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1.
World Neurosurg ; 2024 May 20.
Article in English | MEDLINE | ID: mdl-38777315

ABSTRACT

BACKGROUND: The rise of minimally invasive lumbar fusions and advanced imaging technologies has facilitated the introduction of novel surgical techniques with the trans-facet approach being one of the newest additions. We aimed to quantify any pathology-driven anatomic changes to the trans-facet corridor, which could thereby alter the ideal laterality of approach to the disc space. METHODS: In this retrospective cohort study, we measured the areas and maximum permissible cannula diameters of the trans-facet corridor using commercially available software (BrainLab, Munich, Germany). Exiting and traversing nerve roots, thecal sacs, and lumbar vertebrae were manually segmented on T2-SPACE magnetic resonance imaging. Spondylolisthesis, disc protrusions, and disc space heights were recorded. RESULTS: A total of 118 trans-facet corridors were segmented bilaterally in 16 patients (65.6 ± 12.1 years, 43.8% female, body mass index 29.2 ± 5.1 kg/m2). The mean areas at L1-L2, L2-L3, L3-L4, and L4-L5 were 89.4 ± 24.9 mm2, 124 ± 39.4 mm2, 123 ± 26.6 mm2, and 159 ± 42.7 mm2, respectively. The mean permissible cannula diameter at the same levels were 7.85 ± 1.43 mm, 8.98 ± 1.72 mm, 8.93 ± 1.26 mm, and 10.2 ± 1.94 mm, respectively. Both parameters increased caudally. Higher degrees for spondylolisthesis were associated with larger areas and maximum cannula diameters on regression analysis (P < 0.001). CONCLUSIONS: Our results illustrate that pathology, like spondylolisthesis, can increase the area of the trans-facet corridor. By understanding this effect, surgeons can better decide on the optimal approach to the disc while taking into consideration a patient's unique anatomy.

2.
J Clin Med ; 13(5)2024 Mar 06.
Article in English | MEDLINE | ID: mdl-38592365

ABSTRACT

The transfacet minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) is a novel approach available for the management of lumbar spondylolisthesis. It avoids the need to manipulate either of the exiting or traversing nerve roots, both protected by the bony boundaries of the approach. With the advancement in operative technologies such as navigation, mapping, segmentation, and augmented reality (AR), surgeons are prompted to utilize these technologies to enhance their surgical outcomes. A 36-year-old male patient was complaining of chronic progressive lower back pain. He was found to have grade 2 L4/5 spondylolisthesis. We studied the feasibility of a trans-Kambin or a transfacet MIS-TLIF, and decided to proceed with the latter given the wider corridor it provides. Preoperative trajectory planning and level segmentation in addition to intraoperative navigation and image merging were all utilized to provide an AR model to guide us through the surgery. The use of AR can build on the safety and learning of novel surgical approaches to spine pathologies. However, larger high-quality studies are needed to further objectively analyze its impact on surgical outcomes and to expand on its application.

3.
J Clin Med ; 13(7)2024 Apr 06.
Article in English | MEDLINE | ID: mdl-38610887

ABSTRACT

Cervical endoscopic spine surgery is rapidly evolving and gaining popularity for the treatment of cervical radiculopathy and myelopathy. This approach significantly reduces muscular damage and blood loss by minimizing soft tissue stripping, leading to less postoperative pain and a faster postoperative recovery. As scientific evidence accumulates, the efficacy and safety of cervical endoscopic spine surgery are continually affirmed. Both anterior and posterior endoscopic approaches have surfaced as viable alternative treatments for various cervical spine pathologies. Newer techniques, such as endoscopic-assisted fusion, the anterior transcorporeal approach, and unilateral laminotomy for bilateral decompression, have been developed to enhance clinical outcomes and broaden surgical indications. Despite its advantages, this approach faces challenges, including a steep learning curve, increased radiation exposure for both surgeons and patients, and a relative limitation in addressing multi-level pathologies. However, the future of cervical endoscopic spine surgery is promising, with potential enhancements in clinical outcomes and safety on the horizon. This progress is fueled by integrating advanced imaging and navigation technologies, applying regional anesthesia for improved and facilitated postoperative recovery, and incorporating cutting-edge technologies, such as augmented reality. With these advancements, cervical endoscopic spine surgery is poised to broaden its scope in treating cervical spine pathologies while maintaining the benefits of minimized tissue damage and rapid recovery.

