Predictors for hemostatic thrombin-gelatin matrix usage in spine surgery: a multicenter observational study.

STUDY DESIGN: A prospective cohort study. OBJECTIVES: Thrombin-gelatin matrix (TGM) is a rapid and potent hemostatic agent, but it has some limitations, including the cost and its preparation time. The purpose of this study was to investigate the current trend in the use of TGM and to identify the predictors for TGM usage in order to ensure its proper use and optimized resource allocation. METHODS: A total of 5520 patients who underwent spine surgery in a multicenter study group within a year were included in the study. The demographic factors and the surgical factors including spinal levels operated, emergency surgery, reoperation, approach, durotomy, instrumented fixation, interbody fusion, osteotomy, and microendoscopy-assistance were investigated. TGM usage and whether it was routine or unplanned use for uncontrolled bleeding were also checked. A multivariate logistic regression analysis was used to identify predictors for unplanned use of TGM. RESULTS: Intraoperative TGM was used in 1934 cases (35.0%), among which 714 were unplanned (12.9%). Predictors of unplanned TGM use were female gender (adjusted odds ratio [OR]: 1.21, 95% confidence interval [CI]: 1.02-1.43, p = 0.03), ASA grade ≥ 2 (OR: 1.34, 95% CI: 1.04-1.72, p = 0.02), cervical spine (OR: 1.55, 95% CI: 1.24-1.94, p < 0.001), tumor (OR: 2.02, 95% CI: 1.34-3.03, p < 0.001), posterior approach (OR: 1.66, 95% CI: 1.26-2.18, p < 0.001), durotomy (OR: 1.65, 95% CI: 1.24-2.20, p < 0.001), instrumentation (OR: 1.30, 1.03-1.63, p = 0.02), osteotomy (OR: 5.00, 2.76-9.05, p < 0.001), and microendoscopy (OR: 2.24, 1.84-2.73, p < 0.001). CONCLUSIONS: Many of the predictors for unplanned TGM use have been previously reported as risk factors for intraoperative massive hemorrhaging and blood transfusion. However, other newly revealed factors can be predictors of bleeding that is technically challenging to control. While routine usage of TGM in these cases will require further justification, these novel findings are valuable for implementing preoperative precautions and optimizing resource allocation.

Risk of radiculopathy caused by second course of spine stereotactic body radiotherapy.

OBJECTIVE: Stereotactic body radiotherapy is used to treat spinal metastases; however, 10% of patients experience local failure. We aimed to clarify the outcomes of the second course of stereotactic body radiotherapy for spinal metastases with a uniform fractionation schedule at our institution. METHODS: Data of patients treated with a second salvage stereotactic body radiotherapy course at the same spinal level or adjacent level from July 2018 to December 2020 were retrospectively reviewed. The initial prescribed dose was 24 Gy in two fractions, and the second dose 30 or 35 Gy in five fractions. The spinal cord dose constraint at the second course was 15.5 Gy at the maximum point dose. The endpoints were local failure and adverse effects. Local failure was defined as tumor progression using imaging. RESULTS: We assessed 19 lesions in 17 patients, with radioresistant lesions in 14 (74%) cases, the second stereotactic body radiotherapy to the same/adjacent spinal level in 13/6 cases, the median interval between stereotactic body radiotherapy of 23 (range, 6-52) months, and lesions compressing the cord in 5 (26%) cases. The median follow-up period was 19 months. The 12- and 18-month local failure rates were 0% and 8%, respectively. Radiation-induced myelopathy, radiculopathy and vertebral compression fractures were observed in 0 (0%), 4 (21%) and 2 (11%) lesions, respectively. Three patients with radiculopathy experienced almost complete upper or lower limb paralysis. CONCLUSIONS: The second course of salvage stereotactic body radiotherapy for spinal metastases achieved good local control with a reduced risk of myelopathy. However, a high occurrence rate of radiation-induced radiculopathy has been confirmed.

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.

Transcription factor Hes1 modulates osteoarthritis development in cooperation with calcium/calmodulin-dependent protein kinase 2.

