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Development of an International AO Spine Guideline for the Use of Osteobiologics in Anterior Cervical Fusion and Decompression (AO-GO)
Buser, Zorica; Meisel, Hans Jörg; Agarwal, Neha; Wu, Yabin; Jain, Amit; van Hooff, Miranda; Alini, Mauro; Yoon, Sangwook Tim; Wang, Jeffrey C; Santesso, Nancy; ,
STUDY DESIGN/METHODS:Methodological study for guideline development. OBJECTIVE:AO Spine Guideline for Using Osteobiologics (AO-GO) project for spine degenerative pathologies was an international, multidisciplinary collaborative initiative to identify and evaluate evidence on existing use of osteobiologics in Anterior Cervical Fusion and Decompression (ACDF). The aim was to formulate precisely defined, clinically relevant and internationally applicable guidelines ensuring evidence-based, safe and effective use of osteobiologics, considering regional preferences and cost-effectiveness. METHODS:Guideline was completed in two phases: Phase 1- evidence synthesis; Phase 2- recommendation development based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. In Phase 1, key questions identified by a panel of experts were addressed in a series of systematic reviews of randomized and non-randomized studies. In Phase 2, the GRADE approach was used to formulate a series of recommendations, including expert panel discussions via web calls and face-to-face meetings. DISCUSSION/CONCLUSIONS:AO-GO aims to bridge an important gap between evidence and use of osteobiologics in spine fusion surgeries. Owing to differences in osteobiologics preparation and functional characteristics, regulatory requirements for approval may vary, therefore it is highly likely that these products enter market without quality clinical trials. With a holistic approach the guideline aims to facilitate evidence-based, patient-oriented decision-making processes in clinical practice, thus stimulating further evidence-based studies regarding osteobiologics usage in spine surgeries. In Phase 3, the guideline will be disseminated and validated using prospectively collected clinical data in a separate effort of the AO Spine Knowledge Forum Degenerative in a global multicenter clinical study.
PMCID:10913912
PMID: 38421327
ISSN: 2192-5682
CID: 5722732
Comparative Complications Associated With BMP Use In Patients Undergoing ACDF for Degenerative Spinal Conditions: Systematic Review and Meta-Analysis
Martin, Christopher T; Holton, Kenneth; Broida, Samuel E; Hickmann, Anne-Katrin; Bakker, Caitlin; Lender, Paul A; Watanabe, Kota; Meisel, Hans Jörg; Buser, Zorica; Presciutti, Steven M; Yoon, Sangwook Tim; ,
STUDY DESIGN/METHODS:Systematic Review and Meta-Analysis. OBJECTIVES/OBJECTIVE:To compare complication incidence in patients with or without the use of recombinant human Bone Morphogenic Protein-2 (BMP2) undergoing anterior cervical discectomy and fusion (ACDF) for degenerative conditions. METHODS:A systematic search of eight online databases was conducted using PRISMA guidelines. Inclusion criteria included English language studies with a minimum of 10 adult patients undergoing instrumented ACDF surgery for a degenerative spinal condition in which BMP2 was used in all patients or one of the treatment arms. Studies with patients undergoing circumferential fusions, with non-degenerative indications, or which did not report post-operative complication data were excluded. Patients with and without BMP2 were compared in terms of the incidence of dysphagia/dysphonia, anterior soft tissue complications (hematoma, seroma, infection, dysphagia/dysphonia), nonunion, medical complications, and new neurologic deficits. RESULTS:= .66), and additional medical complications (RR = 1.53, CI 95% .98-2.38, P = .06) were not found to be statistically different between the groups. CONCLUSIONS:This meta-analysis identified a high rate of arthrodesis when BMP2 was used in ACDF, but confirmed increased rates of dysphagia and anterior soft tissue complications. Surgeons may consider reserving BMP2 implementation for cases with a high risk of non-union, and should be aware of the risk of airway compromise.
