Spine最新文献

Study design: Observational epidemiological study.

Objective: This study's primary objective was to examine the risk of recall for novel spine devices over time. Secondarily, we sought to analyze interbody fusion and vertebral body replacement (VBR) devices (corpectomy cages) as a risk factor for recall.

Background: The recall risk of a novel spine device over time has not been reported. In addition, FDA regulations were lowered for interbody fusion devices to enter the market in 2007. As well, VBR implants were recently approved by the FDA for use in the cervical spine in 2015.

Materials and methods: Spine devices cleared between January 1, 2008 and December 31, 2018 were identified from the FDA's 510(k) database. All recall data were collected from the database in January 2021 to provide a 2-year minimum follow-up for a recall to occur. Product labels were used to classify interbody fusion and VBR devices. Cumulative incidence function was conducted to compare the overall risk of recall for FDA-cleared spine devices, and the hazard ratio determined for VBR and all other devices versus interbody implants during the study period.

Results: A total of 2384 spine devices were cleared through 510(k) in the study period. The hazard of recall at 5 years was 5.3% (95% CI: 4.4%-6.2%) and 6.5% (95% CI: 5.4%-7.7%) at 10 years. No significant difference in recall risk was identified for interbody fusion and VBR devices.

Conclusion: The risk of recall at 5 and 10 years of a novel spine device is about half the 12% rate reported for orthopedic devices in general. Despite lowered FDA regulations for interbody fusion devices and recent approval for VBR device use in the cervical spine, no increased risk of recall was detected. Further research is necessary to explain the reason for the lower risk of recall with spine devices.

Level of evidence: 4.

Study design: Systematic review and meta-analysis.

Objective: This study aims to assess the effectiveness of lumbar segmental stabilization exercise (LSSE) in managing spondylolysis and spondylolisthesis.

Summary of background data: Spondylolysis and spondylolisthesis are spinal disorders associated with lumbar segmental instability. LSSE has shown positive effects in treating these conditions; however, systematic reviews and meta-analyses are lacking.

Materials and methods: A systematic search adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, including studies from the inception of the databases used up to January 2024, was conducted. Disability improvement and pain intensity change were the primary and secondary outcomes, respectively, standardized using Hedges g . Eligible articles underwent independent scrutiny by two authors, who also performed data extraction and quality assessment. Data pooling was accomplished using a random-effects model.

Results: In total, five randomized controlled trials comprising 198 participants were included, revealing a trend effect toward disability improvement in the LSSE group (Hedges g =-0.598, 95% CI: -1.211 to 0.016, P =0.056, I2 =75.447%). When the LSSE was administered as a single treatment, disability improvement became significant (Hedge g =-1.325, 95% CI: -2.598 to -0.053, P =0.041, I2 =80.020%). No significant effect of LSSE on pain reduction was observed (Hedges g =-0.496, 95% CI: -1.082 to 0.090, P =0.097, I2 =73.935%).

Conclusions: In summary, our meta-analysis suggests that LSSE can potentially improve disability, especially when used as a single treatment. LSSE appears more beneficial in reducing disability than alleviating pain. Future research on different patient groups is needed to understand comprehensively LSSE's effects on other musculoskeletal disorders.

Study design: Translation and psychometric testing.

Objectives: The objective of this study was to translate and culturally adapt the Pain Self-Efficacy Questionnaire (PSEQ) into Hindi (PSEQ-H), the local language of India, and assess its psychometric properties.

Background: The PSEQ is a commonly used outcome measure in patients with pain and related psychosocial aspects too. The PSEQ invites participants to consider their pain while assessing their self-efficacy views. Because about half of India's population understands Hindi, there is a need to translate the PSEQ into Hindi for patient convenience and better comprehension, as well as for research purposes.

Materials and methods: The PSEQ has been translated and culturally adapted into Hindi. A total of 120 patients with chronic neck pain were recruited. The PSEQ-H's content validity, construct validity, internal consistency, test-retest reliability, and responsiveness were all assessed. To determine test-retest reliability, the intraclass correlation coefficient was calculated. Cronbach alpha was used to determine internal consistency. Criterion validity was assessed using the neck disability index, NRS, and anxiety and depression measures. The area under the curve and the change cut-point were determined using the receiver operating characteristic curve analysis.

Results: The PSEQ-H exhibited strong test-retest reliability (intraclass correlation coefficient = 0.90) and good internal consistency (Cronbach alpha = 0.88). Factor analysis confirmed a one-factor structure for the PSEQ-H. Furthermore, the PSEQ-H demonstrated a moderate correlation with the neck disability index, numerical pain rating scale, anxiety, and depression scales. A change detection threshold of 8.3 was established.

