BACKGROUND: Ehlers-Danlos syndrome (EDS) and its connective tissue laxity often result in high-grade lumbosacral spondylolisthesis. Patients present with debilitating symptoms and neurological deficits. Reports of surgical techniques in non-EDS patients for the treatment of high-grade lumbosacral spondylolisthesis mainly described an open approach, multilevel fusions, and multiple stages with different circumferential approaches. Sagittal adjusting screws (SASs) can be used in a minimally invasive (MI) fashion, allowing intraoperative reduction.
METHODS: A 17-year-old female with EDS presented to the authors\' institute with severe lower back and left L5 radicular pain in 2017. She presented with a left foot drop and difficulty ambulating. Magnetic resonance imaging showed grade IV L5-S1 spondylolisthesis. She underwent lumbar fusion for intractable back pain with radiculopathy. Intraoperatively, percutaneous SASs and extension towers were used to distract the L5-S1 disc space and reduce the spondylolisthesis. MI transforaminal lumbar interbody fusion was completed with significant symptomatic relief postoperatively. The patient was discharged to home 3 days postoperatively. Routine follow-up visits up to 3 years later demonstrated solid fusion radiographically and favorable patient-reported outcomes.
CONCLUSIONS: The authors used SASs in a MI approach to successfully correct and stabilize grade IV spondylolisthesis in an EDS patient with a favorable long-term patient-reported outcome.

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.
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.
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.
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.

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.

OBJECTIVE Lumbar spinal stenosis (LSS) is a common condition that leads to significant disability, particularly in the elderly. Current therapeutic options have certain drawbacks. This study evaluates the 5-year clinical and radiographic results of a minimally invasive pedicle-lengthening osteotomy (PLO) for symptomatic LSS. METHODS A prospective, single-arm, clinical pilot study was conducted involving 20 patients (mean age 61.7 years) with symptomatic LSS treated by a PLO procedure at 1 or 2 lumbar levels. All patients had symptoms of neurogenic claudication or radiculopathy secondary to LSS, and had not improved after a minimum 6-month course of nonoperative treatment. Eleven patients had a Meyerding grade I degenerative spondylolisthesis in addition to LSS. Clinical outcomes were measured using the Oswestry Disability Index, Zürich Claudication Questionnaire, 12-Item Short Form Health Survey, and a visual analog scale for back and leg pain. Procedural variables, neurological outcomes, adverse events, and radiological imaging (plain radiographs and CT scans) were collected at the 1.5-, 3-, 6-, 9-, 12-, 24-, and 60-month time points. RESULTS The PLOs were performed through percutaneous incisions, with minimal blood loss in all cases. There were no operative complications. Four adverse events occurred during the follow-up period. Statistically significant improvement was observed in each of the outcome instruments and maintained over the 5-year follow-up period. Imaging studies, reviewed by an independent radiologist, showed no evidence of device subsidence, migration, breakage, or heterotopic ossification. Thin-slice CT scans documented healing of the osteotomy site in all patients at the 6-month time point and an increase of 115% in the mean cross-sectional area of the spinal canal. CONCLUSIONS Treatment of patients with symptomatic LSS with a PLO procedure provided substantial enlargement of the area of the spinal canal and favorable clinical results for both disease-specific and non-disease-specific outcome measures at all follow-up time points out to 5 years. Future research is needed to compare this technique to alternative therapies for LSS.

OBJECTIVE The purpose of this study was to investigate whether the intraoperative application of an epidural steroid (ES) on the decompressed nerve root improves short- and midterm subjective and objective clinical outcomes after lumbar microdiscectomy. METHODS This study was a retrospective analysis of a 2-center database including consecutive cases in which patients underwent lumbar microdiscectomy. All patients who received ES application (40 mg triamcinolone, ES group) were matched by age and sex to patients who had not received ES application (control group). Objective functional impairment (OFI) was determined using age- and sex-adjusted T-scores of the Timed Up and Go (TUG) test. Back and leg pain (visual analog scale), functional impairment (Oswestry Disability Index [ODI], Roland-Morris Disability Index [RMDI], and health-related quality of life (hrQoL; 12-Item Short Form Health Survey [SF-12] physical component summary [PSC] score and EuroQol [EQ-5D index]) were measured at baseline, on postoperative day 3, and at postoperative week 6. RESULTS Fifty-three patients who received ES application were matched with 101 controls. There were no baseline demographic or disease-specific differences between the study groups, and preoperative pain, functional impairment, and hrQoL were similar. On postoperative day 3, the ES group had less disability on the RMDI (mean 7.4 vs 10.3, p = 0.003) and higher hrQoL as determined by the SF-12 PCS (36.5 vs 32.7, p = 0.004). At week 6, the ES group had less disability on the RMDI (3.6 vs 5.7, p = 0.050) and on the ODI by trend (17.0 vs 24.4, p = 0.056); better hrQoL, determined by the SF-12 PCS (44.3 vs 39.9, p = 0.018); and lower OFI (TUG test T-score 100.5 vs 110.2, p = 0.005). The week 6 responder status based on the minimum clinically important difference (MCID) was similar in the ES and control groups for each metric. The rates and severity of complications were similar, with a 3.8% and 4.0% reoperation rate in the ES group and control group, respectively (p = 0.272). There was a tendency for shorter hospitalization in the ES group (5.0 vs 5.8 days, p = 0.066). CONCLUSIONS Intraoperative ES application on the decompressed nerve root is an effective adjunct treatment that may lower subjective and objective functional impairment and increase hrQoL in the short and intermediate term after lumbar microdiscectomy. However, group differences were lower than the commonly accepted MCIDs for each metric, indicating that the effect size of the benefit is limited. ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: retrospective cohort trial; evidence: Class II.

OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 ( clinicaltrials.gov ).

OBJECT The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care. METHODS All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months. RESULTS A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10.5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity. CONCLUSIONS In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.

OBJECTIVE: The authors present clinical outcome data and satisfaction of patients who underwent minimally invasive vertebral body corpectomy and cage placement via a mini-open, extreme lateral, transpsoas approach and posterior short-segment instrumentation for lumbar burst fractures.
METHODS: Patients with unstable lumbar burst fractures who underwent corpectomy and anterior column reconstruction via a mini-open, extreme lateral, transpsoas approach with short-segment posterior fixation were reviewed retrospectively. Demographic information, operative parameters, perioperative radiographic measurements, and complications were analyzed. Patient-reported outcome instruments (Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12]) and an anterior scar-specific patient satisfaction questionnaire were recorded at the latest follow-up.
RESULTS: Twelve patients (7 men, 5 women, average age 42 years, range 22-68 years) met the inclusion criteria. Lumbar corpectomies with anterior column support were performed (L-1, n = 8; L-2, n = 2; L-3, n = 2) and supplemented with short-segment posterior instrumentation (4 open, 8 percutaneous). Four patients had preoperative neurological deficits, all of which improved after surgery. No new neurological complications were noted. The anterior incision on average was 6.4 cm (range 5-8 cm) in length, caused mild pain and disability, and was aesthetically acceptable to the large majority of patients. Three patients required chest tube placement for pleural violation, and 1 patient required reoperation for cage subsidence/hardware failure. Average clinical follow-up was 38 months (range 16-68 months), and average radiographic follow-up was 37 months (range 6-68 months). Preoperative lumbar lordosis and focal lordosis were significantly improved/maintained after surgery. Patients were satisfied with their outcomes, had minimal/moderate disability (average ODI score 20, range 0-52), and had good physical (SF-12 physical component score 41.7% ± 10.4%) and mental health outcomes (SF-12 mental component score 50.2% ± 11.6%) after surgery.
CONCLUSIONS: Anterior corpectomy and cage placement via a mini-open, extreme lateral, transpsoas approach supplemented by short-segment posterior instrumentation is a safe, effective alternative to conventional approaches in the treatment of single-level unstable burst fractures and is associated with excellent functional outcomes and patient satisfaction.

OBJECT A lack of information exists on the relationship between preoperative epidural spinal injections and outcomes after spine surgery. There is concern that injections might cause local changes, increasing the infection risk and surgical difficulty. Therefore, the authors explored the relationship between preoperative spinal injections and postoperative outcome. METHODS The cohort was comprised of patients who underwent thoracic and/or lumbar arthrodesis during the years 2007-2010 and had complete (preoperatively and 3 months postoperatively) outcome scores. Patients\' clinical courses were reviewed to determine the occurrence of major complications within a 30-day postoperative period. Patient-perceived outcomes were evaluated using the Oswestry Disability Index (ODI) and the SF-12 (12-Item Short Form Health Survey): mental component summary (MCS) and physical component summary (PCS) scores. Analyses were based on exposure to injections and were performed using chi-square exact tests and paired and unpaired t-tests. RESULTS Two hundred eighty patients met the inclusion criteria: 117 patients (41.8%) received and 163 patients (58.2%) did not receive preoperative epidural spinal injections. Overall, the likelihood of complication did not differ with respect to exposure (13.7% injection vs 11.7% noninjection); however, injected patients observed a 7.4-fold risk of developing surgical wound complications over noninjected patients (5.1% vs 0.6%, p = 0.02). Patient-perceived outcomes measures demonstrated no differences between groups. Three months postoperatively, the MCS and ODI scores were similar (MCS: 49.6 ± 11.6 injection vs 47.4 ± 12.8 noninjection; ODI: 35.8 ± 18.0 vs 34.4 ± 19.1). MCS or ODI score improvement (preoperatively compared with 3 months postoperatively) did not vary between groups. Injected patients maintained a 2-point lower PCS score at entry and 3 months postoperatively as compared with noninjected peers (entry: 27.6 ± 8.2 injection vs 29.5 ± 9.3 noninjection, p = 0.09; 3 months: 33.3 ± 8.6 vs 35.7 ± 9.0, p = 0.03); the PCS score improvements between injected and noninjected groups were similar (5.7 ± 9.9 vs 6.2 ± 9.7). CONCLUSIONS Patients exposed to preoperative epidural injections had similar complication rates to those who never received a spinal injection. However, they had a greater risk of developing wound complications. These complications had no effect on short-term improvements in outcome measures.

OBJECTIVE: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months\' follow-up.
METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.
RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.
CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).