Pulmonary symptoms in adolescent idiopathic scoliosis: a systematic review to identify patient-reported and clinical measurement instruments.

STUDY DESIGN: Systematic review. PURPOSE: Adolescent idiopathic scoliosis (AIS) is a deformity of the trunk and chest and can cause a spectrum of pulmonary symptoms. However, no standardized measurement instrument exists. The aim of this systematic review is to identify and describe patient-reported and clinical measurement instruments used to evaluate pulmonary symptoms in patients with AIS. METHODS: Studies published after 01.01.2000 were included in a systematic search. Patient-reported outcome measures (PROMs) and clinical measurement instruments for pulmonary symptoms were extracted as well as their measurement properties (floor-ceiling effects, validity, reliability, responsivity and interpretability). The Risk of Bias (RoB) was evaluated. RESULTS: Out of 3146 studies, 122 were eligible for inclusion. Seven clinical measurement instruments, measuring 50 measurement parameters, were identified. Five PROMs for pulmonary symptoms were identified. Studies assessing the quality of measurement properties in the AIS population were not identified. As such, the RoB could not be determined. CONCLUSION: No available adequate patent centric instruments were identified that measure pulmonary functioning and symptoms. Although clinical measurement instruments are regularly used, their use in routine practice does not seem feasible. The measurement properties of some identified PROMs seem promising; however, they have not been validated in an AIS population. As pulmonary symptoms in patients with AIS are still poorly understood, the development of such a construct and potentially a subsequent PROM to routinely measure pulmonary functioning and patient experience is recommended.

The Scoliosis Research Society adult spinal deformity standard outcome set.

PURPOSE: Symptomatic adult spinal deformity (ASD) with an extremely variable presentation with pain, with and without neurogenic leg pain, and/or disturbed sagittal and coronal balance, causes a significant societal burden of disease. It is an important consequence of the aging adult population, generating a plethora of spine-related interventions with variable treatment efficacy and consistently high costs. Recent years have witnessed more than a threefold increase in the prevalence and treatment of ASD, and further increases over the coming decades are expected with the growing elderly population worldwide. The ability to monitor and assess clinical outcomes has not kept pace with these developments. This paper addresses the pressing need to provide a set of common outcome metrics for this growing group of patients with back pain and other disabilities due to an adult spinal deformity. METHODS: The standard outcome set was created by a panel with global representation, using a thorough modified Delphi procedure. The three-tiered outcome hierarchy (Porter) was used as a framework to capture full cycle of care. The standardized language of the International Classification of Functioning, Disability and Health (WHO-ICF) was used. RESULTS: Consensus was reached on a core set of 25 WHO-ICF outcome domains ('What to measure'); on the accompanying globally available clinician and patient reported measurement instruments and definitions ('How to measure'), and on the timing of the measurements ('When to measure'). The current work has brought to light domains not routinely reported in the spinal literature (such as pulmonary function, return to work, social participation), and domains for which no adequate instruments have yet been identified (such as how to clinically quantify in routine practice lumbar spinal stenosis, neurogenic claudication, radicular pain, and loss of lower extremity motor function). CONCLUSION: A standard outcome set was developed for patients undergoing treatment for adult spinal deformity using globally available outcome metrics. The current framework can be considered a reference for further work, and may provide a starting point for routine methodical and systematic monitoring of outcomes. Post-COVID e-health may accelerate the routine capture of these types of data.

The Natural History of Progression in Adult Spinal Deformity: A Radiographic Analysis.

STUDY DESIGN: Historical cohort study. OBJECTIVE: To evaluate progression in the coronal and sagittal planes in nonsurgical patients with adult spinal deformity (ASD). METHODS: A retrospective analysis of nonsurgical ASD patients between 2005 and 2017 was performed. Magnitude of the coronal and sagittal planes were compared on the day of presentation and at most recent follow-up. Previous reported prognostic factors for progression in the coronal plane, including the direction of scoliosis, curve magnitude, and the position of the intercrest line (passing through L4 or L5 vertebra), were studied. RESULTS: Fifty-eight patients were included with a mean follow-up of 59.8 ± 34.5 months. Progression in the coronal plane was seen in 72% of patients. Mean Cobb angle on the day of presentation and most recent follow-up was 37.2 ± 14.6° and 40.8° ± 16.5°, respectively. No significant differences were found in curve progression in left- versus right-sided scoliosis (3.3 ± 7.1 vs 3.7 ± 5.4, P = .81), Cobb angle <30° versus ≥30° (2.6 ± 5.0 vs 4.3 ± 6.5, P = .30), or when the intercrest line passed through L4 rather than L5 vertebra (3.4 ± 5.0° vs 3.8 ± 7.1°, P = .79). No significant differences were found in the sagittal plane between presentation and most recent follow-up. CONCLUSIONS: This is the first study that describes progression in the coronal and sagittal planes in nonsurgical patients with ASD. Previous reported prognostic factors were not confirmed as truly relevant. Although progression appears to occur, large variation exists and these results may not be directly applicable to the individual patient.