PMCID:10913901
PMID: 38421328
ISSN: 2192-5682
CID: 5722742
Dosing Strategy for Osteobiologics Used in ACDF Surgery: Influence on Fusion Rates and Associated Complications. A Systematic Literature Review
Hamouda, Waeel O; Veranis, Sotiris; Krol, Oscar; Sagoo, Navraj S; Passias, Peter G; Buser, Zorica; Meisel, Hans Jörg; Yoon, Tim; ,
STUDY DESIGN/METHODS:Systematic review. OBJECTIVE:To assess the available evidence related to dose-dependent effectiveness (i.e., bone fusion) and morbidity of osteobiologics used in anterior cervical discectomy and fusion (ACDF). METHODS:Studies with more than 9 adult patients with degenerated/herniated cervical discs operated for one-to four-levels ACDF reporting used osteobiologics doses, fusion rates at six months or later, and related comorbidities were included. PubMed, EMBASE, ClinicalTrials, and Cochrane were searched through September 2021. Data extracted in spread sheet and risk of bias assessed using MINORS and Rob-2. RESULTS:Sixteen studies were selected and sub-grouped into BMP and non-BMP osteobiologics. For the 10 BMP studies, doses varied from 0.26 to 2.1 mg in 649 patients with fusion rates of 95.3 to 100% at 12 months. For other osteobiologics, each of six studies reported one type of osteobiologic in certain dose/concentration/volume in a total of 580 patients with fusion rates of 6.8 to 96.9% at 12 months. Risk of bias was low in three of the 13 non-randomized (18.75%) and in all the three randomized studies (100%). CONCLUSIONS:Taking into account the inconsistent reporting within available literature, for BMP usage in ACDF, doses lower than 0.7 mg per level can achieve equal successful fusion rates as higher doses, and there is no complication-free dose proved yet. It seems that the lower the dose the lower the incidence of serious complications. As for non-BMP osteobiologics the studies are very limited for each osteobiologic and thus conclusions must be drawn individually and with caution.
PMCID:10913908
PMID: 38421331
ISSN: 2192-5682
CID: 5722762
Identification and impact of failure of pelvic compensation in patients with adult spinal deformity
Wang, Dongfan; Wang, Wei; Wang, Yu; Kong, Chao; Wang, Shuaikang; Buser, Zorica; Diwan, Ashish D; Chen, Xiaolong; Lu, Shibao
BACKGROUND CONTEXT/BACKGROUND:Previous research has identified a specific subtype known as failure of pelvic compensation (FPC) in patients with adult spinal deformity (ASD). However, the criteria for assessing FPC remain inconsistent, and its impacts on spinal sagittal alignment and health-related quality-of-life (HRQoL) scores remain unclear. PURPOSE/OBJECTIVE:To propose a novel criterion for identifying FPC based on variations in spinopelvic alignment during the transition from the supine to upright position and to evaluate the effects of FPC on patients' spinal sagittal alignment and HRQoL scores. STUDY DESIGN/SETTING/METHODS:Retrospective cross-sectional study. PATIENT SAMPLE/METHODS:Patients with ASD from a monocenter database. OUTCOME MEASURES/METHODS:Radiographic measures, including thoracic kyphosis (TK), lumbar lordosis (LL), sacral slope (SS), pelvic tilt, pelvic incidence (PI), and sagittal vertical axis (SVA), were measured on lateral whole-spine radiographs. LL and SS were also measured on reconstructed lumbar computed tomography images in the sagittal view taken in the supine position. The relative functional cross-sectional area (rFCSA) of paraspinal muscles was evaluated via lumbar magnetic resonance imaging. HRQoL measures, encompassing visual analog scale for back pain (VAS-BP), Oswestry Disability Index (ODI), and Scoliosis Research Society-22R (SRS-22R), were collected. METHODS:A total of 154 patients were enrolled. Based on the calculated minimum detectable change of SS, FPC was defined as the change in SS of less than 3.4° between supine and upright positions. Patients were divided into 3 groups: sagittal balance with pelvic compensation (SI-PC), sagittal imbalance with pelvic compensation (SI-PC), and sagittal imbalance with failure of pelvic compensation (SI-FPC). Radiographic parameters and HRQoL scores were compared among the groups. RESULTS:Thirty-six patients were categorized into the SB-PC group, 87 into the SI-PC group, and 31 into the SI-FPC group. Patients with low PI and small paraspinal muscles rFCSA were more prone to experiencing FPC accompanied by severe sagittal imbalance. The SI-FPC group exhibited less TK and a larger SS than the SI-PC group exhibited and had a similar SVA as that of the SI-PC group. Additionally, they displayed worse VAS-BP, ODI, SRS-function, and SRS-22 total scores than the SB-PC group displayed. CONCLUSIONS:In patients with ASD, an inherently low pelvic compensatory reserve and a high fatty infiltration in paraspinal muscles are pivotal factors contributing to FPC. Compared with SI-PC patients, SI-FPC patients demonstrate a thoracic-dominant compensatory pattern for sagittal malalignment. In addition, these patients experienced more severe pain and functional decline than the SB-PC patients experienced.
