Spine最新文献

Study design: Experimental study.

Objective: To create an early-onset scoliosis (EOS) rabbit model and use a design-based stereological method to quantitatively assess lung structure changes at 24 weeks of age.

Summary of background data: Scoliosis affects thoracic and lung development, impacting children's chest and lung growth.

Materials and methods: EOS was induced via rib tethering in 4-week-old rabbits with ongoing CT scans and weight measures. Lungs were extracted postfixation for volume estimation and tissue sampling, followed by microscopic analysis of lung morphology.

Results: The mean Cobb angle increased with the rabbits' growth. The EOS group showed significant decreases in total and right lung volumes. Quantitative lung stereology revealed reduced volumes of lung parenchyma and nonparenchymal tissue in all lobes. Alveolar duct volumes decreased significantly in multiple lobes, and alveolar septal volume was notably reduced in the right upper, middle, and lower lobes. The alveolar septal area decreased, and septal thickness increased in the EOS group. Alveoli numbers dropped, with variable changes in mean alveolar volume across lobes. Vascular lumen volume decreased in the right middle and lower lobes, and blood vessel and perivascular tissue volumes were significantly reduced in the right lung. Vessel diameter changes varied across lobes, with significant decreases in the right middle and lower lobes and increases in the left upper and lower lobes. Vascular endothelial surface area decreased in the left lower, right middle, and right lower lobes, with increased vessel and perivascular tissue thickness in the left upper and lower lobes compared with the right lobes.

Conclusion: The EOS rabbit model demonstrated reduced lung volume, impaired alveolarization, septal thickening, and vascular changes, indicating scoliosis's negative impact on thoracic and lung development, especially on the concave lung.

Study design: Single-center retrospective cohort study.

Objective: To identify risk factors for transfusion during long-segment thoracolumbar fusion surgery and benchmark cutoffs that could be used by the operative team to guide the use of transfusion.

Summary of background data: Perioperative transfusion for patients undergoing long-segment thoracolumbar fusion surgery is common. To date, no standardized intraoperative and perioperative management of transfusion administration has been defined.

Methods: Patients who underwent thoracolumbar fusion surgeries of 8 or more levels between 2015 and 2020 were identified. Patient demographics, surgical details, anesthesia and critical care records, and laboratory data were compared between patients who received intraoperative and postoperative blood transfusions and those who did not. Univariate and multivariate propensity-matched analyses were performed to identify independent predictors for blood transfusion, and ordinal analysis was performed to identify possible benchmark cutoffs.

Results: Among 233 patients identified who underwent long-segment fusions, 133 (57.1%) received a blood transfusion. Multivariate propensity-matched logistic regression showed that intravenous (IV) fluid volume was an independent predictor for transfusion (transfusion group 8051 mL vs. non-transfusion group 5070 mL, P <0.01). Patients who received ≥4 L total IV fluids were more likely to undergo transfusion than those who received <4 L (93.2% vs. 50.7%, P <0.01). Those receiving total IV fluids at a rate ≥60 mL/kg (OR 10.45; 95% CI, 2.62-41.72; P <0.01) or intraoperative IV fluids at a rate ≥9 mL/kg/hr (OR 4.46; 95% CI, 1.39-14.32; P <0.01) were more likely to require transfusions.

Conclusions: IV fluid administration is an independent predictor for blood transfusion after long-segment fusion surgery. Limiting IV fluid administration may prevent iatrogenic hemodilution and decrease transfusion rates. These data can be used to create perioperative protocols with the goal of decreasing transfusion rates when not indicated and allowing earlier administration when indicated.

Study design: Prospective observational cohort.

Objectives: To report on the role of a single wearable sensor in the evaluation of patients with Cervical Spondylotic Myelopathy (CSM).

Summary of background data: Clinical evaluation of CSM is limited, as Hoffmann's sign, Romberg testing and Tandem Gait are largely subjective and binary, making deterioration or improvement difficult to document accurately.

Methods: Patients scheduled for surgical treatment of CSM underwent in-office and 24-hour continuous at-home data collection using a single wearable sensor. In-office testing consisted of Standing, Romberg testing, Tandem Gait and Timed Up & Go (TUG). Testing was repeated 6-months post-operatively.

Results: Statistically significant improvements were seen following surgical treatment in the Romberg test eyes-open maximum antero-posterior sway (P=0.010), eyes-open total path traveled (P=0.048); in Tandem Gait speed (P=0.021), duration (P=0.002), antero-posterior sway (P=0.046) and initial peak acceleration (P=0.001). There was no statistically significant difference in TUG testing. At-home gait pattern revealed a trend toward decreased lateral sway post-operatively (P=0.062) and fewer sleep turns (P=0.078).

