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: Prospective cohort study.

Objective: To identify patient factors that predict changes in adjacent segment kinematics three years after ACDF.

Summary of background data: Approximately 25% of patients who undergo anterior cervical discectomy and fusion (ACDF) develop symptomatic adjacent segment disease (ASD) requiring reoperation within 10 years. Studies have found associations between ASD and patient genetics, age, BMI, psychiatric history, and preoperative disc degeneration. Few studies have linked these factors to mechanical changes to explain ASD.

Methods: Patients performed flexion/extension and axial rotation captured by biplane radiography before, one year after, and three years after ACDF (3YR-POST). Digitally reconstructed cervical radiographs were matched to the biplane radiographs to calculate intervertebral kinematics and preoperative disc height. Patient age, sex, BMI, smoking, diabetes, psychiatric history, inciting event, length of symptoms, preoperative disc bulge, and NDI were collected. Multivariate linear regression identified patient factors associated with changes in adjacent segment kinematics and NDI 3YR-POST.

Results: 62 patients completed testing. Younger age (1.1° per 10 years, 95% CI [0.04, 1.8], P=0.011), female sex (1.8°, 95% CI [0.5, 3.1], P=0.016), lower BMI (1.4° per 10 kg/m², 95% CI [0.4, 2.5], P=0.019), and no superior adjacent disc bulge (1.4°, 95% CI [0.0, 2.7], P=0.035) predicted larger increase in superior adjacent segment flexion/extension range of motion (ROM) 3YR-POST. Lack of superior adjacent disc bulge (1.2°, 95% CI [0.2, 2.2], P=0.025) predicted larger increase in superior adjacent segment axial rotation ROM. No patient factors were associated with changes in inferior adjacent segment ROM.

Conclusion: Greater increase in superior adjacent segment motion 3YR-POST is predicted in younger, lower BMI, female patients with healthier preoperative discs. These results support the theory that disc degeneration progresses from early instability in younger, healthier discs to stabilization in older, less healthy discs.

Study design/setting: Retrospective study at a single academic tertiary care center.

Objective: To evaluate osseous and vascular structures at C1 on preoperative MRIs and CTAs.

Background data: No prior studies have compared the diagnostic accuracy between magnetic resonance imaging (MRI) and computed tomography angiography (CTA) to assess C1 and internal carotid artery (ICA) anatomy prior to surgical instrumentation.

Methods: We retrospectively reviewed adult patients who underwent both cervical spine CTA and MRI between 2007 and 2018. Patients with prior cervical surgery or MRIs not extending to the atlas were excluded. Ten standardized osseous and vascular measurements were performed on both modalities using anatomical landmarks at C1. Paired t-tests and intraclass correlation coefficients (ICCs) assessed differences and agreement. A sub-analysis normalized measurements to anterior-posterior C1 length to account for potential modality-based scaling differences.

Results: Of 209 patients reviewed, 119 met inclusion criteria (mean age 65.1 years; 56% female). The agreement between CTA and MRI across 10 anatomical measurements was low, with ICCs ranging from 0.006 to 0.427. All measurements except the distance from the end of the ideal screw trajectory to the anterior plane of C1 demonstrated statistically significant differences between CTA and MRI (P<0.05). After standardizing values to anterior-posterior C1 length, ICCs for the nine measurements remained low (0.012 to 0.305), with only standardized measurements, distance from the end of the ideal screw trajectory to the anterior plane of C1 and the distance from the origin of the ideal screw trajectory to the ICA showing no statistically significant differences.

Conclusions: This study evaluated the accuracy of preoperative CTA and MRI in assessing C1 and ICA anatomy for atlantoaxial fusion planning, revealing variability in measurement agreement between the two. The findings highlight the need to tailor imaging choices to each clinical scenario, balancing diagnostic value, radiation exposure and surgical risk.