4.
J Clin Med ; 13(8)2024 Apr 14.
Article in English | MEDLINE | ID: mdl-38673544

ABSTRACT

The transforaminal lumbar interbody fusion (TLIF) has seen significant evolution since its early inception, reflecting advancements in surgical techniques, patient safety, and outcomes. Originally described as an improvement over the posterior lumbar interbody fusion (PLIF), the TLIF began as an open surgical procedure, that notably reduced the need for the extensive neural retractation that hindered the PLIF. In line with the broader practice of surgery, trending toward minimally invasive access, the TLIF was followed by the development of the minimally invasive TLIF (MIS-TLIF), a technique that further decreased tissue trauma and postoperative complications. Subsequent advancements, including Trans-Kambin's Triangle TLIF (percLIF) and transfacet LIF, have continued to refine surgical access, minimize surgical footprint, and reduce the risk of injury to the patient. The latest evolution, as we will describe it, the patient-specific TLIF, is a culmination of the aforementioned adaptations and incorporates advanced imaging and segmentation technologies into perioperative planning, allowing surgeons to tailor approaches based on individual patient anatomy and pathology. These developments signify a shift towards more precise methods in spine surgery. The ongoing evolution of the TLIF technique illustrates the dynamic nature of surgery and emphasizes the need for continued adaptation and refinement.

5.
J Clin Med ; 13(4)2024 Feb 16.
Article in English | MEDLINE | ID: mdl-38398424

ABSTRACT

The Prone Transpsoas (PTP) approach to lumbar spine surgery, emerging as an evolution of lateral lumbar interbody fusion (LLIF), offers significant advantages over traditional methods. PTP has demonstrated increased lumbar lordosis gains compared to LLIF, owing to the natural increase in lordosis afforded by prone positioning. Additionally, the prone position offers anatomical advantages, with shifts in the psoas muscle and lumbar plexus, reducing the likelihood of postoperative femoral plexopathy and moving critical peritoneal contents away from the approach. Furthermore, operative efficiency is a notable benefit of PTP. By eliminating the need for intraoperative position changes, PTP reduces surgical time, which in turn decreases the risk of complications and operative costs. Finally, its versatility extends to various lumbar pathologies, including degeneration, adjacent segment disease, and deformities. The growing body of evidence indicates that PTP is at least as safe as traditional approaches, with a potentially better complication profile. In this narrative review, we review the historical evolution of lateral interbody fusion, culminating in the prone transpsoas approach. We also describe several adjuncts of PTP, including robotics and radiation-reduction methods. Finally, we illustrate the versatility of PTP and its uses, ranging from 'simple' degenerative cases to complex deformity surgeries.

6.
BMC Musculoskelet Disord ; 24(1): 553, 2023 Jul 05.
Article in English | MEDLINE | ID: mdl-37408033

ABSTRACT

BACKGROUND: Preoperative prediction of prolonged postoperative opioid use (PPOU) after total knee arthroplasty (TKA) could identify high-risk patients for increased surveillance. The Skeletal Oncology Research Group machine learning algorithm (SORG-MLA) has been tested internally while lacking external support to assess its generalizability. The aims of this study were to externally validate this algorithm in an Asian cohort and to identify other potential independent factors for PPOU. METHODS: In a tertiary center in Taiwan, 3,495 patients receiving TKA from 2010-2018 were included. Baseline characteristics were compared between the external validation cohort and the original developmental cohorts. Discrimination (area under receiver operating characteristic curve [AUROC] and precision-recall curve [AUPRC]), calibration, overall performance (Brier score), and decision curve analysis (DCA) were applied to assess the model performance. A multivariable logistic regression was used to evaluate other potential prognostic factors. RESULTS: There were notable differences in baseline characteristics between the validation and the development cohort. Despite these variations, the SORG-MLA ( https://sorg-apps.shinyapps.io/tjaopioid/ ) remained its good discriminatory ability (AUROC, 0.75; AUPRC, 0.34) and good overall performance (Brier score, 0.029; null model Brier score, 0.032). The algorithm could bring clinical benefit in DCA while somewhat overestimating the probability of prolonged opioid use. Preoperative acetaminophen use was an independent factor to predict PPOU (odds ratio, 2.05). CONCLUSIONS: The SORG-MLA retained its discriminatory ability and good overall performance despite the different pharmaceutical regulations. The algorithm could be used to identify high-risk patients and tailor personalized prevention policy.


