Magnetic resonance spectroscopy (MRS) identification of chemically painful lumbar discs leads to improved 6-, 12-, and 24-month outcomes for discogenic low back pain surgeries.

PURPOSE: MRS was shown to reliably quantify relative levels of degenerative pain biomarkers, differentiating painful versus non-painful discs in patients with chronic discogenic low back pain (DLBP), and this correlates with surgical success rates. We now report results based on more patients and longer follow-up. METHODS: Disc MRS was performed in DLBP patients who subsequently received lumbar surgery. Custom post-processing (NOCISCAN-LS®; Aclarion Inc.) calculated disc-specific NOCISCORES® that reflect relative differences in degenerative pain biomarkers for diagnosing chemically painful discs. Outcomes in 78 patients were evaluated using Oswestry Disability Index (ODI) scores. Surgical success (≥ 15-point ODI improvement) was compared between surgeries that were "Concordant" (Group C) versus "Discordant" (Group D) with NOCISCORE-based diagnosis for painful discs. RESULTS: Success rates were higher for Group C versus Group D: 6 months (88% vs. 62%; p = 0.01), 12 months (91% vs. 56%; p < 0.001), and 24 months (85% vs. 63%; p = 0.07). Success rates for Group C surgeries were also higher than Group D surgeries in a variety of sub-group comparisons. Group C had a greater reduction in ODI from pre-operative to follow-up than Group D [absolute change (% change), (p)]: 6 months: - 35 (- 61%) versus - 23 (- 39%), (p < 0.05); 12 months: - 39 (- 69%) versus - 22 (- 39%), (p < 0.01); and 24 months: - 38 (- 66%) versus - 26 (- 48%), (p < 0.05). CONCLUSION: More successful, sustained outcomes were obtained when surgically treating chemically painful discs identified by NOCISCAN-LS post-processed disc MRS exams. Results suggest that NOCISCAN-LS provides a valuable new diagnostic tool to help clinicians better select treatment levels.

Establishing a Standardized Clinical Consensus for Reporting Complications Following Lateral Lumbar Interbody Fusion.

Background and Objectives: Mitigating post-operative complications is a key metric of success following interbody fusion. LLIF is associated with a unique complication profile when compared to other approaches, and while numerous studies have attempted to report the incidence of post-operative complications, there is currently no consensus regarding their definitions or reporting structure. The aim of this study was to standardize the classification of complications specific to lateral lumbar interbody fusion (LLIF). Materials and Methods: A search algorithm was employed to identify all the articles that described complications following LLIF. A modified Delphi technique was then used to perform three rounds of consensus among twenty-six anonymized experts across seven countries. Published complications were classified as major, minor, or non-complications using a 60% agreement threshold for consensus. Results: A total of 23 articles were extracted, describing 52 individual complications associated with LLIF. In Round 1, forty-one of the fifty-two events were identified as a complication, while seven were considered to be approach-related occurrences. In Round 2, 36 of the 41 events with complication consensus were classified as major or minor. In Round 3, forty-nine of the fifty-two events were ultimately classified into major or minor complications with consensus, while three events remained without agreement. Vascular injuries, long-term neurologic deficits, and return to the operating room for various etiologies were identified as important consensus complications following LLIF. Non-union did not reach significance and was not classified as a complication. Conclusions: These data provide the first, systematic classification scheme of complications following LLIF. These findings may improve the consistency in the future reporting and analysis of surgical outcomes following LLIF.

Kickstand rods and correction of coronal malalignment in patients with adult spinal deformity.

PURPOSE: Coronal malalignment (CM) is a challenging spinal deformity to treat. The kickstand rod (KR) technique is powerful for correcting truncal shift. This study tested the hypothesis that the KR technique provides superior coronal alignment correction in adult deformity compared with traditional rod techniques. METHODS: A retrospective evaluation of a prospectively collected multicenter database was performed. A 2:1 matched cohort of non-KR accessory rod and KR patients was planned based on preoperative coronal balance distance (CBD) and a vector of global shift. Patients were subgrouped according to CM classification with a 30-mm CBD threshold defining CM, and comparisons of surgical and clinical outcomes among groups was performed. RESULTS: Twenty-one patients with preoperative CM treated with a KR were matched to 36 controls. KR-treated patients had improved CBD compared with controls (18 vs. 35 mm, P < 0.01). The postoperative CBD did not result in clinical differences between groups in patient-reported outcomes (P ≥ 0.09). Eight (38%) of 21 KR patients and 12 (33%) of 36 control patients with preoperative CM had persistent postoperative CM (P = 0.72). CM class did not significantly affect the likelihood of treatment failure (postoperative CBD > 30 mm) in the KR cohort (P = 0.70), the control cohort (P = 0.35), or the overall population (P = 0.31). CONCLUSIONS: Application of the KR technique to coronal spinal deformity in adults allows for successful treatment of CM. Compared to traditional rod techniques, the use of KRs did not improve clinical outcome measures 1 year after spinal deformity surgery but was associated with better postoperative coronal alignment.

Artificial intelligence clustering of adult spinal deformity sagittal plane morphology predicts surgical characteristics, alignment, and outcomes.

