So Close yet So Far: The impact of undercorrection of cervical sagittal alignment during adult cervical deformity surgery - An Incremental correction analysis.

BACKGROUND: To compare degrees of cSVA correction and to theorize possible minimum and maximum thresholds of cSVA correction for patients to benefit clinically. METHODS: 657 operative ACD patients in a retrospective cohort study of a prospectively enrolled database with complete baseline and two year radiographic and HRQL data were examined. Patients were grouped into an optimally corrected cohort (OC; postop cSVA ≤ 4 cm) and an undercorrected cohort (UC; postop cSVA > 4 cm) based on postoperative radiographs. RESULTS: 265 patients met inclusion criteria (mean age 58.2 ± 11.4 years, BMI 28.9 ± 7.5, CCI 0.9 ± 1.3). 11.2 % of patients were UC, while 88.8 % of patients were OC. UC cohort experienced a significantly greater occurrence of radiographic complications (47.8 % v. 27.6 %, p = 0.046). UC also demonstrated a significantly greater rate of severe 6 M DJK (p < 0.001) and 1Y DJK (26.1 % v. 2.7 %, p < 0.001). In terms of HRQLs, the OC cohort demonstrated significantly greater 2Y EQ5D-Health values (76.9 v. 46.7, p = 0.012). Being UC was a significant predictor of moderate-high 1Y mJOA score (OR 3.0, CI 95 % 1.2-7.3, p = 0.015) Still, in terms of CIT, the threshold for DJF risk increased significantly (p = 0.026) when the cSVA were surgically corrected greater than 5 cm. CONCLUSION: Undercorrection of cSVA yielded worse clinical outcomes and posed a significant risk for radiographic complications. Although undercorrection does not seem to be efficacious, surgical correction beyond certain thresholds should still be respected as there is a risk for DJK on either end of the spectrum.

Discectomy versus sequestrectomy in the treatment of lumbar disc herniation: a systematic review and meta-analysis.

BACKGROUND CONTEXT: Lumbar disc herniation (LDH) is a leading cause of low back pain (LBP) and leg pain and may require surgical treatment in case of persistent pain and/or neurological deficits. Conventional discectomy involves removing the herniated fragment and additional material from the disc space, potentially accelerating disc degeneration and contributing to chronic LBP. Conversely, by resecting the herniated fragment only, sequestrectomy may reduce postoperative LBP while increasing the risk of LDH recurrence. PURPOSE: To compare discectomy versus sequestrectomy in terms of risk of reherniation, reoperation rate, complications, pain, satisfaction, and perioperative outcomes (operative time, blood loss, length of stay [LOS]). STUDY DESIGN: Systematic review and meta-analysis. METHODS: A systematic search of PubMed/MEDLINE and Scopus databases was performed through May 1, 2024 for both randomized and nonrandomized studies. The search was conducted according to PRISMA guidelines. The RoB-2 and MINORS tools were utilized to assess the risk of bias in included studies. The quality of the evidence was evaluated according to the GRADE approach. Relevant outcomes were pooled for meta-analysis. RESULTS: A total of 16 articles (1 randomized controlled trial with 2 follow-up studies, 6 prospective studies, and 7 retrospective studies) published between 1991 and 2020 involving 2009 patients were included for analysis. No significant differences were noted between discectomy versus sequestrectomy in terms of risk of reherniation (OR: 0.85, 95% CI: 0.57 to 1.26, p=.42), reoperation rate (OR: 0.95, 95% CI: 0.64 to 1.40, p=.78), and complications (OR: 1.03, 95% CI: 0.50 to 2.11, p=.94). Although LBP (MD: -0.06, 95% CI: -0.39 to 0.28, p=.74) and leg pain intensity (MD: 0.11, 95% CI: -0.21 to 0.42, p=.50) were similar postoperatively, significantly better outcomes were reported by patients treated with sequestrectomy at 1 year (leg pain: MD: 0.37, 95% CI: 0.19 to 0.54, p<.0001) and 2 years (LBP: MD: 0.19, 95% CI: 0.03 to 0.34, p=.02; leg pain: MD: 0.20, 95% CI: 0.09 to 0.31, p=.0005). Sequestrectomy also resulted in a higher patient satisfaction (OR: 0.60, 95% CI: 0.40 to 0.90, p=.01) and shorter operative time (MD: 8.71, 95% CI: 1.66 to 15.75, p=.02), while blood loss (MD: 0.18, 95% CI: -2.31 to 2.67, p=.89) and LOS (MD: 0.02 days, 95% CI: -0.07 to 0.12, p=.60) did not significantly differ compared to discectomy. CONCLUSIONS: Based on the current evidence, discectomy and sequestrectomy do not significantly differ in terms of risk of reherniation, reoperation rate, and postoperative complications. Patients treated with sequestrectomy may benefit from a marginally higher pain improvement, better satisfaction outcomes, and a shorter operative time, although the clinical relevance of these differences needs to be validated in larger, prospective, randomized studies.