Conclusion: Wearable sensor data effectively quantifies standard exam findings and identifies new metrics with the potential to assess more accurately pre-operative and post-operative function in patients with CSM. Previously unreported pre-operative to 6-month post-operative changes were seen in speed of gait and ground impact force during Tandem Gait. These metrics were more sensitive as compared to the normal antero-posterior and lateral sway assessment. 24-hour sensor data showed decreased number of turns during sleep post-operatively. This study suggests that wearable sensor data will be a viable source for quantifiable data with the potential to guide treatment for patients with CSM. This capability is based partly on better quantification of existing binary measures, but also on identification of unanticipated patterns within the data.

Study design: A retrospective real-world study.

Objective: Using machine learning models to identify risk factors for residual pain after PLIF in patients with degenerative lumbar spine disease.

Summary of background data: Residual pain after PLIF is a frequent phenomenon, and the specific risk factors for residual pain are not known.

Materials and methods: Between June 2018 and March 2023, 936 patients with lumbar degenerative disease who underwent PLIF surgery were recruited. Group A (n=501) had <7 days of VAS ≥3 pain within 1 month post-PLIF, while Group B (n=435) had ≥7 days. Imaging outcomes included PMI, MMI, MMD, lumbar lordosis (LL), and LL improvement rate. Functional outcomes were assessed by VAS. Univariate and multivariate logistic regression analyses were used to determine the potential risk of short-term postoperative pain. Risk factors were identified using machine learning models and predicted whether residual pain would occur.

Results: A total of 435 (46.5%) patients experienced residual postoperative pain. Independent risk factors included surgical segment, PMI, MMI, and depression level. The Random Forest Model model had an accuracy of 95.7%, a sensitivity of 96.4%, a specificity of 94.1%, and an F1 score of approximately 95.2% for predicting recurrent pain, indicating high reliability and generalizability.

Conclusions: Our study reveals risk factors for the development of residual pain after PLIF. Compared to the group with residual pain, the group without pain had more robust paravertebral muscles, improved psychological characteristics and a greater LL improvement rate. These factors may represent targets for pre-operative and peri-operative optimization as a means to minimize the potential for residual pain following PLIF.

Study design: Randomized controlled trial.

Objective: The aim of this study was to investigate whether instrumented posterolateral fusion is cost-effective compared to un-instrumented posterolateral fusion in elderly patients who undergo fusion surgery for one-level degenerative spondylolisthesis with spinal stenosis.

Summary of background data: For patients with persistent symptoms due to degenerative spondylolisthesis, surgical intervention may be recommended, typically decompression and fusion. Evidence on cost-effectiveness of choice of fusion method, related complications and outcome is sparse.

Methods: This cost-effectiveness analysis is based on a single-center, open label, randomized controlled trial, where patients with symptomatic degenerative spondylolisthesis were randomly assigned 1:1 to either instrumented or un-instrumented posterolateral fusion. Quality-Adjusted Life Years were obtained from EQ-5D. Use of health services were obtained from patient charts and accumulated until 2 years after index surgery.

Results: Of the 108 patients included in the study, 107 patients received the allocated intervention. There were no differences in preoperative demographics. Although the base price for the index instrumented surgery was significantly higher than the index uninstrumented surgery, average cost of surgery was only €146 higher in the instrumented group based on two-year cost data. The instrumented fusion group had a significantly lower reoperation rate (1/54 (1.9%)) than the uninstrumented fusion group 7/53 (13.2%), significantly less visits to the outpatient clinic, less Magnetic Resonance Imaging performed and fewer days of hospitalization. The base case incremental cost-effectiveness ratio was estimated at €1,536 per QALY gained over a two-year time horizon. Instrumented fusion was favored over uninstrumented fusion in sensitivity analyses including all reoperations or using hospital reimbursement rate.

Conclusion: Insturumented fusion is cost-effective compared uninstrumented fusion, with an incremental cost-effectiveness ration well below the standard range of cost-effectivenes, the difference in cost was driven by lower re-operation rates and less healthcare resource utilization over a two-year time horizon.

Study design: Retrospective review of a prospectively collected single-center adolescent idiopathic scoliosis (AIS) database.

Objective: To evaluate the incidence and predictors of growth modulation and overcorrection after vertebral body tethering (VBT) in AIS.