PURPOSE: AI algorithms have shown promise in medical image analysis. Previous studies of ASD clusters have analyzed alignment metrics-this study sought to complement these efforts by analyzing images of sagittal anatomical spinopelvic landmarks. We hypothesized that an AI algorithm would cluster preoperative lateral radiographs into groups with distinct morphology. METHODS: This was a retrospective review of a multicenter, prospectively collected database of adult spinal deformity. A total of 915 patients with adult spinal deformity and preoperative lateral radiographs were included. A 2 × 3, self-organizing map-a form of artificial neural network frequently employed in unsupervised classification tasks-was developed. The mean spine shape was plotted for each of the six clusters. Alignment, surgical characteristics, and outcomes were compared. RESULTS: Qualitatively, clusters C and D exhibited only mild sagittal plane deformity. Clusters B, E, and F, however, exhibited marked positive sagittal balance and loss of lumbar lordosis. Cluster A had mixed characteristics, likely representing compensated deformity. Patients in clusters B, E, and F disproportionately underwent 3-CO. PJK and PJF were particularly prevalent among clusters A and E. Among clusters B and F, patients who experienced PJK had significantly greater positive sagittal balance than those who did not. CONCLUSIONS: This study clustered preoperative lateral radiographs of ASD patients into groups with highly distinct overall spinal morphology and association with sagittal alignment parameters, baseline HRQOL, and surgical characteristics. The relationship between SVA and PJK differed by cluster. This study represents significant progress toward incorporation of computer vision into clinically relevant classification systems in adult spinal deformity. LEVEL OF EVIDENCE IV: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Effect of race, age, and gender on lumbar muscle volume and fat infiltration in the degenerative spine.

BACKGROUND: The quantity and quality of spinal muscles in patients with degenerative spinal diseases and various backgrounds such as age, gender, or race is unclear. We quantitatively evaluated the cross-sectional area (CSA) and fatty degeneration of the muscles around the spine, using magnetic resonance imaging (MRI) in patients with degenerative spinal disease, and studied the effects of age, gender, and race in multicenter retrospective study. METHODS: The subjects were Caucasian and Asian patients with degenerative lumbar disease who underwent L4-5 single level spinal fusion surgery at centers in the United States and Japan. Using preoperative axial T2 MRI at the L4-5 disc level, the cross-sectional areas of the psoas and paraspinal muscles were measured. Fat infiltration was measured using the threshold method, and percent fat area (%FA) was calculated for each muscle. The muscle/disc area ratio (MDAR) was used to control for size differences per patient. T-test, Pearson's correlation coefficient, partial correlation, and multiple linear regression were used for statistical analysis. RESULTS: In total, 140 patients (53 men; 87 women; mean age, 69.2 years) were analyzed. Age was similar in Caucasians (n = 64) and Asians (n = 76). MDARs were larger in Caucasians for paraspinal and psoas muscles (p < 0.005). Percent FA of psoas was similar in Caucasians and Asians, but greater in the paraspinal muscles of Asians (p < 0.05). After controlling for race and gender, age was correlated negatively with MDAR (p < 0.001) and positively with %FA (p < 0.001). In the multiple linear regression analysis, age, gender, and race were independently affected by MDAR and %FA. CONCLUSIONS: Lumbar muscle mass and quality were affected by age, gender, and race, independently, in patients with degenerative lumbar disease.

Intermediate-term clinical and radiographic outcomes with less invasive adult spinal deformity surgery: patients with a minimum follow-up of 4 years.

BACKGROUND: Little information exists regarding longer-term outcomes with minimally invasive spine surgery (MISS), particularly regarding long-segment and deformity procedures. We aimed to evaluate intermediate-term outcomes of MISS for adult spinal deformity (ASD). METHODS: This retrospective review of a prospectively collected multicenter database examined outcomes at 4 or more years following circumferential MIS (cMIS) or hybrid (HYB) surgery for ASD. A total of 53 patients at 8 academic centers satisfied the following inclusion criteria: age > 18 years and coronal Cobb > 20°, pelvic incidence-lumbar lordosis (PI-LL) > 10°, or sagittal vertical axis (SVA) > 5 cm. RESULTS: Radiographic outcomes demonstrated improvements of PI-LL from 16.8° preoperatively to 10.8° and coronal Cobb angle from 38° preoperatively to 18.2° at 4 years. The incidence of complications over the follow-up period was 56.6%. A total of 21 (39.6%) patients underwent reoperation in the thoracolumbar spine, most commonly for adjacent level disease or proximal junctional kyphosis, which occurred in 11 (20.8%) patients. Mean Oswestry Disability Index (ODI) at baseline and years 1 through 4 were 49.9, 33.1, 30.2, 32.7, and 35.0, respectively. The percentage of patients meeting minimal clinically important difference (MCID) (defined as 12% or more from baseline) decreased over time, with leg pain reduction more durable than back pain reduction. CONCLUSIONS: Intermediate-term clinical and radiographic improvement following MISS for ASD is sustained, but extent of improvement lessens over time. Outcome variability exists within a subset of patients not meeting MCID, which increases over time after year two. Loss of improvement over time was more notable in back than leg pain. However, average ODI improvement meets MCID at 4 years after MIS ASD surgery.

Magnetic resonance spectroscopy (MRS) can identify painful lumbar discs and may facilitate improved clinical outcomes of lumbar surgeries for discogenic pain.

