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Segmental Motion of Cervical Arthroplasty Leads to Decreased Adjacent-Level Degeneration: Analysis of the 7-Year Postoperative Results of a Multicenter Randomized Controlled Trial

Spivak, Jeffrey M; Zigler, Jack E; Philipp, Travis; Janssen, Michael; Darden, Bruce; Radcliff, Kris
BACKGROUND:Cervical artificial disc replacement (C-ADR) has become a common and accepted surgical treatment for many patients with cervical disc degeneration/herniation and radiculopathy who have failed nonoperative treatment. Midterm follow-up studies of the original investigational device exemption trials comparing C-ADR to traditional anterior cervical discectomy and fusion (ACDF) have revealed C-ADR patients have less adjacent-level disease and fewer reoperations at 5 to 7 years. The purpose of this study was to examine the relationship of radiographic adjacent-level disease (R-ALD) with the amount of index-level segmental range of motion (ROM) in C-ADR patients using the long-term follow-up data from the ProDisc-C investigational device exemption trial. METHODS:This was a post hoc analysis of a 1:1 randomized controlled trial. The initial previously described Food and Drug Administration-approved 2-year study was extended, and consenting patients in the original study were followed at annual intervals up to 7 years. Logistic regression was used to assess any progression in adjacent-level disease (ALD). Ordinal logistic regression was also used to assess the relationship between any progressive R-ALD and final flexion extension (F/E) ROM in C-ADR patients. Spearman's rank-order correlation was used when R-ALD was kept as an ordinal variable to assess the same relationship. RESULTS:= 0.01). CONCLUSIONS:C-ADR leads to a significant decrease in R-ALD compared to ACDF. The difference in R-ALD is related to the preservation of motion at the index level and resultant preservation of kinematics and forces across the adjacent disc space. LEVEL OF EVIDENCE/METHODS:4.
PMID: 35177528
ISSN: 2211-4599
CID: 5175732

Cervical fusion for treatment of degenerative conditions: Development of appropriate use criteria

Reitman, C A; Hills, J M; Standaert, C J; Bono, C M; Mick, C A; Furey, C G; Kauffman, C P; Resnick, D K; Wong, D A; Prather, H; Harrop, J S; Baisden, J; Wang, J C; Spivak, J M; Schofferman, J; Riew, K D; Lorenz, M A; Heggeness, M H; Anderson, P A; Rao, R D; Baker, R M; Emery, S E; Watters, W C; Sullivan, W J; Mitchell, W; Tontz, W; Ghogawala, Z
BACKGROUND CONTEXT: High quality evidence is difficult to generate, leaving substantial knowledge gaps in the treatment of spinal conditions. Appropriate use criteria (AUC) are a means of determining appropriate recommendations when high quality evidence is lacking. PURPOSE: Define appropriate use criteria (AUC) of cervical fusion for treatment of degenerative conditions of the cervical spine. STUDY DESIGN/SETTING: Appropriate use criteria for cervical fusion were developed using the RAND/UCLA appropriateness methodology. Following development of clinical guidelines and scenario writing, a one-day workshop was held with a multidisciplinary group of 14 raters, all considered thought leaders in their respective fields, to determine final ratings for cervical fusion appropriateness for various clinical situations. OUTCOME MEASURES: Final rating for cervical fusion recommendation as either "Appropriate," "Uncertain" or "Rarely Appropriate" based on the median final rating among the raters.
METHOD(S): Inclusion criteria for scenarios included patients aged 18 to 80 with degenerative conditions of the cervical spine. Key modifiers were defined and combined to develop a matrix of clinical scenarios. The median score among the raters was used to determine the final rating for each scenario. The final rating was compared between modifier levels. Spearman's rank correlation between each modifier and the final rating was determined. A multivariable ordinal regression model was fit to determine the adjusted odds of an "Appropriate" final rating while adjusting for radiographic diagnosis, number of levels and symptom type. Three decision trees were developed using decision tree classification models and variable importance for each tree was computed.
RESULT(S): Of the 263 scenarios, 47 (17.9 %) were rated as rarely appropriate, 66 (25%) as uncertain and 150 (57%) were rated as appropriate. Symptom type was the modifier most strongly correlated with the final rating (adjusted rho2 = 0.58, p<.01). A multivariable ordinal regression adjusting for symptom type, diagnosis, and number of levels and showed high discriminative ability (C statistic = 0.90) and the adjusted odds ratio (aOR) of receiving a final rating of "Appropriate" was highest for myelopathy (aOR, 7.1) and radiculopathy (aOR, 4.8). Three decision tree models showed that symptom type and radiographic diagnosis had the highest variable importance.
CONCLUSION(S): Appropriate use criteria for cervical fusion in the setting of cervical degenerative disorders were developed. Symptom type was most strongly correlated with final rating. Myelopathy or radiculopathy were most strongly associated with an "Appropriate" rating, while axial pain without stenosis was most associated with "Rarely Appropriate."
ISSN: 1529-9430
CID: 4935452