Subject(s)
Arthroplasty, Replacement, Knee , Opioid-Related Disorders , Humans , Analgesics, Opioid/adverse effects , Arthroplasty, Replacement, Knee/adverse effects , Machine Learning , Algorithms , Prescriptions , Retrospective Studies
7.
J Formos Med Assoc ; 122(12): 1321-1330, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37453900

ABSTRACT

BACKGROUND/PURPOSE: Identifying patients at risk of prolonged opioid use after surgery prompts appropriate prescription and personalized treatment plans. The Skeletal Oncology Research Group machine learning algorithm (SORG-MLA) was developed to predict the risk of prolonged opioid use in opioid-naive patients after lumbar spine surgery. However, its utility in a distinct country remains unknown. METHODS: A Taiwanese cohort containing 2795 patients who were 20 years or older undergoing primary surgery for lumbar decompression from 2010 to 2018 were used to validate the SORG-MLA. Discrimination (area under receiver operating characteristic curve [AUROC] and area under precision-recall curve [AUPRC]), calibration, overall performance (Brier score), and decision curve analysis were applied. RESULTS: Among 2795 patients, the prolonged opioid prescription rate was 5.2%. The validation cohort were older, more inpatient disposition, and more common pharmaceutical history of NSAIDs. Despite the differences, the SORG-MLA provided a good discriminative ability (AUROC of 0.71 and AURPC of 0.36), a good overall performance (Brier score of 0.044 compared to that of 0.039 in the developmental cohort). However, the probability of prolonged opioid prescription tended to be overestimated (calibration intercept of -0.07 and calibration slope of 1.45). Decision curve analysis suggested greater clinical net benefit in a wide range of clinical scenarios. CONCLUSION: The SORG-MLA retained good discriminative abilities and overall performances in a geologically and medicolegally different region. It was suitable for predicting patients in risk of prolonged postoperative opioid use in Taiwan.


Subject(s)
Analgesics, Opioid , Machine Learning , Humans , Analgesics, Opioid/therapeutic use , Algorithms , Prescriptions , Probability , Retrospective Studies
8.
Article in English | MEDLINE | ID: mdl-37306629

