Intravenous Ketorolac Substantially Reduces Opioid Use and Length of Stay After Lumbar Fusion: A Randomized Controlled Trial.

STUDY DESIGN: A randomized, double-blinded, placebo-controlled trial. OBJECTIVE: To examine the effect of intravenous ketorolac (IV-K) on hospital opioid use compared with IV-placebo (IV-P) and IV acetaminophen (IV-A). SUMMARY OF BACKGROUND DATA: Controlling postoperative pain while minimizing opioid use after lumbar spinal fusion is an important area of study. PATIENTS AND METHODS: Patients aged 18 to 75 years undergoing 1 to 2 level lumbar fusions between April 2016 and December 2019 were included. Patients with chronic opioid use, smokers, and those on systemic glucocorticoids or contraindications to study medications were excluded. A block randomization scheme was used, and study personnel, hospital staff, and subjects were blinded to the assignment. Patients were randomized postoperatively. The IV-K group received 15 mg (age > 65) or 30 mg (age < 65) every six hours (q6h) for 48 hours, IV-A received 1000 mg q6h, and IV-P received normal saline q6h for 48 hours. Demographic and surgical details, opioid use in morphine milliequivalents, opioid-related adverse events, and length of stay (LOS) were recorded. The primary outcome was in-hospital opioid use up to 72 hours. RESULTS: A total of 171 patients were included (58 IV-K, 55 IV-A, and 58 IV-P) in the intent-to-treat (ITT) analysis, with a mean age of 57.1 years. The IV-K group had lower opioid use at 72 hours (173 ± 157 mg) versus IV-A (255 ± 179 mg) and IV-P (299 ± 179 mg; P = 0.000). In terms of opiate use, IV-K was superior to IV-A ( P = 0.025) and IV-P ( P = 0.000) on ITT analysis, although on per-protocol analysis, the difference with IV-A did not reach significance ( P = 0.063). When compared with IV-P, IV-K patients reported significantly lower worst ( P = 0.004), best ( P = 0.001), average ( P = 0.001), and current pain ( P = 0.002) on postoperative day 1, and significantly shorter LOS ( P = 0.009) on ITT analysis. There were no differences in opioid-related adverse events, drain output, clinical outcomes, transfusion rates, or fusion rates. CONCLUSIONS: By reducing opioid use, improving pain control on postoperative day 1, and decreasing LOS without increases in complications or pseudarthrosis, IV-K may be an important component of "enhanced recovery after surgery" protocols.

Differences in imaging and clinical characteristics are associated with higher rates of decompression-fusion versus decompression-alone in women compared to men for lumbar degenerative spondylolisthesis.

PURPOSE: The goals were to ascertain if differences in imaging/clinical characteristics between women and men were associated with differences in fusion for lumbar degenerative spondylolisthesis. METHODS: Patients had preoperative standing radiographs, CT scans, and intraoperative fluoroscopic images. Symptoms and comorbidity were obtained from patients; procedure (fusion-surgery or decompression-alone) was obtained from intraoperative records. With fusion surgery as the dependent variable, men and women were compared in multivariable logistic regression models with clinical/imaging characteristics as independent variables. The sample was dichotomized, and analyses were repeated with separate models for men and women. RESULTS: For 380 patients (mean age 67, 61% women), women had greater translation, listhesis angle, lordosis, and pelvic incidence, and less diastasis and disc height (all p ≤ 0.03). The rate of fusion was higher for women (78% vs. 65%; OR 1.9, p = 0.008). Clinical/imaging variables were associated with fusion in separate models for men and women. Among women, in the final multivariable model, less comorbidity (OR 0.5, p = 0.05), greater diastasis (OR 1.6, p = 0.03), and less anterior disc height (OR 0.8, p = 0.0007) were associated with fusion. Among men, in the final multivariable model, opioid use (OR 4.1, p = 0.02), greater translation (OR 1.4, p = 0.0003), and greater diastasis (OR 2.4, p = 0.0002) were associated with fusion. CONCLUSIONS: There were differences in imaging characteristics between men and women, and women were more likely to undergo fusion. Differences in fusion within groups indicate that decisions for fusion were based on composite assessments of clinical and imaging characteristics that varied between men and women.

