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.

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.

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.

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.

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.

Surgical correction of severe adult lumbar scoliosis (major curves ≥ 75°): retrospective analysis with minimum 2-year follow-up.

OBJECTIVE: Prior reports have demonstrated the efficacy of surgical correction for adult lumbar scoliosis. Many of these reports focused on mild to moderate scoliosis. The authors' objective was to report their experience and to assess outcomes and complications after deformity correction for severe adult scoliosis. METHODS: The authors retrospectively analyzed consecutive adult scoliosis patients with major thoracolumbar/lumbar (TL/L) curves ≥ 75° who underwent deformity correction at their institution. Those eligible with a minimum 2 years of follow-up were included. Demographic, surgical, coronal and sagittal plane radiographic measurements, and health-related quality of life (HRQL) scores were analyzed. RESULTS: Among 26 potentially eligible patients, 22 (85%) had a minimum 2 years of follow-up (range 24-89 months) and were included in the study (mean age 57 ± 11 years; 91% women). The cohort comprised 16 (73%), 4 (18%), and 2 (9%) patients with adult idiopathic scoliosis, de novo degenerative scoliosis, and iatrogenic scoliosis, respectively. The surgical approach was posterior-only and multistage anterior-posterior in 18 (82%) and 4 (18%) patients, respectively. Three-column osteotomy was performed in 5 (23%) patients. Transforaminal and anterior lumbar interbody fusion were performed in 14 (64%) and 4 (18%) patients, respectively. All patients had sacropelvic fixation with uppermost instrumented vertebra in the lower thoracic spine (46% [10/22]) versus upper thoracic spine (55% [12/22]). The mean fusion length was 14 ± 3 levels. Preoperative major TL/L and lumbosacral fractional (L4-S1) curves were corrected from 83° ± 8° to 28° ± 13° (p < 0.001) and 34° ± 8° to 13° ± 6° (p < 0.001), respectively. Global coronal and sagittal balance significantly improved from 5 ± 4 cm to 1 ± 1 cm (p = 0.001) and 9 ± 8 cm to 2 ± 3 cm (p < 0.001), respectively. Pelvic tilt significantly improved from 33° ± 9° to 23° ± 10° (p < 0.001). Significant improvement in HRQL measures included the following: Scoliosis Research Society (SRS) pain score (p = 0.009), SRS appearance score (p = 0.004), and SF-12/SF-36 physical component summary (PCS) score (p = 0.026). Transient and persistent neurological deficits occurred in 8 (36%) and 2 (9%) patients, respectively. Rod fracture/pseudarthrosis occurred in 6 (27%) patients (supplemental rods were utilized more recently in 23%). Revisions were performed in 7 (32%) patients. CONCLUSIONS: In this single-center surgical series for severe adult scoliosis (major curves ≥ 75°), a posterior-only or multistage anterior-posterior approach provided major curve correction of 66% and significant improvements in global coronal and sagittal spinopelvic alignment. Significant improvements were also demonstrated in HRQL measures (SRS pain, SRS appearance, and SF-12/SF-36 PCS). Complications and revisions were comparable to those of other reports involving less severe scoliosis. The results of this study warrant future prospective multicenter studies to further delineate outcomes and complication risks for severe adult scoliosis correction.

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial.

OBJECTIVE: The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF). METHODS: A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite-based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF. RESULTS: From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3-4) implant-related or implant/surgical procedure-related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] -0.92 [-1.88, -0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] -1.39 [-2.15, -0.61]) as well as at adjacent levels (9.0% vs 17.9%). CONCLUSIONS: The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.Clinical trial registration no.: NCT00637156 (clinicaltrials.gov).

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.

Factors influencing patient satisfaction after adult scoliosis and spinal deformity surgery.