ABSTRACT

BACKGROUND: The Skeletal Oncology Research Group machine-learning algorithm (SORG-MLA) was developed to predict the survival of patients with spinal metastasis. The algorithm was successfully tested in five international institutions using 1101 patients from different continents. The incorporation of 18 prognostic factors strengthens its predictive ability but limits its clinical utility because some prognostic factors might not be clinically available when a clinician wishes to make a prediction. QUESTIONS/PURPOSES: We performed this study to (1) evaluate the SORG-MLA's performance with data and (2) develop an internet-based application to impute the missing data. METHODS: A total of 2768 patients were included in this study. The data of 617 patients who were treated surgically were intentionally erased, and the data of the other 2151 patients who were treated with radiotherapy and medical treatment were used to impute the artificially missing data. Compared with those who were treated nonsurgically, patients undergoing surgery were younger (median 59 years [IQR 51 to 67 years] versus median 62 years [IQR 53 to 71 years]) and had a higher proportion of patients with at least three spinal metastatic levels (77% [474 of 617] versus 72% [1547 of 2151]), more neurologic deficit (normal American Spinal Injury Association [E] 68% [301 of 443] versus 79% [1227 of 1561]), higher BMI (23 kg/m2 [IQR 20 to 25 kg/m2] versus 22 kg/m2 [IQR 20 to 25 kg/m2]), higher platelet count (240 × 103/µL [IQR 173 to 327 × 103/µL] versus 227 × 103/µL [IQR 165 to 302 × 103/µL], higher lymphocyte count (15 × 103/µL [IQR 9 to 21× 103/µL] versus 14 × 103/µL [IQR 8 to 21 × 103/µL]), lower serum creatinine level (0.7 mg/dL [IQR 0.6 to 0.9 mg/dL] versus 0.8 mg/dL [IQR 0.6 to 1.0 mg/dL]), less previous systemic therapy (19% [115 of 617] versus 24% [526 of 2151]), fewer Charlson comorbidities other than cancer (28% [170 of 617] versus 36% [770 of 2151]), and longer median survival. The two patient groups did not differ in other regards. These findings aligned with our institutional philosophy of selecting patients for surgical intervention based on their level of favorable prognostic factors such as BMI or lymphocyte counts and lower levels of unfavorable prognostic factors such as white blood cell counts or serum creatinine level, as well as the degree of spinal instability and severity of neurologic deficits. This approach aims to identify patients with better survival outcomes and prioritize their surgical intervention accordingly. Seven factors (serum albumin and alkaline phosphatase levels, international normalized ratio, lymphocyte and neutrophil counts, and the presence of visceral or brain metastases) were considered possible missing items based on five previous validation studies and clinical experience. Artificially missing data were imputed using the missForest imputation technique, which was previously applied and successfully tested to fit the SORG-MLA in validation studies. Discrimination, calibration, overall performance, and decision curve analysis were applied to evaluate the SORG-MLA's performance. The discrimination ability was measured with an area under the receiver operating characteristic curve. It ranges from 0.5 to 1.0, with 0.5 indicating the worst discrimination and 1.0 indicating perfect discrimination. An area under the curve of 0.7 is considered clinically acceptable discrimination. Calibration refers to the agreement between the predicted outcomes and actual outcomes. An ideal calibration model will yield predicted survival rates that are congruent with the observed survival rates. The Brier score measures the squared difference between the actual outcome and predicted probability, which captures calibration and discrimination ability simultaneously. A Brier score of 0 indicates perfect prediction, whereas a Brier score of 1 indicates the poorest prediction. A decision curve analysis was performed for the 6-week, 90-day, and 1-year prediction models to evaluate their net benefit across different threshold probabilities. Using the results from our analysis, we developed an internet-based application that facilitates real-time data imputation for clinical decision-making at the point of care. This tool allows healthcare professionals to efficiently and effectively address missing data, ensuring that patient care remains optimal at all times. RESULTS: Generally, the SORG-MLA demonstrated good discriminatory ability, with areas under the curve greater than 0.7 in most cases, and good overall performance, with up to 25% improvement in Brier scores in the presence of one to three missing items. The only exceptions were albumin level and lymphocyte count, because the SORG-MLA's performance was reduced when these two items were missing, indicating that the SORG-MLA might be unreliable without these values. The model tended to underestimate the patient survival rate. As the number of missing items increased, the model's discriminatory ability was progressively impaired, and a marked underestimation of patient survival rates was observed. Specifically, when three items were missing, the number of actual survivors was up to 1.3 times greater than the number of expected survivors, while only 10% discrepancy was observed when only one item was missing. When either two or three items were omitted, the decision curves exhibited substantial overlap, indicating a lack of consistent disparities in performance. This finding suggests that the SORG-MLA consistently generates accurate predictions, regardless of the two or three items that are omitted. We developed an internet application (https://sorg-spine-mets-missing-data-imputation.azurewebsites.net/) that allows the use of SORG-MLA with up to three missing items. CONCLUSION: The SORG-MLA generally performed well in the presence of one to three missing items, except for serum albumin level and lymphocyte count (which are essential for adequate predictions, even using our modified version of the SORG-MLA). We recommend that future studies should develop prediction models that allow for their use when there are missing data, or provide a means to impute those missing data, because some data are not available at the time a clinical decision must be made. CLINICAL RELEVANCE: The results suggested the algorithm could be helpful when a radiologic evaluation owing to a lengthy waiting period cannot be performed in time, especially in situations when an early operation could be beneficial. It could help orthopaedic surgeons to decide whether to intervene palliatively or extensively, even when the surgical indication is clear.