PURPOSE: The goal of this study was to refine clinical MRS to optimize performance and then determine whether MRS-derived biomarkers reliably identify painful discs, quantify degeneration severity, and forecast surgical outcomes for chronic low back pain (CLBP) patients. METHODS: We performed an observational diagnostic development and accuracy study. Six hundred and twenty-three (623) discs in 139 patients were scanned using MRS, with 275 discs also receiving provocative discography (PD). MRS data were used to quantify spectral features related to disc structure (collagen and proteoglycan) and acidity (lactate, alanine, propionate). Ratios of acidity to structure were used to calculate pain potential. MRS-SCOREs were compared to PD and Pfirrmann grade. Clinical utility was judged by evaluating surgical success for 75 of the subjects who underwent lumbar surgery. RESULTS: Two hundred and six (206) discs had both a successful MRS and independent pain diagnosis. When comparing to PD, MRS had a total accuracy of 85%, sensitivity of 82%, and specificity of 88%. These increased to 93%, 91%, and 93% respectively, in non-herniated discs. The MRS structure measures differed significantly between Pfirrmann grades, except grade I versus grade II. When all MRS positive discs were treated, surgical success was 97% versus 57% when the treated level was MRS negative, or 54% when the non-treated adjacent level was MRS positive. CONCLUSION: MRS correlates with PD and may support improved surgical outcomes for CLBP patients. Noninvasive MRS is a potentially valuable approach to clarifying pain mechanisms and designing CLBP therapies that are customized to the patient. These slides can be retrieved under Electronic Supplementary Material.

Preliminary results of anterior lumbar interbody fusion, anterior column realignment for the treatment of sagittal malalignment.

OBJECTIVE Sagittal malalignment decreases patients' quality of life and may require surgical correction to achieve realignment goals. High-risk posterior-based osteotomy techniques are the current standard treatment for addressing sagittal malalignment. More recently, anterior lumbar interbody fusion, anterior column realignment (ALIF ACR) has been introduced as an alternative for correction of sagittal deformity. The objective of this paper was to report clinical and radiographic results for patients treated using the ALIF-ACR technique. METHODS A retrospective study of 39 patients treated with ALIF ACR was performed. Patient demographics, operative details, radiographic parameters, neurological assessments, outcome measures, and preoperative, postoperative, and mean 1-year follow-up complications were studied. RESULTS The patient population comprised 39 patients (27 females and 12 males) with a mean follow-up of 13.3 ± 4.7 months, mean age of 66.1 ± 11.6 years, and mean body mass index of 27.3 ± 6.2 kg/m2. The mean number of ALIF levels treated was 1.5 ± 0.5. Thirty-three (84.6%) of 39 patients underwent posterior spinal fixation and 33 (84.6%) of 39 underwent posterior column osteotomy, of which 20 (60.6%) of 33 procedures were performed at the level of the ALIF ACR. Pelvic tilt, sacral slope, and pelvic incidence were not statistically significantly different between the preoperative and postoperative periods and between the preoperative and 1-year follow-up periods (except for PT between the preoperative and 1-year follow-up, p = 0.018). Sagittal vertical axis, T-1 spinopelvic inclination, lumbar lordosis, pelvic incidence-lumbar lordosis mismatch, intradiscal angle, and motion segment angle all improved from the preoperative to postoperative period and the preoperative to 1-year follow-up (p < 0.05). The changes in motion segment angle and intradiscal angle achieved in the ALIF-ACR group without osteotomy compared with the ALIF-ACR group with osteotomy at the level of ACR were not statistically significant. Total visual analog score, Oswestry Disability Index, and Scoliosis Research Society-22 scores all improved from preoperative to postoperative and preoperative to 1-year follow-up. Fourteen patients (35.9%) experienced 26 complications (15 major and 11 minor). Eleven patients required reoperation. The most common complication was proximal junctional kyphosis (6/26 complications, 23%) followed by vertebral body/endplate fracture (3/26, 12%). CONCLUSIONS This study showed satisfactory radiographic and clinical outcomes at the 1-year follow-up. Proximal junctional kyphosis was the most common complication followed by fracture, complications that are commonly associated with sagittal realignment surgery and may not be mitigated by the anterior approach.

Complication rates associated with open versus percutaneous pedicle screw instrumentation among patients undergoing minimally invasive interbody fusion for adult spinal deformity.

OBJECTIVE High-quality studies that compare outcomes of open and minimally invasively placed pedicle screws for adult spinal deformity are needed. Therefore, the authors compared differences in complications from a circumferential minimally invasive spine (MIS) surgery and those from a hybrid surgery. METHODS A retrospective review of a multicenter database of patients with spinal deformity who were treated with an MIS surgery was performed. Database inclusion criteria included an age of ≥ 18 years and at least 1 of the following: a coronal Cobb angle of > 20°, a sagittal vertical axis of > 5 cm, a pelvic incidence-lumbar lordosis angle of > 10°, and/or a pelvic tilt of > 20°. Patients were propensity matched according to the levels instrumented. RESULTS In this database, a complete data set was available for 165 patients, and after those who underwent 3-column osteotomy were excluded, 137 patients were available for analysis; 76 patients remained after propensity matching (MIS surgery group 38 patients, hybrid surgery group 38 patients). The authors found no difference in demographics, number of levels instrumented, or preoperative and postoperative radiographic results. At least 1 complication was suffered by 55.3% of patients in the hybrid surgery group and 44.7% of those in the MIS surgery group (p = 0.359). Patients in the MIS surgery group had significantly fewer neurological, operative, and minor complications than those in the hybrid surgery group. The reoperation rates in both groups were similar. The most common complication category for the MIS surgery group was radiographic and for the hybrid surgery group was neurological. Patients in both groups experienced postoperative improvement in their Oswestry Disability Index and visual analog scale (VAS) back and leg pain scores (all p < 0.05); however, MIS surgery provided a greater reduction in leg pain according to VAS scores. CONCLUSIONS Overall complication rates in the MIS and hybrid surgery groups were similar. MIS surgery resulted in significantly fewer neurological, operative, and minor complications. Reoperation rates in the 2 groups were similar, and despite complications, the patients reported significant improvement in their pain and function.