Diagnosis of spine pseudoarthrosis based on the biomechanical properties of bone.

BACKGROUND CONTEXT: 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: Develop and test a biomechanically based approach to the diagnosis of pseudoarthrosis. STUDY DESIGN: 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: In a symptomatic postspine 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.

Rate of Reoperation Following Decompression-Only Procedure for Lumbar Degenerative Spondylolisthesis: A Systematic Review of Literature.

Background: Management of lumbar degenerative spondylolisthesis with decompression-only procedure has been performed for its added benefit of a shorter duration of surgery, lower blood loss, and shorter hospital stay. However, reported failure rates for decompression-only procedures vary depending on the methods utilized for decompression. Hence, we aim to identify the failure rates of individual methods of decompression-only procedures performed for degenerative lumbar spondylolisthesis. Methods: An independent systematic review of 4 scientific databases (PubMed, Scopus, clinicaltrials.gov, Web of Science) was performed to identify relevant articles as per the preferred reporting in systematic reviews and meta-analysis guidelines. Studies reporting on failure rates defined by reoperation at the index level following decompression-only procedure for degenerative lumbar spondylolisthesis were included for analysis. Studies were appraised using ROBINS tool of Cochrane, and analysis was performed using the Open Meta[Analyst] software. Results: The overall failure rate of decompression-only procedure was 9.1% (95% confidence interval [CI] [6.5-11.7]). Furthermore, open decompression had failure rate of 10.9% (95% CI [6.0-15.8]), while microendoscopic decompression had failure rate of 6.7% (95% CI [2.9-10.6]). The failure rate gradually increased from 6.9% (95% CI [2.0-11.7]) at 1 year to 7% (95% CI [3.6-10.3]), 11.7% (95% CI [4.5-18.9]), and 11.7% (95% CI [6.6-16.7]) at 2, 3, and 5 years, respectively. Single level decompression had a failure rate of 9.6% (95% CI [6.3-12.9]), while multilevel decompression recorded a failure rate of 8.7% (95% CI [5.6-11.7]). Conclusion: High-quality evidence on the decompression-only procedure for degenerative spondylolisthesis is limited. The decompression-only procedure had an overall failure rate of 9.1% without significant differences between the decompression techniques. Level of Evidence: Level IV. See Instructions for Authors for a complete description of levels of evidence.

Identification and impact of failure of pelvic compensation in patients with adult spinal deformity.

BACKGROUND CONTEXT: 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: 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: Retrospective cross-sectional study. PATIENT SAMPLE: Patients with ASD from a monocenter database. OUTCOME MEASURES: 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.

Closing the Gap: The Incidence of Complications in Minimally Invasive Tubular, Endoscopic, and Robotic-Assisted Transforaminal Lumbar Interbody Fusion Procedures.

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.

The impact of enhanced recovery after surgery (ERAS) on opioid consumption and postoperative pain levels in elective spine surgery.

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.