Biomechanical properties in motion of lumbar spines with degenerative scoliosis.

Degenerative lumbar scoliosis presumably alters spinal biomechanics, but a lack of quantitative reference measurements of these spines exists. We aimed to assess the biomechanical properties of spines with degenerative scoliosis, and to relate these to intervertebral disc degeneration (DD) and Cobb angle. Secondly, we compared these results to previous measurements of non-scoliotic spines. Ten cadaveric spines (Th12-L5, mean age 82 ±â€¯11 years) with Cobb angle ≥10° and apex at L3 were acquired. Three loading cycles (-4 to 4 Nm) were applied in flexion/extension (FE), lateral bending (LB), and axial rotation (AR). The range of motion (ROM), neutral zone (NZ) stiffness, NZ ROM, elastic zone (EZ) stiffness and hysteresis were calculated for each motion segment in the loading direction. ROM was calculated in coupled directions, expressed as a percentage of rotation in the loaded direction. For Th12-L5, there was a ROM (degrees ±â€¯SD) of 14.9 ±â€¯6.5 in FE, 14.9 ±â€¯7.8 in LB, and 10.2 ±â€¯5.5 in AR. The median (Nm/degree (Q1;Q3)) NZs was 0.24 (0.19;0.35) in FE, 0.25 (0.22;0.42) in LB, and 0.49 (0.33;0.99) in AR. Greater coupled motions related to higher Cobb angle, especially during AR on segments around the apex (FE: ρ = 0.539, p = 0.021 and LB: ρ = 0.821, p = 0.000). DD correlated to lower ROM and increased NZs on L2-L3 in FE (ρ = -0.721, p = 0.028 and ρ = 0.694, p = 0.038, respectively). Compared to non-scoliotic spines, smaller ROM in FE (p = 0.030) was found. This study describes the biomechanical properties of lumbar spines with degenerative scoliosis. Compared to non-scoliotic spines, they tended to be stiffer and exhibited smaller ROM in FE. DD only affected the ROM and NZs of the segments around the apex.

Prognostic factors in the progression of intervertebral disc degeneration: Which patient should be targeted with regenerative therapies?

OBJECTIVE: Possible regenerative treatments for lumbar intervertebral disc degeneration (DD) are rapidly emerging. There is consensus that the patient that would benefit most has early-stage DD, with a predicted deterioration in the near future. To identify this patient, the aim of this study was to identify prognostic factors for progression of DD. STUDY DESIGN: Systematic review. METHODS: A systematic search was performed on studies evaluating one or more prognostic factor(s) in the progression of DD. The criteria for inclusion were (a) patients diagnosed with DD on MRI, (b) progression of DD at follow-up, and (c) reporting of one or more prognostic factor(s) in progression of DD. Two authors independently assessed the methodological quality of the included studies. Due to heterogeneity in DD determinants and outcomes, only a best-evidence synthesis could be conducted. RESULTS: The search generated 3165 references, of which 16 studies met our inclusion criteria, involving 2.423 patients. Within these, a total of 23 clinical and environmental and 12 imaging factors were identified. There was strong evidence that disc herniation at baseline is associated with progression of DD at follow-up. There is limited evidence that IL6 rs1800795 genotype G/C male was associated with no progression of DD. Some clinical or environmental factors such as BMI, occupation and smoking were not associated with progression. CONCLUSIONS: Disc herniation is strongly associated with the progression of DD. Surprisingly, there was strong evidence that smoking, occupation, and several other factors were not associated with the progression of DD. Only one genetic variant may have a protective effect on progression, otherwise there was conflicting or only limited evidence for most prognostic factors. Future research into these prognostic factors with conflicting and limited evidence is not only needed to determine which patients should be targeted by regenerative therapies, but will also contribute to spinal phenotyping.