Phase 1 evaluation of an elastomeric nucleus pulposus device as an option to augment disc at microdiscectomy: Experimental results from biomechanical and biocompatibility testing and first in human.

Objective: Whilst microdiscectomy is an excellent reliever of pain for recalcitrant lumbar disc herniation (LDH), it has a high failure rate over time due to the ensuing reduction in mechanical stabilization and support of the spine. One option is to clear the disc and replace it with a nonhygroscopic elastomer. Here, we present the evaluation of biomechanical and biological behavior of a novel elastomeric nucleus device (Kunovus disc device [KDD]), consisting of a silicone jacket and a two-part in situ curing silicone polymer filler. Materials and Methods: ISO 10993 and American Society for Testing and Materials (ASTM) standards were used to evaluate the biocompatibility and mechanics of KDD. Sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, muscle implantation study, direct contact matrix toxicity assay, and cell growth inhibition assay were performed. Fatigue test, static compression creep testing, expulsion testing, swell testing, shock testing, and aged fatigue testing were conducted to characterize the mechanical and wear behavior of the device. Cadaveric studies to develop a surgical manual and evaluate feasibility were conducted. Finally, a first-in-human implantation was conducted to complete the proof of principle. Results: The KDD demonstrated exceptional biocompatibility and biodurability. Mechanical tests showed no Barium-containing particles in fatigue test, no fracture of nucleus in static compression creep testing, no extrusion and swelling, and no material failure in shock and aged fatigue testing. Cadaver training sessions showed that KDD was deemed implantable during microdiscectomy procedures in a minimally invasive manner. Following IRB approval, the first implantation in a human showed no intraoperative vascular and neurological complications and demonstrated feasibility. This successfully completed Phase 1 development of the device. Conclusion: The elastomeric nucleus device may mimic native disc behavior in mechanical tests, offering an effective way for treating LDH by way of Phase 2 and subsequent clinical trials or postmarket surveillance in the future.

Emerging Need for PROMs to Measure the Impact of Spine Disorders on Overall Health and Well-being: Measuring Expectations as an Example for Lumbar Degenerative Spondylolisthesis.

Background: Assessing the impact of spine disorders such as lumbar degenerative spondylolisthesis (LDS) on overall health is a component of quality of care that may not be comprehensively captured by spine-specific and single-attribute patient-reported outcome measures (PROMs). Purpose: We sought to compare PROMs to the Lumbar Surgery Expectations Survey ("Expectations Survey"), which addresses multiple aspects of health and well-being, and to compare the relevance of surgeon-selected versus survey-selected Patient-Reported Outcomes Measurement Information System (PROMIS) items to LDS. Methods: In a cross-sectional study, 379 patients with LDS preoperatively completed the Expectations Survey, Numerical Rating Pain Scales, Oswestry Disability Index (ODI), and PROMIS computer-adaptive physical function, pain, and mental health surveys. Expectations Survey scores were compared to PROMs with correlation coefficients (indicating strengths of relationships) and probability values (indicating associations by chance). Surgeons reviewed physical function questions to identify those particularly relevant to LDS. Results: Patients' mean age was 67 years, 64% were women, and 83% had single-level and 17% had multiple-level LDS. Probability values between the Expectations Survey and PROMs were reliable, but strengths of relationships were only mild to moderate, indicating PROMs did not comprehensively capture the impact of LDS. None of the surgeon-selected PROMIS physical function questions were posed to patients. Conclusion: This cross-sectional study found PROMs to be reliably associated but not strongly correlated with the Expectations Survey, which addresses the whole-patient impact of LDS. New measures that complement PROMIS and ODI should be developed to capture the whole-person effects of LDS and permit attribution of LDS treatments to overall health.

Identification of Novel Genetic Markers for the Risk of Spinal Pathologies: A Genome-Wide Association Study of 2 Biobanks.

