Spine最新文献

Study design: Prospective, multicenter, single-blind, randomized, 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 to 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 1 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 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: 1.

Study design: Prospective, randomized, double-blinded, multi-center trial; Level 1.

Objective: Evaluate safety and effectiveness of Oxiplex (dual-polymer gel) as an adjuvant during single-level partial discectomy in patients with severe leg and back pain.

Summary of background data: Dual-polymer gel previously reduced leg and back pain after partial lumbar discectomy in a subgroup of patients with severe leg and back pain.

Methods: Following single-level partial lumbar discectomy, subjects were randomized to surgery plus dual-polymer gel (Treatment) or surgery alone (Control). Primary endpoint was reduction in leg pain visual analog scale (VAS) at 6-months. Secondary outcomes were reductions in Sciatica Bothersomeness Index (SBI), back pain VAS, Oswestry Disability Index (ODI), SF-12 Mental (MCS) and Physical (PCS) Component Summaries, return to work, and patient satisfaction at 6-months.

Results: 134 participants were randomized 2:1 (ITT cohort (N=134); n=87 Treatment; n=47 Controls). There were no clinical differences in safety or adverse events. Following removal of participants with protocol deviations, Per Protocol cohort was N=102 (n=69 Treatments; n=33 Controls). Reductions in VAS leg pain, primary outcome measure, were not different (Treatment -73.9; Control -72.7). However, VAS Leg Pain improved by 100% for 33 of 68 Treatments (5% increase vs. Controls); ≥90% for 50 Treatments (11% increase vs. Controls). SBI decreased by 100% for 20 of 67 Treatments (11% increase vs. Controls); SBI decreased by ≥90% for 33 Treatments (24% increase vs. Controls). SBI Leg Pain Component decreased ≥80% in Treatments versus 66% of Controls; P =0.039. More Treatments achieved meaningful VAS back pain reduction (≥30%) than Controls (93% vs. 88%). ODI decreased by 100% for 20 of 68 Treats (13% increase vs. Controls).

Conclusion: Addition of dual-polymer gel as an adjuvant to partial discectomy for treatment of severe pain reduced leg and back pain, as well as increased the proportion of subjects with best responses to surgery.

Study design: Multicenter cross-sectional study.

Background: Lumbar spine degeneration (LSD) is a prevalent clinical condition, yet the influence of paravertebral muscles on LSD remains insufficiently explored. This study investigates the effects of various paravertebral muscles and muscle parameters on lumbar degeneration.

Methods: This cross-sectional analysis of 4,305 adults from the China Action on Spine and Hip (CASH) cohort utilized quantitative CT to measure psoas and paraspinal muscle parameters at L1/L3/L5 levels. Intervertebral disc degeneration (IVDD) and facet joint degeneration (FJD) were radiologically graded. Adjusted binary logistic regression models (for age/sex/BMI) evaluated muscle-degeneration associations.

Results: 3,734 participants (2,266 females, 1,468 males) were included. After adjusting for confounding factors, paraspinal muscle area (PSMA) at the L3 and L5 levels was significantly associated with IVDD and FJD. An increase in L5-PSMA significantly reduced the risk of both IVDD and FJD (OR=0.49, 95% CI 0.41-0.60, P<0.01; OR=0.71, 95% CI 0.62-0.83, P<0.01). A similar effect was observed at the L3 level (L3-PSMA: OR=0.59, 95% CI 0.48-0.72, P<0.01; OR=0.98, 95% CI 0.96-0.99, P<0.05). No significant correlation was found at L1. Stratified by sex, males had higher paravertebral muscle area and density and lower fat fraction (P<0.01). Females had higher lumbar FJD scores across all segments (P<0.05) and higher IVDD scores at L5-S1 (P<0.01). The impact of PMSA on lumbar degeneration is more significant in females compared to males. (L5-IVDD OR=0.12 (0.08, 0.19) vs. 0.71 (0.55, 0.9); L5-FJD OR=0.44 (0.34, 0.56) vs. 0.88 (0.78, 0.98)).

Conclusion: Paravertebral muscle at L3 and L5 is associated with lumbar degeneration, with PSMA exerting the most stable effect on both IVDD and FJD. These effects were more pronounced at L5 and in females, with IVDD more susceptible to influence.

Level of evidence: Level 3.

Study design: Retrospective cohort.