The biomechanical effect of single-level laminectomy and posterior instrumentation on spinal stability in degenerative lumbar scoliosis: a human cadaveric study.

OBJECTIVEDegenerative lumbar scoliosis, or de novo degenerative lumbar scoliosis, can result in spinal canal stenosis, which is often accompanied by disabling symptoms. When surgically treated, a single-level laminectomy is performed and short-segment posterior instrumentation is placed to restore stability. However, the effects of laminectomy on spinal stability and the necessity of placing posterior instrumentation are unknown. Therefore, the aim of this study was to assess the stability of lumbar spines with degenerative scoliosis, characterized by the range of motion (ROM) and neutral zone (NZ) stiffness, after laminectomy and placement of posterior instrumentation.METHODSTen lumbar cadaveric spines (T12-L5) with a Cobb angle ≥ 10° and an apex on L3 were included. Three loading cycles were applied per direction, from -4 Nm to 4 Nm in flexion/extension (FE), lateral bending (LB), and axial rotation (AR). Biomechanical evaluation was performed on the native spines and after subsequent L3 laminectomy and the placement of posterior L2-4 titanium rods and pedicle screws. Nonparametric and parametric tests were used to analyze the effects of laminectomy and posterior instrumentation on NZ stiffness and ROM, respectively, both on an individual segment's motion and on the entire spine section. Spearman's rank correlation coefficient was used to study the correlation between disc degeneration and spinal stability.RESULTSThe laminectomy increased ROM by 9.5% in FE (p = 0.04) and 4.6% in LB (p = 0.01). For NZ stiffness, the laminectomy produced no significant effects. Posterior instrumentation resulted in a decrease in ROM in all loading directions (-22.2%, -24.4%, and -17.6% for FE, LB, and AR, respectively; all p < 0.05) and an increase in NZ stiffness (+44.7%, +51.7%, and +35.2% for FE, LB, and AR, respectively; all p < 0.05). The same changes were seen in the individual segments around the apex, while the adjacent, untreated segments were mostly unaffected. Intervertebral disc degeneration was found to be positively correlated to decreased ROM and increased NZ stiffness.CONCLUSIONSLaminectomy in lumbar spines with degenerative scoliosis did not result in severe spinal instability, whereas posterior instrumentation resulted in a rigid construct. Also, prior to surgery, the spines already had lower ROM and higher NZ stiffness in comparison to values shown in earlier studies on nonscoliotic spines of the same age. Hence, the authors question the clinical need for posterior instrumentation to avoid instability.

Predictive factors for brace treatment outcome in adolescent idiopathic scoliosis: a best-evidence synthesis.

PURPOSE: To evaluate predictive factors for brace treatment outcome in adolescent idiopathic scoliosis (AIS) by a systematic review of the literature. METHODS: Eligible studies evaluating one or more predictive factors for brace treatment outcome were included following a systematic search in PubMed and EMBASE on October 23, 2017. Inclusion criteria were: (1) subjects diagnosed with AIS, (2) age ≤ 18 years, (3) treated with a thoraco-lumbo-sacral orthosis (TLSO), and (4) evaluated one or more predictive factors of treatment outcome (failure and/or success). The methodological quality of included studies was independently assessed by two authors. Pooling was not possible due to heterogeneity in statistical analysis. Predictive factors were presented according to a best-evidence synthesis. RESULTS: The literature search identified 26 studies that met the inclusion criteria, and multiple types of TLSO braces were identified (Boston, Wilmington, Chêneau, Osaka Medical College, Dresdner Scoliosis Orthosis and SPoRT). A total of 19 radiographic and 8 clinical predictive factors were reported. Strong evidence was found that lack of initial in-brace correction is associated with treatment failure. Moderate evidence suggests that brace wear time is associated with failure and success, whereas initial curve magnitude and curve type are not. CONCLUSION: The results of this review suggest that lack of initial in-brace correction is strongly associated with brace treatment failure. Future studies on the threshold for minimal immediate in-brace correction, as a potential indication for brace treatment, are recommended. These slides can be retrieved under Electronic Supplementary Material.

