The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol.

BACKGROUND AND PURPOSE: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences. METHODS AND ANALYSES: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.

Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.

STUDY DESIGN: Prospective multicenter database post-hoc analysis. OBJECTIVES: Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. METHODS: Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. RESULT: Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. CONCLUSIONS: In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.

Lumbar spine segmentation in MR images: a dataset and a public benchmark.

This paper presents a large publicly available multi-center lumbar spine magnetic resonance imaging (MRI) dataset with reference segmentations of vertebrae, intervertebral discs (IVDs), and spinal canal. The dataset includes 447 sagittal T1 and T2 MRI series from 218 patients with a history of low back pain and was collected from four different hospitals. An iterative data annotation approach was used by training a segmentation algorithm on a small part of the dataset, enabling semi-automatic segmentation of the remaining images. The algorithm provided an initial segmentation, which was subsequently reviewed, manually corrected, and added to the training data. We provide reference performance values for this baseline algorithm and nnU-Net, which performed comparably. Performance values were computed on a sequestered set of 39 studies with 97 series, which were additionally used to set up a continuous segmentation challenge that allows for a fair comparison of different segmentation algorithms. This study may encourage wider collaboration in the field of spine segmentation and improve the diagnostic value of lumbar spine MRI.

Development and validation of AI-based automatic measurement of coronal Cobb angles in degenerative scoliosis using sagittal lumbar MRI.

OBJECTIVES: Severity of degenerative scoliosis (DS) is assessed by measuring the Cobb angle on anteroposterior radiographs. However, MRI images are often available to study the degenerative spine. This retrospective study aims to develop and evaluate the reliability of a novel automatic method that measures coronal Cobb angles on lumbar MRI in DS patients. MATERIALS AND METHODS: Vertebrae and intervertebral discs were automatically segmented using a 3D AI algorithm, trained on 447 lumbar MRI series. The segmentations were used to calculate all possible angles between the vertebral endplates, with the largest being the Cobb angle. The results were validated with 50 high-resolution sagittal lumbar MRI scans of DS patients, in which three experienced readers measured the Cobb angle. Reliability was determined using the intraclass correlation coefficient (ICC). RESULTS: The ICCs between the readers ranged from 0.90 (95% CI 0.83-0.94) to 0.93 (95% CI 0.88-0.96). The ICC between the maximum angle found by the algorithm and the average manually measured Cobb angles was 0.83 (95% CI 0.71-0.90). In 9 out of the 50 cases (18%), all readers agreed on both vertebral levels for Cobb angle measurement. When using the algorithm to extract the angles at the vertebral levels chosen by the readers, the ICCs ranged from 0.92 (95% CI 0.87-0.96) to 0.97 (95% CI 0.94-0.98). CONCLUSION: The Cobb angle can be accurately measured on MRI using the newly developed algorithm in patients with DS. The readers failed to consistently choose the same vertebral level for Cobb angle measurement, whereas the automatic approach ensures the maximum angle is consistently measured. CLINICAL RELEVANCE STATEMENT: Our AI-based algorithm offers reliable Cobb angle measurement on routine MRI for degenerative scoliosis patients, potentially reducing the reliance on conventional radiographs, ensuring consistent assessments, and therefore improving patient care. KEY POINTS: • While often available, MRI images are rarely utilized to determine the severity of degenerative scoliosis. • The presented MRI Cobb angle algorithm is more reliable than humans in patients with degenerative scoliosis. • Radiographic imaging for Cobb angle measurements is mitigated when lumbar MRI images are available.

The Dutch version of the Spinal Appearance Questionnaire for adolescents with idiopathic scoliosis: patient-based cross-cultural adaptation and measurement properties evaluation.