Impact of case type, length of stay, institution type, and comorbidities on Medicare diagnosis-related group reimbursement for adult spinal deformity surgery.

OBJECTIVE The aim of this study was to educate medical professionals about potential financial impacts of improper diagnosis-related group (DRG) coding in adult spinal deformity (ASD) surgery. METHODS Medicare's Inpatient Prospective Payment System PC Pricer database was used to collect 2015 reimbursement data for ASD procedures from 12 hospitals. Case type, hospital type/location, number of operative levels, proper coding, length of stay, and complications/comorbidities (CCs) were analyzed for effects on reimbursement. DRGs were used to categorize cases into 3 types: 1) anterior or posterior only fusion, 2) anterior fusion with posterior percutaneous fixation with no dorsal fusion, and 3) combined anterior and posterior fixation and fusion. RESULTS Pooling institutions, cases were reimbursed the same for single-level and multilevel ASD surgery. Longer stay, from 3 to 8 days, resulted in an additional $1400 per stay. Posterior fusion was an additional $6588, while CCs increased reimbursement by approximately $13,000. Academic institutions received higher reimbursement than private institutions, i.e., approximately $14,000 (Case Types 1 and 2) and approximately $16,000 (Case Type 3). Urban institutions received higher reimbursement than suburban institutions, i.e., approximately $3000 (Case Types 1 and 2) and approximately $3500 (Case Type 3). Longer stay, from 3 to 8 days, increased reimbursement between $208 and $494 for private institutions and between $1397 and $1879 for academic institutions per stay. CONCLUSIONS Reimbursement is based on many factors not controlled by surgeons or hospitals, but proper DRG coding can significantly impact the financial health of hospitals and availability of quality patient care.

Despite worse baseline status depressed patients achieved outcomes similar to those in nondepressed patients after surgery for cervical deformity.

OBJECTIVE Depression and anxiety have been demonstrated to have negative impacts on outcomes after spine surgery. In patients with cervical deformity (CD), the psychological and physiological burdens of the disease may overlap without clear boundaries. While surgery has a proven record of bringing about significant pain relief and decreased disability, the impact of depression and anxiety on recovery from cervical deformity corrective surgery has not been previously reported on in the literature. The purpose of the present study was to determine the effect of depression and anxiety on patients' recovery from and improvement after CD surgery. METHODS The authors conducted a retrospective review of a prospective, multicenter CD database. Patients with a history of clinical depression, in addition to those with current self-reported anxiety or depression, were defined as depressed (D group). The D group was compared with nondepressed patients (ND group) with a similar baseline deformity determined by propensity score matching of the cervical sagittal vertical axis (cSVA). Baseline demographic, comorbidity, clinical, and radiographic data were compared among patients using t-tests. Improvement of symptoms was recorded at 3 months, 6 months, and 1 year postoperatively. All health-related quality of life (HRQOL) scores collected at these follow-up time points were compared using t-tests. RESULTS Sixty-six patients were matched for baseline radiographic parameters: 33 with a history of depression and/or current depression, and 33 without. Depressed patients had similar age, sex, race, and radiographic alignment: cSVA, T-1 slope minus C2-7 lordosis, SVA, and T-1 pelvic angle (p > 0.05). Compared with nondepressed individuals, depressed patients had a higher incidence of osteoporosis (21.2% vs 3.2%, p = 0.028), rheumatoid arthritis (18.2% vs 3.2%, p = 0.012), and connective tissue disorders (18.2% vs 3.2%, p = 0.012). At baseline, the D group had greater neck pain (7.9 of 10 vs 6.6 on a Numeric Rating Scale [NRS], p = 0.015), lower mean EQ-5D scores (68.9 vs 74.7, p < 0.001), but similar Neck Disability Index (NDI) scores (57.5 vs 49.9, p = 0.063) and myelopathy scores (13.4 vs 13.9, p = 0.546). Surgeries performed in either group were similar in terms of number of levels fused, osteotomies performed, and correction achieved (baseline to 3-month measurements) (p < 0.05). At 3 months, EQ-5D scores remained lower in the D group (74.0 vs 78.2, p = 0.044), and NDI scores were similar (48.5 vs 39.0, p = 0.053). However, neck pain improved in the D group (NRS score of 5.0 vs 4.3, p = 0.331), and modified Japanese Orthopaedic Association (mJOA) scores remained similar (14.2 vs 15.0, p = 0.211). At 6 months and 1 year, all HRQOL scores were similar between the 2 cohorts. One-year measurements were as follows: NDI 39.7 vs 40.7 (p = 0.878), NRS neck pain score of 4.1 vs 5.0 (p = 0.326), EQ-5D score of 77.1 vs 78.2 (p = 0.646), and mJOA score of 14.0 vs 14.2 (p = 0.835). Anxiety/depression levels reported on the EQ-5D scale were significantly higher in the depressed cohort at baseline, 3 months, and 6 months (all p < 0.05), but were similar between groups at 1 year postoperatively (1.72 vs 1.53, p = 0.416). CONCLUSIONS Clinical depression was observed in many of the study patients with CD. After matching for baseline deformity, depression symptomology resulted in worse baseline EQ-5D and pain scores. Despite these baseline differences, both cohorts achieved similar results in all HRQOL assessments 6 months and 1 year postoperatively, demonstrating no clinical impact of depression on recovery up until 1 year after CD surgery. Thus, a history of depression does not appear to have an impact on recovery from CD surgery.

Patients with spinal deformity over the age of 75: a retrospective analysis of operative versus non-operative management.