BACKGROUND: Identifying genetic risk factors for spinal disorders may lead to knowledge regarding underlying molecular mechanisms and the development of new treatments. METHODS: Cases of lumbar spondylolisthesis, spinal stenosis, degenerative disc disease, and pseudarthrosis after spinal fusion were identified from the UK Biobank. Controls were patients without the diagnosis. Whole-genome regressions were used to test for genetic variants potentially implicated in the occurrence of each phenotype. External validation was performed in FinnGen. RESULTS: A total of 389,413 participants were identified from the UK Biobank. A locus on chromosome 2 spanning GFPT1, NFU1, AAK1, and LOC124906020 was implicated in lumbar spondylolisthesis. Two loci on chromosomes 2 and 12 spanning genes GFPT1, NFU1, and PDE3A were implicated in spinal stenosis. Three loci on chromosomes 6, 10, and 15 spanning genes CHST3, LOC102723493, and SMAD3 were implicated in degenerative disc disease. Finally, 2 novel loci on chromosomes 5 and 9, with the latter corresponding to the LOC105376270 gene, were implicated in pseudarthrosis. Some of these variants associated with spinal stenosis and degenerative disc disease were also replicated in FinnGen. CONCLUSIONS: This study revealed nucleotide variations in select genetic loci that were potentially implicated in 4 different spinal pathologies, providing potential insights into the pathological mechanisms. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Instability Missed by Flexion-Extension Radiographs Subsequently Identified by Alternate Imaging in L4-L5 Lumbar Degenerative Spondylolisthesis.

STUDY DESIGN: Cross-sectional preoperative and intraoperative imaging study of L4-L5 lumbar degenerative spondylolisthesis (LDS). OBJECTIVE: To determine if alternate imaging modalities would identify LDS instability that did not meet the criteria for instability based on comparison of flexion and extension radiographs. SUMMARY OF BACKGROUND DATA: Pain may limit full flexion and extension maneuvers and thereby lead to underreporting of true dynamic translation and angulation in LDS. Alternate imaging pairs may identify instability missed by flexion-extension. MATERIALS AND METHODS: Consecutive patients scheduled for surgery for single-level L4-L5 LDS had preoperative standing radiographs in the lateral, flexion, and extension positions, supine computed tomography (CT) scans, and intraoperative fluoroscopic images in the supine and prone positions after anesthesia but before incision. Instability was defined as translation ≥3.5 mm or angulation ≥11° between the following pairs of images: (1) flexion-extension; (2) CT-lateral; (3) lateral-intraoperative supine; (4) lateral-intraoperative prone; and (5) intraoperative supine-prone. RESULTS: Of 240 patients (mean age 68 y, 54% women) 15 (6%) met the criteria for instability by flexion-extension, and 225 were classified as stable. Of these 225, another 84 patients (35% of total enrollment) were reclassified as unstable by comparison of CT-lateral images (21 patients) and by lateral-intraoperative images (63 patients). Nine of the 15 patients diagnosed with instability by flexion-extension had fusion (60%), and 68 of the 84 patients reclassified as unstable by other imaging pairs had fusion (81%) ( P =0.07). The 84 reclassified patients were more likely to undergo fusion compared with the 141 patients who persistently remained classified as stable (odds ratio=2.6, 95% CI: 1.4-4.9, P =0.004). CONCLUSIONS: Our study provides evidence that flexion and extension radiographs underreport the dynamic extent of LDS and therefore should not be solely relied upon to ascertain instability. These findings have implications for how instability should be established and the extent of surgery that is indicated.

Quantitative CT for Preoperative Assessment of Lumbar Degenerative Spondylolisthesis: The Unique Impact of L4 Bone Mineral Density on Single-Level Disease.

