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Abstract The research retrospectively analyzed cases of spinal chordoma and chondrosarcoma involving patients who received treatment at the two hospitals between 2001 and 2023. Among the 48 patients studied (39 chordoma and 9 chondrosarcoma cases), the average age was 53.9 ± 15.8 years, with a range of 17 to 86 years. Out of these patients, 43 underwent excision surgery and were categorized based on tumor margin into negative (R0) or microscopically positive (R1) margin (n = 14) and macroscopically positive (R2) margin (n = 29) groups. The mean overall survival (OS) for R0/R1 and R2 groups was 156.5 ± 19.3 and 79.2 ± 11.9 months, respectively (p value = 0.012). The mean progression-free survival (PFS) for R0/R1 and R2 was 112.9 ± 24.4 and 25.5 ± 5.5 months (p value

Background/objective: The Tomita, revised Tokuhashi and Tokuhashi lung scores are commonly used tools to predict the survival of patients with spinal metastases and to guide decisions regarding surgical treatment. These prognostic scores, however, tend to underestimate the prognosis of patients with lung cancer. We examined surgical outcome and hopefully provide a more accurate reference for management. Methods: The consistency between predicted and actual survival was examined using the Tomita and Tokuhashi scores. Various factors that may influence survival were analyzed. Primary outcomes were overall survival (OS) and progression-free survival (PFS), defined as the ambulatory time after the initial surgery. Secondary outcomes included reoperation events, blood loss, and hospitalization days. Results: One hundred seventy-two patients were enrolled. Correct survival predictions were made for 28%, 42%, and 56% with the Tomita, revised Tokuhashi, and Tokuhashi lung scores, respectively. The Tokuhashi lung scores underestimated OS by 35%–40%. Body mass index ≥20, systemic treatment-naïve, good general condition, the use of denosumab, and adenocarcinoma were found to positively affect OS and PFS. There was no significant difference between palliative decompression and excisional surgery regarding OS and PFS. Conclusion: Patients with spinal metastases from lung cancer had better prognosis than that predicted by the Tomita and Tokuhashi scores. Spine surgeons should acknowledge this discrepancy and treat these patients with at least the aggressiveness suggested. Patients with adenocarcinoma, amenable to target therapy, denosumab, good general condition, systemic treatment-naïve are better candidates for surgery. Those with cachexic status and unresectable visceral metastases are worse candidates.

Background: Given the limited studies addressing the issue about the effect of different surgical modalities for metastatic spinal cord compression (MSCC) as the first malignancy manifestation, we conducted a retrospective case-control study to evaluate the surgical outcome of MSCC as the first malignancy manifestation. Methods: A total of 128 patients who were suspected of having metastatic spinal cord compression and underwent surgery from 2008 to 2021 were enrolled in the study. All patients were categorized into either ‘debulking group’ or ‘palliative group’. Results: The primary outcome was progression-free survival (PFS). The secondary outcomes were overall survival (OS), Frankel scale, and Karnofsky scores. All the outcomes were analyzed with a data cutoff of December 31, 2021. There was a significant difference between groups in progression-free survival (PFS) (p = 0.0094). However, there was no significant difference between groups in the overall survival (OS) (p = 0.0746). Age of onset, gender, duration of symptoms, and location of spinal metastasis, initial Frankel, initial Tomita scores, and initial Karnofsky performance scale showed no significant differences between groups. Conclusion: In conclusion, debulking surgery was shown to provide better neurological recoveries and could be considered first in patients with metastatic spinal cord compression as the first malignancy manifestation.

Abstract Background The inclusion of a connecting path in a porous implant can promote nutrient diffusion to cells and enhance bone ingrowth. Consequently, this study aimed to evaluate the biomechanical, radiographic, and histopathological performance of a novel 3D-printed porous suture anchor in a rabbit femur model. Methods Three test groups were formed based on the type of suture anchor (SA): Commercial SA (CSA, Group A, n = 20), custom solid SA (CSSA, Group B, n = 20), and custom porous SA (CPSA, Group C, n = 20). The SAs were implanted in the lateral femoral condyle of the right leg in each rabbit. The rabbits (New Zealand white rabbits, male, mean body weight of 2.8 ± 0.5 kg, age 8 months) underwent identical treatment and were randomized into experimental and control groups via computer-generated randomization. Five rabbits (10 femoral condyles) were euthanized at 0, 4, 8, and 12 weeks post-implantation for micro-CT, histological analysis, and biomechanical testing. Results At 12 weeks, the CPSA showed a higher BV/TV (median 0.7301, IQR 0.7276–0.7315) than the CSSA and CSA. The histological analysis showed mineralized osteocytes near the SA. At 4 weeks, new bone was observed around the CPSA and had penetrated its porous structure. By 12 weeks, there was no significant difference in ultimate failure load between the CSA and CPSA. Conclusions We demonstrated that the innovative 3D-printed porous suture anchor exhibited comparable pullout strength to conventional threaded suture anchors at the 12-week postoperative time-point period. Furthermore, our porous anchor design enhanced new bone formation and facilitated bone growth into the implant structure, resulting in improved biomechanical stability.