Notch signaling modulates skeletal formation and pathogenesis of osteoarthritis (OA) through induction of catabolic factors. Here we examined roles of Hes1, a transcription factor and important target of Notch signaling, in these processes. SRY-box containing gene 9 (Sox9)-Cre mice were mated with Hes1(fl/fl) mice to generate tissue-specific deletion of Hes1 from chondroprogenitor cells; this deletion caused no obvious abnormality in the perinatal period. Notably, OA development was suppressed when Hes1 was deleted from articular cartilage after skeletal growth in type II collagen (Col2a1)-Cre(ERT);Hes1(fl/fl) mice. In cultured chondrocytes, Hes1 induced metallopeptidase with thrombospondin type 1 motif, 5 (Adamts5) and matrix metalloproteinase-13 (Mmp13), which are catabolic enzymes that break down cartilage matrix. ChIP-seq and luciferase assays identified Hes1-responsive regions in intronic sites of both genes; the region in the ADAMTS5 gene contained a typical consensus sequence for Hes1 binding, whereas that in the MMP13 gene did not. Additionally, microarray analysis, together with the ChIP-seq, revealed novel Hes1 target genes, including Il6 and Il1rl1, coding a receptor for IL-33. We further identified calcium/calmodulin-dependent protein kinase 2δ (CaMK2δ) as a cofactor of Hes1; CaMK2δ was activated during OA development, formed a protein complex with Hes1, and switched it from a transcriptional repressor to a transcriptional activator to induce cartilage catabolic factors. Therefore, Hes1 cooperated with CaMK2δ to modulate OA pathogenesis through induction of catabolic factors, including Adamts5, Mmp13, Il6, and Il1rl1. Our findings have contributed to further understanding of the molecular pathophysiology of OA, and may provide the basis for development of novel treatments for joint disorders.

Risk factors for surgical site infection after posterior fixation surgery and intraoperative radiotherapy for spinal metastases.

PURPOSE: Posterior surgery with intraoperative radiotherapy for spinal metastases offers effective therapy, as we have reported previously. However, the procedure involves transfer from the operating room to the radiotherapy room, and as these patients are somewhat immunocompromised, the risk of postoperative surgical site infection (SSI) may be increased. The aim of our study was to identify risk factors and patient characteristics associated with postoperative SSI following posterior fixation surgery and intraoperative radiotherapy for spinal metastases. METHODS: Participants comprised 279 patients who underwent IORT for the treatment of spinal metastases between August 2004 and June 2013. Patients who suffered SSI within 1 month after surgery were categorized as infected, and all others were categorized as non-infected. We compared factors of age, sex, use of pre-operative corticosteroid, medical history of diabetes, prognosis scores (Tomita, Tokuhashi, and Katagiri), pre- and postoperative Frankel scale scores, site of tumor origin, administration of pre-operative radiotherapy, operation time, intraoperative blood loss, intraoperative irradiation dose, and pre- and postoperative performance status between groups. RESULTS: SSI occurred in 41 patients (14.7%). Katagiri's and Tokuhashi's prognostic scores (P < 0.05 each), postoperative Frankel scale score (P < 0.01), administration of pre-operative radiotherapy (P < 0.05), and postoperative performance status (P < 0.05) all correlated significantly with occurrence of SSI. Multivariate analysis using those factors revealed administration of pre-operative radiotherapy as a factor independently associated with SSI (P < 0.05). CONCLUSIONS: Patient prognosis, postoperative ambulatory function, and pre-operative radiotherapy were risk factors for SSI in patients with spinal metastases. Duration of surgery and intraoperative blood loss were not associated with occurrence of SSI.

Disappearance of lung adenocarcinoma after total en bloc spondylectomy using frozen tumor-bearing vertebra for reconstruction.

PURPOSE: Total en bloc spondylectomy (TES) is a surgical procedure performed to achieve complete resection of an aggressive benign spinal tumor or a malignant spinal tumor. When reconstructing the spine after resection, we have been using liquid nitrogen-frozen resected spine bearing tumor as a bone graft, expecting an immunological response to tumor-specific antigen(s). The purpose of this article is to report a successful treatment case of lung adenocarcinoma metastasis with TES and this cryotherapy. METHODS: A 59-year-old male presented with rapid progression of neurological deterioration of the lower limbs due to a spinal metastasis from T8 to T10. The primary lung adenocarcinoma had already been excised under thoracoscopy. The patient underwent TES with reconstruction using frozen tumor-bearing vertebra for the bone graft. RESULTS: One month after surgery, a new nodule appeared at the right middle lobe of the lung. However, we carried out no biopsy of the newly emerged nodule and the patient received no adjuvant chemotherapy or radiotherapy. Six months after surgery, the tumor vanished. No local recurrence or metastasis of the tumor has been observed until now. CONCLUSIONS: TES with a liquid nitrogen-frozen tumor specimen could be a promising therapeutic option for cancer patients with spine metastasis.

