Does surgical site infection affect patient-reported outcomes after spinal surgery? A multicenter cohort study.

BACKGROUND: Surgical site infections are common in spinal surgeries. It is uncertain whether outcomes in spine surgery patients with vs. without surgical site infection are equivalent. Therefore, we assessed the effects of surgical site infection on postoperative patient-reported outcomes. METHODS: We enrolled patients who underwent elective spine surgery at 12 hospitals between April 2017 and February 2020. We collected data regarding the patients' backgrounds, operative factors, and incidence of surgical site infection. Data for patient-reported outcomes, namely numerical rating scale, Neck Disability Index/Oswestry Disability Index, EuroQol Five-Dimensional questionnaire, and 12-Item Short-Form Health Survey scores, were obtained preoperatively and 1 year postoperatively. We divided the patients into with and without surgical site infection groups. Multivariate logistic regression analyses were performed to identify the risk factors for surgical site infection. Using propensity score matching, we obtained matched surgical site infection-negative and -positive groups. Student's t-test was used for comparisons of continuous variables, and Pearson's chi-square test was used to compare categorical variables between the two matched groups and two unmatched groups. RESULTS: We enrolled 8861 patients in this study; 74 (0.8 %) developed surgical site infections. Cervical spine surgery and American Society of Anesthesiologists physical status classification ≥3 were identified as risk factors; microendoscopy was identified as a protective factor. Using propensity score matching, we compared surgical site infection-positive and -negative groups (74 in each group). No significant difference was found in postoperative pain or dysesthesia of the lower back, buttock, leg, and plantar area between the groups. When comparing preoperative with postoperative pain and dysesthesia, statistically significant improvement was observed for both variables in both groups (p < 0.01 for all variables). No significant differences were observed in postoperative outcomes between the matched surgical site infection-positive and -negative groups. CONCLUSIONS: Patients with surgical site infections had comparable postoperative outcomes to those without surgical site infections.

Does T1 slope minus cervical lordosis mismatch affect surgical outcomes of cervical laminoplasty in the absence of preoperative severe kyphosis?

BACKGROUND: The impact of the T1 slope minus cervical lordosis (T1S-CL) on surgical outcomes in patients with degenerative cervical myelopathy undergoing laminoplasty (LP) remain uncertain. METHODS: One hundred patients who underwent cervical LP were retrospectively reviewed. Radiographic measurements included C2-C7 lordosis (CL), T1 slope (T1S), and C2-C7 sagittal vertical axis (SVA). Additionally, pain numeric rating scale, neck disability index (NDI), 12-Item Short-Form Health Survey, Euro QOL 5 dimensions (EQ5D), and Japanese Orthopedic Association score were investigated. According to past reports, T1S-CL > 20° was defined as mismatched. Then, based on T1S-CL mismatching, patients were divided into 2 groups. RESULTS: This research understudied 67 males and 33 females with a mean age of 67 y. Preoperatively, only eight patients showed a T1S-CL mismatch. While the C2-7 Cobb angles did not change significantly after surgery, the T1 slope (T1S) angle increased, increasing the T1S-CL as a result. As we compared the clinical outcomes based on the preoperative T1S-CL mismatching, there were no significant differences between the two groups. On the other hand, the number of patients in the mismatched group increased to 21 patients postoperatively. As we compared clinical outcomes based on the postoperative T1S-CL mismatching, the postoperative NDI score and preop/postop EQ5D score were significantly worse in the mismatch group. CONCLUSIONS: Although cervical LP showed inferior outcomes in patients with postoperative T1S-CL mismatch even in the absence of severe preoperative kyphosis (> 10°), preoperative T1S-CL mismatch was not adversely prognostic.

Postoperative outcomes after degenerative lumbar spine surgery in rheumatoid arthritis patients -a propensity score-matched analysis.