PMID: 38925300
ISSN: 1878-1632
CID: 5698022
Diagnosis of spine pseudoarthrosis based on the biomechanical properties of bone
Hipp, John A; Mikhael, Mark M; Reitman, Charles A; Buser, Zorica; Patel, Vikas V; Chaput, Christopher D; Ghiselli, Gary; DeVine, John; Berven, Sigurd; Nunley, Pierce; Grieco, Trevor F
BACKGROUND CONTEXT/BACKGROUND:Failure to fuse following anterior cervical discectomy and fusion (ACDF) may result in symptomatic pseudoarthrosis. Traditional diagnosis involves computerized tomography to detect bridging bone and/or flexion-extension radiographs to assess whether segmental motion is above specific thresholds; however, there are currently no well-validated diagnostic tests. We propose a biomechanically rational approach to achieve a reliable diagnostic test for pseudoarthrosis. PURPOSE/OBJECTIVE:Develop and test a biomechanically based approach to the diagnosis of pseudoarthrosis. STUDY DESIGN/METHODS:Literature review, development of theory, re-analysis of a previously published study with surgical exploration as the gold-standard, and retrospective analysis of pooled studies to understand time to fusion. METHODS:Fully automated methods were used to measure disc space strains (change in disc space height divided by initial height). Measurement error combined with the reported failure strain of trabecular bone led to a proposed strain threshold for diagnosis of pseudoarthrosis following ACDF. We reanalyzed previously reported flexion-extension radiographs for asymptomatic volunteers to assess whether flexion-extension radiographs, in the absence of fusion surgery, can be expected to provide sufficient stress on motion segments to allow for reliable strain-based fusion assessment. The sensitivity and specificity of strain- and rotation-based pseudoarthrosis diagnosis were assessed by reanalysis of previously reported post-ACDF flexion-extension radiographs, where intraoperative fusion assessments were also available. Finally, we assessed changes in strain over time using 9,869 flexion-extension radiographs obtained 6 weeks to 84 months post-ACDF surgery from 1,369 patients. RESULTS:The estimated error in automated measurement of disc space strain from radiographs was approximately 3%, and the reported failure strain of bridging bone was less than 2.5%. On that basis, we propose a 5% strain threshold for pseudoarthrosis diagnosis. Reanalysis of a study in which intraoperative fusion assessments were available revealed 67% sensitivity and 82% specificity for strain-based diagnosis of pseudoarthrosis, which was comparable to rotation-based diagnosis. Analysis of post-ACDF flexion-extension radiographs revealed rapid strain reduction for up to 24 months, followed by a slower decrease for up to 84 months. When rotation is less than 2 degrees, the strain-based diagnosis differed from the rotation-based diagnosis in approximately 14% of the cases. CONCLUSIONS:We propose steps for standardizing diagnosis of pseudoarthrosis based on the failure strain of bone, measurement error, and retrospective data. These steps include obtaining high-quality flexion-extension studies, the application of proposed diagnostic thresholds, and the use of image stabilization for conclusive diagnosis, when motion is near thresholds. The necessity for an accurate diagnosis with minimal radiation exposure underscores the need for further optimization and standardization in diagnosing pseudoarthrosis following ACDF surgery. CLINICAL SIGNIFICANCE/CONCLUSIONS:In a symptomatic post-spine fusion patient, it is important to diagnose or rule-out pseudoarthrosis. There are currently no well-validated diagnostic tests for this condition. Incorporating strain-based intervertebral motion analysis into the diagnosis could lead to a standardized and validated test for detecting spine pseudoarthrosis.