Enhanced Recovery After Surgery Trends in Adult Spine Surgery: A Systematic Review

Tong, Yixuan; Fernandez, Laviel; Bendo, John A; Spivak, Jeffrey M
BACKGROUND:Enhanced Recovery After Surgery (ERAS) is a multimodal, multidisciplinary approach to optimizing the postsurgical recovery process through preoperative, perioperative, and postoperative interventions. ERAS protocols are emerging quickly within orthopedic spine surgery, yet there is a lack of consensus on optimal ERAS practices. OBJECTIVE:The aim of this systematic review is to identify and discuss the trends in spine ERAS protocols and the associated outcomes. METHODS:A literature search on PubMed was conducted to identify clinical studies that implemented ERAS protocols for various spine procedures in the adult population. The search included English-language literature published through December 2019. Additional sources were retrieved from the reference lists of key studies. Studies that met inclusion criteria were identified manually. Data regarding the study population, study design, spine procedures, ERAS interventions, and associated outcome metrics were extracted from each study that met inclusion criteria. RESULTS:Of the 106 studies identified from the literature search, 22 studies met inclusion criteria. From the ERAS protocols in these studies, common preoperative elements include patient education and modified preoperative nutrition regimens. Perioperative elements include multimodal analgesia and minimally invasive surgery. Postoperative elements include multimodal pain management and early mobilization/rehabilitation/nutrition regimens. Outcomes from ERAS implementation include significant reductions in length of stay, cost, and opioid consumption. Although these trends were observed, there remained great variability among the ERAS protocols, as well as in the reported outcomes. CONCLUSIONS:ERAS may improve cost-effectiveness to varying degrees for spinal procedures. Specifically, the use of multimodal analgesia may reduce overall opioid consumption. However, the benefits of ERAS likely will vary based on the specific procedure. CLINICAL RELEVANCE/CONCLUSIONS:This review contributes to the assessment of ERAS protocol implementation in the field of adult spine surgery.
PMID: 32986587
ISSN: 2211-4599
CID: 4615812

Three-Dimensional Printing in Spine Surgery: A Review of Current Applications

Tong, Yixuan; Kaplan, Daniel James; Spivak, Jeffrey M; Bendo, John A
In recent years, the use of three-dimensional printing (3DP) technology has gained traction in orthopedic spine surgery. Although research on this topic is still primarily limited to case reports and small cohort studies, it is evident that there are many avenues for 3DP innovation in the field. This review article aims to discuss the current and emerging 3DP applications in spine surgery, as well as the challenges of 3DP production and limitations in its use. 3DP models have been presented as helpful tools for patient education, medical training, and pre-surgical planning. Intraoperatively, 3DP devices may serve as patient-specific surgical guides and implants that improve surgical outcomes. However, the time, cost, and learning curve associated with constructing a 3DP model are major barriers to widespread use in spine surgery. Considering the costs and benefits of 3DP along with the varying risks associated with different spine procedures, 3DP technology is likely most valuable for complex or atypical spine disorder cases. Further research is warranted to gain a better understanding of how 3DP can and will impact spine surgery.
PMID: 31731009
ISSN: 1878-1632
CID: 4187082

The Effect of Vascular Approach Surgeons on Peri-operative Complications in Lateral Transpsoas Lumbar Interbody Fusions