PURPOSE: Adolescent idiopathic scoliosis (AIS) affects the appearance of spine and trunk. The Spinal Appearance Questionnaire (SAQ) assesses the perception of appearance in AIS patients. The aim of this study is to translate and culturally adapt the recommended short version of the SAQ into Dutch and to test its measurement properties. METHODS: A Dutch SAQ (14-item; appearance and expectations domains) was developed following guidelines for translation and cross-cultural adaptation. The COSMIN Study Design checklist was used for measurement properties evaluation. In this multicenter study, the Dutch SAQ, SRS-22R and NPRS (back pain) were administered to 113 AIS patients (aged 15.4 years [SD 2.2], 21.2% male). Floor and ceiling effects were evaluated for content analysis. For reliability, internal consistency (Cronbach's alpha) and test-retest reliability (ICC; n = 34) were evaluated. Predefined hypotheses of relationships with other questionnaires and between subgroups based on scoliosis severity (radiological and clinical) were tested for construct validity. Exploratory factor analysis (EFA) was performed to investigate the validity of the underlying structure of this 14-item questionnaire. RESULTS: No floor and ceiling effects were found for domains and total scores. Cronbach's alpha ranged from 0.84 to 0.89. ICCs varied from 0.76 to 0.77. For construct validity, 89% (8/9) of the predefined hypotheses were confirmed. Significant higher scores for the appearance domain were found for subgroups based on radiological (Cobb angle; > 25.0°) and clinical outcomes. (Angle of Trunk Rotation; > 9.0°). A two-factor structure was found (EV 5.13; 36.63% explained variance). CONCLUSION: The Dutch SAQ is an adequate, valid and reliable instrument to evaluate patients' perception of appearance in AIS. LEVEL OF EVIDENCE: Level I-diagnostic studies.

Clinical and radiological assessment of scoliosis in Koolen-de Vries syndrome.

The Koolen-de Vries syndrome (KdVS) is a multisystem disorder characterized by developmental delay, intellectual disability, characteristic facial features, epilepsy, cardiovascular and urogenital malformations, and various musculoskeletal disorders. Scoliosis is a common feature. The aim of this study is to fill the gap in the current knowledge about scoliosis in individuals with KdVS and to provide recommendations for management and follow-up. In total, 54 individuals with KdVS were included in the study, with a mean age of 13.6 years (range 1.9-38.8 years). Spine radiographs, MR scans, and corresponding radiology reports were analyzed retrospectively for scoliosis and additional anomalies. The presence of scoliosis-related clinical conditions was assessed in participants' medical records and by use of a parent survey. Scoliosis was present in 56% of the participants (30/54) with a mean age of onset of 10.6 years and curve progression during the growth spurt. Prevalence at age 6, 10, and 18 years was, respectively, 9%, 41%, and 65%. Most participants were diagnosed with a single curve (13/24, 54%), of which five participants had a long C-curve type scoliosis. No significant risk factors for development of scoliosis could be identified. Severity was mostly classified as mild, although 29% (7/24) of the curves were larger than 30° at last follow-up. Bracing therapy was received in 13% (7/54), and surgical spinal fusion was warranted in 6% (3/54). Remarkably, participants with scoliosis received less often physical therapy compared to participants without scoliosis (P = 0.002). Scoliosis in individuals with KdVS should be closely monitored and radiologic screening for scoliosis and vertebrae abnormalities is recommended at diagnosis of KdVS, and the age of 10 and 18 years.

Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.

STUDY DESIGN: Prospective, multicenter, international, observational study. OBJECTIVE: Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery. METHODS: Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively. RESULTS: 171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches. CONCLUSION: In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID.

The Influence of Multilevel Spinal Deformity Surgery on the EuroQol 5 Dimensions' (EQ-5D) Questionnaire and Residential Status in the Elderly: A Prospective, Observational, Multicenter Study.