9.
J Clin Med ; 11(18)2022 Sep 14.
Article in English | MEDLINE | ID: mdl-36143035

ABSTRACT

INTRODUCTION: Predicting survival time for patients with spinal metastases is important in treatment choice. Generally speaking, six months is a landmark cutoff point. Revised Tokuhashi score (RTS), the most widely used scoring system, lost its accuracy in predicting 6-month survival, gradually. Therefore, a more precise scoring system is urgently needed. OBJECTIVE: The aim of this study is to create a new scoring system with a higher accuracy in predicting 6-month survival based on the previously used RTS. METHODS: Data of 171 patients were examined to determine factors that affect prognosis (reference group), and the remaining (validation group) were examined to validate the reliability of a new score, adjusted Tokuhashi score (ATS). We compared their discriminatory abilities of the prediction models using area under receiver operating characteristic curve (AUC). RESULTS: Target therapy and the Z score of BMI (Z-BMI), which adjusted to the patients' sex and age, were additional independent prognostic factors. Patients with target therapy use are awarded 4 points. The Z score of BMI could be added directly to yield ATS. The AUCs were 0.760 for ATS and 0.636 for RTS in the validation group. CONCLUSION: Appropriate target therapy use can prolong patients' survival. Z-BMI which might reflect nutritional status is another important influencing factor. With the optimization, surgeons could choose a more individualized treatment for patients.

10.
Ear Hear ; 43(6): 1800-1806, 2022.
Article in English | MEDLINE | ID: mdl-35666542

ABSTRACT

OBJECTIVE: Falls are a major cause of disability and mortality in the elderly. Postural balance is associated with falls and can be evaluated by posturography. However, conventional posturography is costly and requires a sufficiently large space to perform. Hence, this study developed a portable system to meet the requirement of field studies, and investigated its reliability and validity. DESIGN: A custom-written software application was developed to link a computer to the Nintendo Wii balance board (WBB) and the center of pressure was acquired, which was then compared with that obtained from commercially available foam posturography (FP). Forty younger adults including 20 patients with peripheral vestibular disorders as well as 20 healthy controls, and 50 older patients with peripheral vestibular disorders were enrolled. All subjects underwent postural balance testing using the WBB system (WBSS) and FP system (FPS) in a randomized order. RESULTS: For the intersystem reliability, although the WBSS obtained a significantly smaller mean sway area than the FPS, both systems revealed adequate to excellent reliability with an intraclass correlation coefficient (ICC) of 0.67 to 0.87. The WBBS showed adequate to excellent test-retest reliability (ICC: 0.53 to 0.88). For the validity, the respective cutoff sway areas were 1.03 and 3.09 cm 2 under conditions C and D via the WBBS for discriminating the fallers from nonfallers. CONCLUSION: The WBBS yielded adequate to excellent reliability and validity for accessing postural balance, and had good performance in discriminating the fallers from nonfallers. The WBBS has advantages over the commercial FPS of low cost, easy portability, programmability, and may be better-suited to mass detection and research programs. Most importantly, this WBBS can be performed outside the hospital for testing postural balance, especially in the elderly.


Subject(s)
Vestibular Diseases , Video Games , Adult , Aged , Humans , Postural Balance , Reproducibility of Results , Software , Vestibular Diseases/diagnosis
11.
Spine J ; 22(7): 1119-1130, 2022 07.
Article in English | MEDLINE | ID: mdl-35202784