Abstract Background The I-FEED classification, scored 0–8, was reported to accurately describe the clinical manifestations of gastrointestinal impairment after colorectal surgery. Therefore, it is interesting to determine whether the I-FEED scoring system is also applicable to patients undergoing lumbar spine surgery. Methods Adult patients undergoing elective lumbar spine surgery were enrolled, and the I-FEED score was measured for 4 days after surgery. The I-FEED scoring system incorporates five elements: intake (score: 0, 1, 3), feeling nauseated (score: 0, 1, 3), emesis (score: 0, 1, 3), results of physical exam (score: 0, 1, 3), and duration of symptoms (score: 0, 1, 2). Daily I-FEED scores were summed, and the highest overall score is used to categorize patients into one of three categories: normal (0–2 points), postoperative gastrointestinal intolerance (POGI; 3–5 points), and postoperative gastrointestinal dysfunction (POGD; 6 + points). The construct validity hypothesis testing determines whether the I-FEED category is consistent with objective clinical findings relevant to gastrointestinal impairment, namely, the longer length of hospital stay (LOS), higher inhospital medical cost, more postoperative gastrointestinal medical treatment, and more postoperative non-gastrointestinal complications. Results A total of 156 patients were enrolled, and 25.0% of patients were categorized as normal, 49.4% POGI, and 25.6% POGD. Patients with higher I-FEED scores agreed with the four validity hypotheses. Patients with POGD had a significantly longer length of hospital stay (1 day longer median stay; p = 0.049) and more inhospital medical costs (approximately 500 Taiwanese dollars; p = 0.037), and more patients with POGD required rectal laxatives (10.3% vs. 32.5% vs. 32.5%; p = 0.026). In addition, more patients with POGD had non-gastrointestinal complications (5.1% vs. 11.7% vs. 30.0%; p = 0.034). Conclusion This study contributes preliminary validity evidence for the I-FEED score as a measure for postoperative gastrointestinal impairment after elective lumbar spine surgery.

Objective: This study aims to predict new-onset secondary adrenal insufficiency (NOSAI) after transsphenoidal pituitary tumor resection surgery using perioperative growth hormone (GH) and prolactin (PRL) levels, among other factors. Methods: A cohort of 124 adult patients who underwent transsphenoidal resection for non-functioning pituitary adenoma, with routine perioperative glucocorticoid use, was used to develop the predictive regression model. An additional 46 patients served as the validation cohort. Generalized additive models were used to identify optimal cut-off points for the variables. Results: The GH level on postoperative day one (POD1) can be a simple predictor by implementing a cut-off point of 0.41 ng/ml. A value ≤ 0.41 ng/mL predicted NOSAI with 0.6316 sensitivity and 0.7810 specificity for the original cohort and 1.0000 sensitivity and 0.7143 specificity for the validation cohort. The multiple logistic regression model included perioperative PRL level difference, perioperative GH level difference, intraoperative cerebrospinal fluid (CSF) leakage, tumor size, and the combined effect of diabetes insipidus (DI) and relative perioperative GH level difference. The areas under the receiver operating characteristic curves were 0.9410 (original cohort) and 0.9494 (validation cohort) for the regression model. Conclusion: Early morning GH level on POD1 can predict NOSAI with fair accuracy when perioperative stress dose glucocorticoid is administered. Prediction accuracy can be improved by considering CSF leakage, DI, and perioperative changes in GH and PRL in the final regression model.

Objective The present study is to analyze the effects of the coronavirus disease 2019 (COVID 2019) outbreak and the subsequent lockdown on the outcomes of spinal metastasis patients. Methods The study was a retrospective analysis of data from a prospective cohort study. All patients underwent surgical intervention for spinal metastases between January 2019 and December 2021 and had at least 3 months of postoperative follow-up. The primary outcome was overall mortality during the 4 different stages (pre-COVID-19 era, COVID-19 pandemic except in Taiwan, national lockdown, lifting of the lockdown). The secondary outcomes were the oncological severity scores, medical/surgical accessibility, and patient functional outcome during the 4 periods as well as survival/mortality. Results A total of 233 patients were included. The overall mortality rate was 41.20%. During the Taiwan lockdown, more patients received palliative surgery than other surgical methods, and no total en bloc spondylectomy was performed. The time from surgeon visit to operation was approximately doubled after the COVID-19 outbreak in Taiwan (75.97, 86.63, 168.79, and 166.91 hours in the 4 periods, respectively). The estimated survival probability was highest after the national lockdown was lifted and lowest during the lockdown. In the multivariate analysis, increased risk of mortality was observed with delay of surgery, with emergency surgery having a higher risk with delays above 33 hours, urgent surgery (below 59 and above 111 hours), and elective surgery (above 332 hours). Conclusion The COVID-19 pandemic and related policies have altered daily clinical practice and negatively impacted the survival of patients with spinal metastases.