STUDY DESIGN: Multicenter, international prospective study. OBJECTIVE: This study investigated the clinical outcome up to 2 years after multi-level spinal deformity surgery in the elderly by reporting the minimal clinically important difference (MCID) of EuroQol 5-dimensions (EQ-5D), EQ-VAS, and residential status. METHODS: As an ancillary study of 219 patients ≥60 years with spinal deformity undergoing primary instrumented fusion surgery of ≥5 levels, this study focuses on EQ-5D (3-L) as the primary outcome and EQ-VAS and residential status as secondary outcomes. Data on EQ-5D were compared between pre-operatively and postoperatively at 10 weeks, 12 months, and 24 months. An anchor-based approach was used to calculate the MCID. RESULTS: The EQ-5D index and EQ-VAS, respectively, improved significantly at each time point compared to pre-operatively (from .53 (SD .21) and 55.6 (SD 23.0) pre-operatively to .64 (SD .18) and 65.8 (SD 18.7) at 10 weeks, .74 (SD .18) and 72.7 (SD 18.1) at 12 months, and .73 (SD .20) and 70.4 (SD 20.4) at 24 months). 217 (99.1%) patients lived at home pre-operatively, while 186 (88.6%), 184 (98.4%), and 172 (100%) did so at 10 weeks, 12 months, and 24 months, respectively. Our calculated MCID for the EQ-5D index at 1 year was .22 (95% CI .15-.29). CONCLUSIONS: The EQ-5D index significantly increased at each time point over 24 months after ≥5 level spinal deformity surgery in elderly patients. The MCID of the EQ-5D-3 L was .22. Patients living at home pre-operatively can expect to be able to live at home 2 years postoperatively.

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

BACKGROUND: The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events. QUESTIONS/PURPOSES: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture? METHODS: Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death. RESULTS: Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention. CONCLUSION: Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant. LEVEL OF EVIDENCE: Level III, therapeutic study.

Spinal deformity surgery is accompanied by serious complications: report from the Morbidity and Mortality Database of the Scoliosis Research Society from 2013 to 2020.

PURPOSE: The Morbidity and Mortality (M&M) report of the Scoliosis Research Society (SRS) has been collected since 1965 and since 1968 submission of complications has been required of all members. Since 2009, the SRS has collected information on death, blindness, and neurological deficit, with acute infection being added in 2012 and unintentional return to the operating room (OR) being added in 2017. In this report, we use the most recent data submitted to the SRS M&M database to determine the rate of neurological deficit, blindness, acute infection, unintentional return to the OR, and death, while also comparing this information to previous reports. METHODS: The SRS M&M database was queried for all cases from 2013 to 2020. The rates of death, vision loss, neurological deficit, acute infection, and unintentional return to the OR were then calculated and analyzed. The rates were compared to previously published data if available. Differences in complication rates between years were analyzed with Poisson regression with significance set at α = 0.05. RESULTS: The total number of cases submitted per year varied with a maximum of 49,615 in 2018 and a minimum of 40,464 in 2020. The overall reported complication rate from 2013 to 2020 was 2.86%. The overall mortality rate ranged from 0.09% in 2018 to 0.14% in 2015. The number of patients with visual impairment ranged from 4 to 13 between 2013 and 2015 (no data on visual impairment were collected after 2015). The overall infection rate varied from 0.95 in 2020 to 1.30% in 2015. When the infection rate was analyzed based on spinal deformity group, the neuromuscular scoliosis group consistently had the highest infection rate ranging from 3.24 to 3.94%. The overall neurological deficit rate ranged from 0.74 to 0.94%, with the congenital kyphosis and dysplastic spondylolisthesis groups having the highest rates. The rates of unintentional return to the OR ranged from 1.60 to 1.79%. Multiple groups showed a statistically significant decreasing trend for infection, return to the operating room, neurologic deficit, and death. CONCLUSIONS: Neuromuscular scoliosis had the highest infection rate among all spinal deformity groups. Congenital kyphosis and dysplastic spondylolisthesis had the highest rate of neurological deficit postoperatively. This is similar to previously published data. Contrary to previous reports, neuromuscular scoliosis did not have the highest annual death rate. Multiple groups showed a statistically significant decreasing trend in complication rates during the reporting period, with only mortality in degenerative spondylolisthesis significantly trending upwards. LEVEL OF EVIDENCE: Level III.

