Change in Lumbar Lordosis after Decompressive Surgery in Lumbar Spinal Stenosis Patients and Associations with Patient Related Outcomes 2 Years after Surgery. Radiological and Clinical Results from the NORDSTEN Spinal Stenosis Trial.

STUDY DESIGN: A prospective cohort study. OBJECTIVE: The aim was to investigate changes in lumbar lordosis (LL) and its association to changes in patient reported outcome measures (PROMs) after decompressive surgery for lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND: Few studies have addressed change in LL after decompression surgery for LSS in relation to outcomes. METHOD: Pre- and postoperative data from 310 patients having standing x-ray both before and 2 years after surgery were included. The patients were grouped based on the change in LL preoperatively to 2 years after surgery; group 1: <5 degrees (n=196), group 2: ≥5 <10 degrees (n=55) or group 3: ≥10 degrees (n=59) of change in LL. The changes in function, disability and pain were assessed by the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Zurich claudication questionnaire (ZCQ). The three groups were compared regarding baseline variables using the ANOVA test for continuous variables and the chi-square test for categorical variables. The groups were further compared with a likelihood ratio test in relation to changes in PROMs 2 year after surgery and outcomes were adjusted for respective baseline PROMs, age, sex, smoking, BMI, Schizas and Pfirrmann scores. RESULTS: LL was significantly changed at group level 2 years after surgery with a mean difference of 2.2 (SD 9.4) degrees ( P =0.001). The three LL change groups did not show any significant differences in patient characteristics, function, disability, and pain at baseline. The two groups with a change of more than 5 degrees in LL 2 year after surgery (group 2 and 3) had significantly greater improvements in ODI ( P =0.022) and ZCQ function ( P =0.016) in the adjusted analyses, but was not significant for back and leg pain. CONCLUSION: Changed LL after decompressive surgery for LSS was associated with improved ODI and physical function.

Evaluation of Cervical Vertebral Motion and Foraminal Changes During the Spurling Test Using Zero Echo Time MRI and CT Micromotion Analysis.

STUDY DESIGN: Clinical experimental diagnostic study. OBJECTIVE: The objective of the study was to investigate cervical spine dynamics including changes of the cervical foramina in patients experiencing intermittent arm radiculopathy. SUMMARY OF BACKGROUND DATA: Cervical foraminal stenosis is a frequent cause of radicular arm pain. The Spurling test, while specific, lacks the precision to identify symptomatic nerve roots. The relationship between vertebral motion, foraminal changes, and radiculopathy during a Spurling test remains underexplored. METHODS: Ten patients with positive Spurling tests and MRI-confirmed one or two level cervical foraminal stenosis were scanned using the Dynamic MRI Compression System (DMRICS) enabling a simulated Spurling test inside the MRI gantry of a 3T MRI scanner with a dedicated neck coil. First, a relaxed image acquisition was undertaken followed by slowly applying the Spurling test until the patient reported aggravation of radiculopathy or discomfort, where the next image series was taken. Zero Echo Time (ZTE) MRI was employed to obtain CT-like images. The images were thereafter analyzed using the Sectra® CT-based Micromotion Analysis (CTMA) software for motion analysis. RESULTS: The C4/C5 level exhibited the most significant movements both in translation and rotation, with less movements observed in C5-6 and C6-C7 levels. No uniform pattern emerged that differentiated suspected stenotic levels from non-suspected levels. Despite relatively small vertebral movements, 9/10 of patients reported arm pain during provocation, indicating extremely narrow margins of tolerance. CONCLUSION: This study demonstrates the utility of ZTE MRI and CTMA in detecting subtle yet clinically relevant vertebral motions influencing the foramina in the cervical spine during the Spurling maneuver. These findings could lead to better understanding and potentially improved diagnostic strategies for cervical foraminal stenosis, although further research with a larger cohort is necessary to confirm these results.

Dural Sac Cross-sectional area change from preoperatively and up to 2 years after decompressive surgery for central lumbar spinal stenosis: investigation of operated levels, data from the NORDSTEN study.