Notch signaling in chondrocytes modulates endochondral ossification and osteoarthritis development.

Here we examined the involvement of Notch signaling in the endochondral ossification process, which is crucial for osteoarthritis (OA) development. Intracellular domains of Notch1 and -2 were translocated into the nucleus of chondrocytes with their differentiation in mouse limb cartilage and in mouse and human OA articular cartilage. A tissue-specific inactivation of the Notch transcriptional effector recombination signal binding protein for Ig kappa J (RBPjκ) in chondroprogenitor cells of SRY-box containing gene 9 (Sox9)-Cre;Rbpj(fl/fl) mouse embryos caused an impaired terminal stage of endochondral ossification in the limb cartilage. The RBPjκ inactivation in adult articular cartilage after normal skeletal growth using type II collagen (Col2a1)-Cre(ERT);Rbpj(fl/fl) mice by tamoxifen injection caused resistance to OA development in the knee joint. Notch intracellular domain with the effector RBPjκ stimulated endochondral ossification through induction of the target gene Hes1 in chondrocytes. Among the Notch ligands, Jagged1 was strongly induced during OA development. Finally, intraarticular injection of N-[N-(3,5-diflurophenylacetate)-L-alanyl]-(S)-phenylglycine t-butyl ester (DAPT), a small compound Notch inhibitor, to the mouse knee joint prevented OA development. The RBPjκ-dependent Notch signaling in chondrocytes modulates the terminal stage of endochondral ossification and OA development, representing an extracellular therapeutic target of OA.

Repeated total en bloc spondylectomy for spinal metastases at different sites in one patient.

PURPOSE: Total en bloc spondylectomy (TES) is accompanied by preoperative embolization of segmental arteries, which is limited to three consecutive levels to avoid the risk of spinal cord ischemia. We retrospectively examined the efficacy and safety of repeated TES with embolization of more than three levels of segmental arteries. METHODS: Seven patients underwent TES twice for spinal metastases at different levels. Every patient underwent embolization of the bilateral segmental arteries before each surgery. We assessed the total number of segmental arteries embolized, the existence of Adamkiewicz arteries during the embolization procedure, intraoperative blood loss, and the motor function of the lower limbs, using the American Spinal Injury Association (ASIA) motor score. RESULTS: No patient experienced any motor deficit after embolization. During the embolization procedure, an Adamkiewicz artery was depicted in five patients, which precluded embolization at that level. The median number of segmental arteries embolized in total was 9 (9-11). Intraoperative blood loss (median, IQR) was 480 (420-630) ml during the first surgery and 520 (280-600) ml during the second surgery. The ASIA motor scores (median, IQR) were as follows; 100 (98-100) (first admission), 100 (100-100) (first discharge), 100 (98-100) (second admission), and 97 (94-100) (second discharge). No patients had developed statistically significant neurological deterioration, and there had been no local recurrence after a median follow-up of 17.8 months (range 1-51 months). CONCLUSION: Repeated TES procedures can be performed safely even if more than three levels of segmental arteries are embolized.

Clinical characteristics of rheumatoid arthritis patients undergoing cervical spine surgery: an analysis of National Database of Rheumatic Diseases in Japan.

BACKGROUND: The aim of this study was to examine the clinical characteristics of rheumatoid arthritis (RA) patients who underwent cervical spine surgery using a multicenter observational database. METHODS: We obtained data from a nationwide observational cohort database of patients with rheumatic diseases (National Database of Rheumatic Diseases by iR-net in Japan (NinJa)) for the fiscal years 2003 to 2011. A total of 39 out of 60 patients who underwent cervical spine surgery for a RA-related cause and whose data were available for two consecutive years (to assess the preoperative patient status) were chosen as cases. Patients with a non-RA-related cause of surgery (e.g., trauma) were excluded. First, we compared the patient characteristics between the cases and total patients in the same fiscal year. Next, 106 eligible controls, who were defined as RA patients enrolled in the same fiscal year as the case subjects, who were matched for age, gender and disease duration (within ±1 year), were selected. We compared the demographic data between the two groups. We also calculated the percentage of patients who underwent cervical spine surgery (surgeries/total number of patients) in fiscal years 2003 to 2011. RESULTS: Although the proportion of patients using biologics linearly increased during study period, the percentage of patients undergoing cervical spine surgeries remained unchanged, at approximately 0.15%. These cases had more tender joints (3 vs. 1, p < 0.01) and exhibited a significantly higher Modified Health Assessment Questionnaire (MHAQ) score (1.13 vs. 0.5, p < 0.01), C-reactive protein (CRP) (1.5 vs. 0.36, p < 0.01), and disease activity score (DAS) 28-CRP (3.63 vs. 2.81, p < 0.01) compared to the controls. CONCLUSIONS: Our study revealed that RA patients requiring cervical spine surgery have a higher disease activity (as represented by the DAS28-CRP) and are more functionally disabled (as represented by the MHAQ) than control patients.