PMID: 39154949
ISSN: 1878-1632
CID: 5680332
Closing the Gap: The Incidence of Complications in Minimally Invasive Tubular, Endoscopic, and Robotic-Assisted Transforaminal Lumbar Interbody Fusion Procedures
Gerling, Michael; Baker, Melissa; Stanton, Eloise; Pyun, Joseph; Chaladoff, Evan; Passias, Peter; Buser, Zorica
BACKGROUND:The aim of the current study was to compare the incidence of postoperative complications among minimally invasive surgery (MIS) tubular, endoscopic, and robot-assisted transforaminal lumbar interbody fusion (TLIF) techniques. METHODS:We studied consecutive patients who underwent single-level or multilevel TLIF between 2020 and 2022. Preoperative and postoperative patient-reported outcomes (Visual Analog Scale leg score and Oswestry Disability Index), demographic, and intraoperative variables were recorded. One-way analysis of variance with Bartlett's equal-variance and Pearson chi-squared tests were used. RESULTS:The study included 170 TLIF patients: 107 (63%) tubular, 42 (25%) endoscopic, and 21 (12%) robot assisted. All 3 TLIF techniques had similar complication rates: tubular 6 (5.6%), endoscopic 2 (4.8%), and robot assisted 1 (4.8%) all occurring within the first 2 weeks. Tubular TLIF reported the lowest incidence of new-onset neurologic symptoms, primarily radiculitis or numbness/tingling, at 2 weeks postoperatively (P < 0.05) with 21 (20%) tubular, 17 (41%) endoscopic, and 9 (43%) robot-assisted patients. There were 2 revisions in the robot-assisted group, while tubular and endoscopic each had one within 1 year. There was no statistical difference in preoperative or postoperative patient-reported outcomes between the TLIF groups. CONCLUSIONS:The current study demonstrated that tubular, endoscopic, and robot-assisted TLIF procedures had similar complication rates. The tubular MIS TLIF reported fewer new neurologic symptoms compared with endoscopic and robot-assisted TLIF procedures at 2 weeks postoperative, with all groups declining in symptom persistency at later time intervals. Average Visual Analog Scale scores continuously improved up to 1 year postoperatively among all groups.