Radiographic Risk Factors for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion (ACDF): A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: To assess the radiographic risk factors for adjacent segment disease (ASD) following anterior cervical discectomy and fusion (ACDF) for degenerative cervical spine pathologies. METHODS: PubMed, Embase and the Cochrane Library databases were searched up to December 2023. The primary inclusion criteria were degenerative spinal conditions treated with ACDF, comparing radiological parameters in patients with and without postoperative ASD. The radiographic parameters included intervertebral disc height, cervical sagittal alignment, sagittal segmental alignment, range of motion, segmental height, T1 slope, sagittal vertical axis (SVA), thoracic inlet angle (TIA), and plate to disc distance (PPD). Risk of bias was assessed for all studies. The Cochrane Review Manager was utilized to perform the meta-analysis. RESULTS: From 7044 articles, 13 retrospective studies were included in the final analysis. Three studies had "not serious" bias and the other 10 studies had serious or very serious bias. The total number of patients in the included studies was 1799 patients. Five studies included single-level ACDF, 2 studies included multi-level ACDF, and 6 studies included single or multi-level ACDF. On meta-analysis, the significant risk factors associated with ASD development were reduced postoperative cervical lordosis (mean difference [MD] = 3.35°, P = .002), reduced last-follow-up cervical lordosis (MD = -3.02°, P = .0003), increased preoperative to postoperative cervical sagittal alignment change (MD = -3.68°, P = .03), and the presence of developmental cervical canal stenosis (Odds ratio [OR] = 4.17, P < .001). CONCLUSIONS: Decreased postoperative cervical lordosis, greater change in cervical sagittal alignment and developmental cervical canal stenosis were associated with an increased risk of ASD following ACDF.

Analysis of Complications in Multilevel Anterior Cervical Discectomy and Fusion Using Osteobiologics Other than Bone Morphogenetic Protein: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVES: The aim of this study is to analyze the complications related to multilevel anterior cervical discectomy and fusion (ACDF) using osteobiologics other than bone morphogenetic protein (BMP). METHODS: A systematic review of the literature was conducted using PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov databases. The search to identify studies reporting complications in multilevel ACDF surgery using osteobiologics other than bone morphogenetic protein was performed in August 2020. The study was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). RESULTS: A total of 584 articles were found after searching the databases and removing duplicates. Next, screening was performed in a double reviewer process, and 153 eligible articles-with 4 retrospective studies-in full-text were selected; these met all inclusion criteria. A total of 197 patients received 3-level ACDF, while 72 patients received 4-level ACDF. Osteobiologics were used in all selected articles, allograft was used in 4 studies, autologous bone graft was utilized in 3 articles, and hydroxyapatite was used in 1 article. The main complications reported were dysphagia, adjacent segment disease, and pseudarthrosis. CONCLUSIONS: Given the limited evidence, no conclusions on complications in multilevel ACDF using osteobiologics other than BMP could be made. However, descriptively, the most common complications found were dysphagia, adjacent segment disease, and pseudoarthrosis. Further prospective studies separately analyzing complications in multilevel ACDF by osteobiologics and a number of treated levels are needed.

Complications of the Use Allograft in 1- or 2-Level Anterior Cervical Discectomy and Fusion: A Systematic Review.

Study Design: Systematic literature reviewObjective: To critically analyze the literature and describe the complications associated with the use of allograft in 1- or 2- level anterior cervical discectomy and fusion (ACDF)Methods: A systematic search of PubMed/MEDLINE, EMBASE, and ClinicalTrials.gov databases was conducted for literature published between January 2000 and August 2020 reporting complications associated with the use of allograft in 1- or 2- level ACDF.Results: From 584 potentially relevant citations, 21 met the inclusion criteria (4 randomized controlled trials (RCT), 4 prospective, and 13 retrospective studies). The patient number varied between 26 and 463 in comparative studies (RCT and non-RCT) and between 29 and 345 in non-comparative studies. Fusion rate was reported in 14 studies and ranged between 68.5-100%. The most frequently reported complication was post-operative dysphagia or dysphonia, with incidences ranging between .5% and 14.4%. Revision surgery was the second most reported complication (14 studies) and ranged between 0% and 10.3%. Wound-related complications were reported in 6 studies and ranged between 0% and 22.8%.Conclusion: The overall reporting of complications was low with very few comparative studies. Reported complications with allografts are within the range of other osteobiologics and autografts and in most cases may not attributable to the use of osteobiologics and may be complications of the procedure itself. Comparative studies with a more robust methodology analyzing complications with allograft and other osteobiologics are needed to inform current practice with strong recommendations.

Development of an International AO Spine Guideline for the Use of Osteobiologics in Anterior Cervical Fusion and Decompression (AO-GO).

STUDY DESIGN: 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: 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.