Manning, Jordan; Wang, Erik; Varlotta, Christopher; Woo, Dainn; Ayres, Ethan; Eisen, Leon; Bendo, John; Goldstein, Jeffrey; Spivak, Jeffrey; Protopsaltis, Themistocles S; Passias, Peter G; Buckland, Aaron J
BACKGROUND CONTEXT/BACKGROUND:Lateral lumbar interbody fusion is a popular technique used in spine surgery. It is minimally invasive, provides indirect decompression, and allows for coronal plane deformity correction. Despite these benefits, the approach to lateral lumbar interbody fusion has been linked to complications associated with the lumbosacral plexus and vascular anatomy. As a result, vascular surgeons may be recruited for the exposure portion of the procedure. PURPOSE/OBJECTIVE:The purpose of this study was to compare exposure related complication and post-operative (postop) neuropraxia rates between exposure (EXP) and spine surgeon only (SSO) groups when performing the approach for lateral lumbar interbody fusion (LLIF). STUDY DESIGN/SETTING/METHODS:Retrospective analysis of patients treated at a single institution PATIENT SAMPLE: Patients undergoing LLIF procedures between 2012-2018 OUTCOME MEASURES: Operative time, estimated blood loss, fluoroscopy, length of stay, intra- and post-operative complications, and physiologic measures including pre- and post-operative motor examinations and unresolved neuropraxia METHODS: Patients who underwent LLIF were separated into EXP and SSO groups based on the presence or absence of vascular/general surgeon during the approach. The entire clinical history of patients with a decrease in pre and postop motor examination were reviewed for the presence of neuropraxia. All other intra- and postop exposure related complications were recorded for comparison. PSM was performed to account for age, Charlston Comorbity Index (CCI) % LLIFs including L4-L5, and number levels fused. Independent T-test and Chi-squared analyses were used to identify significant differences between EXP and SSO groups. Statistical significance was set at p<0.05. RESULTS:Two hundred seventy-five patients underwent LLIF procedures, 155 SSO and 120 EXP. Post-operatively, 26 patients (11.1%) experienced a drop in any MRC score, and two patients (0.7%) experience unresolved quadriceps palsies. The mean recovery time for MRC scores was 84.4 days. Other complications included 2 pneumothoraces (0.7%), 1 iliac vein injury (0.4%), 14 cases of ileus (5.1%), 3 pulmonary emboli (1.1%), 2 deep vein thrombosis (0.7%), 3 cases of abdominal wall paresis (1.1%), and one abdominal hematoma (0.4%). After PSM, demographics including age, gender, BMI, CCI, levels fused and operative time were similar between cohorts. Twenty patients had changes in pre- to postop motor scores (SSO 9.4%, EXP 12.4%, p>0.05). Iliopsoas motor scores decreased at the highest rate (EXP 12.4%, 8.2% SSO, p>0.05) followed by quadriceps (EXP 5.2%, SSO 4.7%, p>0.05). One SSO patient's postop course was complicated by a foot drop but returned to baseline within 1-year. One patient in EXP group developed an unresolved quadriceps palsy (EXP 1.0%, SSO 0.0% p>0.05). Intra-op exposure complications included one pneumothorax (EXP 1.0%, SSO 0.0%, p>0.05). There were no differences in PE/DVT, Ileus, or LOS. In the EXP cohort, three patients experienced abdominal wall paresis (EXP 2.9%, SSO 0.00%, p=0.246). CONCLUSIONS:Comparing the LLIF exposures performed by EXP and SSO, we found no significant difference in the rates of complications. Additional research is needed to determine the etiology of the abdominal wall complications. In conclusion, neuropraxia- and approach-related complications are similarly low between exposure and spine surgeons.
PMID: 31669613
ISSN: 1878-1632
CID: 4162602

54. Preoperative MRI predictors of health related quality of life improvement after microscopic lumbar discectomy [Meeting Abstract]