BACKGROUND: Although treatment options for rheumatoid arthritis (RA) have evolved significantly since the introduction of biologic agents, degenerative lumbar disease in RA patients remains a major challenge. Well-controlled comparisons between RA patients and their non-RA counterparts have not yet been reported. The objective of the present study was to compare postoperative outcomes of lumbar spine surgery between RA and non-RA patients by a retrospective propensity score-matched analysis. METHODS: Patients who underwent primary posterior spine surgery for degenerative lumbar disease in our prospective multicenter study group between 2017 and 2020 were enrolled. Demographic data including age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status classification, diabetes mellitus, smoking, steroid usage, number of spinal levels involved, and preoperative patient-reported outcome (PRO) scores (numerical rating scale [NRS] for back pain and leg pain, Short Form-12 physical component summary [PCS], EuroQOL 5-dimension [EQ-5D], and Oswestry Disability Index [ODI]) were used to calculate a propensity score for RA diagnosis. One-to-one matching was performed and 1-year postoperative outcomes were compared between groups. RESULTS: Among the 4567 patients included, 90 had RA (2.0%). RA patients in our cohort were more likely to be female, with lower BMI, higher ASA grade and lower current smoking rate than non-RA patients. Preoperative NRS scores for leg pain, PCS, EQ-5D, and ODI were worse in RA patients. Propensity score matching generated 61 pairs of RA and non-RA patients who underwent posterior lumbar surgery. After background adjustment, RA patients reported worse postoperative PCS (28.4 vs. 37.2, p = 0.008) and EQ-5D (0.640 vs. 0.738, p = 0.03), although these differences were not significant between RA and non-RA patients not on steroids. CONCLUSIONS: RA patients showed worse postoperative quality of life outcomes after posterior surgery for degenerative lumbar disease, while steroid-independent RA cases showed equivalent outcomes to non-RA patients.

Minimum clinically important change for outcome scores among patients aged 75 or over undergoing lumbar spine surgery.

PURPOSE: To elucidate the minimum clinically important change (MCIC) of the physical component summary (PCS) of the Short Form-12, Oswestry Disability Index (ODI), EuroQOL-5 dimensions (EQ-5D), and the Core Outcome Measures Index (COMI) in patients aged ≥ 75 years undergoing lumbar spine surgery. METHODS: We retrospectively reviewed patients aged ≥ 75 years with degenerative lumbar spine disease who underwent lumbar spine decompression or fusion surgery within three levels between April 2017 and June 2018. We also evaluated patients aged < 75 years in the same period as reference. We evaluated the baseline and postoperative PCS, ODI, EQ-5D, and COMI scores. Patients were asked to answer an anchor question regarding health transition for MCICs using the anchor-based method. RESULTS: A total of 247 patients aged ≥ 75 years and 398 patients aged < 75 years were included for analysis. Of patients aged ≥ 75 years, 83.4% showed at least "somewhat improved" outcomes, while 91.0% of patients aged < 75 years reported this outcome. PCS change score was not adequately correlated to health transition in patients aged ≥ 75 years. Receiver operating characteristic curve analyses revealed MCICs of 17.8 for ODI, 0.18 for EQ-5D, and 1.6 for COMI in patients aged ≥ 75 years, and 12.7 for ODI, 0.19 for EQ-5D, and 2.3 for COMI in patients aged < 75 years. CONCLUSION: In patients aged ≥ 75 years, PCS may not be feasible for evaluation of health transition. The MCIC value for ODI score was higher and that for EQ-5D/COMI score was lower in patients aged ≥ 75 years, compared with those in patients aged < 75 years.

Validity of the Japanese core outcome measures index (COMI)-neck for cervical spine surgery: a prospective cohort study.

PURPOSE: To investigate the psychometric properties of the Japanese version of the Core Outcome Measures Index-Neck (COMI-Neck) in patients undergoing cervical spine surgery. METHODS: A total of 177 patients undergoing cervical spine surgery for spinal disorders from April to December 2017 were enrolled. Patient-reported outcomes (PROs) included EuroQOL, Neck Disability Index, and treatment satisfaction. To address whether the questionnaire's scores relate to other outcomes based on a predefined hypothesis, the correlations between the COMI-Neck and the other PROs were measured (Spearman's rank correlation coefficients). The minimum clinically important difference (MCID) of the COMI summary score was calculated using the receiver operating characteristic (ROC) curve with a 7-point Likert scale of satisfaction with the treatment results. To assess reproducibility, another group of 59 volunteers with chronic neck pain were asked to reply to the COMI-Neck twice with an interval of 7-14 days. RESULTS: The COMI summary score showed no floor or ceiling effects preoperatively or postoperatively. Each of the COMI domains and the COMI summary score correlated to the hypothesized extent with the scores of the reference questionnaires (ρ = 0.40-0.79). According to the ROC curve with satisfaction (including "very satisfied" and "satisfied"), the area under the curve and MCID of the COMI summary score were 0.78 and 2.1. The intraclass correlation coefficient and the minimum detectable change (MDC 95%) of the COMI summary score were 0.97 and 0.77. CONCLUSION: The Japanese version of the COMI-Neck is valid and reliable for Japanese-speaking patients with cervical spinal disorders.