The Evidence for the Use of Osteobiologics in Hybrid Constructs (Anterior Cervical Discectomy and Fusion and Total Disc Replacement) in Multilevel Cervical Degenerative Disc Disease: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVE: Examine the clinical evidence for the use of osteobiologics in hybrid surgery (combined anterior cervical discectomy and fusion (ACDF) and total disc replacement (TDR)) in patients with multilevel cervical degenerative disc disease (DDD). METHODS: PubMed and Embase were searched between January 2000 and August 2020. Clinical studies investigating 18-80 year old patients with multilevel cervical DDD who underwent hybrid surgery with or without the use of osteobiologics were considered eligible. Two reviewers independently screened and assessed the identified articles. The methodological index for non-randomized studies (MINORS) tool and the risk of bias (RoB 2.0) assessment tool were used to assess risk of bias. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) was used to evaluate quality of evidence across studies per outcome. RESULTS: Eleven studies were included. A decrease in cervical range of motion was observed in most studies for both the hybrid surgery and the control groups consisting of stand-alone ACDF or TDR. Fusion rates of 70-100% were reported in both the hybrid surgery and control groups consisting of stand-alone ACDF. The hybrid surgery group performed better or comparable to the control group in terms of adjacent segment degeneration. Studies reported an improvement in visual analogue scale for pain and neck disability index values after surgery compared to preoperative scores for both treatment groups. The included studies had moderate methodological quality. CONCLUSIONS: There is insufficient evidence for assessing the use of osteobiologics in multilevel hybrid surgery and additional high quality and controlled research is deemed essential.

The Role of Osteobiologics in Augmenting Spine Fusion in Unplated Anterior Cervical Discectomy and Fusion Compared to Plated Constructs: A Systematic Review and Meta-analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: To compare clinical and radiographic outcomes as well as complications of unplated vs plated anterior cervical discectomy and fusion (ACDF) surgery considering the role of osteobiologics in single- and multi-level procedures. METHODS: A systematic search of PubMed/MEDLINE, Scopus, CINAHL, EMBASE, CENTRAL, Cochrane and ClinicalTrials.gov databases was performed. Briefly, we sought to identify studies comparing unplated vs. plated ACDF for cervical degenerative disc disease reporting the use of osteobiologics in terms of clinical outcomes, radiographic fusion, and complications. Data on study population, follow-up time, type of cage and plate used, type of osteobiologic employed, number of levels treated, patient-reported outcomes (PROs), radiographic outcomes and complications were collected and compared. Relevant information was pooled for meta-analyses. RESULTS: Thirty-eight studies met the inclusion criteria. No significant difference was found in terms of clinical outcomes between groups. Unplated ACDF was characterized by reduced blood loss, operation time and length of hospital stay. Fusion was achieved by the majority of patients in both groups, with no evidence of any specific contribution depending on the osteobiologics used. Dysphagia was more commonly associated with anterior plating, while cage subsidence prevailed in the unplated group. CONCLUSION: Unplated and plated ACDF seem to provide similar outcomes irrespective of the osteobiologic used, with minor differences with doubtful clinical significance. However, the heterogeneity and high risk of bias affecting included studies markedly prevent significant conclusions.

What Is the Evidence Supporting Osteobiologic Use in Revision Anterior Cervical Discectomy and Fusion?

STUDY DESIGN: Systematic literature review. OBJECTIVE: To analyze the literature and describe the evidence supporting osteobiologic use in revision anterior cervical discectomy and fusion (ACDF) surgery. METHODS: A systematic search of PubMed/MEDLINE, EMBASE, Cochrane library, and ClinicalTrials.gov databases was conducted for literature reporting the use of osteobiologics in revision ACDF. We searched for studies reporting outcomes of using any osteobiologic use in revision ACDF surgeries (independently of the number of levels) in the above databases. RESULTS: There are currently no studies in the literature describing the outcome and comparative efficacy of diverse osteobiologic agents in the context of revision ACDF surgery. A majority of the current evidence is based only upon studies involving primary ACDF surgery. CONCLUSION: The current study highlights the paucity of literature evidence on the role of diverse osteobiologics in revision ACDF, and foregrounds the need for high-quality evidence on this subject.

AO Spine Guideline for the Use of Osteobiologics (AOGO) in Anterior Cervical Discectomy and Fusion for Spinal Degenerative Cases.