Neuropathic pain development and maintenance and its association with motor recovery after cervical spinal cord injury.

BACKGROUND: In our published randomized controlled trial, we revealed that patients with acute ASIA Grade C incomplete cervical spinal cord injury (SCI) who underwent early surgery (within 24 h post-injury) had accelerated motor recovery at six months than those with delayed surgery (>2 weeks post-injury); however, neuropathic pain (NeP) worsened regardless of surgery timing. Here, we conducted post-hoc analyses to intensively assess NeP development and maintenance. METHODS: Of 44 patients (median 64.5 years; three female; early intervention, n = 26), NeP was categorized into at-level and below-level pain and evaluated at  two weeks and one year after injury using the Neuropathic Pain Symptom Inventory (NPSI). We compared the two groups based on background characteristics. A mixed-design analysis of variance with sex as a covariate was conducted to analyze motor recovery and Health-related quality of life (HRQOL) in groups with severe (NPSI ≥ 10) or mild (NPSI < 10) pain. RESULTS: Upper and lower limb motor impairments were comparable between both groups regardless of pain severity. Severe at-level pain remained stable and worsened at one year than mild at-level pain; however, the upper- and lower-limb motor scores and HRQOL had comparable recovery. Background characteristics did not affect severity or time course of NeP. Patients with severe below-level pain demonstrated slower lower-limb motor recovery than those with mild below-level pain, whereas HRQOL improved regardless of pain severity. CONCLUSIONS: Both at-level and below-level NeP developed and persisted relatively early in the course of traumatic SCI with incomplete motor paralysis; their severities worsened over time or remained severe since onset.

Comparative Analysis of Microendoscopic and Open Laminectomy for Single-Level Lumbar Spinal Stenosis at L1-L2 or L2-L3.

BACKGROUND: Several reports have highlighted comparable surgical outcomes between microendoscopic laminectomy (MEL) and open laminectomy (open) for lumbar spinal stenosis. However, the unilateral approach in MEL may present challenges for the upper lumbar levels, where facet joints are located deeper inside. Our objective was to compare surgical outcomes and radiographic evaluations for single-level decompression cases at L1-L2 or L2-L3 between MEL and open laminectomy. METHODS: We analyzed patients who underwent single-level decompression for upper lumbar spinal stenosis at 12 distinguished spine centers from April 2017 to September 2021. Baseline demographics, preoperative, and 1-year postoperative patient-reported outcomes, along with imaging parameters, were compared between the MEL and open groups. To account for potential confounding, patients' backgrounds were adjusted using the inverse probability weighting method based on propensity scores. RESULTS: Among the 2487 patients undergoing decompression surgery, 118 patients (4.7%) underwent single-level decompression at L1-L2 or L2-L3. Finally, 80 patients (51 in the MEL group, 29 in the open group) with postoperative data were deemed eligible for analysis. The MEL group exhibited significantly improved postoperative EuroQol 5-Dimension values compared to the open group. Additionally, the MEL group showed a lower facet preservation rate according to computed tomography examination, whereas the open group had a higher incidence of retrolisthesis. CONCLUSIONS: Although overall surgical outcomes were similar, the MEL group demonstrated potential advantages in enhancing EuroQol 5-Dimension scores. The MEL group's lower facet preservation rate did not translate into a higher postoperative instability rate.

Impact of age and comorbidity burden on mortality and major complications in older adults undergoing orthopaedic surgery: an analysis using the Japanese diagnosis procedure combination database.

