Spine最新文献

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.

Background: 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.

Materials and 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 were 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 "Packaging and Processing Control" (24.1%). The median number of devices recalled by manufacturers included in the study was 2, 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. Of recalls, 88.1% 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: Level IV.

Study design: Prospective, multicenter, single-blind, randomized, controlled pivotal study.

Objective: To evaluate whether P-15L (PearlMatrix P-15 Peptide Enhanced Bone Graft) is noninferior in effectiveness to local autograft when applied in single-level instrumented transforaminal lumbar interbody fusion (TLIF).

Summary of background data: P-15L, an FDA-designated Breakthrough Drug-Device, is a composite drug-device combination bone graft containing P-15, a 15-amino acid polypeptide, which enhances cell binding, proliferation, and differentiation, resulting in bone formation.

Materials and methods: Skeletally mature patients, aged 22 to 80 years, with degenerative disc disease (DDD) were randomized 1:1 to P-15L (investigational) or to the local autograft (control) during single-level TLIF with a polyetheretherketone (PEEK) cage and supplemental pedicle screw fixation. The primary outcome was composite clinical success (CCS) at 24 months, defined as: no index level secondary surgical procedures; achievement of fusion; ≥15-point improvement in Oswestry low back pain disability questionnaire (ODI) from baseline; no new or worsening persistent neurological deficit relative to baseline; and no device-related serious adverse events (SAEs).

Results: A total of 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was noninferior ( P <0.0001) and superior ( P =0.002) to autograft with respect to CCS, with 55.5% of the investigational group achieving composite clinical success compared with 37.5% of the control group. P-15L had a 25.8% higher fusion rate as compared with autograft for the CCS at 24 months (84.3% vs. 58.5%, respectively). Device-related SAE rates were similar in both groups.

Conclusion: P-15L was superior to local autograft in achieving clinical success at 24 months. Furthermore, P-15L produced a significantly higher fusion rate as compared with autograft. No meaningful clinical differences were found in the incidence of device-related SAEs. P-15L appears to be a safe and effective option for TLIF.

Level of evidence: Level I.

Study design: Prospective, multicenter, single-blind, randomized, and controlled pivotal study.

Objective: Compare time-to-fusion in patients treated with P-15L (PearlMatrix TM P-15 peptide enhanced bone graft) versus local autograft over 24 months and evaluate changes in pain and quality of life at 24 months relative to baseline.

Summary of background data: P-15L, an FDA-designated breakthrough device, is a composite bone graft with P-15, a 15-amino acid polypeptide that promotes cellular adhesion, proliferation, and differentiation to support bone formation.

Methods: Patients (22-80 y) with degenerative disc disease were randomized to the investigational (P-15L) or control (local autograft) group during single-level transforaminal lumbar interbody fusion (TLIF) with a PEEK cage and supplemental pedicle screw fixation. Fusion assessments occurred at 6, 12, and 24 months. Time-to-fusion was tested for superiority as compared with the control using Kaplan-Meier survival analysis. Back and leg pain were measured using the Visual Analog Scale (VAS) and quality of life was assessed using the Short Form Survey (SF-12).

Results: The analysis included 290 patients from 33 sites; 141 (48.6%) received P-15L and 149 (51.3%) received local autograft. At randomization, at least one risk factor for pseudoarthrosis (obesity, nicotine use, or diabetes) was reported in 58.9% (83/141) of the investigational group and 60.4% (90/149) of the control group. More patients in the investigational group than the control group achieved fusion at 6 months (Kaplan-Meier fusion rates 57.6% vs. 26.9%, respectively), 12 months (68.8% vs. 41.5%, respectively), and 24 months (81.1% vs. 54.9%, respectively). P-15L was statistically superior to autograft for time-to-fusion (hazard ratio=1.87, 95% CI: 1.47-2.38; P  < 0.0001). There was marked improvement in VAS and SF-12 relative to baseline in both groups at 24 months.

Conclusion: P-15L promotes statistically superior earlier time-to-fusion than local autograft in instrumented TLIF. Both treatments resulted in clinically meaningful improvements in pain and quality of life at 24 months.

Level of evidence: Level I.

Study design: A multicenter prospective cohort study.

