVE: Preoperative mood disorders such as depression and anxiety are known to be associated with poor health-related quality of life (HRQOL) outcomes after lumbar spine surgery. However, the effects of preoperative depression and anxiety on postoperative HRQOL outcomes and patient satisfaction in cervical compressive myelopathy are yet to be clarified. This study aimed to investigate the effect of depression and anxiety on HRQOL outcomes and patient satisfaction following surgery for cervical compressive myelopathy. METHODS: The authors reviewed the cases of all consecutive patients with cervical compressive myelopathy who had undergone surgical treatment in the period between January 2012 and March 2017 at their institution. Using the Hospital Anxiety and Depression Scale (HADS), the authors classified patients as depressed (HADS-D+) or not depressed (HADS-D-) and anxious (HADS-A+) or not anxious (HADS-A-). Patient HRQOL was evaluated preoperatively and at the end of at least 1 year after surgery using the physical and mental component summaries of the SF-12 Health Survey, EQ-5D (EuroQol health survey of five dimensions), Neck Disability Index, and Japanese Orthopaedic Association scale. Patient satisfaction was evaluated on the basis of a seven-item questionnaire and divided into two categories: satisfied and dissatisfied. Preoperative HRQOL statuses, postoperative improvements in HRQOL outcomes, and patient satisfaction were compared between the groups. RESULTS: Among the 121 patients eligible for inclusion in the study, there were 69 patients (57.0%) without depression (HADS-D-) and 52 (43.0%) with depression (HADS-D+) and 82 patients (67.8%) without anxiety (HADS-A-) and 39 (32.2%) with anxiety (HADS-A+). All patients who completed both the preoperative and postoperative questionnaires had significant postoperative improvements in all HRQOL outcomes. The HADS-D+ and HADS-A+ patients had poorer preoperative HRQOL statuses than the HADS-D- and HADS-A- patients, respectively. However, statistically significant improvements in all HRQOL outcomes were observed in both HADS-D+ and HADS-A+ patients. Patient satisfaction was comparable between the HADS-D or HADS-A groups. CONCLUSIONS: Cervical compressive myelopathy patients with preoperative depression or anxiety according to the HADS tool had worse preoperative HRQOL statuses. However, patients with cervical compressive myelopathy showed significant improvements in HRQOL outcomes and had sufficient levels of satisfaction after surgery regardless of the presence of preoperative depression or anxiety.

Examining the Patient-Reported Outcomes Measurement Information System versus the Scoliosis Research Society-22r in adult spinal deformity.

OBJECTIVEAfter using PROsetta Stone crosswalk tables to calculate Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores, the authors sought to examine 1) correlations with Scoliosis Research Society-22r (SRS-22r) scores, 2) responsiveness to change, and 3) the relationship between baseline scores and 2-year follow-up scores in adult spinal deformity (ASD).METHODSPROsetta Stone crosswalk tables were used to converted SF-36 scores to PROMIS scores for pain and physical function in a cohort of ASD patients with 2-year follow-up. Spearman correlations were used to evaluate the relationship of PROMIS scores with SRS-22r scores. Effect size (ES) and adjusted standardized response mean (aSRM) were used to assess responsiveness to change. Linear regression was used to evaluate the association between baseline scores and 2-year follow-up scores.RESULTSIn total, 425 (425/625, 68%) patients met inclusion criteria. Strong correlations (all |r| > 0.7, p < 0.001) were found between baseline and 2-year PROMIS values and corresponding SRS-22r domain scores. PROMIS-PI showed a large ES (1.09) and aSRM (0.88), indicating good responsiveness to change. PROMIS-PF showed a moderate ES (0.52) and moderate aSRM (0.69), indicating a moderate responsiveness to change. Patients with greater baseline pain complaints were associated with greater pain improvement at 2 years for both SRS-22r Pain (B = 0.39, p < 0.001) and PROMIS-PI (B = 0.45, p < 0.001). Higher functional scores at baseline were associated with greater average improvements in both SRS-22r Activity (B = 0.62, p < 0.001) and PROMIS-PF (B = 0.40, p < 0.001).CONCLUSIONSThe authors found strong correlations between the SRS-22r Pain and Activity domains with corresponding PROMIS-PI and -PF scores. Pain measurements showed similar and strong ES and aSRM while the function measurements showed similar, moderate ES and aSRM at 2-year follow-up. These data support further exploration of the use of PROMIS-computer adaptive test instruments in ASD.