Abstract Background Surgeons are routinely required to remove loose or failed pedicle screws and insert a new screw in their place. However, inserting a new screw into an existing hole may compromise the holding capacity of the pedicle screw. The purpose of this study is to evaluate the pullout strength of pedicle screws with different thread designs after the primary insertion and revision surgery in a synthetic bone model. Methods Four pedicle screws with different thread designs (single-lead-thread (SLT) screw, dual-lead-thread (DLT) screw, mixed-single-lead-thread (MSLT) screw, and proximal-unthreaded-dual-thread (PUDL) screw) were inserted into pre-drilled, untapped holes (ø 4.2 mm, length 35 mm) in Sawbone blocks of density 20 pcf. In the first sequence, a 6.0 mm screw was inserted into the predrilled foam block and the primary pullout strength of the screw was measured according to ASTM F543. In the second sequence, a 6.0 mm screw was inserted and removed, and then either a 6.5 mm screw of the same design or a different screw design was inserted into the same hole and the pullout strength recorded. Results In the first sequence, the mean pullout strength of the MSLT screw was significantly (p

Objective The long-term survival data of lung cancer patients with spinal metastases are crucial for informed treatment decision-making. However, most studies in this field involve small sample sizes. Moreover, survival benchmarking and an analysis of changes in survival over time are required, but data are unavailable. To meet this need, we performed a meta-analysis of survival data from small studies to obtain a survival function based on large-scale data. Methods We performed a single-arm systematic review of survival function following a published protocol. Data of patients who received surgical, nonsurgical, and mixed modes of treatment were meta-analyzed separately. Survival data were extracted from published figures with a digitizer program and then processed in R. Median survival time was used as an effect size for moderator analysis to explain the heterogeneity. Results Sixty-two studies with 5,242 participants were included for pooling. The survival functions showed a median survival of 6.72 months for surgery (95% confidence interval [CI], 61.9–7.01; 2,367 participants; 36 studies), 5.99 months for nonsurgery (95% CI, 5.33–6.47; 891 participants; 12 studies), and 5.96 months for mixed (95% CI, 5.67–6.43; 1,984 participants; 18 studies). Patients enrolled since 2010 showed the highest survival rates. Conclusion This study provides the first large-scale data for lung cancer with spinal metastasis that allows survival benchmarking. Data from patients enrolled since 2010 had the best survival and thus may more accurately reflect current survival. Researchers should focus on this subset in future benchmarking and remain optimistic in the management of these patients.

Abstract Background Degenerative disc disease is one of the most common ailments severely affecting the quality of life in elderly population. Cervical intervertebral body fusion devices are utilized to provide stability after surgical intervention for cervical pathology. In this study, we design a biomimetic porous spinal cage, and perform mechanical simulations to study its performances following American Society for Testing and Materials International (ASTM) standards before manufacturing to improve design process and decrease cost and consumption of material. Methods The biomimetic porous Ti-6Al-4 V interbody fusion devices were manufactured by selective laser melting (laser powder bed fusion: LPBF in ISO/ASTM 52900 standard) and subsequently post-processed by using hot isostatic pressing (HIP). Chemical composition, microstructure and the surface morphology were studied. Finite element analysis and in vitro biomechanical test were performed. Findings The post heat treatment can optimize its mechanical properties, as the stiffness of the cage decreases to reduce the stress shielding effect between two instrumented bodies. After the HIP treatment, the ductility and the fatigue performance are substantially improved. The use of HIP post-processing can be a necessity to improve the physical properties of customized additive manufacturing processed implants. Interpretation In conclusion, we have successfully designed a biomimetic porous intervertebral device. HIP post-treatment can improve the bulk material properties, optimize the device with reduced stiffness, decreased stress shielding effect, while still provide appropriate space for bone growth. Clinical significance The biomechanical performance of 3-D printed biomimetic porous intervertebral device can be optimized. The ductility and the fatigue performance were substantially improved, the simultaneously decreased stiffness reduces the stress shielding effect between two instrumented bodies; while the biomimetic porous structures provide appropriate space for bone growth, which is important in the patients with osteoporosis.