PURPOSE: The aim of the present study was to investigate how canal area size changed from before surgery and up to 2 years after decompressive lumbar surgery lumbar spinal stenosis. Further, to investigate if an area change postoperatively (between 3 months to 2 years) was associated with any preoperative demographic, clinical or MRI variables or surgical method used. METHODS: The present study is analysis of data from the NORDSTEN- SST trial where 437 patients were randomized to one of three mini-invasive surgical methods for lumbar spinal stenosis. The patients underwent MRI examination of the lumbar spine before surgery, and 3 and 24 months after surgery. For all operated segments the dural sac cross-sectional area (DSCA) was measured in mm2. Baseline factors collected included age, gender, BMI and smoking habits. Furthermore, surgical method, index level, number of levels operated, all levels operated on and baseline Schizas grade were also included in the analysis. RESULTS: 437 patients were enrolled in the NORDSTEN-SST trial, whereof 310 (71%) had MRI at 3 months and 2 years. Mean DSCA at index level was 52.0 mm2 (SD 21.2) at baseline, at 3 months it increased to 117.2 mm2 (SD 43.0) and after 2 years the area was 127.7 mm2 (SD 52.5). Surgical method, level operated on or Schizas did not influence change in DSCA from 3 to 24 months follow-up. CONCLUSION: The spinal canal area after lumbar decompressive surgery for lumbar spinal stenosis increased from baseline to 3 months after surgery and remained thereafter unchanged 2 years postoperatively.

Preoperative fatty infiltration of paraspinal muscles assessed by MRI is associated with less improvement of leg pain 2 years after surgery for lumbar spinal stenosis.

PURPOSE: Fatty infiltration (FI) of the paraspinal muscles may associate with pain and surgical complications in patients with lumbar spinal stenosis (LSS). We evaluated the prognostic influence of MRI-assessed paraspinal muscles' FI on pain or disability 2 years after surgery for LSS. METHODS: A muscle fat index (MFI) was calculated (by dividing signal intensity of psoas to multifidus and erector spinae) on preoperative axial T2-weighted MRI of patients with LSS. Pain and disability 2 years after surgery were assessed using the Oswestry disability index, the Zurich claudication questionnaire and numeric rating scales for leg and back pain. Multivariate linear and logistic regression analyses (adjusted for preoperative outcome scores, age, body mass index, sex, smoking status, grade of spinal stenosis, disc degeneration and facet joint osteoarthritis) were used to assess the associations between MFI and patient-reported clinical outcomes. In the logistic regression models, odds ratios (OR) and 95% confidence intervals (CI) were calculated for associations between the MFI and ≥ 30% improvement of the outcomes (dichotomised into yes/no). RESULTS: A total of 243 patients were evaluated (mean age 66.6 ± 8.5 years), 49% females (119). Preoperative MFI and postoperative leg pain were significantly associated, both with leg pain as continuous (coefficient - 3.20, 95% CI - 5.61, - 0.80) and dichotomised (OR 1.51, 95% CI 1.17, 1.95) scores. Associations between the MFI and the other outcome measures were not statistically significant. CONCLUSION: Preoperative FI of the paraspinal muscles on MRI showed statistically significant association with postoperative NRS leg pain but not with ODI or ZCQ.

Evaluating a targeted person-centred pain management intervention programme in lumbar spine surgery - a controlled segment-specific before-and-after interventional design.

BACKGROUND: Postoperative pain management in lumbar spine surgery care remains a challenge. The aim of this study was to evaluate the impact of a person-centred postoperative pain management intervention programme on lumbar spine surgery patients on postoperative pain, shared decision-making, and satisfaction with postoperative pain management. METHODS: The study was performed with a controlled before-and-after interventional design in an orthopaedic unit at a university hospital. Person-centred pain management for patients undergoing spine surgery was developed in co-creation by a multi-professional team and implemented throughout the care pathway. The usual care group (pre-intervention) served as a comparison to the intervention group. Pain intensity, shared decision-making in pain management, and patient satisfaction with results of pain management, served as patient-reported measures, collected using the International Pain Outcomes questionnaire and analysed using descriptive statistics. RESULTS: The intervention showed no benefit for patients' pain and satisfaction, while shared decision-making in pain management was significant lower in the intervention group than in the conventional group. The per-protocol analysis showed no significant differences between groups. CONCLUSION: The initial assumption of the study, that the implementation of a co-created structured person-centred care pathway would improve patient-reported outcomes, was not confirmed. The periodically low fidelity to the intervention due to organizational constraints (due to sub-optimal organizational conditions and managerial support) may have affected the results.