Varlotta, C; Vasquez-Montes, D; Manning, J H; Ayres, E W; Wang, E; Woo, D; Alas, H; Brown, A; Kim, Y H; Spivak, J M; Bendo, J A; Protopsaltis, T S; Stieber, J R; Buckland, A J
BACKGROUND CONTEXT: Lumbar herniated nucleus pulposus (HNP) is a common spinal pathology often treated by microscopic lumbar discectomy (MLD), though prior reports have not demonstrated which preoperative MRI factors may contribute to significant clinical improvement after MLD. PURPOSE: To analyze the MRI characteristics in patients with HNP that predict meaningful clinical improvement in Health Related Quality of Life scores (HRQL) after MLD. STUDY DESIGN/SETTING: Retrospective clinical and radiological study of patients undergoing MLD for HNP at a single institution over a two year period of time. PATIENT SAMPLE: Eighty-eight patients receiving MLD treatment for HNP. OUTCOME MEASURES: Cephalocaudal canal migration; canal & HNP anterior-posterior (AP) lengths and ratio; canal & HNP axial areas and ratio; hemi-canal & hemi-HNP axial areas and ratio; disc appearance (black, grey or mixed), baseline (BL) and 3-month (3M) postoperative HRQL scores.
METHOD(S): Patients >18 years old who received MLD for HNP with BL and 3M HRQL scores of PROMIS (Physical Function, Pain Interference, and Pain Intensity), ODI, VAS Back, and VAS Leg scores were included. HNP and spinal canal measurements of cephalocaudal migration, AP length, area, hemi-area, and disc appearance were performed using T2 axial and sagittal MRI. HNP measurements were divided by corresponding canal measurements to calculate AP, Area, and Hemi-Area ratios. Using known minimal clinically importance differences (MCID) for each DELTAHRQoL score, patients were separated into two groups based on whether they reached MCID (+) or did not reach MCID (-). The MCID for Pain Intensity was calculated using a decision tree. A linear regression illustrated correlations between PROMIS vs ODI and VAS Back/Leg scores. Independent t-tests and chi-square tests were utilized to investigate significant differences in HNP measurements between the (+) and (-) MCID groups.
RESULT(S): Eighty-eight MLD patients were included (age=44.6+/-14.9, 38.6% female). Pain Interference and pain intensity were strongly correlated with ODI and VAS Back/Leg (R>=.505), and physical function was significantly correlated with ODI and VAS Back/Leg (R=-.349) (all p<.01). The strongest MRI predictors of meeting HRQL MCID were grey disc appearance, HNP area (>116.6 mm2), hemi-HNP Area (>84.6 mm2), and Hemi-Area Ratio (>51.8%); (+) patients were 2.7 times more likely to have a grey HNP than (-) patients in 5 out of 6 HRQL score comparisons (p<.025). Also, (+) patients had larger HNP areas than (-) patients had in 5 out of 6 HRQoL score comparisons (116.6 mm2 +/- 46.4 vs 90.0 mm2 +/- 43.2, p<.04), and had larger hemi-HNP areas than (-) patients had in 4 out of 6 HRQL score comparisons (84.6 mm2 +/- 38.8 vs 66.3 mm2 +/- 29.7, p<.04). (+) patients had a greater hemi-area ratio than (-) patients had in 4 out of 6 HRQL score comparisons (51.8% +/- 14.7 vs 43.9% +/- 14.9, p<.05).
CONCLUSION(S): Patients who met MCID after MLD had larger HNP areas by 26.6 mm2 and larger hemi-HNP areas by 18.3 mm2 than those who did not meet MCID. These patients were also 2.7x more likely to have a grey HNP compared to patients who did not meet MCID. When accounting for HNP area relative to canal area, patients who met MCID had a 7.9% greater Hemi-HNP canal occupation than patients who did not meet MCID. The results of this study suggest that preoperative MRI parameters can be useful in predicting patient reported improvement after MLD. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
ISSN: 1878-1632
CID: 4052012

Five-Year Reoperation Rates of 2-Level Lumbar Total Disk Replacement Versus Fusion: Results of a Prospective, Randomized Clinical Trial

Radcliff, Kris; Spivak, Jeffrey; Darden, Bruce; Janssen, Michael; Bernard, Thierry; Zigler, Jack
STUDY DESIGN/METHODS:Long-term analysis of prospective randomized clinical trial data. SUMMARY OF BACKGROUND DATA/BACKGROUND:Lumbar total disk replacement (TDR) has been found to have equivalent or superior clinical outcomes compared with fusion and decreased radiographic incidence of adjacent level degeneration in single-level cases. OBJECTIVE:The purpose of this particular analysis was to determine the incidence and risk factors for secondary surgery in patients treated with TDR or circumferential fusion at 2 contiguous levels of the lumbar spine. METHODS:A total of 229 patients were treated and randomized to receive either TDR or circumferential fusion to treat degenerative disk disease at 2 contiguous levels between L3 and S1 (TDR, n=161; fusion, n=68). RESULTS:Overall, at final 5-year follow-up, 9.6% of subjects underwent a secondary surgery in this study. The overall rate of adjacent segment disease was 3.5% (8/229). At 5 years, the percentage of subjects undergoing secondary surgeries was significantly lower in the TDR group versus fusion (5.6% vs. 19.1%, P=0.0027).Most secondary surgeries (65%, 17/26) occurred at the index levels. Index level secondary surgeries were most common in the fusion cohort (16.2%, 11/68 subjects) versus TDR (3.1%, 5/161 subjects, P=0.0009). There no statistically significant difference in the adjacent level reoperation rate between TDR (2.5%, 4/161) and fusion (5.9%, 4/68). The most common reason for index levels reoperation was instrumentation removal (n=9). Excluding the instrumentation removals, there was not a significant difference between the treatments in index level reoperations or in reoperations overall. CONCLUSIONS:There were significantly fewer reoperations in TDR patients compared with fusion patients. However, most of the secondary surgeries were instrumentation removal in the fusion cohort. Discounting the instrumentation removals, there was no significant difference in reoperations between TDR and fusion. These results are indicative that lumbar TDR is noninferior to fusion.
PMID: 28005616
ISSN: 2380-0194
CID: 3044412