Background: The Quick Mild Cognitive Impairment (Qmci) test has been suggested to be an easy-to-use and precise screening tool for detecting postoperative cognitive dysfunction (POCD). To provide essential information for future POCD studies in Taiwan, the present study provided data regarding the Taiwan version of the Qmci (Qmci-TW) test conducted in the normative Taiwanese population and changes in them over time. Methods: The present study recruited adult native Taiwanese volunteers without known neurologic or psychiatric diseases. All enrolled participants received protocolized serial Qmci-TW test at baseline, 2-day follow-up, and 6-month follow-up. Results: In total, 30 participants, 15 men and 15 women, were enrolled in this study. The baseline Qmci-TW score ranged from 55 to 80, with a mean of 68.9 and a standard deviation (SD) of 7. At 2-day follow-up, the mean Qmci-TW test score was significantly higher (by 5.3; SD = 7.3) than that at baseline (P = 0.001). At 6-month follow-up, the mean Qmci-TW score was 71.3 (SD = 6.1), with no significant difference compared with that at baseline. The decline in Qmci-TW scores by > 9 points on postoperative day 1 and by > 11 points at 6-month follow-up was the criterion for POCD. Conclusion: The present study provided data regarding the Qmci-TW test conducted in the normative Taiwanese population and its time trajectory during the 6-month follow-up.

Abstract High-grade gliomas are notorious for a high recurrence rate even after curative resection surgery. Studies regarding the influence of scalp block on high-grade gliomas have been inconclusive, possibly because the condition’s most important genetic mutation profile, namely the isocitrate dehydrogenase 1 (IDH1) mutation, had not been analyzed. Therefore, we conducted a single-center study including patients with high-grade glioma who underwent tumor resection between January 2014 and December 2019. Kaplan–Meier survival analysis revealed that scalp block was associated with longer progression-free survival (PFS; 15.17 vs. 10.77 months, p = 0.0018), as was the IDH1 mutation (37.37 vs. 10.90 months, p = 0.0149). Multivariate Cox regression analysis revealed that scalp block (hazard ratio: 0.436, 95% confidence interval: 0.236–0.807, p = 0.0082), gross total resection (hazard ratio: 0.405, 95% confidence interval: 0.227–0.721, p = 0.0021), and IDH1 mutation (hazard ratio: 0.304, 95% confidence interval: 0.118–0.784, p = 0.0138) were associated with better PFS. Our results demonstrate that application of scalp block, regardless of IDH1 profile, is an independent factor associated with longer PFS for patients with high-grade glioma.

BackgroundObjectively detecting perioperative swallowing changes is essential for differentiating the reporting of subjective trouble sensations in patients undergoing anterior cervical spine surgery (ACSS). Swallowing indicates the transmission of fluid boluses from the pharynx (velopharynx, oropharynx, and hypopharynx) through the upper esophageal sphincter (UES). Abnormal swallowing can reveal fluid accumulation at the pharynx, which increased the aspiration risk. However, objective evidence is limited. High-resolution impedance manometry (HRIM) was applied for an objective swallowing evaluation for a more detailed analysis. We aimed to elucidate whether HRIM can be used to detect perioperative swallowing changes in patients undergoing ACSS.MethodsFourteen patients undergoing elective ACSS underwent HRIM with the Dysphagia Short Questionnaire (DSQ, score: 0–18) preoperatively (PreOP), on postoperative at day 1 (POD1), and postoperative at day seven (POD7). We calculated hypopharyngeal and UES variables, including hypopharyngeal mean peak pressure (PeakP) and UES peak pressure, representing their contractility (normal range of PeakP, 69–280 mmHg; peak pressure, 149–548 mmHg). The velopharynx-to-tongue base contractile (VTI) was also calculated (normal range, 300–700 mmHg.s.cm), indicating contractility. The swallowing risk index (SRI) from HRIM combined with four hypopharyngeal parameters, including PeakP, represents the global swallowing function (normal range, 0–11). A higher SRI value indicated higher aspiration.ResultsSRI was significantly higher on POD1 (10.88 ± 5.69) than PreOP (6.06 ± 3.71) and POD7 (8.99 ± 4.64). In all patients, PeakP was significantly lower on POD1 (61.8 ± 18.0 mmHg) than PreOP (84.9 ±34.7 mmHg) and on POD7 (75.3 ± 23.4 mmHg). The UES peak pressure was significantly lower on POD1 (80.4 ± 30.0 mmHg) than PreOP (112.9 ± 49.3 mmHg) and on POD7 (105.6 ± 59.1 mmHg). Other variables, including VTI, did not change significantly among the three time points. DSQ scores were 1.36, 3.43, and 2.36 at PreOP, POD1, and POD7 respectively.ConclusionsWith similar trends in DSQ and SRI, swallowing was significantly decreased on POD1 because of decreased hypopharyngeal and UES contractility but recovered to the preoperative state on POD7 after ACSS. Applying HRIM is superior to DSQ in detecting mechanisms and monitoring the recovery from swallowing dysfunction.Clinical Trial RegistrationThe study was registered at ClinicalTrials.gov (NCT03891940).