Radiographic Axial Malalignment is Associated With Pretreatment Patient-Reported Health-Related Quality of Life Measures in Adult Degenerative Scoliosis: Implementation of a Novel Radiographic Software Tool.

STUDY DESIGN: Retrospective study of prospectively collected data. OBJECTIVES: The purpose of this study was to evaluate the relationship between apical vertebral axial rotation and pretreatment patient-reported health-related quality of life (HRQOL), disability, and pain in patients with adult degenerative scoliosis (ADS) using a novel radiographic software tool. SUMMARY OF BACKGROUND DATA: Recent studies have demonstrated that in ADS, sagittal and coronal plane deformity are weakly to moderately associated with HRQOL, disability, and pain. However, as ADS is a three-dimensional spinal deformity, the impact of axial malalignment on HRQOL is yet to be determined. METHODS: A total of 74 ADS patients were enrolled. HRQOL measures included the Short Form-36v2 (SF-36v2) and Scoliosis Research Society questionnaire (SRS-22r). Disability and pain measures included the Oswestry Disability Index (ODI) and numeric rating scale back and leg pain. Radiographic measures included Cobb angle (CA), sagittal spinopelvic parameters, lateral and anteroposterior (AP) translation of the apical vertebra. The amount of apical vertebral axial rotation was measured on digital AP radiograph images using a novel software technology. Subjects were stratified into four clinical groups based on the degree of apical vertebral axial rotation. RESULTS: Apical vertebral axial rotation showed no association with lateral (r = 0.21; p = .15) and AP (r = 0.08, p = .80) translation of the apical vertebra. A significant moderate association was found between apical vertebral axial rotation and Cobb angle (r = 0.57; p < .05). Patients in the group with the highest degree of apical vertebral axial rotation reported significantly worse ODI and SRS-22r Subtotal and Pain scores (p < .05), irrespective of sagittal spinopelvic parameters. CONCLUSIONS: This is the first study that reports on the association between apical vertebral axial rotation and pretreatment HRQOL, disability, and pain in ADS. This study suggests that increased apical vertebral axial rotation is associated with suboptimal pretreatment health status scores. LEVEL OF EVIDENCE: Level III.

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.

Functional outcome of non-surgical and surgical management for de novo degenerative lumbar scoliosis: a mean follow-up of 10 years.

BACKGROUND: No studies have evaluated the long-term results of non-surgical and surgical management in de novo degenerative lumbar scoliosis (DNDLS). This study reports on the long-term functional outcome of patients being treated for DNDLS by non-surgical and surgical management. METHODS: This is a retrospective review of a single center database of DNDLS patients that underwent surgical or usual non-surgical management between 1996 and 2007. In a total of 88 patients, 50 (57%) underwent non-surgical and 38 (43%) surgical management. Baseline demographic, radiological-, clinical-, and surgical-related variables were collected. An Oswestry Disability Index (ODI) 2.0 questionnaire was sent to all patients after written informed consent. RESULTS: Twenty-nine of 88 patients participated in the study, 15 (52%) had undergone surgical and 14 (48%) non-surgical management with a mean follow-up of 10.9 years (range 8-15 years). There were no significant differences (p > 0.05) between non-surgical and surgical patients at baseline for age, body mass index, coronal Cobb angle, and clinical data. None of the non-surgical patients had undergone surgery during follow-up. In the surgical group, 40% had revision surgery. There was no significant difference in ODI total scores between groups at final follow-up (p = 0.649). A larger proportion of patients in the non-surgical group reported an ODI total score of ≤ 22, reflecting minimal disability (43 versus 20%; p = 0.245). CONCLUSIONS: This is the first study that describes the long-term 10-year functional outcome of non-surgical and surgical management in a cohort of patients with DNDLS. No significant difference in functional outcome was found between groups after a mean follow-up of 10 years. Despite the significant potential for selection bias, these results indicate that non-surgical management of patients with DNDLS may lead to adequate functional outcome after long periods of time, with no crossover to surgery. Further study is warranted to define which patients may benefit most from which management regimen.

Defining a core outcome set for adolescent and young adult patients with a spinal deformity.