OBJECTIVE: Achieving high patient satisfaction with management is often one of the goals after adult spinal deformity (ASD) surgery. However, literature on associated factors and their correlations with patient satisfaction is limited. The aim of this study was to determine the clinical and radiographic factors independently correlated with patient satisfaction in terms of management at 2 years after surgery. METHODS: A multicenter prospective database of ASD surgery was retrospectively reviewed. The demographics, complications, health-related quality of life (HRQOL) subdomains, and radiographic parameters were examined to determine their correlation coefficients with the Scoliosis Research Society-22 questionnaire (SRS-22R) satisfaction scores at 2 years (Sat-2y score). Subsequently, factors determined to be independently associated with low satisfaction (Sat-2y score ≤ 4.0) were used to construct 2 types of multivariate models: one with 2-year data and the other with improvement (score at 2 years - score at baseline) data. RESULTS: A total of 422 patients who underwent ASD surgery (mean age 53.1 years) were enrolled. All HRQOL subdomains and several coronal and sagittal radiographic parameters had significantly improved 2 years after surgery. The Sat-2y score was strongly correlated with the SRS-22R self-image (SI)/appearance subdomain (r = 0.64), followed by moderate correlation with subdomains related to standing (r = 0.53), body pain (r = 0.49-0.55), and function (r = 0.41-0.55) at 2 years. Conversely, the correlation between radiographic or demographic parameters with Sat-2y score was weak (r < 0.4). Multivariate analysis to eliminate confounding factors revealed that a worse Oswestry Disability Index (ODI) score for standing (≥ 2 points; OR 4.48) and pain intensity (≥ 2 points; OR 2.07), SRS-22R SI/appearance subdomain (< 3 points; OR 2.70) at 2 years, and a greater sagittal vertical axis (SVA) (> 5 cm; OR 2.68) at 2 years were independent related factors for low satisfaction. According to the other model, a lower improvement in ODI for standing (< 30%; OR 2.68), SRS-22R pain (< 50%; OR 3.25) and SI/appearance (< 50%; OR 2.18) subdomains, and an inadequate restoration of the SVA from baseline (< 2 cm; OR 3.16) were associated with low satisfaction. CONCLUSIONS: Self-image, pain, standing difficulty, and sagittal alignment restoration may be useful goals in improving patient satisfaction with management at 2 years after ASD surgery. Surgeons and other medical providers have to take care of these factors to prevent low satisfaction.

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).

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).

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.

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.

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.

Impact of sagittal spinopelvic alignment on clinical outcomes and health-related quality of life after decompression surgery without fusion for lumbar spinal stenosis.

OBJECTIVEPatients with lumbar spinal stenosis (LSS) tend to bend forward to relieve neurological symptoms. They therefore have a positive sagittal vertical axis (SVA). The importance of the SVA value is well known in the field of adult spinal deformity; however, little is known about its impact on LSS. The authors sought to investigate the impact of sagittal spinopelvic alignment on clinical outcome and health-related quality of life (HRQOL) after decompression surgery for LSS.METHODSThe authors retrospectively reviewed 83 patients who underwent lumbar decompression without fusion between January 2014 and September 2015 with a minimum follow-up of 2 years. Standing whole-spine radiographs were examined preoperatively and at final follow-up. Based on the SVA, patients were allocated to a sagittal balance group (group B; SVA < 50 mm) or a sagittal imbalance group (group I; SVA ≥ 50 mm). The authors compared the groups using Japanese Orthopaedic Association (JOA), Zurich Claudication Questionnaire (ZCQ), Roland-Morris Disability Questionnaire (RMDQ), and the 8-item Short Form Health Survey (SF-8) scores.RESULTSPreoperative groups B (group pre-B) and I (group pre-I) included 58 and 25 patients, respectively. Preoperative sagittal malalignment had negative effects on the JOA score recovery rate, postoperative ZCQ physical function domain score, and numeric rating scale (NRS) score of postoperative low-back pain (LBP), but no significant effects were observed for RMDQ and SF-8 domain scores. Postoperatively, groups B (group post-B) and I (group post-I) included 60 and 23 patients, respectively. Group post-I had a significantly worse JOA score recovery rate, postoperative symptom severity domain score in the ZCQ, and NRS score for postoperative LBP. Similarly, the postoperative RMDQ score and the Physical Component Summary score of the SF-8 were significantly worse in group post-I.CONCLUSIONSPositive SVA had significantly negative effects on clinical outcome and HRQOL in LSS patients after lumbar decompression surgery.