STUDY DESIGN: Guideline. OBJECTIVES: To develop an international guideline (AOGO) about the use of osteobiologics in anterior cervical discectomy and fusion (ACDF) for treating degenerative spine conditions. METHODS: The guideline development process was guided by AO Spine Knowledge Forum Degenerative (KF Degen) and followed the Guideline International Network McMaster Guideline Development Checklist. The process involved 73 participants with expertise in degenerative spine diseases and surgery from 22 countries. Fifteen systematic reviews were conducted addressing respective key topics and evidence was collected. The methodologist compiled the evidence into GRADE Evidence-to-Decision frameworks. Guideline panel members judged the outcomes and other criteria and made the final recommendations through consensus. RESULTS: Five conditional recommendations were created. A conditional recommendation is about the use of allograft, autograft or a cage with an osteobiologic in primary ACDF surgery. Other conditional recommendations are about the use of osteobiologic for single- or multi-level ACDF, and for hybrid construct surgery. It is suggested that surgeons use other osteobiologics rather than human bone morphogenetic protein-2 (BMP-2) in common clinical situations. Surgeons are recommended to choose 1 graft over another or 1 osteobiologic over another primarily based on clinical situation, and the costs and availability of the materials. CONCLUSION: This AOGO guideline is the first to provide recommendations for the use of osteobiologics in ACDF. Despite the comprehensive searches for evidence, there were few studies completed with small sample sizes and primarily as case series with inherent risks of bias. Therefore, high-quality clinical evidence is demanded to improve the guideline.

Comparative Complications Associated With BMP Use In Patients Undergoing ACDF for Degenerative Spinal Conditions: Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic Review and Meta-Analysis. OBJECTIVES: 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: Of 1832 preliminary search results, 27 manuscripts were included. Meta-analysis revealed the relative risk of dysphagia or dysphonia (RR = 1.39, CI 95% 1.18 - 1.64, P = <.001), anterior soft tissue complications (RR = 1.43, CI 95% 1.25-1.64, P = <.001), and medical complications (RR = 1.32, CI 95% 1.06-1.66, P = .013) were statistically significant in the BMP2 group while the relative risk of non-union (RR = .5, CI 95% .23 - 1.13, P = .09) trended lower in the BMP2 group. Neurological deficit (RR = 1.06, CI 95% .82-1.37, P = .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.

Do Osteobiologics Augment Fusion in Anterior Cervical Discectomy and Fusion Surgery Performed With Mechanical Interbody Devices (Polyether ether ketone, Carbon Fiber, Metal Cages) and is the Fusion Rate Comparable to that With Autograft? A Systematic Review.

STUDY DESIGN: Systematic Review of the Literature. OBJECTIVE: The purpose of this study was to perform a systematic review describing fusion rates for anterior cervical discectomy and fusion (ACDF) using autograft vs various interbody devices augmented with different osteobiologic materials. METHODS: A systematic review limited to the English language was performed in Medline, Embase and Cochrane library using Medical Subject Heading (MeSH) terms. Studies that evaluated fusion after ACDF using autografts and osteobiologics combined with PEEK, carbon fibre, or metal cages were searched for. Articles in full text that met the criteria were included in the review. The main outcomes evaluated were the time taken to merge, the definition of the fusion assessment, and the modality of the fusion assessment. The risk of bias of each article was assessed by the MINORS score or ROB 2.0 depending on the randomisation process. RESULTS: The total number of references reviewed was six hundred and eighty-two. After applying the inclusion criteria, 54 were selected for the retrieval of the full text. Eight studies were selected and included for final analysis in this study. Fusion rates were reported between 83.3% and 100% for autograft groups compared to 46.5% and 100% for various interbody device/osteobiological combinations. The overall quality of the evidence in all radiographic fusion studies was considered insufficient due to a serious risk of bias. CONCLUSION: Mechanical interbody devices augmented with osteobiologics performed similarly to autografts in terms of reliability and efficacy. Their time to fusion and fusion rate were comparable to autografts at the end of the final follow-up.

Complications With Demineralized Bone Matrix, Hydroxyapatite and Beta-Tricalcium Phosphate in Single and Two-Level Anterior Cervical Discectomy and Fusion Surgery.