The Effect of Smoking on Spinal Fusion

Berman, Daniel; Oren, Jonathan H; Bendo, John; Spivak, Jeffrey
Background/UNASSIGNED:Spinal fusion surgery is performed about half a million times per year in the United States and millions more worldwide. It is an effective method for reducing pain, increasing stability, and correcting deformity in patients with various spinal conditions. In addition to being a well-established risk factor for a variety of medical conditions, smoking has deleterious effects on the bone healing of spinal fusions. This review aims to specifically analyze the ways in which smoking affects the outcomes of spinal fusion and to explore ways in which these negative consequences can be avoided. Purpose/UNASSIGNED:This article provides a complete understanding of the ways smoking affects spinal fusion from a biochemical and clinical perspective. Recommendations are also provided for ways in which surgeons can limit patient exposure to the most serious negative outcomes associated with cigarette smoking. Study Design/Setting/UNASSIGNED:This study was a retrospective literature review done using the NCBI database. The research was compiled at NYU Hospital for Joint Diseases and the NYU Center for Musculoskeletal Care. Methods/UNASSIGNED:A comprehensive literature review was done spanning research on a variety of subjects related to smoking and spinal fusion surgery. The biochemistry of smoking and fusion healing were examined in great detail. In addition, both in vivo animal studies and human clinical studies were evaluated to explore fusion success related to the effects of smoking and its biochemical factors on spinal fusion surgery. Results/UNASSIGNED:Smoking significantly increases the risk of pseudoarthrosis for patients undergoing both lumbar and cervical fusions. In addition to nonunion, smoking also increases the risk of other perioperative complications such as infection, adjacent-segment pathology, and dysphagia. Treatment options are available that can be explored to reduce the risk of smoking-related morbidity, such as nicotine replacement therapy and use of bone morphogenetic proteins (BMPs). Conclusions/UNASSIGNED:It has been clearly demonstrated from both a biochemical and clinical perspective that smoking increases the rate of perioperative complications for patients undergoing spinal fusion surgery, particularly pseudoarthosis. It has also been shown that there are certain approaches that can reduce the risk of morbidity. The most important recommendation is smoking cessation for four weeks after surgery. In addition, patients may be treated with certain surgical techniques, including the use of BMPs, to reduce the risk of pseudoarthrosis. Lastly, nicotine replacement therapy is an area of continued interest in relation to spinal fusion outcomes and more research needs to be done to determine its efficacy moving forward.
PMID: 29372133
ISSN: 2211-4599
CID: 2927742

209 - Intraoperative Fluid (IVF) Administration during Multilevel Spine Surgery Impacts Extubation Status: A Propensity Score Matched Analysis

Day, Louis M; Ramchandran, Subaraman; Cruz, Dana; Line, Breton; Buckland, Aaron J; Protopsaltis, Themistocles S; Bendo, John A; Passias, Peter G; Oren, Jonathan H; Spivak, Jeffrey M; Goldstein, Jeffrey A; Huncke, Tessa K; Errico, Thomas J; Bess, Shay
ISSN: 1529-9430
CID: 2309042

Cervical disc replacement - emerging equivalency to anterior cervical discectomy and fusion

Buckland, Aaron J; Baker, Joseph F; Roach, Ryan P; Spivak, Jeffrey M
PURPOSE: Cervical disc replacement has become an acceptable alternative to anterior cervical fusion for the surgical treatment of cervical spine spondylosis resulting in radiculopathy or myelopathy following anterior discectomy and decompression. This concise overview considers the current state of knowledge regarding the continued debate of the role of cervical disc replacement with an update in light of the latest clinical trial results. METHODS: A literature review was performed identifying clinical trials pertaining to the use of cervical disc replacement compared to cervical discectomy and fusion. Single level disease and two level disease were considered. Outcome data from the major clinical trials was reviewed and salient points identified. RESULTS: With lengthier follow-up data becoming available, the equivalence of CDR in appropriately selected cases is becoming clear. This is chiefly manifested by reduced re-operation rates and reduced incidence of adjacent level disease in those treated with arthroplasty. CONCLUSION: Cervical disc replacement shows emerging equivalence in outcomes compared to the gold standard anterior cervical discectomy and fusion. Further longer term results are anticipated to confirm this trend.
PMID: 27055447
ISSN: 1432-5195
CID: 2066212