PURPOSE: The goal of the present study was to compare the outcomes of operative and non-operative patients with adult spinal deformity (ASD) over 75 years of age. METHODS: A retrospective review of a multicenter prospective adult spinal deformity database was conducted examining patients with ASD over the age of 75 years. Demographics, comorbidities, operation-related variables, complications, radiographs, and Health-related quality of life (HRQOL) measures collected included Oswestry Disability Index, Short Form-36, and Scoliosis Research Society-22 preoperatively, and at 1 and 2 years later. Minimum clinically important difference (MCID) was calculated and also compared. RESULTS: 27 patients (12 operative, 15 non-operative) were studied. There were no significant differences (p > 0.05) between operative and non-operative patients for age, body mass-index, and comorbidities, but operative patients had worse baseline HRQOL than non-operative patients. Operative patients had a significant improvement in radiographic parameters in 2-year HRQOL, whereas non-operative patients did not (p > 0.05). Operative patients were significantly more likely to reach MCID (range 41.7-81.8 vs. 0-33.3 %, p < 0.05). In the surgical group, 9 (75 %) patients had at least 1 complication (24 total complications). CONCLUSIONS: In the largest series to date comparing operative and non-operative management of adult spinal deformity in elderly patients greater than 75 years of age, reconstructive surgery provides significant improvements in pain and disability over a 2-year period. Furthermore, operative patients were more likely to reach MCID than non-operative patients. When counseling elderly patients with ASD, such data may be helpful in the decision-making process regarding treatment.

Do Longer Surgical Procedures Result in Greater Contamination of Surgeons' Hands?

BACKGROUND: A surgical site infection is a substantial cause of complications in patients. Different methods are being used to decrease surgical site infections; however, these infections still can cause complications, especially in patients undergoing longer operations (> 3 hours). There is evidence that the efficacy of the scrubbing material fades after 3 hours. However, we do not know the longevity of hand cleanliness after application of scrubbing materials in a long operation. It can be postulated that if the surgeon's scrubbed hands are recolonized after a certain time, they may serve as a progressive source of contamination during surgery. QUESTIONS/PURPOSES: We asked: (1) Is there a correlation between surgical duration and hand contamination at the end of surgery? (2) At what point during surgery does hand contamination reach or exceed prescrub levels? METHODS: Three spine surgeons using the same scrubbing technique and materials consisting of chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w were enrolled in our study. Between December 2014 and April 2015, spine procedures of 3 hours or more, which were the first case of the day, were selected for this study (20 cases). Cases in which glove changing occurred (perforations, reprepping, and redraping) or cultures obtained after scrubbing were positive (indicative of insufficient hand sanitization) were excluded (0% of cases). Twenty cases (100% enrollment) were analyzed. Surgeons' hands were swabbed with sterile cotton tip applicators and 5 mL sterile phosphate-buffered saline before hand scrubbing (prescrub), immediately after hand scrubbing (postscrub), and immediately after surgery (postoperative). Results were reported in colony-forming units per milliliter. The correlation between duration of surgery and hand recontamination was tested by regression analysis of time versus colony-forming units per milliliter. Receiver-operating characteristic curve tested the cutoff point, where recontamination occurred. RESULTS: With a longer duration of surgery, more colony-forming units are recovered from gloved hands at the end of surgery (R = 0.94, R(2) = 0.89, p = 0.005). The receiver-operating characteristic curve suggested that 5 hours is the cutoff point for hand recolonization. At 5 hours, contamination reached or exceeded prescrub levels (area under the curve, 0.66; 95% CI, 0.23-1.0), whereas before 5 hours, there was no contamination detected at the end of surgery. CONCLUSIONS: Our results show that duration of surgery correlates with hand recontamination and at 5 hours, recolonization of a surgeon's hands become detectable. Recolonization may have started even earlier than 5 hours. However, these levels are not detectable in the laboratory at earlier times. CLINICAL RELEVANCE: Based on this pilot study, rescrubbing is highly recommended before the fifth hour of an operation, ideally at some point between the fourth and fifth hours. FUTURE: We also recommend the surgical site infection rates in operations using rescrubbing should be compared with those from surgeries with just the conventional single-scrubbing technique, in a randomized controlled trial, to determine the effectiveness of this novel rescrubbing method.

Radiographic outcomes of anterior column realignment for adult sagittal plane deformity: a multicenter analysis.