STUDY DESIGN: Systematic literature review. OBJECTIVES: To analyze the evidence available reporting complications in single or two-level anterior cervical discectomy and fusion (ACDF) using a demineralized bone matrix (DBM), hydroxyapatite (HA), or beta-tricalcium phosphate (ß-TCP). METHODS: A systematic review of the literature using PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov databases was performed in August 2020 to identify studies reporting complications in one or two-level ACDF surgery using DBM, HA, or ß-TCP. The study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. RESULTS: A total of 1857 patients were included, 981 male and 876 female, across 17 articles; 5 prospective, and 12 retrospectives. We noted heterogeneity among the included studies concerning the study design and combination of graft materials utilized in them. However, we noted a higher incidence of adjacent segment disease (17.7%) and pseudoarthrosis (9.3%) in fusion constructs using DBM. Studies using ß-TCP reported a higher incidence of pseudoarthrosis (28.2%) and implant failures (17.9%). CONCLUSIONS: Degenerative cervical conditions treated with one or two-level ACDF surgery using DBM, HA, or ß-TCP with or without cervical plating are associated with complications such as adjacent segment disease, dysphagia, and pseudarthrosis. However, consequent to the study designs and clinical heterogeneity of the studies, it is not possible to correlate these complications accurately with any specific graft material employed. Further well-designed prospective studies are needed to correctly know the related morbidity of each graft used for achieving fusion in ACDF.

Structural Allograft Versus Mechanical Interbody Devices Augmented With Osteobiologics in Anterior Cervical Discectomy and Fusion: A Systematic Review.

STUDY DESIGN: Systematic Literature Review. OBJECTIVE: Perform a systematic review evaluating postoperative fusion rates for anterior cervical discectomy and fusion (ACDF) using structural allograft vs various interbody devices augmented with different osteobiologic materials. METHODS: Comprehensive literature search using PubMed, Embase, The Cochrane Library, and Web of Science was performed. Included studies were those that reported results of 1-4 levels ACDF using pure structural allograft compared with a mechanical interbody device augmented with an osteobiologic. Excluded studies were those that reported on ACDF with cervical corpectomy; anterior and posterior cervical fusions; circumferential (360° or 540°) fusion or revision ACDF for nonunion or other conditions. Risk of bias was determined using the Cochrane review guidelines. RESULTS: 8 articles reporting fusion rates of structural allograft and an interbody device/osteobiologic pair were included. All included studies compared fusion rates following ACDF among structural allograft vs non-allograft interbody device/osteobiologic pairs. Fusion rates were reported between 84% and 100% for structural allograft, while fusion rates for various interbody device/osteobiologic combinations ranged from 26% to 100%. Among non-allograft cage groups fusion rates varied from 73-100%. One study found PEEK cages filled with combinations of autograft, allograft, and demineralized bone matrix (DBM) to have an overall fusion rate of 26%. In one study comparing plate and zero-profile constructs, there was no difference in fusion rates for two-level fusions. CONCLUSION: There was limited data comparing fusion outcomes of patients undergoing ACDF using structural allograft vs interbody devices augmented with osteobiologic materials to support superiority of one method.

Comparison of Different Osteobiologics in Terms of Imaging Modalities and Time Frames for Fusion Assessment in Anterior Cervical Discectomy and Fusion: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVES: The study's primary objective was to determine how osteobiologic choice affects fusion rates in patients undergoing anterior cervical discectomy and fusion (ACDF). The study's secondary objectives were to 1) determine the optimal timing of fusion assessment following ACDF and 2) determine if osteobiologic type affects the timing and optimal modality of fusion assessment. METHODS: A systematic search of PubMed/MEDLINE was conducted for literature published from 2000 through October 2020 comparing anterior fusion in the cervical spine with various osteobiologics. Both comparative studies and case series of ≥10 patients were included. RESULTS: A total of 74 studies met the inclusion criteria. Seventeen studies evaluated the efficacy of autograft on fusion outcomes, and 23 studies assessed the efficacy of allograft on fusion outcomes. 3 studies evaluated the efficacy of demineralized bone matrix, and seven assessed the efficacy of rhBMP-2 on fusion outcomes. Other limited studies evaluated the efficacy of ceramics and bioactive glasses on fusion outcomes, and 4 assessed the efficacy of stem cell products. Most studies utilized dynamic radiographs for the assessment of fusion. Overall, there was a general lack of supportive data to determine the optimal timing of fusion assessment meaningfully or if osteobiologic type influenced fusion timing. CONCLUSIONS: Achieving fusion following ACDF appears to remain an intricate interplay between host biology and various surgical factors, including the selection of osteobiologics. While alternative osteobiologics to autograft exist and may produce acceptable fusion rates, limitations in study methodology prevent any definitive conclusions from existing literature.