Background: Quantitative computed tomography (qCT) efficiently measures 3-dimensional vertebral bone mineral density (BMD), but its utility in measuring BMD at various vertebral levels in patients with lumbar degenerative spondylolisthesis (LDS) is unclear. Purpose: We sought to determine whether qCT could differentiate BMD at different levels of LDS, particularly at L4-L5, the most common single level for LDS. In addition, we sought to describe patterns of BMD for single-level and multiple-level LDS. Methods: We conducted a study of patients undergoing surgery for LDS who were part of a larger longitudinal study comparing preoperative and intraoperative images. Preoperative patients were grouped as single-level or multiple-level LDS, and qCT BMD was obtained for L1-S1 vertebrae. Mean BMD was compared with literature reports; in multivariable analyses, BMD of each vertebra was assessed according to the level of LDS, controlling for covariates and for BMD of other vertebrae. Results: Of 250 patients (mean age: 67 years, 64% women), 22 had LDS at L3-L4 only, 170 at L4-L5 only, 13 at L5-S1 only, and 45 at multiple levels. Compared with other disorders reported in the literature, BMD in our sample similarly decreased from L1 to L3 then increased from L4 to S1, but mean BMD per vertebra in our sample was lower. Nearly half of our sample met criteria for osteopenia. In multivariable analysis controlling for BMD at other vertebrae, lower L4 BMD was associated with LDS at L4-L5, greater pelvic incidence minus lumbar lordosis, and not having diabetes. In contrast, in similar multivariable analysis, greater L4 BMD was associated with LDS at L3-L4. Bone mineral density of L3 and L5 was not associated with LDS levels. Conclusion: In our sample of preoperative patients with LDS, we observed lower BMD for LDS than for other lumbar disorders. L4 BMD varied according to the level of LDS after controlling for covariates and BMD of other vertebrae. Given that BMD can be obtained from routine imaging, our findings suggest that qCT data may be useful in the comprehensive assessment of and strategy for LDS surgery. More research is needed to elucidate the cause-effect relationships among spinopelvic alignment, LDS, and BMD.

Radiographic evaluation of lumbar intervertebral disc height index: An intra and inter-rater agreement and reliability study.

PURPOSE: To evaluate intra- and inter-rater agreement and reliability of seven reported disc height index (DHI) measurement methods on standing lateral X-ray of lumbar spine. METHODS: The adult patients who had standing lateral X-ray of lumbar spine were recruited. Seven methods were used to measure DHI of each lumbar intervertebral disc level, including a ratio of sum of anterior and posterior disc height (DH) to disc diameter (Method 1), a ratio of middle DH to mid-vertebral body height (Method 2), a ratio of middle DH to disc diameter (Method 3), a ratio of the mean of anterior, middle, and posterior DH to the sagittal diameter of the proximal vertebral body (Method 4), a ratio of DH to vertebral height which cross the centre of adjacent vertebral bodies (Method 5), a ratio of the mean of anterior, middle, and posterior DH to the mean of proximal and distal vertebral body height (Method 6), and a ratio of the sum of anterior and posterior DH to the sum of superior and inferior disc depth (Method 7). Two raters conducted the measurements (one medical student (SS) and the other an experienced spine surgeon (XC)). Bland and Altmans Limits of Agreement (LOA) with standard difference were calculated to examine intra- and inter-rater agreements between two out of seven methods for DHI. Intra-class correlations (ICC) with 95% confidence intervals were calculated to assess intra- and inter-rater reliability. RESULTS: The intra-rater reliability in DHI measurements for 288 participants were ICCs from 0.807 (0.794, 0.812) to 0.922 (0.913, 0.946) by rater 1 (SS) and from 0.827 (0.802, 0.841) to 0.918 (0.806, 0.823) by rater 2 (XC). Method 2, 3, and 5 on all segmental levels had bias (95 % CI does not include zero) or/and out of the acceptable cut-off proportion (>50 %). A total of 609 outliers in 9174 segmental levels' LOA range. Inter-rater reliability was good-to-excellent in all but method 2 (0.736 (0.712, 0.759)) and method 5 (0.634 (0.598, 0.667)). ICCs of related lines to good-to-excellent reliability methods was excellent in all but only indirect lines in method 1 and 4 (ICCs lie in the range from 0.8 to 0.9). CONCLUSION: Following a structured protocol, intra- and inter-rater reliability was good-to-excellent for most DHI measurement methods on X-ray. However, the complicated methods (more indirect lines) and IVD degeneration (nucleus pulposus degeneration and disc herniation) potentially affected the agreement on inter-rater measurements. Method 7 is the best reproducible method to measure disc height index for all intervertebral disc segmental levels with a good-to-excellent intra- and inter-rater reliability and agreement.