The association between lumbar lordosis preoperatively and changes in PROMs for lumbar spinal stenosis patients 2 years after spinal surgery: radiological and clinical results from the NORDSTEN-spinal stenosis trial.

BACKGROUND: Patients with lumbar spinal stenosis (LSS) sometimes have lower lumbar lordosis (LL), and the incidence of LSS correlates closely with the loss of LL. The few studies that have evaluated the association between LL and clinical outcomes after non-instrumented surgery for LSS show conflicting results. This study investigates the association between preoperative LL and changes in PROMs 2 years after decompressive surgery. METHOD: This prospective cohort study obtained preoperative and postoperative data for 401 patients from the multicenter randomized controlled spinal stenosis trial as part of the NORwegian degenerative spondylolisthesis and spinal STENosis (NORDSTEN) study. Before surgery, the radiological sagittal alignment parameter LL was measured using standing X-rays. The association between LL and 2-year postoperative changes was analyzed using the oswestry disability index (ODI), a numeric rating scale (NRS) for low back and leg pain, the Zurich claudication questionnaire (ZCQ), and the global perceived effect (GPE) score. The changes in PROMs 2 years after surgery for quintiles of lumbar lordosis were adjusted for the respective baseline PROMs: age, sex, smoking, and BMI. The Schizas index and the Pfirrmann index were used to analyze multiple regressions for changes in PROMs. RESULTS: There were no associations in the adjusted and unadjusted analyses between preoperative LL and changes in ODI, ZCQ, GPE, and NRS for back and leg pain 2 years after surgery. CONCLUSION: LL before surgery was not associated with changes in PROMs 2 years after surgery. Lumbar lordosis should not be a factor when considering decompressive surgery for LSS.

Get Back, a person-centred digital programme targeting physical activity for patients undergoing spinal stenosis surgery-a study protocol of a randomized feasibility study.

BACKGROUND: Spinal stenosis is the most common reason for elective spine surgery, and the cardinal symptom is leg pain and discomfort when walking. Patients with spinal stenosis have a decreased level of physical activity and thereby an increased risk of poor health. Get Back is a person-centred digital programme that strives to support patients being physically active after surgery. The aim is to explore if Get Back, in its present format (referred to as Get Backfeasibility), is feasible and contributes to detectable change in variables related to intervention content. METHODS: Thirty patients planned for decompression surgery due to central lumbar spinal stenosis who present with low physical activity, pain catastrophizing or fear of movement, will be included in a randomized feasibility study. All patients will be randomly allocated to either Get Backfeasibility or usual physical therapy. Get Backfeasibility aims to increase the patient's physical activity level by combining a person-centred and cognitive behavioural approach. It comprises 10 video and telephone sessions led by a physical therapist over 12 weeks (pre/postoperatively). Outcomes are treatment fidelity (treatment dose, adherence, and content), process feasibility (recruitment, intervention use, and acceptability of measurements and intervention), and variables related to the intervention content (steps per day, physical activity level, pain catastrophizing, fear of movement, and general self-efficacy). Treatment fidelity and feasibility data will be assessed during the full study period (12 weeks). Physical activity, physical capacity, and patient-reported outcomes will be assessed digitally at baseline (2 weeks preoperatively) and 11-12 weeks postoperatively. Variables related to the intervention content will be monitored weekly through a digital application. Feasibility data will be analysed descriptively and inferentially using a nonparametric approach, data from repeated measures will be displayed graphically and data from telephone interviews will be analysed using content analysis with a descriptive manifest approach. DISCUSSION: The results will provide information on whether Get Back in its present format is feasible and can be evaluated for effectiveness in a larger randomized controlled trial, for patients with a low physical activity level and a high fear of movement who are undergoing decompression surgery. TRIAL REGISTRATION: Registered at ClinicalTrails.gov 04/08/2023, registration no. NCT05806593.

Do patients with lumbar spinal stenosis benefit from decompression of levels with adjacent moderate stenosis? A prospective cohort study from the NORDSTEN study.