PMID: 38914133
ISSN: 1878-8769
CID: 5678322
The impact of enhanced recovery after surgery (ERAS) on opioid consumption and postoperative pain levels in elective spine surgery
Stanton, Eloise; Buser, Zorica; Mesregah, Mohamed Kamal; Hu, Kelly; Pickering, Trevor A; Schafer, Betsy; Hah, Raymond; Hsieh, Patrick; Wang, Jeffrey C; Liu, John C
OBJECTIVE:Enhanced Recovery after Surgery (ERAS) protocols were developed to counteract the adverse effects of the surgical stress response, aiming for quicker postoperative recovery. Initially applied in abdominal surgeries, ERAS principles have extended to orthopedic spine surgery, but research in this area is still in its infancy. The current study investigated the impact of ERAS on postoperative pain and opioid consumption in elective spine surgeries. METHODS:A single-center retrospective study of patients undergoing elective spine surgery from May 2019 to July 2020. Patients were categorized into two groups: those enrolled in the ERAS pathway and those adhering to traditional surgical protocols. Data on demographics, comorbidities, length of stay (LOS), surgical procedures, and postoperative outcomes were collected. Postoperative pain was evaluated using the Numerical Rating Scale (NRS), while opioid utilization was quantified in morphine milligram equivalents (MME). NRS and MME were averaged for each patient across all days under observation. Differences in outcomes between groups (ERAS vs. treatment as usual) were tested using the Wilcoxon rank sum test for continuous variables and Pearson's or Fisher's exact tests for categorical variables. RESULTS:The median of patient's mean daily NRS scores for postoperative pain were not statistically significantly different between groups (median = 5.55 (ERAS) and 5.28 (non-ERAS), p=.2). Additionally, the median of patients' mean daily levels of MME were similar between groups (median = 17.24 (ERAS) and 16.44 (non-ERAS), p=.3) ERAS patients experienced notably shorter LOS (median=2 days) than their non-ERAS counterparts (median=3 days, p=.001). The effect of ERAS was moderated by whether the patient had ACDF surgery. ERAS (vs. non-ERAS) patients who had ACDF surgery had 1.64 lower average NRS (p=.006). ERAS (vs. non-ERAS) patients who had a different surgery had 0.72 higher average NRS (p=.02) but had almost half the length of stay, on average (p<.001). CONCLUSIONS:The current study underscores the dynamic nature of ERAS protocols within the realm of spine surgery. While ERAS demonstrates advantages such as reduced LOS and improved patient-reported outcomes, it requires careful implementation and customization to address the specific demands of each surgical discipline. The potential to expedite recovery, optimize resource utilization, and enhance patient satisfaction cannot be overstated. However, the fine balance between achieving these benefits and ensuring comprehensive patient care, especially in the context of postoperative pain management, must be maintained. As ERAS continues to evolve and find its place in diverse surgical domains, it is crucial for healthcare providers to remain attentive to patient needs, adapting ERAS protocols to suit individual patient populations and surgical contexts.
PMID: 38788543
ISSN: 1872-6968
CID: 5655172
Nerve root retraction time during lumbar endoscopic discectomy: association with new onset radiculitis, a post-operative neurologic complication
Gerling, Michael C; Baker, Melissa; Stanton, Eloise; Chaladoff, Evan; Buser, Zorica
PURPOSE/OBJECTIVE:To evaluate the relationship between nerve root retraction time, post-operative radiculitis and patient reported outcomes. METHODS:Patients who underwent single- or multi-level lumbar discectomy between 2020 and 2022 for lumbar disk herniations were prospectively followed with pre-operative, interoperative and post-operative variables including radiculitis and patient reported outcomes including VAS, ODI and CAT domains Pain interference, Pain intensity and Physical function. Intraoperative nerve root retraction time was recorded. Paired sample two-tailed t-test and multivariate regression were utilized with p < 0.05 being significant. RESULTS:A total of 157 patients who underwent single- or multi-level endoscopic lumbar discectomy. Average patient age was 44 years, and 64% were male patients. Nerve retraction time ranged from 4 to 15 min. Eighteen percent reported new radiculitis at 2-weeks post-operatively. In patients with new-onset radiculitis 79.2% reported significantly worse VAS leg at 2 weeks post-operative (4.2 vs. 8.3, p < 0.001) compared to 12.5% who had improved VAS leg (9.3 vs. 7, p = 0.1181). Patients with radiculitis and worse VAS scores had substantially longer nerve retraction time (13.8 ± 7.5 min) than patients with improved VAS leg (6.7 ± 1.2 min). At 6 months, patients with longer nerve retraction time had no significant improvement in the ODI or CAT compared to the baseline. CONCLUSIONS:This is the first study in discectomy literature to show that new onset radiculitis and poorer outcomes in VAS leg correlate with longer nerve retraction time at early and later time points.