Telemedicine Visits Can Generate Highly Accurate Diagnoses and Surgical Plans for Spine Patients.

STUDY DESIGN: A Retrospective cohort study. OBJECTIVE: To (1) assess whether diagnoses and surgical plans established during a new patient telemedicine visit changed following an in-person evaluation and (2) determine any differences in perioperative outcomes between patients who only had a telemedicine visit before surgery versus those who had a telemedicine visit followed by an in-person evaluation before surgery. SUMMARY OF BACKGROUND DATA: Data on capability of telemedicine to deliver high-quality preoperative assessment without a traditional in-person interaction and physical examination is lacking. MATERIALS AND METHODS: Records of patients who had a new patient telemedicine visit and indicated for surgery with documented specific diagnosis as well as surgical plans from a spine department at an urban tertiary center from April 2020 to April 2021 were reviewed. For a subset of patients that had a follow-up in-person evaluation before surgery, these diagnoses and plans were compared. Perioperative outcomes were compared between patients who only had a telemedicine visit before surgery versus those who had a telemedicine visit followed by an in-person evaluation before surgery. RESULTS: A total of 166 patients were included. Of these, 101 patients (61%) only had a new patient telemedicine visit before surgery while 65 (39%) had a telemedicine visit followed by an in-person evaluation. There were no differences in the rate of case cancellations before surgery and patient-reported outcome measures between these two groups ( P >0.05). Of 65 patients who had both a telemedicine followed by an in-person visit, the diagnosis was unchanged for 61 patients (94%) and the surgical plan did not change for 52 patients (80%). The main reason for surgical plan change was due to updated findings on new imaging, 10 patients, (77%). CONCLUSIONS: The current study suggests that telemedicine evaluations can provide an effective means of preoperative assessment for spine patients. LEVEL OF EVIDENCE: Level 3.

Recovery Kinetics After Commonly Performed Minimally Invasive Spine Surgery Procedures.

STUDY DESIGN: Single-center, multisurgeon, retrospective review. OBJECTIVE: To evaluate the timing of return to commonly performed activities following minimally invasive spine surgery. Identify preoperative factors associated with these outcomes. SUMMARY OF BACKGROUND DATA: Studies have reported return to activities with open techniques, but the precise timing of when patients return to these activities after minimally invasive surgery remains uncertain. MATERIALS AND METHODS: Patients who underwent either minimally invasive lumbar laminectomy (MI-L) or minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) were included. Patient-reported outcome measures, return to drive, return to work, and discontinuation of opioids data were reviewed. Regression was conducted to identify factors associated with return to driving by 15 days, return to work by 30 days, and for discontinuing opioids by 15 days. A composite group analysis was also performed for patients who returned to all three activities by 30 days. RESULTS: In total, 123 MI-L patients and 107 MI-TLIF patients were included. Overall, 88.8% of MI-L patients and 96.4% of MI-TLIF patients returned to driving in 11 and 18.5 days, respectively. In all, 91.9% of MI-L patients and 85.7% of MI-TLIF patients returned to work in 14 and 25 days. In all, 88.7% of MI-L patients and 92.6% of MI-TLIF patients discontinued opioids in a median of seven and 11 days. Overall, 96.2% of MI-L patients and 100% of MI-TLIF patients returned to all three activities, with a median of 27 and 31 days, respectively. Male sex [odds ratio (OR)=3.57] and preoperative 12-Item Short Form Physical Component Score (OR=1.08) are associated with return to driving by 15 days. Male sex (OR=3.23) and preoperative 12-Item Short Form Physical Component Score (OR=1.07) are associated with return to work by 30 days. Preoperative Visual Analog Scale back was associated with decreased odds of discontinuing opioids by 15 days (OR=0.84). CONCLUSION: Most patients return to activity following MI-L and MI-TLIF. These findings serve as an important compass for preoperative counseling.

Appropriate Telemedicine Utilization in Spine Surgery: Results From a Delphi Study.