Background and purpose - Routine outcome measurement has been shown to improve performance in several fields of healthcare. National spine surgery registries have been initiated in 5 Nordic countries. However, there is no agreement on which outcomes are essential to measure for adolescent and young adult patients with a spinal deformity. The aim of this study was to develop a core outcome set (COS) that will facilitate benchmarking within and between the 5 countries of the Nordic Spinal Deformity Society (NSDS) and other registries worldwide. Material and methods - From August 2015 to September 2016, 7 representatives (panelists) of the national spinal surgery registries from each of the NSDS countries participated in a modified Delphi study. With a systematic literature review as a basis and the International Classification of Functioning, Disability and Health framework as guidance, 4 consensus rounds were held. Consensus was defined as agreement between at least 5 of the 7 representatives. Data were analyzed qualitatively and quantitatively. Results - Consensus was reached on the inclusion of 13 core outcome domains: "satisfaction with overall outcome of surgery", "satisfaction with cosmetic result of surgery", "pain interference", physical functioning", "health-related quality of life", "recreation and leisure", "pulmonary fatigue", "change in deformity", "self-image", "pain intensity", "physical function", "complications", and "re-operation". Panelists agreed that the SRS-22r, EQ-5D, and a pulmonary fatigue questionnaire (yet to be developed) are the most appropriate set of patient-reported measurement instruments that cover these outcome domains. Interpretation - We have identified a COS for a large subgroup of spinal deformity patients for implementation and validation in the NSDS countries. This is the first study to further develop a COS in a global perspective.

Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.

PURPOSE: Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD. METHODS: Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated. RESULTS: The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD. CONCLUSIONS: Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.

Spinal biomechanical properties are significantly altered with a novel embalming method.

In vitro tests on the biomechanical properties of human spines are often performed using fresh frozen specimens. However, this carries the risk of pathogen transfer from specimen to the worker and the specimens can only be used for a limited amount of time. Human spinal specimens embalmed with formaldehyde carry an almost absent risk of transfer of pathogens and can be stored and used for a long time, but the tissue properties are strongly affected making this method inapplicable for biomechanical testing. In this study, a new embalming technique called Fix for Life (F4L), which claims to preserve the tissue properties, was tested. The range of motion (ROM) and stiffness of six fresh human spinal specimens was measured using a spinal motion simulator before and after F4L embalming. After F4L embalming, spinal stiffness increased in flexion-extension by 230%, in lateral bending by 284% and in axial rotation by 271%. ROM decreased by 46% in flexion-extension, 56% in lateral bending and 54% in axial rotation. In conclusion, based on this study, F4L does not maintain physiological spinal biomechanical properties, and we propose that this method should not be used for biomechanical studies. Nevertheless, the method may be an alternative to formaldehyde fixation in situations such as training and education because the effect on spinal biomechanics is less detrimental than formaldehyde and tissue color is maintained.

De novo degenerative lumbar scoliosis: a systematic review of prognostic factors for curve progression.

PURPOSE: To identify prognostic factors for curve progression in de novo degenerative lumbar scoliosis (DNDLS) by performing a systematic review of the literature. METHODS: Studies were selected for inclusion following a systematic search in the bibliographic databases PubMed and EMBASE prior to September 2015 and hand searches of the reference lists of retrieved articles. Two authors independently assessed methodological quality. Data were extracted and presented according to a best evidence synthesis. RESULTS: The literature search generated a total of 2696 references. After removing duplicates and articles that did not meet inclusion criteria, 12 studies were included. Due to the lack of statistical analyses, pooling of data was not possible. Strong evidence indicates that increasing intervertebral disk degeneration, lateral vertebral translation ≥6 mm, and an intercrest line through L5 (rather than L4) are associated with DNDLS curve progression. Moderate evidence suggests that apical vertebral rotation Grade II or III is associated with curve progression. For the majority of other prognostic factors, we found limited, conflicting, or inconclusive evidence. Osteoporosis, a coronal Cobb angle <30°, lumbar lordosis, lateral osteophytes difference of ≥5 mm, and degenerative spondylolisthesis have not been shown to be risk factors. Clinical risk factors for progression were not identified. CONCLUSIONS: This review shows strong evidence that increased intervertebral disk degeneration, an intercrest line through L5, and apical lateral vertebral translation ≥6 mm are associated with DNDLS curve progression. Moderate evidence was found for apical vertebral rotation (Grade II/III) as a risk factor for curve progression. These results, however, may not be directly applicable to the individual patient.