Objective: To comprehensively evaluate the surgical impact, including patient-reported outcomes (PROs), in elderly patients with cervical ossification of the posterior longitudinal ligament (OPLL).

Background: With the rise of aging populations worldwide, understanding the impact of age on treatment outcomes for cervical OPLL has become increasingly important. Previous studies on degenerative cervical myelopathy have highlighted inconsistent outcomes for elderly patients, with limited focus on OPLL and PROs.

Materials and methods: This prospective, multi-institutional study included 402 cervical OPLL patients from 2014 to 2017, categorized into elderly (≥75 yr, n = 79) and nonelderly (<75 yr, n = 323) groups. Clinical outcomes were assessed preoperatively and 2 years postoperatively using cervical Japanese Orthopedic Association (JOA) scores, Visual Analog Scale (VAS) scores, and the JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ). Multivariable regression analyses were conducted, adjusting for potential confounders, including demographic variables and imaging characteristics.

Results: Elderly patients had worse preoperative JOA scores (9.6 vs . 11.1, P < 0.01) and lower postoperative scores at 2 years (12.3 vs . 14.0, P < 0.01). However, the improvement in JOA scores was comparable (2.7 vs . 3.0, P = 0.48), with both exceeding the minimum clinically important difference (MCID). Complication rates and VAS score improvements were also comparable. JOACMEQ outcomes demonstrated significantly poorer upper extremity function in the elderly group following surgery ( P = 0.02), whereas no significant differences were observed between the two groups in other functional domains.

Conclusion: Despite worse baseline neurological function, elderly OPLL patients achieved similar degrees of postoperative neurological improvement as nonelderly patients. However, upper extremity function is unlikely to show significant improvement following surgery in elderly patients.

Study design: Retrospective observational cohort.

Objective: To assess the impact of short-term perioperative use of systemic steroids on the surgical outcomes of one-level to two-level transforaminal lumbar fusion (TLIF), with a primary focus on complications.

Summary of background data: Steroids are commonly used in the perioperative period, including as a standard anesthesia practice and control for postoperative pain. However, the impact of perioperative use of systemic steroids on the surgical outcomes of lumbar fusion surgery remains unclear.

Methods: We retrospectively reviewed 560 patients who underwent one-level or two-level TLIF. Complications rates within one year postoperatively were compared between the patients who received perioperative steroids and those who did not. In addition, the total cumulative steroid dose as prednisolone equivalents was compared between patients with and without complications.

Results: Three hundred eighty patients (68%) received steroids perioperatively, with a mean prednisolone equivalent dose of 110±341.3 mg. Intraoperative steroids were administered to 359 patients (64%), with a mean dose of 46.6±13.8 mg, whereas 45 patients (8%) received steroids postoperatively, with a mean dose of 558.1±863.5 mg. There were no significant differences in any complication rates between patients who received steroids perioperatively, postoperatively, or intraoperatively and those who did not, respectively. Patients who experienced complications had lower total cumulative steroid dose compared with those without any complications, and the differences reached to significant in infections (39.9±53.2 vs. 77.6±297.0 mg, P =0.015); minor complications (37.2±51.5 vs. 79.9±304.2 mg, P =0.005); and nonunion (49.8±78.1 vs. 89.1±336.5 mg, P =0.046).

Conclusion: This study found that short-term perioperative use of systemic steroids was not associated with increased complications, and perioperative administration of steroids may have potential protective effects.

Study design: Scoping review for historical perspective.

Objective: We sought to provide a comprehensive review of the number of physicians and support staff assigned to Role II and Role III facilities, and performance over the course of the 20th and 21st centuries. We sought to use the historical experience to lay the groundwork for reform efforts in anticipation of large-scale combat.

Summary of background data: The conflicts in Iraq and Afghanistan were characterized by air superiority for US forces, asymmetric engagements, and irregular combat operations. Large-scale combat operations (LSCO) that are anticipated in the future will differ in both scale and tactics-with anticipated higher numbers of severely injured personnel and spine trauma.

Materials and methods: We performed a scoping review of the available literature on Role II and Role III facilities in the US Military Health System from 1900 to the present. Compiled data included the types of Role II and III units (or military medical units that filled similar roles) in the time period 1900 to present, their assigned personnel, and performance in combat operations.