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.

Which frailty scales for patients with adult spinal deformity are feasible and adequate? A systematic review.

BACKGROUND CONTEXT: Frailty as a concept is not yet fully understood, and is not the same as comorbidity. It is associated with an increased risk of adverse events and mortality after surgery, which makes its preoperative assessment significant. Despite its relevance, it still remains unclear which scales are appropriate for use in patients with spinal pathology. PURPOSE: To evaluate the feasibility and measurement properties of frailty scales for spine patients, specifically with adult spinal deformity (ASD), and to propose adequate scales for primary triage to prevent surgery in too frail patients and for preoperative assessment to modify patients' condition and surgical plans. STUDY DESIGN/SETTING: Systematic review. METHODS: Systematic search was performed between 2010 and 2021 including terms relating to spinal disorders, frailty scales, and methodological quality. Characteristics of the studies and frailty scales and data describing relation to treatment outcomes were extracted. The risk of bias was determined with the QAREL score. RESULTS: Of the 1993 references found, 88 original studies were included and 23 scales were identified. No prospective interventional study was found where the preoperative frailty assessment was implemented. Predictive value of scales for surgical outcomes varied, dependent on spinal disorders, type of surgeries, patients' age and frailty at baseline, and outcomes. Seventeen studies reported measurement properties of eight scales but these studies were not free of bias. In 30 ASD studies, ASD-Frailty Index (ASD-FI, n=14) and 11-item modified Frailty Index (mFI-11, n=11) were most frequently used. These scales were mainly studied in registry studies including young adult population, and carry a risk of sample bias and make their validity in elderly population unclear. ASD-FI covers multidisciplinary concepts of frailty with 40 items but its feasibility in clinical practice is questionable due to its length. The Risk Analysis Index, another multidisciplinary scale with 14 items, has been implemented for preoperative assessment in other surgical domains and was proven to be feasible and effective in interventional prospective studies. The FRAIL is a simple questionnaire with five items and its predictive value was confirmed in prospective cohort studies in which only elderly patients were included. CONCLUSIONS: No adequate scale was identified in terms of methodological quality and feasibility for daily practice. Careful attention should be paid when choosing an adequate scale, which depends on the setting of interest (eg triage or preoperative work-up). We recommend to further study a simple and predictive scale such as FRAIL for primary triage and a comprehensive and feasible scale such as Risk Analysis Index for preoperative assessment for patients undergoing spine surgery, as their adequacy has been shown in other medical domains.

Relevant impact of surgery on quality of life for adolescent idiopathic scoliosis : a registry-based two-year follow-up cohort study.

AIMS: To determine the value of scoliosis surgery, it is necessary to evaluate outcomes in domains that matter to patients. Since randomized trials on adolescent idiopathic scoliosis (AIS) are scarce, prospective cohort studies with comparable outcome measures are important. To enhance comparison, a core set of patient-related outcome measures is available. The aim of this study was to evaluate the outcomes of AIS fusion surgery at two-year follow-up using the core outcomes set. METHODS: AIS patients were systematically enrolled in an institutional registry. In all, 144 AIS patients aged ≤ 25 years undergoing primary surgery (median age 15 years (interquartile range 14 to 17) were included. Patient-reported (condition-specific and health-related quality of life (QoL); functional status; back and leg pain intensity) and clinician-reported outcomes (complications, revision surgery) were recorded. Changes in patient-reported outcome measures (PROMs) were analyzed using Friedman's analysis of variance. Clinical relevancy was determined using minimally important changes (Scoliosis Research Society (SRS)-22r), cut-off values for relevant effect on functioning (pain scores) and a patient-acceptable symptom state (PASS; Oswestry Disability Index). RESULTS: At baseline, 65 out of 144 patients (45%) reported numerical rating scale (NRS) back pain scores > 5. All PROMs significantly improved at two-year follow-up. Mean improvements in SRS-22r function (+ 1.2 (SD 0.6)), pain (+ 0.6 (SD 0.8)), and self-image (+ 1.1 (SD 0.7)) domain scores, and the SRS-22r total score (+ 0.5 (SD 0.5)), were clinically relevant. At two-year follow-up, 14 out of 144 patients (10%) reported NRS back pain > 5. Surgical site infections did not occur. Only one patient (0.7%) underwent revision surgery. CONCLUSION: Relevant improvement in functioning, condition-specific and health-related QoL, self-image, and a relevant decrease in pain is shown at two-year follow-up after fusion surgery for AIS, with few adverse events. Contrary to the general perception that AIS is a largely asymptomatic condition, nearly half of patients report significant preoperative back pain, which reduced to 10% at two-year follow-up. Cite this article: Bone Joint J 2022;104-B(2):265-273.

Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS).

BACKGROUND CONTEXT: Patients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements. PURPOSE: The purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery. STUDY DESIGN: Prospective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLE: Patients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity. OUTCOME MEASURES: Oswestry Disability Index (ODI) METHODS: : Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10-<20%) or no change (within 10%). RESULTS: Two-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling. CONCLUSIONS: In this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group.

High Failure Rates of a Unilateral Posterior Peri-Apical Distraction Device (ApiFix) for Fusionless Treatment of Adolescent Idiopathic Scoliosis.

BACKGROUND: Conventional surgical treatment for adolescent idiopathic scoliosis (AIS) consists of correction of the spinal deformity with rigid spinal instrumentation and fusion. Less-invasive and fusionless surgery could potentially improve patient outcomes. The purpose of the present study was to evaluate the efficacy of a recently U.S. Food and Drug Administration (FDA)-approved posterior peri-apical self-distracting device (ApiFix) that is designed to gradually correct the deformity without spinal fusion. METHODS: In a prospective cohort study of 20 patients with AIS (Risser stage 1-4; Lenke 1 or 5; major curve Cobb angle, 40° to 55°; and Bunnell scoliometer rotation, <15°) were managed with the ApiFix device. Clinical and radiographic performance was assessed. RESULTS: Twenty patients with a mean age (and standard deviation) of 14.8 ± 1.4 years were followed for a mean of 3.4 ± 1.0 years. The average major curve was reduced from 45.4° preoperatively to 31.4° at 2 weeks postoperatively and 31.0° at the time of the latest follow-up. The average minor curve measured 31.3° preoperatively, 26.1° at 2 weeks postoperatively, and 24.2° at the time of the latest follow-up. Ten patients had serious complications that required revision surgery, including osteolysis (n = 6), screw and/or rod breakage (n = 2), failure of the ratchet mechanism (n = 1), and pain without explainable cause (n = 1). During revision surgery, metallosis was observed in all patients and cultures showed growth of Cutibacterium acnes in 6 patients. Because of the high failure rate, the study was terminated early. CONCLUSIONS: The use of the unilateral peri-apical concave self-distracting ratchet rod initially was associated with promising clinical and radiographic results. However, no distraction was observed and the high rate of serious adverse events within 2 years was considered to be unacceptable for further clinical application of this device in our institution, despite recent FDA approval. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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.

Toward the Development of a Comprehensive Clinically Oriented Patient Profile: A Systematic Review of the Purpose, Characteristic, and Methodological Quality of Classification Systems of Adult Spinal Deformity.