ABSTRACT

BACKGROUND CONTEXT: Preoperative prediction of prolonged postoperative opioid prescription helps identify patients for increased surveillance after surgery. The SORG machine learning model has been developed and successfully tested using 5,413 patients from the United States (US) to predict the risk of prolonged opioid prescription after surgery for lumbar disc herniation. However, external validation is an often-overlooked element in the process of incorporating prediction models in current clinical practice. This cannot be stressed enough in prediction models where medicolegal and cultural differences may play a major role. PURPOSE: The authors aimed to investigate the generalizability of the US citizens prediction model SORG to a Taiwanese patient cohort. STUDY DESIGN: Retrospective study at a large academic medical center in Taiwan. PATIENT SAMPLE: Of 1,316 patients who were 20 years or older undergoing initial operative management for lumbar disc herniation between 2010 and 2018. OUTCOME MEASURES: The primary outcome of interest was prolonged opioid prescription defined as continuing opioid prescription to at least 90 to 180 days after the first surgery for lumbar disc herniation at our institution. METHODS: Baseline characteristics were compared between the external validation cohort and the original developmental cohorts. Discrimination (area under the receiver operating characteristic curve and the area under the precision-recall curve), calibration, overall performance (Brier score), and decision curve analysis were used to assess the performance of the SORG ML algorithm in the validation cohort. This study had no funding source or conflict of interests. RESULTS: Overall, 1,316 patients were identified with sustained postoperative opioid prescription in 41 (3.1%) patients. The validation cohort differed from the development cohort on several variables including 93% of Taiwanese patients receiving NSAIDS preoperatively compared with 22% of US citizens patients, while 30% of Taiwanese patients received opioids versus 25% in the US. Despite these differences, the SORG prediction model retained good discrimination (area under the receiver operating characteristic curve of 0.76 and the area under the precision-recall curve of 0.33) and good overall performance (Brier score of 0.028 compared with null model Brier score of 0.030) while somewhat overestimating the chance of prolonged opioid use (calibration slope of 1.07 and calibration intercept of -0.87). Decision-curve analysis showed the SORG model was suitable for clinical use. CONCLUSIONS: Despite differences at baseline and a very strict opioid policy, the SORG algorithm for prolonged opioid use after surgery for lumbar disc herniation has good discriminative abilities and good overall performance in a Han Chinese patient group in Taiwan. This freely available digital application can be used to identify high-risk patients and tailor prevention policies for these patients that may mitigate the long-term adverse consequence of opioid dependence: https://sorg-apps.shinyapps.io/lumbardiscopioid/.


Subject(s)
Intervertebral Disc Displacement , Opioid-Related Disorders , Algorithms , Analgesics, Opioid/adverse effects , Humans , Intervertebral Disc Displacement/drug therapy , Intervertebral Disc Displacement/surgery , Machine Learning , Prescriptions , Retrospective Studies
12.
BMC Musculoskelet Disord ; 23(1): 137, 2022 Feb 10.
Article in English | MEDLINE | ID: mdl-35144568

ABSTRACT

BACKGROUND: Although patients with lumbar spinal stenosis (LSS) may have impaired postural control, current diagnosis of LSS depends mainly on clinical manifestation and radiological assessment, while functional assessment of postural balance remains less investigated. This study thus correlated radiological assessment via MR imaging with functional assessment using foam posturography in LSS patients. METHODS: Forty-seven LSS patients aged 50-85 years were enrolled. All patients received subjective outcome measures first, followed by plain radiography of whole spine and lumbosacral spine, MR imaging, and foam posturography under four conditions. Then, these results were analyzed using stepwise multiple regression analysis. Another 47 age- and sex-matched healthy controls also underwent foam posturography for comparison. RESULTS: The LSS group revealed significant increases in the sway area of foam posturography than the control group regardless of various conditions. Advanced age, poor walking endurance, and neural compression at the L2/3 level on MR images were significantly correlated with the characteristic parameters of foam posturography (p < 0.05). In contrast, subjectively reported pain and plain radiography did not correlate with posturographic results (p > 0.05). CONCLUSIONS: Patients with LSS who exhibit less severe symptoms do not ensure normal postural balance. Functional assessment (foam posturography) on postural balance significantly correlated with radiological assessment (MR imaging) in LSS patients. The use of foam posturography may help assess postural control in LSS patients. It takes a short time and costs less, and would be practical to make this a routine examination in LSS patients.