Pullout strength is an important indicator of the performance and longevity of pedicle screws and can be heavily influenced by the screw design, the insertion technique and the quality of surrounding bone. The purpose of this study was to investigate the pullout strength of three different pedicle screws inserted using three different strategies and with two different loading conditions. Three pedicle screws with different thread designs (single-lead-thread (SLT) screw, dual-lead-thread (DLT) screw and mixed-single-lead-thread (MSLT) screw) were inserted into a pre-drilled rigid polyurethane foam block using three strategies: (A) screw inserted to a depth of 33.5 mm; (B) screw inserted to a depth of 33.5 mm and then reversed by 3.5 mm to simulate an adjustment of the tulip height of the pedicle screw and (C) screw inserted to a depth of 30 mm. After insertion, each screw type was set up with and without a cyclic load being applied to the screw head prior to the pullout test. To ensure that the normality assumption is met, we applied the Shapiro–Wilk test to all datasets before conducting the non-parametric statistical test (Kruskal–Wallis test combined with pairwise Mann–Whitney-U tests). All screw types inserted using strategy A had a significantly greater pullout strength than those inserted using strategies B and C, regardless of if the screw was pre-loaded with a cyclic load prior to testing. Without the use of the cyclic pre-load, the MSLT screw had a greater pullout strength than the SLT and DLT screws for all three insertion strategies. However, the fixation strength of all screws was reduced when pre-loaded before testing, with the MSLT screw inserted using strategy B producing a significantly lower pullout strength than all other groups (p < 0.05). In contrast, the MSLT screw using insertion strategies A and C had a greater pullout strength than the SLT and DLT screws both with and without pre-loading. In conclusion, the MSLT pedicle screw exhibited the greatest pullout strength of the screws tested under all insertion strategies and loading conditions, except for insertion strategy B with a cyclic pre-load. While all screw types showed a reduced pullout strength when using insertion strategy B (screw-out depth adjustment), the MSLT screw had the largest reduction in pullout strength when using a pre-load before testing. Based on these findings, during the initial screw insertion, it is recommended to not fully insert the screw thread into the bone and to leave a retention length for depth adjustment to avoid the need for screw-out adjustment, as with insertion strategy B.

Abstract Background Lumbar spinal fusion with rigid spinal fixators as one of the high risk factors related to adjacent-segment failure. The purpose of this study is to investigate how the material properties of spinal fixation rods influence the biomechanical behavior at the instrumented and adjacent levels through the use of the finite element method. Methods Five finite element models were constructed in our study to simulate the human spine pre- and post-surgery. For the four post-surgical models, the spines were implanted with rods made of three different materials: (i) titanium rod, (ii) PEEK rod with interbody PEEK cage, (iii) Biodegradable rod with interbody PEEK cage, and (iv) PEEK cage without pedicle screw fixation (no rods). Results Fusion of the lumbar spine using PEEK or biodegradable rods allowed a similar ROM at both the fusion and adjacent levels under all conditions. The models with PEEK and biodegradable rods also showed a similar increase in contact forces at adjacent facet joints, but both were less than the model with a titanium rod. Conclusions Flexible rods or cages with non-instrumented fusion can mitigate the increased contact forces on adjacent facet joints typically found following spinal fixation, and could also reduce the level of stress shielding at the bone graft.

Abstract Background Literature indicates that adjacent-segment diseases after posterior lumbar interbody fusion with pedicle screw fixation accelerate degenerative changes at unfused adjacent segments due to the increased motion and intervertebral stress. Sagittal alignment of the spine is an important consideration as achieving proper lordosis could improve the outcome of spinal fusion and avoid the risk of adjacent segment diseases. Therefore, restoration of adequate lumbar lordosis is considered as a major factor in the long-term success of lumbar fusion. This study hypothesized that the removal of internal fixation devices in segments that have already fused together could reduce stress at the disc at adjacent segments, particularly in patients with inadequate lordosis. The purpose of this study was to analyze the biomechanical characteristics of a single fusion model (posterior lumbar interbody fusion with internal fixation) with different lordosis angles before and after removal of the internal fixation device. Methods Five finite element models were constructed for analysis; 1) Intact lumbar spine without any implants (INT), 2) Lumbar spine implanted with a spinal fixator and lordotic intervertebral cage at L4-L5 (FUS-f-5c), 3) Lumbar spine after removal of the spinal fixator (FUS-5c), 4) Lumbar spine implanted with a spinal fixator and non-lordotic intervertebral cage at L4-L5 (FUS-f-0c), and 5) Lumbar spine after removal of the spinal fixator from the FUS-f-0c model (FUS-0c). Results The ROM of adjacent segments in the FUS-f-0c model was found to be greater than in the FUS-f-5c model. After removing the fixator, the adjacent segments in the FUS-5c and FUS-0c models had a ROM that was similar to the intact spine under all loading conditions. Removing the fixator also reduced the contact forces on adjacent facet joints and reduced the peak stresses on the discs at adjacent levels. The greatest increase in stress on the discs was found in the FUS-f-0c model (at both L2/L3 and L3/L4), with intervertebral stress at L3/L4 increasing by 83% when placed in flexion. Conclusions This study demonstrated how removing the spinal fixation construct after bone fusion could reduce intradiscal pressure and facet contact forces at adjacent segments, while retaining a suitable level of lumbar lordosis.