BACKGROUND: Existing adult spinal deformity (ASD) classification systems are based on radiological parameters but management of ASD patients requires a holistic approach. A comprehensive clinically oriented patient profile and classification of ASD that can guide decision-making and correlate with patient outcomes is lacking. OBJECTIVE: To perform a systematic review to determine the purpose, characteristic, and methodological quality of classification systems currently used in ASD. METHODS: A systematic literature search was conducted in MEDLINE, EMBASE, CINAHL, and Web of Science for literature published between January 2000 and October 2018. From the included studies, list of classification systems, their methodological measurement properties, and correlation with treatment outcomes were analyzed. RESULTS: Out of 4470 screened references, 163 were included, and 54 different classification systems for ASD were identified. The most commonly used was the Scoliosis Research Society-Schwab classification system. A total of 35 classifications were based on radiological parameters, and no correlation was found between any classification system levels with patient-related outcomes. Limited evidence of limited quality was available on methodological quality of the classification systems. For studies that reported the data, intraobserver and interobserver reliability were good (kappa = 0.8). CONCLUSION: This systematic literature search revealed that current classification systems in clinical use neither include a comprehensive set of dimensions relevant to decision-making nor did they correlate with outcomes. A classification system comprising a core set of patient-related, radiological, and etiological characteristics relevant to the management of ASD is needed.

No added value of 2-year radiographic follow-up of fusion surgery for adolescent idiopathic scoliosis.

PURPOSE: For fusion surgery in adolescent idiopathic scoliosis (AIS) consensus exists that a 2-year radiographic follow-up assessment is needed. This standard lacks empirical evidence. The purpose of this study was to investigate the radiographic follow-up after corrective surgery in AIS, from pre-until 2 years postoperative. METHODS: In this historical cohort study, 63 patients surgically treated for AIS, age ≤ 25 years, with 2-year radiographic follow-up, were enrolled. The primary outcome measure was the major Cobb angle. Secondary outcomes were coronal and sagittal spino-pelvic parameters, including proximal junction kyphosis (PJK) and distal adding-on. Change over time was analyzed using a repeated measures ANOVA. RESULTS: The major curve Cobb angle showed a statistically significant change for pre- to 1 year postoperative, but not for 1- to 2-year follow-up. Seven out of 63 patients did show a change exceeding the error of measurement (5°) from 1- to 2-year follow-up (range -8° to +7°), of whom 2 patients showed curve progression and 5 showed improvement. PJK or distal adding-on was not observed. CONCLUSIONS: No statistically significant changes in major curve Cobb angle were found during postsurgical follow-up, or in adjacent non-fused segments. The findings of this study are not supportive for routine radiographs 2 years after fusion surgery in AIS patients.

Intraoperative neuromonitoring practice patterns in spinal deformity surgery: a global survey of the Scoliosis Research Society.

PURPOSE: Although multimodal IONM has reached a widespread use, several unresolved issues have remained in clinical practice. The aim was to determine differences in approaches to form a basis for taking actions to improve patient safety globally. METHODS: A survey comprising 19 questions in four sections (demographics, setup, routine practices and reaction to alerts) was distributed to the membership of the SRS. RESULTS: Of the estimated 1300 members, 205 (~ 15%) completed the survey. Respondent demographics reflected SRS member distribution. Most of the respondents had > 10 years of experience. TcMEP and SSEP were available to > 95%. Less than 5% reported that a MD/PhD with neurophysiology background routinely examines patients preoperatively, while 19% would consult if requested. After an uneventful case, 36% reported that they would decrease sedation and check motor function if the patient was to be transferred to ICU intubated. Reactions to dropped signals that recovered or did not fully recover varied between attempting the same correction to aborting the surgery with no rods and returning another day, with or without implant removal. After a decrease of signals, 85.7% use steroids of varied doses. Of the respondents, 53.7% reported using the consensus-created checklist by Vitale et al. Approximately, 14% reported never using the wake-up test while others use it for various conditions. CONCLUSION: The responses of 205 experienced SRS members from different regions of the world showed that surgeons had different approaches in their routine IONM practices and in the handling of alerts. This survey indicates the need for additional studies to identify best practices.