BACKGROUND: Lumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multi-level stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome. The potential benefits of performing surgery on an adjacent moderate stenosis is debated, and the scientific evidence in scarce. PURPOSE: The aim of the present study was to investigate whether patients with a level of adjacent moderate stenosis, along with an index stenosis, benefitted from a dual-level decompression (DLD) compared with a single-level decompression (SLD). Furthermore, to investigate whether DLD patients had longer duration of surgery and hospital stay, higher rates of complications and/or lower rate of reoperations compared with SLD patients. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: We analyzed data from the Norwegian Degenerative Spondylisthesis and Spinal Stenosis study- Spinal Stenosis Trial (NORDSTEN-SST). In this randomized multicenter study, 437 patients were included, evaluating clinical outcomes of three different surgical treatment options for LSS. Patients with degenerative spondylolisthesis were excluded. METHOD: Based on preoperative MRI, the present analysis included all patients who had a moderate stenosis (defined as Schizas B or C) in addition to a predefined index stenosis (the level with the smallest cross-sectional area). We compared patients who, based on the surgeons` choice, received a dual-level decompression, with those receiving a single-level decompression. OUTCOME MEASURES: The primary outcome was mean change in the Oswestry Disability Index (ODI) score from baseline to 2-year follow up. Secondary outcomes were proportion of success (30% reduction in ODI score), the Numeric Rating Scales for back and leg pain (NRS), the EuroQol 5-dimensional questionnaire utility index (EQ-5D), the Zurich Claudication Questionnaire (ZCQ), the Global Perceived Effect (GPE)-scale, duration of surgery, duration of hospital stay, perioperative complications and reoperation rates. RESULTS: Among the 222 patients, included in the analysis, 108 underwent DLD and 114 underwent SLD. There was no difference in change scores for any of the investigated patient-reported outcomes between the groups after 2 years. However, the DLD group had longer duration of surgery and longer length of hospital stay. There was no difference in reoperation rates or perioperative complications. CONCLUSION: This study, alongside the NORDSTEN-LSS trial on patients with adjacent moderate stenosis as well as an index stenosis, showed no superior clinical effectiveness for dual-level surgery compared with single-level surgery.

Coexistence of Vertebral and Intervertebral Disc Changes in Low Back Pain Patients-In Depth Characterization with Same Day MRI and CT Discography.

The aim of this study was to investigate to what extent annular fissures, vertebral and endplate changes, and Modic changes (MCs), coexist in low back pain (LBP) patients by using multiple imaging modalities. Sixty-two LBP patients (mean age 45 years, range 24-63, 53% men) were examined with same-day CT-discography and MRI. Intervertebral discs punctured for discography (n = 204) were evaluated on MRI [Pfirrmann grade, High-Intensity Zone (HIZ)] and on CT-discograms [Modified Dallas Discogram Score (DDS)]. DDS≥ 1, i.e., disc fissures involving the outer annulus were further digitomized into delimitable fissuring (<50% of annulus affected) or non-delimitable annular fissuring. Using both MRI and CT, adjacent vertebrae and endplates were assessed for MC, vertebral sclerosis, and a modified endplate defect score (EPS). In 194 discs the contrast agent was adequately injected during discography, of which 160 (83%) displayed outer annular fissures, with 91 (47%) of the latter being delimitable fissures. Most discs with delimitable fissures were moderately degenerated; 68% Pfirrmann grade ≤3, 71% EPS ≤ 2, and 12% displayed MC. The majority (76%) of MCs were associated with advanced adjacent disc degeneration; 84% Pfirrmann grade ≥4, 76% with non-delimitable annular fissuring, 59% EPS≥ 4, and 34% EPS of 3. A total 95 HIZ (47%) were found, of which 54 had delimitable fissuring, while the remainder displayed non-delimitable fissuring. Vertebral sclerosis was commonly observed (26%), both with MCs (73%) and without MCs (27%), and not specifically linked to MC type 3. A total of 97% of segments with vertebral sclerosis displayed outer annular fissures. These findings were significant (0.046 > p > 0.0001), except between HIZ and adjacent sclerosis (p = 0.303). To conclude, the present study confirmed a close interplay between the disc and adjacent vertebra and endplates. The fact that a majority of discs with delimitable annular fissures did not coexist with pronounced endplate changes and/or MCs, however, supports the theory that disc fissuring is an early event in the degenerative cascade. This was further supported by the fact that MCs were strongly linked to extensive disc fissuring and to advanced endplate damage. Further, vertebral sclerosis was common also in vertebra without MCs and strongly associated to annular fissuring, indicating that sclerosis is a previously underestimated feature of a general degenerative process.