Lumbar disc herniation (LDH) is a common condition which can lead to back pain. Although surgical treatments for LDH are well established, complications such as spinal instability and narrowing of adjacent facet joints are still frequently reported. The purpose of this study was to use finite element models to evaluate the stability of the L3–L4 segment after conservative or aggressive percutaneous transforaminal endoscopic discectomy (PTED) with and without an artificial material filler to correct LDH. Compared to the intact model, aggressive PTED reduced the stability of the segment (increased ROM) and narrowed the space between facet joints in the medial/lateral (ML) direction during flexion (maximum 6.7 degrees change in ROM and 90.5% spacing between facet joints), extension (maximum 2.1 degrees and 38.6%), and axial rotation (maximum 4.2 degrees and 90.1%). Aggressive PTED had a similar effect in the anterior/posterior (AP) direction during lateral bending (maximum 2.0 degrees and 44.2%). Augmenting the nucleus pulposus with a polyurethane filler after aggressive PTED improved spinal stability in both the ML and AP directions in all simulated motions, with results similar to the intact model. However, using a hydrogel filler did little to stabilize the spine, likely because the material is too soft to support the heavy, sustained loading. In conclusion, this study found that if an aggressive discectomy is required, augmenting the nucleus pulposus with a PU filler provides sufficient support to stabilize the spine, while hydrogel fillers offer little support.

Background and Objectives: Using an appropriate torque to tighten set screws ensures the long-term stability of spinal posterior fixation devices. However, the recommended torque often varies between different devices and some devices do not state a recommended torque level. The purpose of this study is to evaluate the effect of set screw torque on the overall construct stability and fatigue life. Materials and Methods: Two commercial pedicle screw systems with different designs for the contact interface between the set screw and rod (Group A: plane contact, Group B: line contact) were assembled using torque wrenches provided with the devices to insert the set screws and tighten to the device specifications. The axial gipping capacity and dynamic mechanical stability of each bilateral construct were assessed in accordance with ASTM F1798 and ASTM F1717. Results: Increasing or decreasing the torque on the set screw by 1 Nm from the recommended level did not have a significant effect on the axial gripping capacity or fatigue strength of Group A (p > 0.05). For Group B, over-tightening the set screw by 1 Nm did cause a significant reduction in the fatigue strength. Conclusions: Excessive torque can damage the rod surface and cause premature failure. When insertion using a manual driver is preferred, a plane contact interface between the set screw and rod can reduce damage to the rod surface when the set screw is over-torqued.

Self-tapping screws are commonly used in trauma and maxillofacial surgery and are increasingly used for pedicle screw insertions. In order to evaluate how the quantity and length of cutting flutes on self-tapping pedicle screws affect the insertion torque and pullout strength, eight different self-tapping pedicle screw designs were evaluated. All screws had a threaded length of 35 mm and featured variations in the number of leads, as well as the length and quantity of cutting flutes. Five samples of each design were inserted into pre-drilled, untapped holes (ø2.7 mm, length 35 mm) in sawbone blocks of density 20 PCF. The insertion torque and pullout strength were measured according to ASTM F543. The results showed that screws with a longer cutting flute of 9.5 mm had a lower mean maximum insertion torque than screws with shorter 2.9 mm cutting flutes. Pedicle screws with a double-lead thread design had a greater insertion torque than their single-lead counterparts, and the use of three cutting flutes produced a lower torque than two cutting flutes. The results demonstrated a greater pullout strength in screws with a single-lead thread rather than a double-lead, three cutting flutes instead of two, and a longer length for the cutting flute. In conclusion, to provide immediate stability and reduce the surgical insertion time, a single-lead, self-tapping pedicle screw incorporating three long cutting flutes is recommended because of the significantly greater pullout strength. This design could also reduce the risk of implant loosening in comparison to double-lead, self-tapping pedicle screw designs.