Results: The current composition and use of Role II and III surgical facilities primarily reflect the nature of combat experience in Iraq and Afghanistan. The lack of air superiority, increased reliance on ground transportation, and the volume of high-acuity combat casualties, including those with spine trauma, are anticipated to be major challenges to Role II and III facilities in the context of future LSCO. The "Golden Hour" principle that was successfully implemented during the Iraq and Afghanistan conflicts will be difficult to adhere to without adjusting the composition and capabilities of Role II and III units. Increased flexibility, interoperability, and mobility, with a reliance on larger cadres of surgical and intensive care specialists with greater familiarity with military techniques, spine trauma care, and operational medicine, are anticipated to be necessary.

Conclusions: We anticipate less of a "one-size fits all" capability for military medical units in the future and the need for robust medical units as close to the front lines as possible, with an emphasis on prolonged casualty care, including the management of complex spine trauma.

Study design: Systematic review and proportional meta-analysis.

Objective: To quantify overall and specific complication rates associated with tubular minimally invasive spine surgery (MISS) for lumbar pathologies over the past decade.

Summary of background data: Tubular MISS is widely used for lumbar pathologies due to its reduced tissue disruption and faster recovery compared with open surgery. However, reported complication rates vary, and pooled estimates for specific complications remain limited.

Materials and methods: A systematic search of PubMed, Medline, Embase, and the Cochrane Library (January 2013-March 2024) was conducted following PRISMA guidelines. Studies were included if they involved 10 adult patients undergoing tubular lumbar MISS and provided extractable complication data. A random-effects model was used to pool complication rates, and study quality was assessed using the Cochrane Risk of Bias Tool and Newcastle-Ottawa Scale. All analyses were done using R studio.

Results: Seventy-five studies involving ∼12,600 patients were included in the analysis. The complication rate was 10% (95% CI: 8%-14%, I2=93%). Specific complication rates were: dural tears 4% (95% CI: 3%-5%, I2=69%) in 56 studies (6651 patients); nerve injuries 1% (95% CI: 1%-3%, I2=70%) in 41 studies (5278 patients); postoperative hematoma 1% (95% CI: 1%-2%, I2=31%) in 19 studies (2454 patients); surgical site infections 1% (95% CI: 0%-1%, I2=27%) in 46 studies (10,439 patients); revision surgeries 2% (95% CI: 2%-3%, I2=77%) in 43 studies (8948 patients); and disc reherniation 3% (95% CI: 1%-7%, I2=84%) in 14 studies (1928 patients).

Conclusion: This meta-analysis provides a comprehensive overview of complication rates in tubular lumbar MISS, revealing generally low rates but significant heterogeneity across studies. These findings offer valuable insights for patient counseling and surgical planning, though individual patient factors and surgeon experience should be considered.

Study design: Retrospective two-center external validation study conducted at two medical centers, collecting cervical spine MRI data from patients suspected of degenerative cervical myelopathy (DCM) between March 2022 and August 2024, forming a consecutive series with external validation.

Objective: To develop and validate a deep learning model utilizing YOLO11 architecture for automated detection of cervical spinal cord compression on MRI and evaluate its performance against expert annotations.

Summary of background data: DCM represents the leading cause of non-traumatic spinal cord injury in adults. While MRI facilitates early detection and provides the foundation for timely intervention, image interpretation remains subjective and dependent on physician experience, resulting in diagnostic variability and challenges in clinical consistency.

Methods: A YOLO11-based deep learning model was implemented with binary classification scheme (Normal vs. Compression). Five physicians annotated 1,431 sagittal T2-weighted cervical MRI images from 735 patients using standardized protocols, achieving excellent inter-observer agreement. Dataset comprised training/validation sets (577 patients, 1,141 images), internal test set (64 patients, 115 images), and external test set (94 patients, 175 images). Five-fold cross-validation assessed model robustness. Standardized preprocessing incorporating contrast enhancement, noise reduction, and normalization was applied. Gradient-weighted Class Activation Mapping enhanced model interpretability.