Subject(s)
Spinal Stenosis , Aged , Aged, 80 and over , Humans , Lumbar Vertebrae/diagnostic imaging , Middle Aged , Postural Balance , Radiography , Spinal Stenosis/diagnostic imaging , Walking
13.
Front Med (Lausanne) ; 8: 717168, 2021.
Article in English | MEDLINE | ID: mdl-34568375

ABSTRACT

Background: Though denosumab is an effective treatment for osteoporosis, the rebound effect after discontinuation has drawn investigators' attention. It includes a dramatic loss of gained bone mineral density (BMD) and an increased risk of vertebral fractures. This prospective multi-institutional randomized controlled trial aims to investigate whether zoledronate prevents loss of BMD after discontinuation of denosumab. The trial was registered as Denosumab Sequential Therapy (DST) trial in March 2019 at clinicaltrials.gov, with the identifier NCT03868033. Methods: The study is conducted at National Taiwan University Hospital and its branches. Patients who have continuously received denosumab treatment for two or more years are surveyed for eligibility. Baseline characteristics and questionnaires of life quality are recorded after recruitment. BMD, circulating levels of bone turnover markers (BTMs), including serum N-terminal propeptide of type 1 collagen (P1NP) and C-terminal telopeptide (CTX), are checked before the stratified randomization to 4 groups. Biological sex and the T-scores are used to create 4 strata. The participants in group 1 adhere to regular denosumab therapy for another 2 years. All the other patients receive on-time zoledronate treatment in the first year. The participants in group 2, 3, and 4 have on-time denosumab, on-time zoledronate and drug holiday in the second year, respectively. BMDs are checked annually. Pre-scheduled checkpoints of BTMs are also arranged. For patient safety, rescue treatment with another injection of zoledronate will be applied to the patients on drug holiday if the CTX levels raise above the pre-specified threshold, 0.573 ng/mL for women and 0.584 ng/mL for men. The primary outcomes are the percentage changes of BMDs in lumbar spine, total hip and femoral neck. The secondary outcomes include the changes of serum level of the BTMs, new osteoporotic fractures, extra zoledronate injections needed in group 4 and the differences of quality of life. Discussion: We aim to provide evidence whether zoledronate prevents bone loss after denosumab cessation. To our knowledge, the study has the largest sample size. No other randomized controlled study included all the three different treatment strategies and a positive control. It is also the first associated randomized controlled trial outside Europe.

14.
J Intern Med ; 290(6): 1194-1205, 2021 12.
Article in English | MEDLINE | ID: mdl-34237171

ABSTRACT

BACKGROUND: To compare the risks of major osteoporotic, vertebral, and non-vertebral fractures between patients who discontinued anti-osteoporosis medications. METHODS: We conducted a comparative effectiveness study with a nationwide population-based cohort study design. Patients aged ≥50 years admitted between 2012 and 2015 for incident hip fractures and receiving denosumab or bisphosphonates with sufficient compliance for at least 1 year were included. Patients were categorized into persistent or non-persistent denosumab or bisphosphonates users based on their subsequent use pattern. The main outcomes were subsequent hospitalizations for a major osteoporotic, vertebral or non-vertebral fracture. Multivariate, time-varying Cox proportional hazards model was used to evaluate the risk of major outcomes. RESULTS: Compared with persistent denosumab users, non-persistent denosumab users had a significantly higher risk of major osteoporotic fractures (hazard ratio [HR] = 1.60; 95% confidence interval [CI], 1.20-2.14), vertebral fractures (HR = 2.18; 95% CI, 1.46-3.24) and death (HR = 3.57; 95%CI, 2.63-4.84). However, the increased risk of fracture was not found in both persistent and non-persistent bisphosphonates users. Noteworthy, the increased risk of vertebral fractures in non-persistent denosumab users was more pronounced within 1 year post-discontinuation (HR = 2.90; 95% CI, 1.77-4.74) and among patients who discontinued from 2-year denosumab therapy (HR = 3.58; 95% CI, 1.74-7.40). DISCUSSION: Discontinuation of denosumab resulted in an increased risk of major osteoporotic fractures, especially vertebral fractures. The increased risk tends to reveal within 1 year post-discontinuation and be greater after a longer treatment duration. Notably, only fracture with hospitalization was identified as our research outcome, the real risk of osteoporotic fracture post discontinuation is believed to be higher, especially for vertebral fracture.