Risk factors for worsening sexual function after lumbar spine surgery and characteristics of non-responders to the questionnaire of sex life.

PURPOSE: To precisely assess the Oswestry Disability Questionnaire (ODQ) and its total score (Oswestry Disability Index: ODI) and reveal characteristics of non-responders of the 8th item of ODQ (ODI-8) relating to sexual function. Furthermore, we evaluated risk factors for aggravation of postoperative sexual function. METHODS: We enrolled patients undergoing lumbar spine surgery at eight hospitals between April 2017 and November 2018. Patients' background data and operative factors were collected. We also assessed pain or dysesthesia (lower back, buttock, leg, and plantar area) on a numerical rating scale, EuroQol 5 Dimension, core outcome measures index back, and ODI before and 1 year after surgery. Factor analysis was conducted for the ODQ. Non-responders of the ODI-8 were compared with full-responders using propensity score matching. Risk factors for worsening ODI-8 were evaluated by multivariate logistic regression analysis. RESULTS: Of the 2,610 patients enrolled, 601 (23.0%) answered all but the ODI-8 item; these patients were likely to show better preoperative clinical symptoms than full-responders, even after adjusting for age and gender using propensity scores. Age, spinal deformity, and the American Society of Anesthesiologists physical status (ASA-PS) 3/4 were significant risk factors for postoperative aggravation of the ODI-8. Factor analysis revealed that the ODQ was composed of dynamic and static activities; the ODI-8 was considered a dynamic activity. CONCLUSION: Almost a fourth of the patients skipped the ODI-8. Age, the presence of spinal deformity, and worse ASA-PS were found to be risk factors for postoperative aggravation of sexual function. LEVEL OF EVIDENCE I: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Comparison between microendoscopic laminectomy and open posterior decompression surgery for single-level lumbar spinal stenosis: a multicenter retrospective cohort study.

BACKGROUND: Microendoscopic laminectomy (MEL), in which a 16-mm tubular retractor with an internal scope is used, has shown excellent surgical results for patients with lumbar spinal canal stenosis. However, no reports have directly compared MEL with open laminectomy. This study aimed to elucidate patient-reported outcomes (PROs) and perioperative complications in patients undergoing MEL versus open laminectomy. METHODS: This is a multicenter retrospective cohort study of prospectively registered patients who underwent lumbar spinal surgery at one of the six high-volume spine centers between April 2017 and September 2018. A total of 258 patients who underwent single posterior lumbar decompression at L4/L5 were enrolled in the study. With regard to demographic data, we prospectively used chart sheets to evaluate the diagnosis, operative procedure, operation time, estimated blood loss, and complications. The follow-up period was 1-year. PROs included a numerical rating scale (NRS) for lower back pain and leg pain, the Oswestry Disability Index (ODI), EuroQol 5 Dimension (EQ-5D), and patient satisfaction with the treatment. RESULTS: Of the 258 patients enrolled, 252 (97%) completed the 1-year follow-up. Of the 252, 130 underwent MEL (MEL group) and 122 underwent open decompression (open group). The MEL group required a significantly shorter operating time and sustained lesser intraoperative blood loss compared with the open group. The MEL group showed shorter length of postoperative hospitalization than the open group. The overall complication rate was similar (8.2% in the MEL group versus 7.7% in the open group), and the revision rate did not significantly differ. As for PROs, both preoperative and postoperative values did not significantly differ between the two groups. However, the satisfaction rate was higher in the MEL group (74%) than in the open group (53%) (p = 0.02). CONCLUSIONS: MEL required a significantly shorter operating time and resulted in lesser intraoperative blood loss compared with laminectomy. Postoperative PROs and complication rates were not significantly different between the procedures, although MEL demonstrated a better satisfaction rate.

Effect of Spinal Alignment Changes on Lower Back Pain in Patients Treated with Total Hip Arthroplasty for Hip Osteoarthritis.