Background: Little data exists regarding which AIS patients will exhibit growth modulation and/or overcorrection after VBT compared to those whose curve correction will remain unchanged (no modulation).

Materials and methods: A total of 279 patients with AIS with a minimum 2-year follow-up (range 2-10 years) were included. There were 262 thoracic and 65 thoracolumbar VBT surgeries performed. Univariate and multivariate regression analyses were performed to identify the potential clinical/radiographic predictive factors for growth modulation and overcorrection.

Results: Patients with growth modulation and those with no modulation after thoracic VBT were significantly more immature (younger, premenarchal, lower Sanders score/Risser grade, open triradiate cartilage [TRC]) and physically smaller (lower height, weight, and body mass index [BMI]; P<0.02). Patients with growth modulation vs. no modulation after thoracolumbar VBT had lower preoperative Sanders score, weight, and BMI (P<0.04). Preoperative and first-erect thoracic and lumbar curve magnitudes did not affect growth modulation vs. no modulation. Patients with thoracic overcorrection were physically smaller (lower height/weight/BMI) and had lower preoperative and first-erect thoracic curves than patients with growth modulation without overcorrection (P<0.04). Patients with thoracolumbar overcorrection had open-TRC and lower first-erect lumbar curves than patients with growth modulation without overcorrection (P<0.04). Open-TRC (odds ratio: 6.8, P<0.001) and lower BMI (P<0.001) were the only significant predictive factors for thoracic growth modulation in multivariate analysis; none were identified for thoracolumbar growth modulation. Sixty-four percent of patients with overcorrection required revision surgery versus 18% of those with no modulation (P<0.001).

Conclusion: AIS patients with open-TRC and lower BMI had a statistically higher rate of thoracic growth modulation and overcorrection after VBT in multivariate analysis. Preoperative and first-erect curve magnitudes did not affect the incidence of growth modulation.

Study design: Observational epidemiological study.

Objective: To identify and comprehensively assess reasons for recalls of spinal implant devices used in patients over the past 21 years.

Summary of background data: The number of spine implant devices on the market continues to rise. Although the Food and Drug Administration (FDA) regulates the safety of these devices, there is a paucity of literature on the reasons spine implant devices are recalled.

Methods: The FDA device recall database was queried using the search term "spine" for recalls between 2003 and 2024. Data were collected regarding recall class, recall reason, FDA 510(k)/premarket approval decision date, product manufacturer, and device indication. The data was then reviewed to identify recalls for spine implant devices.

Results: A total of 386 spine implant devices were identified between January 2003 and December 2024. Among all recalls classified, 3.4% (n=13) were class I, 88.1% (n=340) were class II, and 8.5% (n=33) were class III. The most common reasons for recall were "Device/Component design" (52.8%) and "Packing/Processing Control" (24.1%). The median number of devices recalled by manufacturers included in the study was two with the highest being 41 devices.

Conclusions: Overall, 76.9% of spine implant recalls reviewed were primarily due to issues with device design and processing control. 88.1% of recalls were classified with a class II FDA designation. This is the first study to present a retrospective regulatory analysis of FDA spine implant recalls and highlights the importance of premarket analysis and postmarketing surveillance to improve device safety.

Level of evidence: 4.

Study design: Retrospective case-control study.

Objective: To evaluate clinical outcomes of cervical microendoscopic laminotomy (CMEL) and segmental partial laminectomy (SPL) in patients with cervical spondylotic myelopathy (CSM).

Summary of background data: CSM often requires posterior decompression surgery. Conventional techniques such as laminoplasty and SPL are associated with significant challenges, including axial neck pain and reduced cervical range of motion (ROM). In contrast, CMEL, a minimally invasive approach, may offer superior outcomes. However, direct comparisons with SPL remain limited.

Methods: We retrospectively analyzed 105 patients (58 with CMEL and 47 with SPL) who underwent posterior decompression surgery for CSM between 2003 and 2020. The evaluated outcomes included intraoperative parameters, postoperative clinical measures (e.g., Neck Disability Index (NDI), Japanese Orthopaedic Association (JOA) scores, including recovery rate and treatment satisfaction), radiographic assessments, and complication rates.

Results: Compared to SPL, CMEL resulted in reduced blood loss, shorter hospital stay, less postoperative neck pain, ROM preservation, and fewer complications at 1 year postoperatively.

Conclusions: CMEL is a minimally invasive alternative to SPL, providing reduced morbidity and improved outcomes. This is particularly true for aging populations that require functional preservation and quality of life improvement. By avoiding instruments such as interlaminar spacers and implants, CMEL can potentially reduce healthcare costs.