Conclusions: The PSEQ-H is a reliable and valid measure for use in research and clinical purposes in the Indian population with chronic neck pain.

Level of evidence: Level II.

Study design: Case-control study.

Objective: To introduce a classification system that will include the major types of degenerative changes and failures related to the proximal junction, and to determine the clinical course and characteristics for the different types of proximal junctional degeneration.

Background: Proximal junctional kyphosis and failures are well recognized after adult spinal fusion; however, a standardized classification is lacking.

Materials and methods: The proposed system identified 4 different patterns of proximal junctional degeneration: (1) Type 1 (multilevel symmetrical collapse), (2) Type 2 (single adjacent level collapse), (3) Type 3 (fracture), and (4) Type 4 (spondylolisthesis). A single-center database was reviewed from 2018 to 2021. Patients 18 years or older of age, who underwent posterior spinal fusion of ≥3 levels with an upper instrumented vertebral level between T8 and L2, and a follow-up of ≥2 years were included. Radiographic measurements, revision surgery, and time to revision were the primary outcomes.

Results: One hundred fifty patients were included with a mean age of 65.1 (±9.8) years and a mean follow-up of 3.2 (±1) years. Sixty-nine patients (46%) developed significant degenerative changes in the proximal junction and were classified accordingly. Twenty (13%) were type 1, 17 (11%) were type 2, 22 (15%) were type 3, and 10 (7%) were type 4. Type 3 had a significantly shorter time to revision with a mean of 0.9 (±0.9) years. Types 3 and 4 had greater preoperative sagittal vertical axis, and types 1 and 3 had greater final follow-up lumbar lordosis. Bone density measured by Hounsfield units showed lower measurements for type 3. Types 1 and 4 had lower rates of developing proximal junctional kyphosis. Type 1 had the lowest revision rate with 40% (types 2, 3, and 4 were 77%, 73%, and 80%, respectively, P = 0.045).

Conclusion: This novel classification system defines different modes of degeneration and failures at the proximal junction, and future studies with larger sample sizes are needed for validation.

Level of evidence: Level III.

Study design: Retrospective cohort study.

Objective: The aim of this study was to compare perioperative adverse events and reoperations between navigation-assisted and robotic-assisted posterior lumbar fusion.

Summary of background data: Navigation has become increasingly utilized for posterior lumbar fusion (PLF). More recently, robotic-assisted systems have been gaining traction. However, the incremental advantage of these systems has been unclear in the literature.

Methods: Patients undergoing one-level to three-level PLF (with or without anterior or posterior interbody fusion) were identified from the 2015 to 2022 M161Ortho PearlDiver Database using CPT codes. Navigation assistance was identified based on CPT coding and robotic assistance was based on ICD-10 procedural coding. Navigation-assisted cases were matched 4:1 to robotic-assisted patients based on age, sex, Elixhauser Comorbidity Index, number of levels fuse, and concomitant anterior fusion. Incidence of 90-day adverse outcomes were assessed and compared with multivariable logistical regression. Bonferroni correction was applied for multiple testing. Rate of reoperation was assessed using the Kaplan-Meier survival analysis.

Results: From 2015 to 2022, there has been a significant increase in both navigation-assisted and robotic-assisted lumbar fusions, with navigation-assisted surgery being significantly more common. After matching, there were 2401 navigation-assisted cases and 651 robotic-assisted cases. On multivariate analysis, there were no significant differences in 90-day any, severe, or minor adverse events. There was a significant increase odd of readmissions in the robotic cohort (OR: 1.77, P <0.001). There were no differences in 3-year reoperation rates between the navigation-assisted and robotic-assisted cohorts (95.8% vs. 94.0%, P =0.30).

Conclusions: As spinal navigation has been gaining popularity and robotic assistance is starting to be further utilized, the incremental advantage of different techniques may be questioned. While further study and technique evolution are ongoing, the current study was not able to demonstrate 90-day or 3-year incremental advantages for robotics relative to navigation based on the metrics evaluated.

Level of evidence: Level III.

Study design: Prospective cohort study.

Objective: Investigating the ability of a 6-minute walking test (6MWT) to assess functional status in patients with cervical spondylotic myelopathy (CSM).

Summary of background data: The 6MWT provides an objective assessment of a patient's ability to walk. There is the potential for its application to the assessment of functional status in patients with CSM.