STUDY DESIGN: Delphi expert panel consensus. OBJECTIVE: To obtain expert consensus on best practices for appropriate telemedicine utilization in spine surgery. SUMMARY OF BACKGROUND DATA: Several studies have shown high patient satisfaction associated with telemedicine during the COVID-19 peak pandemic period as well as after easing of restrictions. As this technology will most likely continue to be employed, there is a need to define appropriate utilization. METHODS: An expert panel consisting of 27 spine surgeons from various countries was assembled in February 2021. A two-round consensus-based Delphi method was used to generate consensus statements on various aspects of telemedicine (separated as video visits or audio visits) including themes, such as patient location and impact of patient diagnosis, on assessment of new patients. Topics with ≥75% agreement were categorized as having achieved a consensus. RESULTS: The expert panel reviewed a total of 59 statements. Of these, 32 achieved consensus. The panel had consensus that video visits could be utilized regardless of patient location and that video visits are appropriate for evaluating as well as indicating for surgery multiple common spine pathologies, such as lumbar stenosis, lumbar radiculopathy, and cervical radiculopathy. Finally, the panel had consensus that video visits could be appropriate for a variety of visit types including early, midterm, longer term postoperative follow-up, follow-up for imaging review, and follow-up after an intervention (i.e., physical therapy, injection). CONCLUSION: Although telemedicine was initially introduced out of necessity, this technology most likely will remain due to evidence of high patient satisfaction and significant cost savings. This study was able to provide a framework for appropriate telemedicine utilization in spine surgery from a panel of experts. However, several questions remain for future research, such as whether or not an in-person consultation is necessary prior to surgery and which physical exam maneuvers are appropriate for telemedicine.Level of Evidence: 4.

The association between pain scores and disc height change following discectomy surgery in lumbar disc herniation patients: a systematic review and meta-analysis.

PURPOSE: To evaluate the impact of discectomy on disc height (DH) in lumbar disc herniation (LDH) patients following discectomy surgery and address the association of DH change with pain score change. METHODS: We searched three online databases for randomized controlled trials (RCTs) and observational studies. In LDH patients, eligible for discectomy surgery, the changes in pre- and post-operative back and/or leg pain score and DH and/or disc height index (DHI) were considered as primary outcomes. Standardize mean difference (SMD) and their 95% confidence intervals (CI) were evaluated. The GRADE approach was used to summarize the strength of evidence. RESULTS: Two RCTs and sixteen observational studies were included in the analysis of 893 LDH patients undergoing discectomy surgery. The mean overall follow-up was 211 weeks. There was a statistically significant reduction in DH (14.4% reduction: SMD = -0.74 (95% CI = -0.86 to -0.61)) and DHI (11.5% reduction: SMD = -0.81 (95% CI = -0.97 to -0.65)) following discectomy surgery. There was a significant relationship between the reduction in DH and decrease in back pain score (r = 0.68, (95% CI = 0.07-1.30), p = 0.034) after discectomy surgery. No significant relationship between DHI change and decrease in clinical pain scores (back and leg pain) could be established. CONCLUSION: Discectomy surgery produces significant and quantifiable reductions in DH and DHI. Additionally, the reduction in DH is responsible for the decrease in back pain scores post discectomy, but further studies will improve understanding and aid preoperative counselling.

Current state of navigation in spine surgery.

The use of navigation has become more prevalent in spine surgery. The multitude of available platforms, as well as increased availability of navigation systems, have led to increased use worldwide. Specific subsets of spine surgeons have incorporated this new technology in their practices, including minimally invasive spine (MIS) spine surgeons, neurosurgeons, and high-volume surgeons. Improved accuracy with the use of navigation has been demonstrated and its use has proven to be a safe alternative to fluoroscopic guided procedures. Navigation use allows the limitation of radiation exposure to the surgeon during common spine procedures, which over the course of a surgeon's lifetime may offer significant health benefits. Navigation has also been beneficial in tumor resection and MIS surgery, where traditional anatomic landmarks are missing or in the case of MIS not visible. As cost effectiveness improves, the use of navigation is likely to continue to expand. Navigation will also continue to expand with further innovation such as coupling the use of navigation with robotics and improving tools to enhance the end user experience.