PURPOSE: Anterior column reconstruction (ACR) is a minimally invasive technique for the treatment of sagittal plane deformity. ACR uses a lateral transpsoas approach with ALL release and the application of an interbody device to achieve correction. Here, we present 1-year radiographic results from a multicenter study of adult spinal deformity (ASD) patients. METHODS: A multicenter database was queried from 2005 to 2013 for ASD patients treated with ACR. Demographics, surgical data, and radiographic measurements were collected and retrospectively analyzed. Radiographic time points included preoperative (pre-op), postoperative (post-op; first visit prior to 3 months), and last follow-up (last FU; minimum of 1 year). Sagittal radiographic measurements included regional lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), T1 spinopelvic inclination (T1SPi), and segmental lordosis (disc angle). RESULTS: Mean patient age was 67.4 years (range 46.5-80.0) and 11 patients (32.4 %) were male. Twenty patients (58.8 %) had previous lumbar surgery. All patients had a minimal of one-level ACR with ALL release (mean 1.7; range 1-4). Mean number of lateral interbody fusion (LLIF) levels without ALL release per patient was 0.7 (range 0-3). Thirty-three patients (97.1 %) received supplemental posterior fixation and 1 patient (2.9 %) had lateral fixation only. In 26 patients (76.5 %), supplemental posterior fixation was performed using an open approach, and 7 patients (20.6 %) were treated with percutaneous placement. Mean of number of levels fused was 7.1 (range 2-16). There was a significant improvement in LL (p < 0.001), PI-LL mismatch (p < 0.001), and PT (p = 0.03) from pre-op to post-op, and pre-op to last FU. There was no change in T1SPi, SS, or PI. Segmental lordosis improved at ACR levels from mean of -2.2° pre-op to -16.0° post-op (p < 0.01) and -16.3° at last FU (p < 0.001). The addition of posterior column osteotomy increased the change in segmental lordosis with ACR by 72.7 % (p < 0.001). LLIF without ALL release led to significant improvement in segmental lordosis from pre-op (-2.4°) to post-op (-7.1°; p < 0.01) but not from pre-op to last FU (-5.7°; p = 0.06). CONCLUSION: ACR successfully restores lumbar lordosis in ASD patients with sagittal imbalance. ACR results in greater segmental correction than is achieved with LLIF alone. Supplementing with posterior osteotomies allows for even greater correction. The ability to achieve the desired radiographic goals is expected to improve as technical nuances are refined and patient selection is optimized.

How does a novel monoplanar pedicle screw perform biomechanically relative to monoaxial and polyaxial designs?

BACKGROUND: Minimally invasive spinal fusions frequently require placement of pedicle screws through small incisions with limited visualization. Polyaxial pedicle screws are favored due to the difficulty of rod insertion with fixed monoaxial screws. Recently, a novel monoplanar screw became available that is mobile in the coronal plane to ease rod insertion but fixed in the sagittal plane to eliminate head slippage during flexion loads; however, the strength of this screw has not been established relative to other available screw designs. QUESTIONS/PURPOSES: We compared the static and dynamic load to failure in polyaxial, monoaxial, and monoplanar pedicle screws. METHODS: Six different manufacturers' screws (42 total) were tested in three categories (polyaxial, n = 4; monoaxial, n = 1; monopolar, n = 1) utilizing titanium rods. An additional test was performed using cobalt-chromium rods with the monopolar screws only. Screws were embedded into polyethylene blocks and rods were attached using the manufacturers' specifications. Static and dynamic testing was performed. Dynamic testing began at 80% of static yield strength at 1 Hz for 50,000 cycles. RESULTS: In static testing, monoaxial and monoplanar screws sustained higher loads than all polyaxial screw designs (range, 37%-425% higher; p < 0.001). The polyaxial screws failed at the head-screw interface, while the monoaxial and monoplanar screws failed by rod breakage in the static test. The dynamic loads to failure were greater with the monoplanar and monoaxial screws than with the polyaxial screws (range, 35%-560% higher; p < 0.001). With dynamic testing, polyaxial screws failed via screw-head slippage between 40% and 95% of static yield strength, while failures in monoaxial and monoplanar screws resulted from either screw shaft or rod breakage. CONCLUSIONS: All polyaxial screws failed at the screw-head interface in static and dynamic testing and at lower values than monoaxial/monoplanar screw designs. Monoplanar and monoaxial screws failed at forces well above expected in vivo values; this was not the case for most polyaxial screws. CLINICAL RELEVANCE: Polyaxial screw heads slip on the screw shank at lower values than monoaxial or monoplanar screws, and this results in angular change between the rod and pedicle screw, which could cause loss of segmental lordosis. The novel monoplanar screw used in this study may combine ease of rod placement with sagittal plane strength.

Complications in adult spinal deformity surgery: an analysis of minimally invasive, hybrid, and open surgical techniques.

OBJECT: It is hypothesized that minimally invasive surgical techniques lead to fewer complications than open surgery for adult spinal deformity (ASD). The goal of this study was to analyze matched patient cohorts in an attempt to isolate the impact of approach on adverse events. METHODS: Two multicenter databases queried for patients with ASD treated via surgery and at least 1 year of follow-up revealed 280 patients who had undergone minimally invasive surgery (MIS) or a hybrid procedure (HYB; n = 85) or open surgery (OPEN; n = 195). These patients were divided into 3 separate groups based on the approach performed and were propensity matched for age, preoperative sagittal vertebral axis (SVA), number of levels fused posteriorly, and lumbar coronal Cobb angle (CCA) in an attempt to neutralize these patient variables and to make conclusions based on approach only. Inclusion criteria for both databases were similar, and inclusion criteria specific to this study consisted of an age > 45 years, CCA > 20°, 3 or more levels of fusion, and minimum of 1 year of follow-up. Patients in the OPEN group with a thoracic CCA > 75° were excluded to further ensure a more homogeneous patient population. RESULTS: In all, 60 matched patients were available for analysis (MIS = 20, HYB = 20, OPEN = 20). Blood loss was less in the MIS group than in the HYB and OPEN groups, but a significant difference was only found between the MIS and the OPEN group (669 vs 2322 ml, p = 0.001). The MIS and HYB groups had more fused interbody levels (4.5 and 4.1, respectively) than the OPEN group (1.6, p < 0.001). The OPEN group had less operative time than either the MIS or HYB group, but it was only statistically different from the HYB group (367 vs 665 minutes, p < 0.001). There was no significant difference in the duration of hospital stay among the groups. In patients with complete data, the overall complication rate was 45.5% (25 of 55). There was no significant difference in the total complication rate among the MIS, HYB, and OPEN groups (30%, 47%, and 63%, respectively; p = 0.147). No intraoperative complications were reported for the MIS group, 5.3% for the HYB group, and 25% for the OPEN group (p < 0.03). At least one postoperative complication occurred in 30%, 47%, and 50% (p = 0.40) of the MIS, HYB, and OPEN groups, respectively. One major complication occurred in 30%, 47%, and 63% (p = 0.147) of the MIS, HYB, and OPEN groups, respectively. All patients had significant improvement in both the Oswestry Disability Index (ODI) and visual analog scale scores after surgery (p < 0.001), although the MIS group did not have significant improvement in leg pain. The occurrence of complications had no impact on the ODI. CONCLUSIONS: Results in this study suggest that the surgical approach may impact complications. The MIS group had significantly fewer intraoperative complications than did either the HYB or OPEN groups. If the goals of ASD surgery can be achieved, consideration should be given to less invasive techniques.