Suture anchor fixation is a common method for securing bone and soft tissue in the body, with proven applications in the hip, elbow, hand, knee and foot. A critical limiting factor of suture anchors is the pull-out strength, particularly in suboptimal bone. This study introduces a novel 3D printed threadless suture anchor with a rectangular cross-section. The titanium anchor was designed with surface fenestration and a porous central core to improve bone ingrowth. The aim of this study was to compare the pull-out properties of the novel threadless anchor with a traditional circular threaded suture anchor. The anchors were inserted into a 0.24 g/cm3 synthetic cancellous bone block at angles of 90° and 135° to the surface. The sutures were pulled at 180° (parallel) to the surface under a static pull test (anchor pullout) and cyclic load test using a tensile testing machine. Under the static load, the greatest pullout strength was seen with the novel threadless anchor inserted at 90° (mean, 105.6 N; standard deviation [SD], 3.5 N). The weakest pullout strength was seen with the threaded anchor inserted at 90° (mean, 87.9 N; SD, 4.1 N). In the cyclic load test, all six of the threaded anchors with a 90° insertion angle pulled out after 18 cycles (70 N). All of the threadless anchors inserted at 90° survived the cyclic test (90 N). In conclusion, the novel threadless suture anchor with rectangular cross-section and traditional threaded suture anchor had similar pullout survivorship when inserted at either 90° or 135°. In addition, the 3D printed threadless anchor has the potential for good bone integration to improve long-term stabilization.

This study proposed a pedicle screw design where the proximal 1/3 of the screw is unthreaded to improve fixation in posterior spinal surgery. This design was also expected to reduce the incidence of mechanical failure often observed when an unsupported screw length is exposed outside the vertebra in deformed or degenerated segments. The aim of this study was to evaluate the fatigue life of the novel pedicle screw design using finite element analysis and mechanical testing in a synthetic spinal construct in accordance with American Society for Testing and Materials (ASTM) F1717. The following setups were evaluated: (i) pedicle screw fully inserted into the test block (EXP-FT-01 and EXP-PU-01; full thread (FT), proximal unthread (PU)) and (ii) pedicle screw inserted but leaving an exposed shaft length of 7.6 mm (EXP-FT-02 and EXP-PU-02). Corresponding finite element models FEM-FT-01, FEM-FT-02, FEM-PU-01, and FEM-PU-02 were also constructed and subjected to the same loading conditions as the experimental groups. The results showed that under a 220 N axial load, the EXP-PU-01 group survived the full 5 million cycles, the EXP-PU-02 group failed at 4.4 million cycles on average, and both EXP-FT-01 and EXP-FT-02 groups failed after less than 1.0 million cycles on average, while the fatigue strength of the EXP-FT-02 group was the lowest at 170 N. The EXP-FT-01 and EXP-FT-02 constructs failed through fracture of the pedicle screw, but a rod fractured in the EXP-PU-02 group. In comparison to the FEM-FT-01 model, the maximum von Mises stress on the pedicle screw in the FEM-PU-01 and FEM-PU-02 models decreased by −43% and −27%, respectively. In conclusion, this study showed that having the proximal 1/3 of the pedicle screw unthreaded can reduce the risk of screw fatigue failure when used in deformed or degenerated segments.

The majority of compressive vertebral fractures in osteoporotic bone occur at the level of the thoracolumbar junction. Immediate decompression is often required in order to reduce the extent of neurological damage. This study evaluated four fixation methods for decompression in patients with thoracolumbar burst fractures, and presented the most suitable method for osteoporotic patients. A finite element model of a T7-L5 spinal segment was created and subjected to an L1 corpectomy to simulate a serious burst fracture. Five models were tested: a) intact spine; 2) two segment fixation (TSF), 3) up-three segment fixation (UTSF), below-three segment fixation (BTSF), and four segment fixation (FSF). The ROM, stiffness and compression ratio of the fractured vertebra were recorded under various loading conditions. The results of this study showed that the ROM of the FSF model was the lowest, and the ROMs of UTSF and BTSF models were similar but still greater than the TSF model. Decreasing the BMD to simulate osteoporotic bone resulted in a ROM for the four instrumented models that was higher than the normal bone model. Of all models, the FSF model had the highest stiffness at T12-L2 in extension and lateral bending. Similarly, the compression ratio of the FSF model at L1 was also higher than the other instrumented models. In conclusion, FSF fixation is suggested for patients with osteoporotic thoracolumbar burst fractures. For patients with normal bone quality, both UTSF and BTSF fixation provide an acceptable stiffness in extension and lateral bending, as well as a favorable compression ratio at L1.