Orthopaedics and the Physician Payments Sunshine Act: An Examination of Payments to U.S. Orthopaedic Surgeons in the Open Payments Database.

BACKGROUND: The U.S. Centers for Medicare & Medicaid Services (CMS) recently released the Open Payments database (OPD) detailing payments from industry to physicians and teaching hospitals. We seek here to provide an overview of the data with a focus on the orthopaedic community. METHODS: We analyzed payments in the OPD from August 1 to December 31, 2013. The OPD consists of three individual databases: General Payments, Research Payments, and Ownership. Physician identification number, physician specialty, payment type, and payment value were collected. Physicians assigned to multiple specialties were excluded. Comparisons were made between orthopaedic surgeons and the remainder of the top fifteen specialties by payment value. RESULTS: In all, 2,697,015 payments with physicians were recorded; 491,223 of these payments (18.2%) were made to physicians with multiple listed specialties and were excluded. Excluding these potentially misattributed payments did not have a significant impact on the trends identified, and $394.5 million in payments remained. Orthopaedic surgeons represented 3.4% of payments but 25.6% of value, and 13,347 orthopaedic surgeons (68.9% of all active orthopaedic surgeons) were listed in the OPD. Payments over $10,000 represented only 1.6% of payments to orthopaedic surgeons but 75.5% of value. The majority of these payments (56.1%) were royalties. The median payment value for orthopaedic surgeons listed in the OPD was $38.11, with two payments per surgeon; the median aggregated value was $132.56 per surgeon. Orthopaedic surgeons listed in the OPD were more likely to receive payments for travel compared with all other specialties (p < 0.001) and more likely to receive payments for royalties compared with all other specialties (p < 0.001) except neurological surgery. CONCLUSIONS: Financial interactions between orthopaedic surgeons and industry are highly prevalent. A small subset of orthopaedic surgeons received large royalties, which accounted for a majority of the transactional value provided by industry. Orthopaedic surgeons were the recipients of more payments for travel and for royalties than all other specialties except neurological surgery; however, the median value of these and other payments was similar to that for other specialties.

The Cost Effectiveness of Polyetheretheketone (PEEK) Cages for Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Cost-effectiveness analysis using a Markov model with inputs from published literature. OBJECTIVE: To learn which graft or hardware option used in a single-level anterior cervical discectomy and fusion (ACDF) is most beneficial in terms of cost, quality of life, and overall cost effectiveness. Options studied were autograft, allograft, and polyetheretherketone (PEEK) cages for cervical fusion. SUMMARY OF BACKGROUND DATA: ACDF is commonly used to treat cervical myelopathy and/or radiculopathy. No study has compared the cost effectiveness of autograft, allograft, and PEEK in 1-level ACDF. MATERIALS AND METHODS: A literature review provided inputs into a Markov decision model to determine the most effective graft or hardware option for 1-level ACDF. Data regarding rate of complications, quality-adjusted life years (QALYs) gained, and cost for each procedure type was collected. The Markov model was first run in a base case, using all currently available data. The model was then tested using 1-way and 2-way sensitivity analyses to determine the validity of the model's conclusions if specific aspects of model were changed. This model was run for 10 years postoperatively. RESULTS: The cost per QALY for each option in the base case analysis was $3328/QALY for PEEK, $2492/QALY for autograft, and $2492/QALY for allograft. All graft/hardware options are cost effective ways to improve outcomes for patients living with chronic neck pain. For graft/hardware options the most cost-effective option was allograft. The incremental cost-effectiveness ratio for PEEK compared with autograft or allograft was >$100,000/QALY. CONCLUSIONS: Allograft is the most cost-effective graft/hardware option for ACDF. Compared with living with cervical myelopathy and/or radiculopathy, ACDF using any graft or hardware option is a cost-effective method of improving the quality of life of patients. PEEK is not a cost-effective option compared with allograft or autograft for use in ACDF.