Comparison of radiographic results after minimally invasive, hybrid, and open surgery for adult spinal deformity: a multicenter study of 184 patients.

OBJECT: Various surgical approaches, including open, minimally invasive, and hybrid techniques, have gained momentum in the management of adult spinal deformity. However, few data exist on the radiographic outcomes of different surgical techniques. The objective of this study was to compare the radiographic and clinical outcomes of the surgical techniques used in the treatment of adult spinal deformity. METHODS: The authors conducted a retrospective review of two adult spinal deformity patient databases, a prospective open surgery database and a retrospective minimally invasive surgery (MIS) and hybrid surgery database. The time frame of enrollment in this study was from 2007 to 2012. Spinal deformity patients were stratified into 3 surgery groups: MIS, hybrid surgery, and open surgery. The following pre- and postoperative radiographic parameters were assessed: lumbar major Cobb angle, lumbar lordosis, pelvic incidence minus lumbar lordosis (PI-LL), sagittal vertical axis, and pelvic tilt. Scores on the Oswestry Disability Index (ODI) and a visual analog scale (VAS) for both back and leg pain were also obtained from each patient. RESULTS: Of the 234 patients with adult spinal deformity, 184 patients had pre- and postoperative radiographs and were thus included in the study (MIS, n = 42; hybrid, n = 33; open, n = 109). Patients were a mean of 61.7 years old and had a mean body mass index of 26.9 kg/m(2). Regarding radiographic outcomes, the MIS group maintained a significantly smaller mean lumbar Cobb angle (13.1°) after surgery compared with the open group (20.4°, p = 0.002), while the hybrid group had a significantly larger lumbar curve correction (26.6°) compared with the MIS group (18.8°, p = 0.045). The mean change in the PI-LL was larger for the hybrid group (20.6°) compared with the open (10.2°, p = 0.023) and MIS groups (5.5°, p = 0.003). The mean sagittal vertical axis correction was greater for the open group (25 mm) compared with the MIS group (≤ 1 mm, p = 0.008). Patients in the open group had a significantly larger postoperative thoracic kyphosis (41.45°) compared with the MIS patients (33.5°, p = 0.005). There were no significant differences between groups in terms of pre- and postoperative mean ODI and VAS scores at the 1-year follow-up. However, patients in the MIS group had much lower estimated blood loss and transfusion rates compared with patients in the hybrid or open groups (p < 0.001). Operating room time was significantly longer with the hybrid group compared with the MIS and open groups (p < 0.001). Major complications occurred in 14% of patients in the MIS group, 14% in the hybrid group, and 45% in the open group (p = 0.032). CONCLUSIONS: This study provides valuable baseline characteristics of radiographic parameters among 3 different surgical techniques used in the treatment of adult spinal deformity. Each technique has advantages, but much like any surgical technique, the positive and negative elements must be considered when tailoring a treatment to a patient. Minimally invasive surgical techniques can result in clinical outcomes at 1 year comparable to those obtained from hybrid and open surgical techniques.

Anterior column realignment (ACR) for focal kyphotic spinal deformity using a lateral transpsoas approach and ALL release.

STUDY DESIGN: Retrospective case series. OBJECTIVES: Introduce and evaluate the safety of a new technique of anterior column realignment (ACR) using a lateral transpsoas approach with release of anterior longitudinal ligament and annulus for correction of focal kyphotic deformity. SUMMARY OF BACKGROUND DATA: Spinal sagittal imbalance can adversely affect the long-term outcomes of patients with spinal deformity. METHODS: Clinical and radiographic review of patients who underwent ACR. RESULTS: Seventeen consecutive patients (12 females; 5 males) with a mean age of 63 years (range, 35-76 y) and a mean follow-up of 24 months (range, 12-82 mo) were identified. Fourteen of 17 (82%) had previous spine surgery and 12/17 (71%) had previous fusion. Twelve of the 17 (71%) underwent ACR for adjacent segment disease. Fifteen patients (88%) had Smith-Petersen osteotomies at the ACR level.The mean motion segment angle was 9 degrees preoperatively, which corrected to -19 degrees after ACR and to -26 degrees after posterior instrumentation. Motion segment angle was maintained at -23 degrees at the latest follow-up. The mean lumbar lordosis was -16 degrees preoperatively, which improved to -38 degrees after ACR and to -45 degrees after posterior instrumentation. Lumbar lordosis was maintained at -51 degrees at the latest follow-up. Pelvic tilt averaged 34 degrees before ACR and improved to 24 degrees after ACR and posterior instrumentation and maintained at 25 degrees at the latest follow-up. Patients with preoperative negative T1 spinopelvic inclination (T1SPI) corrected from -6 to -2 degrees and those with 0 or positive T1SPI corrected from 5 to -3 degrees after ACR at the latest follow-up.Eight patients (47%) had 10 complications. Four complications occurred after ACR. Two of 4 were neurological (1 persistent weakness) and 1 was vascular injury during anterior plate removal. CONCLUSION: Compared with posterior-based techniques, our preliminary results of ACR showed similar correction capacity and similar rate of morbidities for the treatment of focal kyphotic spinal deformity. Careful case selection, attention to the details of the technique, and enough experience are prudent elements for a desirable outcome.