Results: Five-fold cross-validation yielded consistent performance with mAP50 ranging from 0.917 to 0.970, precision from 0.897 to 0.923, and recall from 0.922 to 0.946. External testing demonstrated statistically superior agreement with expert annotations (mAP50=0.944, 95% CI: 0.934-0.953) compared to mid-level physician annotations (mAP50=0.912, 95% CI: 0.908-0.919), with the difference being statistically significant (95% CI of difference: 0.015-0.043, P < 0.05).

Conclusion: The YOLO11-based model demonstrated stable two-center performance with close alignment to expert-level clinical standards. The rapid inference, high sensitivity, and integrated visualization system address key challenges related to efficiency and interpretability in clinical AI applications for cervical spinal cord compression assessment.

Study design: Retrospective Cohort Study.

Objective: To assess long-term changes in spinopelvic alignment following single-level lumbar fusion.

Summary of background data: Restoration of sagittal balance is known to influence outcomes in adult deformity surgery, but its relevance after short-segment fusion for degenerative disease remains uncertain. The durability of spinopelvic parameters after single-level fusion is not well defined.

Methods: Adult patients who underwent primary single-level fusion between L4-S1 (2010-2019) were retrospectively identified. Standing lateral radiographs were analyzed at baseline, immediately postoperatively, and at 6 months, 1 year, and 2-3 years. Parameters included lumbar lordosis (LL), segmental lordosis (SL), disc height (DH), sacral slope (SS), pelvic tilt (PT), pelvic incidence (PI), and PI-LL mismatch. Sagittal imbalance was defined as PT >20° or PI-LL >10°. Data were analyzed with t-tests or Mann-Whitney U tests as appropriate, and stepwise regression modeling identified predictors of imbalance.

Results: A total of 413 patients (mean age 62 y, 53% female) met inclusion criteria. SL decreased progressively, with a greater decline at 2-3 years than at 6 months (-1.48° versus -0.64°, P=0.028). Changes in LL, DH, SS, and PT were minimal across follow-up intervals. The proportion of patients with PI-LL mismatch >10° declined from 40.9% immediately postoperatively to 31.0% at 2-3 years (P <0.001). Similarly, PT >20° decreased from 67.6% to 56.9% (P <0.001). Despite these modest improvements, over half of patients remained imbalanced at final follow-up. Regression analysis showed that older age and greater number of decompressed levels were associated with persistent imbalance.

Conclusions: After single-level lumbar fusion, sagittal parameters stabilize by 6 months, with slight compensatory improvement thereafter. Most patients, however, continue to demonstrate imbalance, and the clinical significance of correcting spinopelvic parameters in focal degenerative disease remains uncertain.

Study design: Meta-Analysis.

Objective: The purpose of this meta-analysis is to appraise the evidence comparing surgical outcomes with and without preoperative embolization.

Background: Hypervascular tumors present a surgical challenge, due to their substantial intraoperative blood loss. Although preoperative embolization is often employed to mitigate intraoperative bleeding, its consistent advantage has not been conclusively demonstrated across existing studies.

Methods: Following the PRISMA guidelines, PubMed, Cochrane, and Google Scholar were accessed and explored until May 2025. Articles were included if they reported comparative studies evaluating perioperative outcomes of preoperative embolization (E) versus no embolization (NE) in the surgical treatment of hypervascular spinal tumors. A sub-analysis was performed based on whether studies reported no statistically significant difference in surgical invasiveness between the two groups.

Results: Fifteen studies met the inclusion criteria, including 225 patients in group NE and 340 in group E. When all studies were analyzed collectively, no significant differences were observed between the NE group and E group for any of the outcomes. However, in the subgroup of studies that reported no statistically significant differences in surgical invasiveness, there was no significant difference in blood loss (P=0.75) between the NE group and E group. In contrast, in the other subgroup of studies, the NE group showed greater blood loss (mean difference=283.08 mL; 95% CI: 2.21-563.95, P=0.05,).

Conclusion: Pre-operative embolization was not associated with consistent benefits in surgical outcomes for hypervascular spinal tumors. While some studies reported reduced blood loss with embolization, these findings were limited to analyses lacking control for specific surgical characteristics. This suggests that the perceived advantages may reflect confounding factors rather than the true effect of embolization. However, surgical equipoise remains and the decision to embolize should be individualized based on surgical and patient-related factors.

Level of evidence: III.