Materials and methods: One hundred thirty-five patients from our institution were prospectively enrolled from July 2022 to August 2023. A control group of age-matched and sex-matched healthy individuals was established. The 6MWT was conducted in strict accordance with established guidelines. The Nurick score, the Prolo score, the Cooper-myelopathy-scale score (CMS), the Japanese Orthopedic Association score (JOA) and the European-myelopathy-scale score (EMS) were assessed preoperatively. Visual Analog Scale (VAS) for pain or numbness and Oswestry Neck Disability Index (NDI) were also collected. Radiographic parameters were measured and recorded. Continuous variables between patients and controls were compared by applying the t test. The χ 2 test was used to compare gender ratios between groups. Pearson correlation analysis was used to analyze the association between continuous variables and ordinal variables. Subgroups of CSM patients were analyzed according to global spinal alignment types based on whether the SVA was ≥50 mm. Clinical scores and imaging parameters were compared by t test.

Results: The preoperative 6-minute walking distance (6MWD) of CSM patients was 309.34 ± 116.71 m, which was significantly lower than that of the controls (464.30 ± 52.59 m, P <0.01). The 6MWD was significantly correlated with scores on all clinical scales except the VAS. CMS Lower extremity score had the strongest correlation with preoperative 6MWD in CSM patients (r=-0.794, P <0.01). Of the sagittal alignment parameters, only C7 sagittal vertical axis (SVA) and T1 slope were significantly correlated with 6MWD(r=-0.510, -0.360, respectively). CSM patients with SVA >50 mm had significantly lower 6MWD than CSM patients with SVA ≤50 mm (168.00 ± 137.26 vs. 346.24 ± 84.27 m, P <.01).

Conclusions: The 6MWD of CSM patients was significantly lower than that of the healthy population and correlated well with commonly used clinical scales. The 6MWD can potentially assist in the assessment of functional status in patients with CSM.

Study design: Retrospective study.

Objective: The objective of this study was to report the clinical data for patients treated with mobile spine chondrosarcoma.

Summary of background data: Chondrosarcoma of the mobile spine is a rare and challenging entity. A handful of case series have been published that report the clinical results of treatment, largely influenced by chondrosarcoma of the appendicular skeleton and pelvis. The clinical results of patients treated for chondrosarcoma of the mobile spine from our institution were published over 10 years ago and this represents and update since that publication.

Methods: Inclusion criteria were adults patients treated for chondrosarcoma of the mobile spine at Massachusetts General Hospital between 2007 and 2020. Patients with large sacral tumors extending into the lumbar spine were excluded. Furthermore, we excluded patients with metastatic chondrosarcoma undergoing palliative decompressions for neurological instability or instrumented procedures for biomechanical instability. Therefore, only patients undergoing definitive surgery at the primary site of disease in the mobile spine were included.

Results: A total of 24 patients were included for review in this series. Seventeen of the 24 patients had their tumors excised with negative (R0) margins. Three of these 17 patients (18%) were dead of disease at final follow-up. There were two patients with R1 resections and five patients with R2 resections. Three of the seven patients (43%) with positive margins were dead of disease at final follow-up. A Cox proportional hazard analysis indicated total radiation dose was a significant covariate (HR=1.18, 95% CI: 1.01-1.39, P =0.03).

Conclusions: We found higher percentages of overall survival with R0 tumor resection and lower histologic grade, whereas development of metastatic disease was closely associated with local recurrence and poor survival. Despite the improvements in treatment paradigms, it is sobering that our findings largely mirror those of previous work considering patients treated between 1984 and 2006.

Study design: Animal laboratory study.

Objective: This study investigated the effects of Cutibacteriumacnes and Staphylococcusepidermidis on the lumbar discs of rabbits, as well as the outcomes of combined infection.

Summary of background data: Many studies have indicated that bacterial infections are associated with lumbar disc degeneration (LDD). The most commonly cultured bacteria from disc tissues are C. acnes and S. epidermidis .

Methods: New Zealand white rabbits (n=40) were randomly divided into control, C. acnes , S. epidermidis , and C. acnes plus S. epidermidis ( i.e. , combined) groups. All groups except the control were injected with 25 μL of saline at L4-L5 and 25 μL of bacteria (1×10 7 CFU/mL) at L5-L6. All injections were performed under x-ray guidance. Weight measurements, haematological evaluations, and magnetic resonance imaging were performed after 4, 8, and 12 weeks. Histological examination and gene expression detection were performed 12 weeks after surgery.