Objective: To examine metformin use on postoperative outcomes amongst patients with diabetes undergoing lumbar fusion.

Summary of background: Several animal studies have demonstrated that metformin, a first-line treatment for type 2 diabetes (T2DM), can attenuate neuropathic pain via decreased activation of microglia and suppression of inflammatory signaling.

Methods: Adult diabetic patients who underwent a 1-2-level posterior lumbar decompression and fusion (PLDF) (2017-2023) were identified and demographics, surgical data, metformin use/dosage, opioid consumption and patient-reported outcome measures (PROMs) collected. Statistical analysis was performed with alpha set at 0.05.

Results: Of the 299 diabetic patients who underwent a 1-2 level PLDF, 203 (67.9%) were taking metformin. There were no differences in morphine milligram equivalents (MMEs) in the 30 days prior to or the 30 days after surgery between groups. Patients on metformin had a lower Elixhauser (2.26 ± 1.48 vs. 2.79 ± 1.71; P=0.005), lower HgbA1c (7.15± 1.12 vs. 7.48± 1.59; p = 0.018), and fewer females (59.4% versus 42.4%, P= 0.009) but were otherwise demographically/surgically similar. Despite both groups having similar preoperative opioid use, metformin use was associated with lower MMEs at 30-90 days (31.8 ± 60.4 vs. 52.0 ± 92.0; P=0.018 and 90-365 days (65.0 ± 183 vs. 129 ± 292 MME; P=0.001), and greater improvement from pre- to postoperative PCS at 6 months (5.12 ± 8.96 vs -1.34 ± 8.57, P=0.048) and at 1-year (4.96 ± 9.47 vs. -1.87 ± 7.55, P = 0.027). Linear regression analysis identified metformin use as independently predictive of fewer postoperative MMEs 30-90 days postoperatively (Estimate -16.03, CI -31.51 to -0.56; P=0.043).

Conclusions: Metformin use was found to be independently associated with fewer MME requirements 30 days after surgery.

Study design: Systematic review.

Objective: This study aims to evaluate the variability of minimum clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds in current anterior cervical discectomy and fusion (ACDF) literature.

Summary of background data: Patient-reported outcome measures (PROMs) are increasingly emphasized in recent studies evaluating outcomes of ACDF. To distinguish clinically meaningful improvements in PROMs, thresholds such as MCID and PASS have been delineated. However, the variability of the MCID/PASS threshold values can significantly influence study outcomes, limit the validity of the results, and complicate comparisons between studies.

Methods: PubMed and Embase were queried for articles from January 1, 2000, to May 1, 2024, reporting MCID or PASS values for PROMs following ACDF. Patient demographics, study characteristics, MCID/PASS thresholds, and threshold calculation methods were extracted for all PROMs.

Results: A total of 55 studies were identified, including 16 unique PROMs reported. There were 231 MCID threshold values and 2 PASS threshold values included. Of these, 47 studies referenced previously established values, while six studies calculated new thresholds. Among these six studies, 15 novel MCID thresholds and one novel PASS threshold were reported across eight distinct PROMs. The ranges of MCID thresholds for the most common PROMs were 7.5-20 for NDI, 2.5-3.1 for VAS-neck, 2.5-4.6 for VAS-arm, 4.1-11.1 for SF-12 PCS, 4.7-9.7 for SF-12 MCS, and 4.5-8 for PROMIS-PF.

Conclusion: There is a high degree of variability among MCID thresholds in the ACDF literature, especially for NDI, VAS-arm, SF-12 PCS, SF-12 MCS, and PROMIS-PF. Interestingly, threshold values may even vary among papers citing the same studies for their reference MCID thresholds, with previously calculated MCID thresholds being cited incorrectly in some cases. This study emphasizes the need for improved standardization of MCID threshold values in spine literature for more reliable and consistent assessments of surgical outcomes.

Study design: Retrospective image analysis study.

Objective: To propose a novel classification system for adolescent idiopathic scoliosis (AIS) curvature using unsupervised machine learning and evaluate its reliability and clinical implications.

Summary of background data: Existing AIS classification systems, such as King and Lenke, have limitations in accurately describing curve variations, particularly long C-shaped curves or curves with distinct characteristics. Unsupervised machine learning offers an opportunity to refine classification and enhance clinical decision-making.