Nighttime versus Fulltime Brace Treatment for Adolescent Idiopathic Scoliosis: Which Brace to Choose? A Retrospective Study on 358 Patients.

The purpose of this study is to retrospectively compare the effectiveness of fulltime Boston Brace (BB) and Providence Nighttime Brace (PNB) treatments in moderate scoliotic curves (20-40°) at a single institution and to carry out analyses for different subgroups. Inclusion criteria: idiopathic scoliosis, age ≥ 10 years, curve 20-40°, Risser ≤ 3 or Sanders stage ≤ 6 and curve apex below T6 vertebra. Exclusion criteria: incomplete radiological or clinical follow-up and previous treatment. The primary outcome was failure according to the SRS outcome assessment: increase in main curve > 5° and/or increase in main curve beyond 45° and/or surgery. The subgroup analyses were secondary outcomes. In total, 249 patients in the PNB and 109 in the BB groups were included. The BB showed a higher success rate compared to the PNB (59% and 46%, respectively) in both crude and adjusted comparisons (p = 0.029 and p = 0.007, respectively). The subgroup analyses showed higher success rates in pre-menarchal females, thoracic curves and curves > 30° in the BB group compared to the PNB group. Based on the findings, fulltime braces should be the treatment of choice for more immature patients and patients with larger and thoracic curves while nighttime braces might be sufficient for post-menarchal females and patients with lumbar and smaller curves.

Detailed MRI evaluation of the spine: a 2-year follow-up study of young individuals reporting different training doses.

OBJECTIVE: To characterize the discs and vertebrae in detail over time in a group of adolescent individuals with varying training doses using magnetic resonance imaging (MRI). METHOD: Thirty-five students were recruited from regular high schools (n=13) as well as schools with athlete competitive skiing programmes (n = 22). The thoraco-lumbar spine of all individuals was examined at baseline and at 2-year follow-up using the same 1.5T scanner and imaging protocol. The individuals were grouped based on their reported training dose: low-to-normal training dose (≤5 h/week, n = 11, mean age 16.5 ± 0.5 years) and high training dose (>5 h/week, n = 24, mean age 17.2 ± 0.6 years.) RESULTS: At baseline, the signal intensity in the discs and vertebrae were significantly lower in individuals reporting high compared to low-to-normal training dose. The vertebral signal changed significantly over the 2-year period in both groups. However, only individuals reporting low-to-normal training dose displayed an overall disc signal change. Interestingly, the regional analysis displayed at baseline high annular signals in the more training-active individuals followed by a reduction over the two-year period. CONCLUSION: This study suggests that disc degeneration is manifested earlier in individuals reporting a higher training dose. Over a 2-year period, however, the degeneration process did not accelerate further. Also, a significant difference in the vertebral signal, at baseline and follow-up as well as over time, could be seen between groups of individuals reporting high versus low-to-normal training dose.

Cervical Foraminal Changes in Patients with Intermittent Arm Radiculopathy Studied with a New MRI-Compatible Compression Device.

Diagnosing cervical foraminal stenosis with intermittent arm radiculopathy is challenging due to discrepancies between MRI findings and symptoms. This can be attributed to the fact that MRI images are often obtained in a relaxed supine position. This study aims to evaluate the feasibility of the Dynamic MRI Compression System (DMRICS) and to assess possible changes in cervical foramina, with both quantitative measurements and qualitative grading systems, with MRI during a simulated Spurling test. Ten patients (five women and five men, ages 29-45) with previously confirmed cervical foraminal stenosis underwent MRI scans using DMRICS. MRI images were acquired in both relaxed and provoked states. A radiologist assessed 30 foramina (C4-C7) on the symptomatic side in both patient positions. Quantitative and qualitative measures were performed, including the numeric rating scale (NRS) and the Park and Kim grading systems. The provoked state induced concordant neck and arm pain in 9 of 10 patients. Significant shifts in Park and Kim foraminal gradings were noted: 13 of 27 Park gradings and 9 of 27 Kim gradings escalated post provocation. No quantitative changes were observed. This pilot study indicates that the DMRICS device has the potential to improve diagnostic accuracy for cervical radiculopathy, demonstrating induced cervical foraminal changes during a simulated Spurling test while performing MRI.