Results: Inflammatory factors in the blood and weight did not differ among the groups after 4, 8, and 12 weeks ( P >0.05). However, after 4 weeks, LDD occurred in the C. acnes group, and discitis occurred in the S. epidermidis and combined groups, all of which worsened after 8 weeks. After 12 weeks, the nucleus pulposus (NP) protruded and compressed the spinal cord in the C. acnes group, and tissue staining showed decreased NP tissue and cartilaginous endplate fracture. In the S. epidermidis and combined groups, the discitis was more confined, but tissue staining revealed a significant decrease in NP tissue, and loss of the normal disc structure.

Conclusions: In the early stage of infection in rabbits, C. acnes caused LDD, and S. epidermidis caused discitis. Coinfection with C. acnes and S. epidermidis caused discitis but was more limited in scope than infection with S. epidermidis alone.

Study design: Systematic review.

Objective: To identify commonly reported indications and outcomes in spinal column shortening (SCS) procedures.

Background: SCS is a surgical procedure used in patients with tethered cord syndrome-characterized by abnormal attachment of neural components to surrounding tissues-to shorten the vertebral column, release tension on the spinal cord/neural elements, and alleviate associated symptoms.

Patients and methods: PubMed and EMBASE searches captured SCS literature published between 1950 and 2023. Prospective/retrospective cohort studies and case series were included without age limit or required follow-up period. Review articles without new patient presentations, meta-analyses, systematic reviews, conference abstracts, and letters were excluded. Studies included adult and pediatric patients.

Results: The 29 identified studies represented 278 patients (aged 5-76 yr). In 24.1% of studies, patients underwent primary tethered cord syndrome intervention through SCS. In 41.4% of studies, patients underwent SCS after failed previous primary detethering (24.1% of studies were mixed and 10.3% were unspecified). The most commonly reported nongenitourinary/bowel surgical indications were back pain (55.2%), lower-extremity pain (48.3%), lower-extremity weakness (48.3%), lower-extremity numbness (34.5%), and lower-extremity motor dysfunction (34.5%). Genitourinary/bowel symptoms were most often described as nonspecific bladder dysfunction (58.6%), bladder incontinence (34.5%), and bowel dysfunction (31.0%). After SCS, nongenitourinary/bowel outcomes included lower-extremity pain (44.8%), back pain (31.0%), and lower-extremity sensory and motor function (both 31.0%). Bladder dysfunction (79.3%), bowel dysfunction (34.5%), and bladder incontinence (13.8%) were commonly reported genitourinary/bowel outcomes. In total, 40 presenting surgical indication categories and 33 unique outcome measures were reported across studies. Seventeen of the 278 patients (6.1%) experienced a complication.

Conclusion: The SCS surgical literature displays variability in operative indications and postoperative outcomes. The lack of common reporting mechanisms impedes higher-level analysis. A standardized outcomes measurement tool, encompassing both patient-reported outcome measures and objective metrics, is necessary.

Level of evidence: Level IV.

Study design: Retrospective multicenter study.

Objective: To examine the shape change of screw-rod constructs over time after short-segment lumbar interbody fusion and to clarify its relationship to clinical characteristics.

Summary of background data: No study has focused on the shape change of screw-rod constructs after short-segment fusion and its clinical implications.

Methods: One hundred eight patients who had single-level lumbar interbody fusion with pedicle screws and cages were enrolled. Three-dimensional (3D) images of screw-rod constructs were generated from baseline CT on the day after surgery and follow-up CT and were superposed on the right and left side, respectively, using the iterative closest point algorithm. The shape change was quantitatively assessed by computing the median distance between the 3D images, which was defined as the shape change value. Among the 5 time-course categories of follow-up CT (≤1, 2-3, 4-6, 7-12, and ≥13 months), the shape change values were compared. The relationships between the shape change values and clinical characteristics, such as age, CT-derived vertebral bone mineral density, screw and rod materials, and postoperative interbody fusion status, cage subsidence, and screw loosening, were evaluated.

Results: A total of 237 follow-up CTs were included (≤1 [34 scans], 2-3 [33 scans], 4-6 [80 scans], 7-12 [48 scans], and ≥13 months [42 scans]) because many patients underwent multiple follow-up CTs. There were significant differences in shape change values among the time-course categories ( P <0.001 in Kruskal-Wallis test). Most shape changes occurred within 6 months postoperatively, with no significant changes observed at 7 months or more. There were no significant relationships between the shape change values and each clinical characteristic.

Conclusions: The temporal shape changes of screw-rod constructs following short-segment lumbar interbody fusion progressed up to 6 months after surgery but not significantly thereafter.