Materials and methods: A total of 1156 AIS patients who underwent deformity correction surgery were analyzed. Standard posteroanterior radiographs were segmented using U-net algorithms. Contrastive clustering was employed for automatic grouping, with the number of clusters ranging from three to 10. Cluster quality was assessed using t-SNE and Silhouette scores. Clusters were defined based on consensus among spine surgeons. Interobserver reliability was evaluated using kappa coefficients.

Results: Six clusters were identified, reflecting variations in structural curve location, single (C-shaped) versus double (S-shaped) curves, and thoracolumbar curve characteristics. Cluster reliability was moderate (kappa = 0.701-0.731). The silhouette score was 0.308, with t-SNE demonstrating distinct clustering patterns. The classification highlighted differences not captured by the Lenke classification, such as thoracic curves confined to the thoracic spine versus those extending to the lumbar spine.

Conclusion: Unsupervised machine learning successfully categorized AIS curvatures into six distinct clusters, revealing meaningful patterns such as unique variations in thoracic and lumbar curves. These findings could potentially inform surgical planning and prognostic assessments. However, further studies are needed to validate clinical applicability and improve clustering quality.

Level of evidence: Level III.

Study design: A cross-sectional cohort study.

Objective: This study aimed to refine the sagittal morphologic classification of the spine in asymptomatic middle-aged and elderly adult populations using the unsupervised machine learning (ML) techniques and, by leveraging these findings, to propose and validate a surgical correction reference for adult spinal deformity (ASD) patients across different morphologic subtypes.

Summary of background data: Restoration of sagittal alignment is the key to preventing mechanical complications and achieving good clinical outcomes in ASD surgery. However, high variations in the reported incidence of mechanical complications and clinical outcomes under current ASD realignment strategies have severely impeded the decision-making process for the optimal surgical plan.

Materials and methods: This study cross-sectionally enrolled asymptomatic middle-aged and elderly Chinese adults. Sagittal spinal morphology clusters and pelvic incidence-based correction criteria for ASD realignment surgery were derived from whole spine radiographs using unsupervised ML algorithms. To externally validate the realignment strategy identified in asymptomatic adults, a consecutive cohort of ASD patients with sagittal deformity who underwent realignment surgery was examined for postoperative mechanical complications, unplanned reoperation, unplanned readmission, and clinical outcomes during follow-up.

Results: A total of 635 asymptomatic adults were enrolled for morphologic stratification, and 103 ASD patients with sagittal deformity were included for validation. The unsupervised ML algorithm successfully stratified spinal morphology into four clusters. The pelvic incidence-based surgical correction criteria computed by the regression algorithm demonstrated plausible clinical relevance, evidenced by the significantly lower incidence of postoperative mechanical complications, unplanned reoperation, unplanned readmission, and superior patient-reported outcomes in the restored group (conforming to the correction criteria) during follow-up.

Conclusion: In this study, unsupervised ML algorithm effectively partitioned asymptomatic sagittal spinal morphology into four distinct clusters. Using the pelvic incidence-based proportional correction criteria, ASD patients can anticipate a reduced incidence of mechanical complications and improved clinical outcomes following spinal realignment surgery.

Level of evidence: Level Ⅲ.

Study design: Retrospective Cohort.

Objective: To compare surgical outcomes and patient reported outcome measures (PROMs) after lumbar fusion between type 2 diabetes mellitus (T2DM) patients with versus without chronic preoperative glucagon-like-peptide-1 (GLP-1) receptor agonist use.

Summary of background data: T2DM is a risk factor for adverse outcomes following spine surgery. GLP-1 receptor agonists are increasingly prescribed for patients with T2DM. However, few studies have investigated their impact on lumbar fusion outcomes.

Methods: T2DM patients undergoing primary, elective posterior lumbar fusion were included; GLP-1 agonist use was identified. Demographic/surgical data were collected by manual chart review. Primary outcomes included surgical outcomes, complications, wound healing, and return of postoperative bowel function. Return of bowel function was defined as flatulence or a bowel movement. Secondary outcomes included PROMs. A Poisson regression predicting the day of postoperative return of bowel function was performed.