BACKGROUND: The purpose of this study was to examine how complications in older adults undergoing orthopaedic surgery vary as a function of age, comorbidity, and type of surgical procedure. METHODS: We abstracted data from the Japanese Diagnosis Procedure Combination database for all patients aged ≥ 50 who had undergone cervical laminoplasty, lumbar decompression, lumbar arthrodesis, or primary total knee arthroplasty (TKA) between July 1 and December 31 in the years 2007 to 2010. Outcome measures included all-cause in-hospital mortality and incidence of major complications. We analyzed the effects of age, sex, comorbidities, and type of surgical procedure on outcomes. Charlson comorbidity index was used to identify and summarize patients' comorbid burden. RESULTS: A total of 107,104 patients were identified who underwent cervical laminoplasty (16,020 patients), lumbar decompression (31,605), lumbar arthrodesis (18,419), or TKA (41,060). Of these, 17,339 (16.2%) were aged 80 years or older. Overall, in-hospital death occurred in 121 patients (0.11%) and 4,448 patients (4.2%) had at least one major complication. In-hospital mortality and complication rates increased with increasing age and comorbidity. A multivariate analysis showed mortality and major complications following surgery were associated with advanced age (aged ≥ 80 years; odds ratios 5.88 and 1.51), male gender, and a higher comorbidity burden (Charlson comorbidity index ≥ 3; odds ratio, 16.5 and 5.06). After adjustment for confounding factors, patients undergoing lumbar arthrodesis or cervical laminoplasty were at twice the risk of in-hospital mortality compared with patients undergoing TKA. CONCLUSIONS: Our data demonstrated that an increased comorbid burden as measured by Charlson comorbidity index has a greater impact on postoperative mortality and major complications than age in older adults undergoing orthopaedic surgery. After adjustment, mortality following lumbar arthrodesis or cervical laminoplasty was twice as high as that in TKA. Our findings suggest that an assessment of perioperative risks in elderly patients undergoing orthopaedic surgery should be stratified according to comorbidity burden and type of procedures, as well as by patient's age.

Cervical canal stenosis caused by progressive fusion and enlargement of cervical vertebrae with features of Proteus syndrome and Klippel-Feil syndrome.

We report the case of a female who presented with progressive fusion and an enlargement of the cervical vertebrae. Her cervical deformity gradually progressed with age, and the abnormal bony protrusion into the spinal canal caused myelopathy. We resected the affected vertebrae to decompress the spinal cord and performed combined anterior-posterior spinal fusion. The progression of the spinal deformity and enlargement of vertebrae stopped after surgery. The enlargement of vertebrae in the present case resembled that observed in Proteus syndrome; however, autonomous vertebral fusion has not been reported previously in patients with this condition. Our report may help expand the knowledge on developmental spine disorders.

The Outcome of Molecularly Targeted Therapy after Surgical Treatment of Spinal Metastasis.

The aim of this study was to investigate outcomes of molecularly targeted therapy after surgical treatment of spinal metastasis. Participants comprised 164 patients who underwent surgical treatment of spinal metastasis, divided according to whether molecularly targeted therapy was performed. We compared survival, local recurrence of metastasis detected by imaging, the disease-free interval, relapses of neurological deterioration, and the ability to walk between groups. Molecularly targeted drugs were administered to 39 patients after surgery (TT group) and were not administered to 125 patients (non-TT group). Median survival was significantly longer in the TT group (1027 days) than in the non-TT group (439 days, p < 0.01). Local recurrence occurred in 25 patients in the non-TT group and 10 patients in the TT group. The disease-free interval did not differ between groups. Neurological deterioration was observed in three patients in the non-TT group and no patients in the TT group. The ability to walk was preserved in 97.6% of patients in the TT group and 88% of patients in the non-TT group (p = 0.12). In conclusion, molecularly targeted drugs improve survival in patients with spinal metastasis but do not alter local control of metastatic tumors.

Incidence and Prognostic Factors of Painful Vertebral Compression Fracture Caused by Spine Stereotactic Body Radiotherapy.

Most studies of vertebral compression fractures (VCF) caused by stereotactic body radiotherapy (SBRT) do not discuss the symptoms of this complication. In this paper, we aimed to determine the rate and prognostic factors of painful VCF caused by SBRT for spinal metastases. Spinal segments with VCF in patients treated with spine SBRT between 2013 and 2021 were retrospectively reviewed. The primary endpoint was the rate of painful VCF (grades 2-3). Patient demographic and clinical characteristics were evaluated as prognosticators. In total, 779 spinal segments in 391 patients were analyzed. The median follow-up after SBRT was 18 (range: 1-107) months. Sixty iatrogenic VCFs (7.7%) were identified. The rate of painful VCF was 2.4% (19/779). Eight (1.0%) VCFs required surgery for internal fixation or spinal canal decompression. The painful VCF rate was significantly higher in patients with no posterolateral tumor involvement than in those with bilateral or unilateral involvement (50% vs. 23%; p = 0.042); it was also higher in patients with spine without fixation than in those with fixation (44% vs. 0%; p < 0.001). Painful VCFs were confirmed in only 2.4% of all the irradiated spinal segments. The absence of posterolateral tumor involvement and no fixation was significantly associated with painful VCF.