Clinical outcomes research in spine surgery: what are appropriate follow-up times?

In BriefThe time course required for the patient-reported outcomes of pain, physical function, and mental health to reach a recovery plateau after elective lumbar spine surgery was assessed utilizing a prospectively maintained multicenter registry. The work is important as it demonstrates that specific health dimensions follow different recovery plateaus and it provides evidence that a 2-year postoperative follow-up is not required to accurately assess the treatment effect of established surgeries for lumbar spinal pathologies.

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.

The use of patient-reported preoperative activity levels as a stratification tool for short-term and long-term outcomes in patients with adult spinal deformity.

OBJECTIVE Given the recent shift in health care toward quality reporting requirements and a greater emphasis on a cost-quality approach, patient stratification with respect to long-term outcomes and the use of health care resources is of increasing value. Stratification tools may be effective if they are simple and evidence based. The authors hypothesize that preoperative patient-reported activity levels might independently predict postoperative outcomes in patients with adult spinal deformity. METHODS This is a retrospective cohort. A total of 575 patients in a prospective adult spinal deformity surgical database were identified with complete data regarding the preoperative level of activity. Answers to question 5 of the Scoliosis Research Society-22r Patient Questionnaire (SRS-22r) were used to stratify patients into active and inactive groups. Outcomes were length of hospital stay (LOS), level of activity, and reaching the minimum clinically important difference (MCID) for SRS-22r domains and the Physical Component Summary (PCS) of the SF-36 at 2 years postoperatively. The 2 groups were compared with respect to several potential confounders. Covariates with p < 0.1 were controlled for. The impact of activity on LOS was assessed using multivariate negative binomial regression analysis. Multivariate logistic regression models additionally controlling for the respective baseline health-related quality of life (HRQOL) scores were used to assess the association between preoperative activity levels and reaching the MCID at 2 years postoperatively. RESULTS A total of 420 (73%) of the 575 patients who met the inclusion criteria had complete data at 2 years postoperatively. The inactive group was more likely to be significantly older, have a higher Charlson Comorbidity Index, worse baseline radiographic deformity, and greater correction of most radiographic parameters. After controlling for possible confounders, the active group had a significantly shorter LOS (incidence risk ratio 0.91, p = 0.043). After adding respective baseline HRQOL scores to the models, active patients were significantly more likely to reach the MCID for the SRS-22r pain domain (OR 1.72, p = 0.026) and PCS (OR 1.94, p = 0.013). Active patients were also significantly more likely to be active at 2 years postoperatively on multivariate analysis (OR 8.94, p < 0.001). CONCLUSIONS The authors' results show that patients who belong to the inactive group are likely to have a longer LOS and lower odds of reaching the MCID in HRQOL or being active at 2 years postoperatively. Inquiring about patients' preoperative activity levels might be a reliable and simple stratification tool in terms of long- and short-term outcomes in ASD patients.

Functional outcomes and quality of life after microsurgical clipping of unruptured intracranial aneurysms: a prospective cohort study.