Pedicle screws are commonly used for posterior stabilization of the spine. When used in deformed or degenerated segments, the pedicle screws are often not fully inserted into the bone, but instead the threaded portion is exposed by 1 or 2 threads to accommodate rod placement and ensure alignment between the tulip of the screw and the rod. However, broken pedicle screws have been reported with the use of this method. The aim of this study was to determine how the fatigue life of the screw is affected by not fully inserting the screw into the bone. Spinal constructs were evaluated in accordance with ASTM F1717. The following three screw positions were subjected to compression bending fatigue loading; (i) pedicle screw fully inserted in the test block with no threads exposed (EXP-T0), (ii) pedicle screw inserted with one thread exposed outside the test block (EXP-T1), (iii) pedicle screw inserted with two threads exposed outside the test block (EXP-T2). Corresponding finite element models FEM-T0, FEM-T1 and FEM-T2 were also constructed and subjected to the same axial loading as the experimental groups to analyze the stress distribution in the pedicle screws and rods. The results showed that under a 190 N axial load, the EXP-T0 group survived the full 5 million cycles, the EXP-T1 group failed at 3.7 million cycles on average and the EXP-T2 groups failed at 1.0 million cycles on average, while the fatigue strength of both the EXP-T1 and EXP-T2 groups was 170 N. The constructs failed through fracture of the pedicle screw. In comparison to the FEM-T0 model, the maximum von Mises stress on the pedicle screw in the FEM-T1 and FEM-T2 models increased by 39% and 58%, respectively. In conclusion, this study demonstrated a drastic decrease in the fatigue life of pedicle screws when they are not full inserted into the plastic block.

Interbody fusion with posterior instrumentation is a common method for treating lumbar degenerative disc diseases. However, the high rigidity of the fusion construct may produce abnormal stresses at the adjacent segment and lead to adjacent segment degeneration (ASD). As such, biodegradable implants are becoming more popular for use in orthopaedic surgery. These implants offer sufficient stability for fusion but at a reduced stiffness. Tailored to degrade over a specific timeframe, biodegradable implants could potentially mitigate the drawbacks of conventional stiff constructs and reduce the loading on adjacent segments. Six finite element models were developed in this study to simulate a spine with and without fixators. The spinal fixators used both titanium rods and biodegradable rods. The models were subjected to axial loading and pure moments. The range of motion (ROM), disc stresses, and contact forces of facet joints at adjacent segments were recorded. A 3-point bending test was performed on the biodegradable rods and a dynamic bending test was performed on the spinal fixators according to ASTM F1717-11a. The finite element simulation showed that lumbar spinal fusion using biodegradable implants had a similar ROM at the fusion level as at adjacent levels. As the rods degraded over time, this produced a decrease in the contact force at adjacent facet joints, less stress in the adjacent disc and greater loading on the anterior bone graft region. The mechanical tests showed the initial average fatigue strength of the biodegradable rods was 145 N, but this decreased to 115N and 55N after 6 months and 12 months of soaking in solution. Also, both the spinal fixator with biodegradable rods and with titanium rods was strong enough to withstand 5,000,000 dynamic compression cycles under a 145 N axial load. The results of this study demonstrated that biodegradable rods may present more favourable clinical outcomes for lumbar fusion. These polymer rods could not only provide sufficient initial stability, but the loss in rigidity of the fixation construct over time gradually transfers loading to adjacent segments.

INTRODUCTION: Treatment for osteoporosis commonly includes the use of bisphosphonates. Serious side effects of these drugs are caused by the inhibition of bone resorption as a result of osteoclast apoptosis. Treatment using calcitonin along with bisphosphonates overcomes these side-effects in some patients. Calcitonin is known to inhibit bone resorption without reducing the number of osteoclasts and is thought to prolong osteoclast survival through the inhibition of apoptosis. Further understanding of how calcitonin inhibits apoptosis could prove useful to the development of alternative treatment regimens for osteoporosis. This study aimed to analyze the mechanism by which calcitonin influences osteoclast apoptosis induced by a bisphosphate analog, sintered dicalcium pyrophosphate (SDCP), and to determine the effects of co-treatment with calcitonin and SDCP on apoptotic signaling in osteoclasts. METHODS: Isolated osteoclasts were treated with CT, SDCP or both for 48 h. Osteoclast apoptosis assays, pit formation assays, and tartrate-resistant acid phosphatase (TRAP) staining were performed. Using an osteoporosis rat model, ovariectomized (OVX) rats received calcitonin, SDCP, or calcitonin + SDCP. The microarchitecture of the fifth lumbar trabecular bone was investigated, and histomorphometric and biochemical analyses were performed. RESULTS: Calcitonin inhibited SDCP-induced apoptosis in primary osteoclast cultures, increased Bcl-2 and Erk activity, and decreased Mcl-1 activity. Calcitonin prevented decreased osteoclast survival but not resorption induced by SDCP. Histomorphometric analysis of the tibia revealed increased bone formation, and microcomputed tomography of the fifth lumbar vertebrate showed an additive effect of calcitonin and SDCP on bone volume. Finally, analysis of the serum bone markers CTX-I and P1NP suggests that the increased bone volume induced by co-treatment with calcitonin and SDCP may be due to decreased bone resorption and increased bone formation. CONCLUSIONS: Calcitonin reduces SDCP-induced osteoclast apoptosis and increases its efficacy in an in vivo model of osteoporosis.