Impact of body mass index on outcomes after lumbar spine surgery.

The impact of body mass index (BMI) on outcomes after lumbar spine surgery is currently unknown. Previous studies have reported conflicting evidence for patients with high BMI, while little research has been conducted on outcomes for underweight patients. This study aims to examine the impact of BMI on outcomes after lumbar spine surgery. This prospective cohort study enrolled 5622 patients; of which, 194, 5027, and 401 were in the low (< 18.5 kg/m2), normal (18.5-30), and high (≥ 30) BMI groups, respectively. Pain was assessed via the numerical pain rating scale (NPRS) for the lower back, buttock, leg, and plantar area. Quality of life was assessed via the EuroQol 5 Dimension (EQ-5D) and Oswestry Disability Index (ODI). Inverse probability weighting with propensity scores was used to adjust patient demographics and clinical characteristics between the groups. After adjustment, the 1-year postoperative scores differed significantly between groups in terms of leg pain. The proportion of patients who achieved a 50% decrease in postoperative NPRS score for leg pain was also significantly different. Obese patients reported less improvement in leg pain after lumbar spine surgery. The outcomes of patients with low BMI were not inferior to those of patients with normal BMI.

Correlation Between Gait and Life Expectancy in Patients with Spinal Metastases.

BACKGROUND: Metastatic epidural spinal cord compression (MESCC) may lead to walking disability. The effect of regaining gait ability on the life expectancy of cancer patients is still unknown. To explore this issue, we evaluated the effect of gait ability recovery in nonambulatory patients after treatment for a metastatic spinal tumor. METHODS: In total, 105 patients who underwent surgery for MESCC between January 2006 and December 2016 and survived longer than 3 months were enrolled. All the patients were nonambulatory because of the MESCC and had undergone posterior decompression and fixation with intraoperative radiotherapy. At postoperative month 3, patients who had regained their gait ability were categorized as ambulatory and those who had not were categorized as nonambulatory. Age, sex, prognosis score (modified Bauer score), preoperative and postoperative Frankel grade scores, tumor origin site, Charlson comorbidity index, and survival time were compared between the groups. RESULTS: Seventy-two patients regained gait ability at postoperative month 3, and 33 patients did not. The modified Bauer score did not differ between the groups (P = 0.08); therefore, the presumptive life expectancy of the groups before treatment was not biased. The median survival time was significantly longer in the ambulatory group (610 days) than that in the nonambulatory group (181 days, P < 0.05). CONCLUSIONS: Patients who regained their gait ability after treatment for MESCC tended to live longer than those who did not, indicating that recovery of gait ability by patients with cancer is associated with improved life expectancy.

Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression.

PURPOSE: Stereotactic body radiation therapy (SBRT) is a postoperative treatment option for spinal metastases. Because data on surgery with SBRT are limited to retrospective studies, this single-center, single-arm, phase 2 study aimed to prospectively evaluate the outcomes of separation surgery and SBRT for metastatic epidural spinal cord compression (MESCC). METHODS AND MATERIALS: Patients with symptomatic MESCC due to a solid carcinoma were enrolled. The protocol for treatments comprised preoperative embolization, separation surgery, and spine SBRT. Surgical procedures were performed via the posterior approach, with decompression and a fixation procedure. The prescribed dose for spine SBRT was 24 Gy in 2 fractions. The primary endpoint was the 12-month local failure rate. The secondary endpoints were ambulatory functions and adverse effects. RESULTS: A total of 33 patients were registered between November 2017 and October 2019. All patients met the inclusion criteria, and all but 1 completed the protocol treatment. Of the included patients, 23 (70%) had radioresistant lesions. The Bilsky grade at registration was 1c in 3 patients, 2 in 8 patients, and 3 in 21 patients. The median follow-up duration after registration was 15 months (range, 3-35 months). Three months after the administration of treatments according to the protocol, 90% of patients (26 of 29) had disease of Bilsky grade ≤1. The 12-month local failure rate was 13%. Twenty patients could walk normally or with a cane 12 months after registration. Radiation-induced myelopathy, radiculopathy, and vertebral compression fracture were observed in 0, 1, and 6 patients, respectively. CONCLUSIONS: Separation surgery with SBRT for MESCC was effective in decompression and long-term local control. These findings suggest that larger randomized controlled trials are warranted to compare SBRT with conventional radiation therapy.