Results: 57 patients had preoperative GLP-1 agonist use, while 60 did not. Patients taking GLP-1 agonists were more commonly female (54.4% vs. 30.5%, P=0.016) and had higher mean body mass index (BMI) (34.6±5.96 vs. 32.6±6.08). Otherwise, the groups were demographically/surgically similar. Patients taking GLP-1 agonists demonstrated quicker return of bowel function (1.35±1.30 vs. 1.90±0.77 days, P=0.013). There were no differences in discharge disposition, length of stay, inpatient complications, postoperative wound abnormalities, or PROMs. Regression showed that GLP-1 agonist use independently decreased the time to return of bowel function (rate ratio: 0.69, P=0.028).

Conclusion: This study suggests that chronic GLP-1 agonist use does not lead to inferior short-term outcomes or long-term PROMs following lumbar fusion. GLP-1 agonists may benefit the return of bowel function, potentially due to chronic gut motility adaptations and/or anti-inflammatory properties. Further study is required to support these findings.

Study design: Retrospective Comparative Study.

Objective: A comparative analysis was aimed at evaluating the clinical and radiologic outcomes of cases managed with versus without ACR.

Summary of background data: Management of spinal tuberculosis (STB) is accomplished with or without anterior column reconstruction (ACR). However, no objective criterion has been defined citing absolute indication.

Methods: A retrospective analysis of prospectively collected data of STB was carried out with a minimum follow-up of one year. Along with basic demography, radiologic parameters like vertebral body height loss (VHL), column height loss (CHL), segmental kyphosis (SK), and adjusted kyphosis (AK) were calculated. A ROC curve analysis was done to identify cutoff values, followed by subgroup analysis for each parameter.

Results: In total 103 patients (60 female, 43 male), 55 cases were managed operatively and ACR was done in 39 of those. Change in ODI, VHL, and kyphosis correction were significantly better in ACR ( P <0.01). ROC analysis identified cutoff values for VHL 0.55 (sensitivity 0.87, 1-specificity 0.37), CHL 1.12 (sensitivity 0.76, 1-specificity 0.25), and AK 15° (sensitivity 0.74, 1-specificity 0.43). Subgroup analysis was carried out in operated patients segregated above these cutoff values. Though vertebral height gain was better with ACR, no significant differences across the change in ODI and loss of correction were noted between ACR and N-ACR. However, the instruments to disease vertebrae (I/D) ratio was significantly different across all subgroups ( P <0.05).

Conclusion: A similar functional outcome, kyphosis correction, and mechanical stability (loss of correction) can be achieved without ACR if index screw purchase with increasing the implant density is feasible. In cases where the index screw deems impossible, the objective criteria of VHL>0.55, CHL>1.1, AK>15 degrees should be considered for deciding the need for anterior column reconstruction to achieve better outcomes.

Level of evidence: Level III.

Study design: Retrospective study.

Objective: To investigate the association between postoperative orientation of the L1 vertebra and proximal junctional kyphosis (PJK) occurrence in adult spinal deformity (ASD) surgery.

Summary of background data: PJK remains a common complication, with various risk factors identified. However, the role of the orientation of L1 vertebra has not been well studied.

Materials and methods: A total of 312 patients who underwent fusion from the pelvis to the lower thoracic spine (T9-12) were analyzed. Patient, surgical, and radiographic variables were evaluated for risk factor analysis of PJK. L1 tilt and L1 slope at six weeks postoperatively were included to represent the L1 orientation. Multivariate logistic regression analysis was performed to identify risk factors for PJK. Receiver operating characteristics (ROC) curve analysis was used to calculate the cutoff value of predictors for PJK.

Results: PJK developed in 109 patients (34.9%). Multivariate regression analysis identified postoperative L1 tilt as the only independent risk factor for PJK (odds ratio=1.173, P <0.001). The cutoff value of L1 tilt for predicting PJK was determined as 8.1° based on ROC curve analysis (area under the curve=0.736, P <0.001). The rates of PJK (50.7% vs. 22.1%, P <0.001) and revision surgery (17.1% vs. 5.2%, P <0.001) were significantly higher in the high L1 tilt group than in the low L1 tilt group. The high L1 tilt group also exhibited significantly greater pelvic tilt, thoracic kyphosis, and T1 pelvic angle, as well as worse clinical outcomes at two years compared with the low L1 tilt group.

Conclusions: An L1 tilt >8.1° was associated with a higher risk of PJK, suboptimal sagittal alignment, and worse clinical outcomes at two years. Therefore, optimizing L1 orientation may reduce PJK risk and improve long-term surgical outcomes.