PMID: 37747545
ISSN: 1432-0932
CID: 5627852
Clinical effectiveness of reduction and fusion versus in situ fusion in the management of degenerative lumbar spondylolisthesis: a systematic review and meta-analysis
Wang, Dongfan; Wang, Wei; Han, Di; Muthu, Sathish; Cabrera, Juan P; Hamouda, Waeel; Ambrosio, Luca; Cheung, Jason P Y; Le, Hai V; Vadalà , Gianluca; Buser, Zorica; Wang, Jeffrey C; Cho, Samuel; Yoon, S Tim; Lu, Shibao; Chen, Xiaolong; Diwan, Ashish D; ,
PURPOSE/OBJECTIVE:To compare the clinical effectiveness of reduction and fusion with in situ fusion in the management of patients with degenerative lumbar spondylolisthesis (DLS). METHODS:The systematic review was conducted following the PRISMA guidelines. Relevant studies were identified from PubMed, Embase, Scopus, Cochrane Library, ClinicalTrials.gov, and Google Scholar. The inclusion criteria were: (1) comparative studies of reduction and fusion versus in situ fusion for DLS patients, (2) outcomes reported as VAS/NRS, ODI, JOA score, operating time, blood loss, complication rate, fusion rate, or reoperation rate, (3) randomized controlled trials and observational studies published in English from the inception of the databases to January 2023. The exclusion criteria included: (1) reviews, case series, case reports, letters, and conference reports, (2) in vitro biomechanical studies and computational modeling studies, (3) no report on study outcomes. The risk of bias 2 (RoB2) tool and the Newcastle-Ottawa scale was conducted to assess the risk of bias of RCTs and observational studies, respectively. RESULTS:Five studies with a total of 704 patients were included (375 reduction and fusion, 329 in situ fusion). Operating time was significantly longer in the reduction and fusion group compared to in situ fusion group (weighted mean difference 7.20; 95% confidence interval 0.19, 14.21; P = 0.04). No additional significant intergroup differences were noted in terms of other outcomes analyzed. CONCLUSION/CONCLUSIONS:While the reduction and fusion group demonstrated a statistically longer operating time compared to the in situ fusion group, the clinical significance of this difference was minimal. The findings suggest no substantial superiority of lumbar fusion with reduction over without reduction for the management of DLS.
PMID: 38043128
ISSN: 1432-0932
CID: 5597502
Surgeon Preferences Worldwide in Wound Drain Utilization in Open Lumbar Fusion Surgery for Degenerative Pathologies
Cabrera, Juan P; Gary, Matthew F; Muthu, Sathish; Yoon, S Tim; Kim, Ho-Joong; Cho, Samuel K; Ćorluka, Stipe; Lewis, Stephen J; Kato, So; Buser, Zorica; Wang, Jeffrey C; Hsieh, Patrick C; ,
STUDY DESIGN/METHODS:Cross-sectional survey. OBJECTIVE:Although literature does not recommend routine wound drain utilization, there is a disconnect between the evidence and clinical practice. This study aims to explore into this controversy and analyze the surgeon preferences related to drain utilization, and the factors influencing drain use and criterion for removal. METHODS:A survey was distributed to AO Spine members worldwide. Surgeon demographics and factors related to peri-operative drain use in 1 or 2-level open fusion surgery for lumbar degenerative pathologies were collected. Multivariate analyses by drain utilization, and criterion of removal were conducted. RESULTS:= .010) were more likely to remove drains based on outputs. CONCLUSIONS:Most spine surgeons worldwide prefer to place a subfascial wound drain for degenerative open lumbar surgery. The choice for drain placement is associated with the surgeon's age and use of coaptive films for wound closure, while the criterion for drain removal is associated with the surgeons' region of practice and experience.
PMID: 37897691
ISSN: 2192-5682
CID: 5736382