Background and objectives: The influence of changes in spinal alignment after total hip arthroplasty (THA) on improvement in lower back pain (LBP) remains controversial. To evaluate how changes in spinal malalignment correlate with improvement in preoperative LBP in patients who underwent THA for hip osteoarthritis. Materials and Methods: From November 2015 to January 2017, 104 consecutive patients who underwent unilateral THA were prospectively registered. Whole spine X-rays and patient-reported outcomes (PROs) were obtained preoperatively and 12 months postoperatively. The PROs used were the Numerical Rating Scale (NRS) for back pain, EuroQol 5 Dimension, and Short Form-12. Results: Seventy-four (71%) patients with complete data were eligible for the analysis. The sagittal parameters changed slightly but significantly. Coronal alignment significantly improved. Twenty-six (37%) patients had LBP preoperatively. These patients had smaller lumbar lordosis (LL), larger PT, and larger PI minus LL than the patients without LBP. Fourteen (54%) of the 26 patients with preoperative LBP showed pain improvement, but there were no significant differences in the radiographic parameters. Conclusions: Although preoperative LBP was likely to be resolved after THA, there were no significant correlations between alignment changes and LBP improvement. The cause of LBP in patients with hip osteoarthritis (OA) patients might be multifactorial.

Association Between Normothermia at the End of Surgery and Postoperative Complications Following Orthopedic Surgery.

BACKGROUND: Maintaining perioperative normothermia is recommended by recent guidelines for the prevention of surgical site infections (SSIs). However, the majority of supporting data originates outside the field of orthopaedic surgery. METHODS: The effect of normothermia was explored using the prospectively collected data of consecutive patients who underwent single-site surgery in 7 tertiary referral hospitals between November 2013 and July 2016. SSIs, urinary tract infections (UTIs), respiratory tract infections (RTIs), cardiac and cerebral events (CCE), and all-cause mortality rates within 30 days after surgery were compared between patients with normothermia (body temperature ≥36°C) and those with hypothermia (<36°C) at the end of surgery, after closure. Multivariable adjusted and inverse-probability weighted regression analyses were performed. RESULTS: The final cohort included 8841 patients. Of these, 11.4% (n = 1008) were hypothermic. More than 96% were evaluated in person by the physicians. After adjusting for multiple covariates, normothermia was not significantly associated with SSIs (adjusted odds ratio [aOR] 1.18, 95% confidence interval [CI] 0.59-2.33), UTIs (aOR 1.14, 95% CI 0.66-1.95), RTIs (aOR 0.60, 95% CI 0.31-1.19), or CCE (aOR 0.53, 95% CI 0.26-1.09). In contrast, normothermia was associated with a lower risk of 30-day mortality (aOR 0.26, 95% CI 0.11-0.64; P < .01; weighted hazard ratio 0.21, 95% CI 0.07-0.68; P = .002). In a subgroup analysis, normothermia was associated with reduced mortality in all types of surgical procedures. CONCLUSIONS: Whereas our findings suggest no clear association with SSI risks following orthopedic surgery, our study supports maintaining perioperative normothermia, as it is associated with reduced 30-day mortality.

Validity of the Japanese Core Outcome Measures Index (COMI)-Back for thoracic and lumbar spine surgery: a prospective cohort study.

PURPOSE: To investigate the psychometric properties of the Japanese version of the Core Outcome Measures Index-Back (COMI-Back), only recently published according to the established linguistic and cultural conversion guidelines, in patients undergoing spine surgery. METHODS: We recruited 145 patients who underwent thoracic or lumbar spine surgery in one of the five specific tertiary care institutions. They were asked to complete a booklet questionnaire (the COMI-Back, the Numerical Rating Scale for pain, the Short Form-12, Euro-QOL-5 dimensions, and Oswestry Disability Index) at baseline and 12 months postoperatively to investigate floor/ceiling effect, construct validity, and postoperative responsiveness. The patients were also asked to answer an anchor question (Global Treatment Outcome) to analyze the minimum clinically important difference (MCID) by receiver operating characteristics curves. Of the 145 patients, 112 completed the study. Another group of 59 volunteers with chronic symptoms completed the questionnaire twice within a 7-14-day interval for the test-retest reproducibility. RESULTS: The COMI summary score displayed no notable floor or ceiling effects. Except for symptom-specific well-being, the individual COMI domains and the COMI summary score correlated as expected with the scores of the chosen reference measures (ρ = 0.4-0.8). A similar trend was observed between the pre-/postoperative changes in the COMI score and those in the reference measures. The MCID for the COMI summary score was 2.5. The intraclass correlation coefficient and minimum detectable change (MDC95%) were 0.93 and 1.26, respectively. CONCLUSION: The Japanese COMI-Back was a reliable and responsive questionnaire in our Japanese patients undergoing thoracic/lumbar spine surgery. These slides can be retrieved under Electronic Supplementary Material.