Associations between Vertebral Localized Contrast Changes and Adjacent Annular Fissures in Patients with Low Back Pain: A Radiomics Approach.

Low back pain (LBP) is multifactorial and associated with various spinal tissue changes, including intervertebral disc fissures, vertebral pathology, and damaged endplates. However, current radiological markers lack specificity and individualized diagnostic capability, and the interactions between the various markers are not fully clear. Radiomics, a data-driven analysis of radiological images, offers a promising approach to improve evaluation and deepen the understanding of spinal changes related to LBP. This study investigated possible associations between vertebral changes and annular fissures using radiomics. A dataset of 61 LBP patients who underwent conventional magnetic resonance imaging followed by discography was analyzed. Radiomics features were extracted from segmented vertebrae and carefully reduced to identify the most relevant features associated with annular fissures. The results revealed three important texture features that display concentrated high-intensity gray levels, extensive regions with elevated gray levels, and localized areas with reduced gray levels within the vertebrae. These features highlight patterns within vertebrae that conventional classification systems cannot reflect on distinguishing between vertebrae adjacent to an intervertebral disc with or without an annular fissure. As such, the present study reveals associations that contribute to the understanding of pathophysiology and may provide improved diagnostics of LBP.

Is the presence of foraminal stenosis associated with outcome in lumbar spinal stenosis patients treated with posterior microsurgical decompression.

BACKGROUND: We aim to investigate associations between preoperative radiological findings of lumbar foraminal stenosis with clinical outcomes after posterior microsurgical decompression in patients with predominantly central lumbar spinal stenosis (LSS). METHODS: The study was an additional analysis in the NORDSTEN Spinal Stenosis Trial. In total, 230 men and 207 women (mean age 66.8 (SD 8.3)) were included. All patients underwent an MRI including T1- and T2-weighted sequences. Grade of foraminal stenosis was dichotomized into none to moderate (0-1) and severe (2-3) category using Lee's classification system. The Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and numeric rating scale (NRS) for back and leg pain were collected at baseline and at 2-year follow-up. Primary outcome was a reduction of 30% or more on the ODI score. Secondary outcomes included the mean improvement on the ODI, ZCQ, and NRS scores. We performed multivariable regression analyses with the radiological variates foraminal stenosis, Pfirrmann grade, Schizas score, dural sac cross-sectional area, and the possible plausible confounders: patients' gender, age, smoking status, and BMI. RESULTS: The cohort of 437 patients presented a high degree of degenerative changes at baseline. Of 414 patients with adequate imaging of potential foraminal stenosis, 402 were labeled in the none to moderate category and 12 in the severe category. Of the patients with none to moderate foraminal stenosis, 71% achieved at least 30% improvement in ODI. Among the patients with severe foraminal stenosis, 36% achieved at least 30% improvement in ODI. A significant association between severe foraminal stenosis and less chance of reaching the target of 30% improvement in the ODI score after surgery was detected: OR 0.22 (95% CI 0.06, 0.83), p=0.03. When investigating outcome as continuous variables, a similar association between severe foraminal stenosis and less improved ODI with a mean difference of 9.28 points (95%CI 0.47, 18.09; p=0.04) was found. Significant association between severe foraminal stenosis and less improved NRS pain in the lumbar region was also detected with a mean difference of 1.89 (95% CI 0.30, 3.49; p=0.02). No significant association was suggested between severe foraminal stenosis and ZCQ or NRS leg pain. CONCLUSION: In patients operated with posterior microsurgical decompression for LSS, a preoperative severe lumbar foraminal stenosis was associated with higher proportion of patients with less than 30% improvement in ODI. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov (22.11.2013) under the identifier NCT02007083.

Transmission-Based Vertebrae Strength Probe Development: Far Field Probe Property Extraction and Integrated Machine Vision Distance Validation Experiments.