OBJECTIVE :Few studies have examined patients' ability to drive and quality of life (QOL) after microsurgical repair for unruptured intracranial aneurysms (uIAs). However, without a strong evidentiary basis, jurisdictional road transport authorities have recommended driving restrictions following brain surgery. In the present study, authors examined the outcomes of the microsurgical repair of uIAs by measuring patients' perceived QOL and cognitive abilities related to driving. METHODS: Between January 2011 and January 2016, patients with a new diagnosis of uIA were prospectively enrolled in this study. Assessments were performed at referral, before surgery, and at 6 weeks and 12 months after surgery in those undergoing microsurgical repair and at referral and at 12 months in conservatively managed patients. Assessments included the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the SF-36, the off-road driver-screening instrument DriveSafe (DS), the modified Barthel Index (mBI), and the modified Rankin Scale (mRS). RESULTS: One hundred sixty-nine patients were enrolled in and completed the study, and 112 (66%) of them had microsurgical repair of their aneurysm. In the microsurgical group, there was a trend for improved DS scores: from a mean (± standard deviation) score of 108 ± 10.7 before surgery to 111 ± 9.7 at 6 weeks after surgery to 112 ± 10.2 at 12 months after surgery (p = 0.05). Two percent of the microsurgical repair group and 4% of the conservatively managed group whose initial scores indicated competency to drive according to the DS test subsequently had 12-month scores deemed as not competent to drive; the difference between these 2 groups was not statistically significant (p > 0.99). Factors associated with a decline in the DS score among those who had a license at the time of initial assessment were an increasing age (p < 0.01) and mRS score > 0 at one of the assessments (initial, 6 weeks, or 12 months; p < 0.01). Mean PCS scores in the microsurgical repair group were 52 ± 8.1, 46 ± 6.8, and 52 ± 7.1 at the initial, 6-week, and 12-month assessments, respectively (p < 0.01). These values represented a significant decline in the mean PCS score at 6 weeks that recovered by 12 months (p < 0.01). There were no significant changes in the MCS, mBI, or mRS scores in the surgical group. CONCLUSIONS: Overall, QOL at 12 months for the microsurgical repair group had not decreased and was comparable to that in the conservatively managed group. Furthermore, as assessed by the DS test, the majority of patients were not affected in their ability to drive.

Sagittal radiographic parameters demonstrate weak correlations with pretreatment patient-reported health-related quality of life measures in symptomatic de novo degenerative lumbar scoliosis: a European multicenter analysis.

OBJECTIVE Previous studies have demonstrated that among patients with adult spinal deformity (ASD), sagittal plane malalignment is poorly tolerated and correlates with suboptimal patient-reported health-related quality of life (HRQOL). These studies included a broad range of radiographic abnormalities and various types of ASD. However, the clinical and radiographic characteristics of de novo degenerative lumbar scoliosis (DNDLS), a subtype of ASD, may influence previously reported correlation strengths. The aim of this study was to correlate sagittal radiographic parameters with pretreatment HRQOL in patients with symptomatic DNDLS. METHODS In this multicenter retrospective study of prospectively collected data, 74 patients with symptomatic DNDLS were enrolled based on anteroposterior and lateral 36-inch standing radiographs. Measurements included Cobb angle, coronal imbalance, pelvic incidence (PI), pelvic tilt (PT), lumbar lordosis (LL), sagittal vertical axis (SVA), thoracic kyphosis, pelvic incidence minus lumbar lordosis (PI-LL), T1-pelvic angle, and global tilt. HRQOL questionnaires included the Oswestry Disability Index (ODI), Scoliosis Research Society (SRS-22r), 36-item Short-Form Health Survey, and numeric rating scale (NRS) for back and leg pain. Correlations between radiographic parameters and HRQOL were assessed. Finally, HRQOL and increasing severity of sagittal modifiers (SVA, PI-LL, and PT) were evaluated. RESULTS Weak correlations were found between SVA and ODI (r = 0.296, p < 0.05) and PT with NRS back pain and the SRS pain domain (r = -0.260, p < 0.05, and r = 0.282, p < 0.05, respectively). Other sagittal radiographic parameters did not show any significant correlation with HRQOL. No significant differences in HRQOL were found concerning the increasing severity of PT, PI-LL, and SVA. CONCLUSIONS While DNDLS is a severe disabling condition, no noteworthy association between clinical and sagittal radiographic parameters was found through this study, demonstrating that sagittal radiographic parameters should not be considered the unique predictor of pretreatment suboptimal health status in this specific group of patients. Future studies addressing classification and treatment algorithms will have to take into account the existing subgroups of ASD.