Cost effectiveness analysis of graft options in spinal fusion surgery using a Markov model.

STUDY DESIGN: Statistical decision model. OBJECTIVE: To determine the most cost-effective graft option in spinal fusion. SUMMARY OF BACKGROUND DATA: Spinal fusion has been shown to be an effective technique to treat lumbar degenerative spondylolisthesis. There have been significant advances in bone graft options to improve outcomes related to spinal fusion. RhBMP-2 (RhBMP), iliac crest bone graft (ICBG), local bone alone (LBG), demineralized bone matrix with local bone (DBM), local bone with corticocancellous allograft chips (CCA) have all been used as graft options. There has not been significant research in which graft option is most cost effective. METHODS: A Markov decision model has been created to identify the most cost-effective graft option for use in spinal fusion to treat 1-level (L4-L5) degenerative spondylolisthesis in a cohort of 60-year-old patients. Costs and effectiveness of successful spinal fusion surgery and revision surgery associated with each graft option was estimated through published data. The quality adjusted life years (QALYs) from these surgeries were compared with the amount of QALYs associated with living with chronic back pain. RESULTS: : In the base case, the incremental cost-effective ratio for each graft option when compared with living with chronic back pain was $21,308/QALY for ICBG, $16,595/QALY for RhBMP, $21,204/QALY for LBG, $21,287/QALY for DBM, and $28,153/QALY for CCA. Therefore, the most cost-effective graft option in the base case was RhBMP. Sensitivity analysis shows that RhBMP is not the most cost-effective option if the revision rate is significantly raised. If the cost of treatment with RhBMP rises >$42,250 then LBG becomes the likely cost-effective treatment. CONCLUSIONS: RhBMP is the most cost-effective graft option for L4-L5 fusion for degenerative spondylolisthesis largely due to the reduced rate of revision spine surgery. The increased upfront cost and list of complications associated with RhBMP is offset by the reduced rate of revision surgery.

Nitric oxide modulates recombinant human bone morphogenetic protein-2-induced corticocancellous autograft incorporation: a study in rat intertransverse fusion.

A novel rat model was used to investigate the effect of nitric oxide synthase inhibition in posterior spinal fusion augmented with recombinant human bone morphogenetic protein-2. Nitric oxide (NO) has important physiological functions including the modulation of fracture healing. Recombinant human BMP-2 (rhBMP-2) enhances spinal fusion. It is not known whether nitric oxide has a role in rhBMP-2 enhanced spinal fusion and remodeling. A novel rat intertransverse fusion model was created using a defined volume of bone graft along with a collagen sponge carrier, which was compacted and delivered using a custom jig. The control groups consisted of a sham group (S, n = 20), an autograft + carrier group (A, n = 28) and a group consisting of 43 microg of rhBMP-2 mixed with autograft + carrier (AB, n = 28). Two experimental groups received a nitric oxide synthase (NOS) inhibitor, N (G)-nitro L-arginine methyl ester, in a dose of 1 mg/ml ad lib in the drinking water (AL, n = 28) and one of these experimental groups had rhBMP-2 added to the graft mixture at the time of surgery (ALB, n = 28). Rats were killed at 22 and 44 days, spinal columns subjected to radiology, biomechanics and histology. On a radiographic score (0-4) indicating progressive maturation of bone fusion mass, no difference was found between the A and AL groups, however, there was a significant enhancement of fusion when rhBMP-2 was added when compared to the A group (P < 0.001). However, on day 44, the ALB group showed significantly less fusion progression when compared to the AB group (P < 0.01). There was a 25% (P < 0.05) more fusion-mass-area in day 44 of ALB group when compared to day 44 of the AB group indicating that NOS inhibition delayed the remodeling of the fusion mass. Biomechanically, the rhBMP-2 groups were stiffer at all time points compared to the NOS inhibited groups. Decalcified histology demonstrated that there was a delay in graft incorporation whenever NOS was inhibited (AL and ALB groups) as assessed by a 5 point histological maturation score. In a novel model of rat intertransverse process fusion, nitric oxide synthase modulates rhBMP-2 induced corticocancellous autograft incorporation.