Electron beam intraoperative radiotherapy for metastatic epidural spinal cord compression: a prospective observational study.

To assess the additional effects of intraoperative radiotherapy (IORT) with decompression surgery and adjuvant external beam radiotherapy (EBRT) for metastatic epidural spinal cord compression (MESCC). This single-arm institutional prospective observational study recruited patients between June 2017 and March 2020 and included those with symptoms of spinal cord compression owing to metastases, who were diagnosed using MRI. Patients with radiation-sensitive primary tumors and those who could not tolerate surgery were excluded. The treatment protocol comprised decompression surgery and electron beam IORT of 20 Gy in a single fraction followed by EBRT of 30 Gy in 10 fractions. The primary endpoints included the 1-year local failure rate and ambulatory functions. The study was closed in May 2019 owing to changes in treatment policies at our institution. Twenty patients were registered between June 2017 and May 2019. Although all patients completed surgery and IORT, 2 did not receive postoperative EBRT. Patients most commonly had colorectal cancer (4 patients), followed by thyroid cancer, renal cell carcinoma, lung cancer, breast cancer, sarcomas, and other cancers (3, 3, 2, 2, 2, and 4 patients, respectively). The median follow-up duration was 16 months (range 2-30 months); the 1-year local failure rate was 16%. On comparing ambulatory functions pre-treatment and at 1 year after treatment, improvement, no change, and worsening were observed in 3, 9, and 0 patients, respectively. This study's findings suggest that decompression surgery and IORT followed by EBRT are effective in achieving local control and maintaining ambulation in patients with MESCC.

Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial.

Importance: The optimal management for acute traumatic cervical spinal cord injury (SCI) is unknown. Objective: To determine whether early surgical decompression results in better motor recovery than delayed surgical treatment in patients with acute traumatic incomplete cervical SCI associated with preexisting canal stenosis but without bone injury. Design, Setting, and Participants: This multicenter randomized clinical trial was conducted in 43 tertiary referral centers in Japan from December 2011 through November 2019. Patients aged 20 to 79 years with motor-incomplete cervical SCI with preexisting canal stenosis (American Spinal Injury Association [ASIA] Impairment Scale C; without fracture or dislocation) were included. Data were analyzed from September to November 2020. Interventions: Patients were randomized to undergo surgical treatment within 24 hours after admission or delayed surgical treatment after at least 2 weeks of conservative treatment. Main Outcomes and Measures: The primary end points were improvement in the mean ASIA motor score, total score of the spinal cord independence measure, and the proportion of patients able to walk independently at 1 year after injury. Results: Among 72 randomized patients, 70 patients (mean [SD] age, 65.1 [9.4] years; age range, 41-79 years; 5 [7%] women and 65 [93%] men) were included in the full analysis population (37 patients assigned to early surgical treatment and 33 patients assigned to delayed surgical treatment). Of these, 56 patients (80%) had data available for at least 1 primary outcome at 1 year. There was no significant difference among primary end points for the early surgical treatment group compared with the delayed surgical treatment group (mean [SD] change in ASIA motor score, 53.7 [14.7] vs 48.5 [19.1]; difference, 5.2; 95% CI, -4.2 to 14.5; P = .27; mean [SD] SCIM total score, 77.9 [22.7] vs 71.3 [27.3]; P = .34; able to walk independently, 21 of 30 patients [70.0%] vs 16 of 26 patients [61.5%]; P = .51). A mixed-design analysis of variance revealed a significant difference in the mean change in ASIA motor scores between the groups (F1,49 = 4.80; P = .03). The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury. Adverse events were common in both groups (eg, worsening of paralysis, 6 patients vs 6 patients; death, 3 patients vs 3 patients). Conclusions and Relevance: These findings suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery, which requires further validation. Trial Registration: ClinicalTrials.gov Identifier: NCT01485458; umin.ac.jp/ctr Identifier: UMIN000006780.