Establishing a Gold Standard for Noninvasive Identification of Painful Lumbar Discs: Prospective Comparison of Magnetic Resonance Spectroscopy vs Low-Pressure Provocation Discography.

PURPOSE: Verifying lumbar disc pain can present a clinical challenge. Low-pressure provocative discography (PD) has served as the gold standard, although it is invasive and often a challenge to interpret. We reported that magnetic resonance spectroscopy (MRS) biomarkers accurately predict PD results in lumbar discs and improved outcomes for patients with surgery at positive MRS levels versus nonsurgery. To further substantiate MRS for diagnosing painful discs, we report a prospective comparison of 2 MRS-derived measures: NOCISCORE (pain) and SI-SCORE (degeneration severity). METHODS: Lumbar MRS and software-based postprocessing (NOCISCAN-LS, Aclarion Inc.) was performed in 44 discs in 14 patients (prospective cohort [PC]). PC data were compared to prior data used to establish the NOCISCORE (training cohort [TC]). The NOCISCORE was converted to an ordinal value (high/intermediate/low; NOCI+/mild/-) and compared against painful (P) versus nonpainful (NP) control diagnosis (PD) for 19 discs where PD was performed in the PC (12 NP; 7 P). Sensitivity, specificity, and positive and negative predictive values were calculated. The SI-SCORE was compared against MRI Pfirrmann Grades for 465 discs in 126 patients (PC plus TC). RESULTS: For the PC, MRS (NOCI+/-) compared to PD (P/NP) with an accuracy of 87% and sensitivity and specificity of 100%. The positive and negative predictive values of MRS were 100%. NOCISCOREs were significantly higher for PD+ versus PD- discs for PC and TC (P < 0.05), and the NOCISCORE distributions for PD+/- group were not statistically different between the PC and TC (P > 0.05). SI-SCORES differed between Pfirrmann Grades 1 and 2 (less degenerated) versus Grades 3 and 4 (more degenerated; P < 0.05), with a progressively decreasing trend with Pfirrmann Grades 1-5. CONCLUSION: These current data provide prospective confirmation of the predictive value of disc MRS for distinguishing painful discs and for assessing the disc structural integrity. CLINICAL RELEVANCE: NOCISCAN is an adoptable, noninvasive, and objectively quantitative test to improve management of low back pain patients.

Does the interfacing angle between pedicle screws and support rods affect clinical outcomes after posterior thoracolumbar fusion? A retrospective clinical study.

BACKGROUND CONTEXT: Proper alignment and tightening of the pedicle screw/rod assembly after instrumented posterior fusion of the lower spine is known to be crucial in order to achieve satisfactory clinical results. Such interfacing angle mismatches indicate stress overloading of the implant system. PURPOSE: The objective of this study is to investigate the incidence of postoperative screw/rod interfacing angle mismatch and to analyze the impact of mismatches on clinical outcome in terms of (1) revision surgery, (2) adjacent segment degeneration (ASD), and (3) pain. STUDY DESIGN: This is a monocentric retrospective observational study. PATIENT SAMPLE: Patients underwent fusion surgery with pedicle screw/rod systems for predominantly degenerative pathologies. OUTCOME MEASURES: Pedicle screw/rod interfacing angle mismatch (mismatch is the angular deviation from 90° formed by the rod axis and the pedicle screw head axis as an indicator for missing form-fit) revision rate, ASD at the immediately adjacent cranial segment and VAS pain. METHODS: Revision refers to subsequent procedures in which all or part of the original implant configuration is changed or removed. Radiographic parameters are evaluated using a/p and lateral radiographs at final follow-up. The interfacing angle mismatch between pedicle screw and rod is measured as the angle between two parallel lines on either side of each pedicle screw head and a line laterally along the associated rod. Multiple comparisons are counteracted by Bonferroni correction, adjusted significance level is at *p<.01. RESULTS: Pedicle screw and rod interfacing angle mismatch was found in 171/406 (42.1%) of patients undergoing fusion surgery, affecting 613/3016 (20.3%) screws. The overall revision incidence was 11.8% (48/406), and a new ASD occurred in 12.1% of all patients (49/406) with an average follow-up of 5 years. Mean VAS pain score at final follow-up was 2.0. Comparison of the two groups with and without mismatches revealed statistically significantly higher (1) numbers of revision procedures performed (26.9% vs 0.9%), (2) numbers of new ASD developed (27.5% vs 3.8%), and (3) higher VAS pain scores (2.8/10 vs 1.4/10) for cases with mismatch. When comparing patients who underwent intraoperative correction and/or reduction with those who did not, statistically significant more screw mismatches (63.4% vs 39.7%) and revision surgeries (29.3% vs 9.9%) were noted in patients who had these forceful maneuvers. CONCLUSIONS: Pedicle screw/rod interfacing angle mismatch is a frequent occurrence after fusion surgery. Mismatches indicate that the construct was assembled under mechanical stress. All preventable mechanical stresses, for example, unintentional uncontrolled forces on the instrumentation, should be avoided as much as possible, as they can negatively influence the clinical outcome.