We are developing a transmission-based probe for point-of-care assessment of vertebrae strength needed for fabricating the instrumentation used in supporting the spinal column during spinal fusion surgery. The device is based on a transmission probe whereby thin coaxial probes are inserted into the small canals through the pedicles and into the vertebrae, and a broad band signal is transmitted from one probe to the other across the bone tissue. Simultaneously, a machine vision scheme has been developed to measure the separation distance between the probe tips while they are inserted into the vertebrae. The latter technique includes a small camera mounted to the handle of one probe and associated fiducials printed on the other. Machine vision techniques make it possible to track the location of the fiducial-based probe tip and compare it to the fixed coordinate location of the camera-based probe tip. The combination of the two methods allows for straightforward calculation of tissue characteristics by exploiting the antenna far field approximation. Validation tests of the two concepts are presented as a precursor to clinical prototype development.

Surgery in degenerative spondylolisthesis: does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial).

BACKGROUND CONTEXT: Patients with spinal stenosis and degenerative spondylolisthesis are treated surgically with decompression alone or decompression with fusion. However, there is debate regarding which subgroups of patients may benefit from additional fusion. PURPOSE: To investigate possible treatment effect modifiers and prognostic variables among patients operated for spinal stenosis and degenerative spondylolisthesis. DESIGN: A secondary exploratory study using data from the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis (NORDSTEN-DS) trial. Patients were randomized to decompression alone or decompression with instrumented fusion. PATIENT SAMPLE: The sample in this study consists of 267 patients from a randomized multicenter trial involving 16 hospitals in Norway. Patients were enrolled from February 12, 2014, to December 18, 2017. The study did not include patients with degenerative scoliosis, severe foraminal stenosis, multilevel spondylolisthesis, or previous surgery. OUTCOME MEASURES: The primary outcome was an improvement of ≥ 30% on the Oswestry Disability Index score (ODI) from baseline to 2-year follow-up. METHODS: When investigating possible variables that could modify the treatment effect, we analyzed the treatment arms separately. When testing for prognostic factors we analyzed the whole cohort (both treatment groups). We used univariate and multiple regression analyses. The selection of variables was done a priori, according to the published trial protocol. RESULTS: Of the 267 patients included in the trial (183 female [67%]; mean [SD] age, 66 [7.6] years), complete baseline data for the variables required for the present analysis were available for 205 of the 267 individuals. We did not find any clinical or radiological variables at baseline that modified the treatment effect. Thus, none of the commonly used criteria for selecting patients for fusion surgery influenced the chosen primary outcome in the two treatment arms. For the whole cohort, less comorbidity (American Society of Anesthesiologists Classification [ASA], OR = 4.35; 95% confidence interval (CI [1.16-16.67]) and more preoperative leg pain (OR = 1.23; CI [1.02-1.50]) were significantly associated with an improved primary outcome. CONCLUSIONS: In this study on patients with degenerative spondylolisthesis, neither previously defined instability criteria nor other pre-specified baseline variables were associated with better clinical outcome if fusion surgery was performed. None of the analyzed variables can be applied to guide the decision for fusion surgery in patients with degenerative spondylolisthesis. For both treatment groups, less comorbidity and more leg pain were associated with improved outcome 2 years after surgery. TRIAL REGISTRATION: NORDSTEN-DS ClinicalTrials.gov, NCT02051374.

High Risk for Persistent Peri-Prosthetic Infection and Amputation in Mega-Prosthesis Reconstruction.

A peri-prosthetic joint infection is a feared complication after mega-prosthesis reconstruction of large bone defects. The current study investigates how patients operated with a mega-prosthesis due to sarcoma, metastasis, or trauma, are affected by a deep infection focusing on re-operations, risk for persistent infection, arthrodesis, or subsequent amputation. Time to infection, causative bacterial strains, mode of treatment and length of hospital stay are also reported. A total of 114 patients with 116 prostheses were evaluated, a median of 7.6 years (range 3.8-13.7) after surgery, of which 35 (30%) were re-operated due to a peri-prosthetic infection. Of the infected patients, the prosthesis was still in place in 51%, 37% were amputated, and 9% had an arthrodesis. The infection was persistent in 26% of the infected patients at follow-up. The mean total length of hospital stay was 68 (median 60) days and the mean number of reoperations was 8.9 (median 6.0). The mean length of antibiotic treatment was 340 days (median 183). Coagulase-negative staphylococci and Staphylococcus aureus were the most frequent bacterial agents isolated in deep cultures. No MRSA- or ESBL-producing Enterobacterales were found but vancomycin-resistant Enterococcus faecium was isolated in one patient. In summary, there is a high risk for peri-prosthetic infection in mega-prostheses, resulting in persistent infection or amputation relatively often.

Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial.

BACKGROUND: Cervical spondylotic myelopathy (CSM) is the predominant cause of spinal cord dysfunction in the elderly. The patients are often frail and susceptible to complications. Posterior surgical techniques involving non-fusion are complicated by postlaminectomy kyphosis and instrumented fusion techniques by distal junction kyphosis, pseudarthrosis, or implant failure. The optimal surgical approach is still a matter of controversy. Since anterior and posterior fusion techniques have been compared without presenting any superiority, the objective of this study is to compare stand-alone laminectomy with laminectomy and fusion to determine which treatment has the lowest frequency of reoperations. METHODS: This is a multicenter randomized, controlled, parallel-group non-inferiority trial. A total of 300 adult patients are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason at 5 years of follow-up. Sample size and power calculation were performed by estimating the reoperation rate after laminectomy to 3.5% and after laminectomy with fusion to 7.4% based on the data from the Swedish spine registry (Swespine) on patients with CSM. Secondary outcomes are the patient-derived Japanese Orthopaedic Association (P-mJOA) score, Neck Disability Index (NDI), European Quality of Life Five Dimensions (EQ-5D), Numeric Rating Scale (NRS) for neck and arm pain, Hospital Anxiety and Depression Scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA), and death. Clinical and radiological follow-up is performed at 3, 12, 24, and 60 months after surgery. The main inclusion criterium is 1-4 levels of CSM in the subaxial spine, C3-C7. The REDcap software will be used for safe data management. Data will be analyzed according to the modified intention to treat (mITT) population, defined as randomized patients who are still alive without having emigrated or left the study after 2 and 5 years. DISCUSSION: This will be the first randomized controlled trial comparing two of the most common surgical treatments for CSM: the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the myelopathy randomized controlled (MyRanC) study will provide surgical treatment recommendations for CSM. This may result in improvements in surgical treatment and clinical practice regarding CSM. TRIAL REGISTRATION: ClinicalTrials.gov NCT04936074 . Registered on 23 June 2021.

Intramuscular Pressure and Patient-Reported Outcomes in Patients Surgically Treated for Anterior Chronic Exertional Compartment Syndrome.

Background: Chronic exertional compartment syndrome (CECS) causes exercise-induced leg pain. The diagnosis is confirmed by intramuscular pressure (IMP) measurements. Fasciotomy has been demonstrated to be a successful treatment for CECS; however, few studies have examined postoperative IMP and long-term outcomes. Purpose: To evaluate long-term outcomes and postoperative IMP in patients surgically treated for anterior CECS, and to identify possible preoperative or postoperative factors associated with overall satisfaction with treatment at follow-up. Study Design: Case-control study; Level of evidence, 3. Methods: A consecutive series of 209 patients who underwent fasciotomy of the anterior compartment for CECS between 2009 and 2019 and had at least 1 year of follow-up were approached for inclusion. A total of 144 patients (69%), with a follow-up time of 1 to 11.5 years, were ultimately included. All patients underwent preoperative and postoperative 1-minute postexercise IMP measurements of the anterior compartment and completed a questionnaire covering pain and activity parameters at both time points. The follow-up questionnaire included an additional question on overall satisfaction with treatment, and surgical details were collected from the patient's medical records. Results: The median IMP was significantly lower at follow-up than at baseline (17 mm Hg [range, 5-91 mm Hg] vs 49 mm Hg [range, 25-130 mm Hg]; P < .001). The overall satisfaction rate was 77%, and 83% reported a decreased pain level. The group of patients who were satisfied with the treatment included more men and had a higher ΔIMP and a lower revision rate (P < .05). Among the 16 patients (11%) who had undergone revision fasciotomies before follow-up, the satisfaction rate was 56%, and 64% reported a decrease in pain level. Conclusion: Fasciotomy significantly reduced 1-minute postexercise IMP in patients with CECS and resulted in satisfaction and decreased pain in more than three-quarters of the patients at long-term follow-up. The male sex and a significant decrease in IMP were both positively associated with treatment satisfaction. Patients who underwent revision surgery before the follow-up had lower satisfaction rates and less pain reduction than the overall group.