Subject(s)
Bone Density Conservation Agents , Hip Fractures , Osteoporosis , Osteoporotic Fractures , Spinal Fractures , Bone Density Conservation Agents/administration & dosage , Cohort Studies , Denosumab/administration & dosage , Diphosphonates/administration & dosage , Hip Fractures/epidemiology , Hip Fractures/prevention & control , Humans , Osteoporosis/drug therapy , Osteoporosis/epidemiology , Osteoporotic Fractures/epidemiology , Osteoporotic Fractures/prevention & control , Spinal Fractures/epidemiology , Spinal Fractures/prevention & control
15.
Int J Clin Pract ; 72(10): e13246, 2018 Oct.
Article in English | MEDLINE | ID: mdl-30144247

ABSTRACT

AIMS: Recent clinical guidelines have suggested that patients experience an osteoporotic fracture should initiate anti-osteoporosis medications (AOMs). However, whether clinical guidelines translate well in "real-world" practices remain questioned. This study aimed to evaluate the "real-world" prescription pattern of AOMs and visualise the unmet treatment needs in different geographical areas in Taiwan. METHODS: Using Taiwan's National Health Insurance Research Database, we identified patients diagnosed with a hip or vertebral fracture between 2009 and 2012. The treatment rate was defined as the proportion of patients receiving AOMs within 1 year after their index fracture. The qualitative geographical information systems approach was adopted to visualise the treatment needs of postfracture patients in different geographical areas. RESULTS: Our study included 276,492 patients diagnosed with a hip or vertebral fracture between 2009 and 2012. The proportion of patients who received AOMs within 1 year after their index fracture increased with age and differed with fracture types and sex. For patients with hip fractures, the treatment rate ranged from 3.43% to 20.88% for female patients and from 0.69% to 10.04% for male patients in different age groups. For patients with vertebral fractures, the treatment rate ranged from 3.23% to 37.08% for female patients and from 1.85% to 23.05% for male patients. Cities in the mid-northern and southern areas of Taiwan had the highest unmet treatment need, with a treatment rate of less than 15%. CONCLUSION: The treatment rate of osteoporotic fractures with AOMs was diverse and suboptimal in Taiwan, especially among male patients. This study used a visualisation technique to display information about the treatment status in different geographical areas and help policymakers allocate resource appropriately.


Subject(s)
Bone Density Conservation Agents/therapeutic use , Health Services Needs and Demand , Osteoporosis/drug therapy , Osteoporotic Fractures/prevention & control , Secondary Prevention/statistics & numerical data , Adult , Age Factors , Aged , Aged, 80 and over , Databases, Factual , Female , Geographic Information Systems , Hip Fractures/etiology , Hip Fractures/prevention & control , Humans , Male , Middle Aged , National Health Programs/statistics & numerical data , Needs Assessment , Osteoporosis/complications , Osteoporotic Fractures/etiology , Retrospective Studies , Sex Factors , Spatial Analysis , Spinal Fractures/etiology , Spinal Fractures/prevention & control , Taiwan
16.
J Orthop Surg (Hong Kong) ; 26(1): 2309499018760130, 2018.
Article in English | MEDLINE | ID: mdl-29486668

ABSTRACT

Headless compression screws (HCSs) are commonly used to fixate small bones and articular fractures. Understanding the biomechanical efficacy of different HCS designs can help surgeons make proper interfragmentary compression when a specific implant is chosen. HCSs with three different central shaft designs (unthreaded, fully threaded, and partially threaded) were studied: the Herbert-Whipple, Mini-Acutrak 2, and headless reduction (HLR). Polyurethane foam blocks were machined with a simulated fracture gap of 0.5 mm and set onto a custom-made jig to simultaneously measure compression force and driving torque during screw insertion. The maximal achievable compression forces and driving torques recorded were 47.4 ± 0.9 N and 145.11 ± 1.65 N mm for the HLR, 50.98 ± 1.29 N and 152.62 ± 2.83 N mm for the Mini-Acutrak 2, and 19.33 ± 1.0 N and 33.4 ± 2.2 N mm for the Herbert-Whipple. Overall, the compression force of the Mini-Acutrak 2 and HLR increased with the torque. Unlike the other screws, the Herbert-Whipple's driving torque increased while the compression force decreased after peak compression force was achieved. The partially threaded shaft design (HLR) demonstrated equivalent biomechanical advantage with the Mini-Acutrak 2 in interfragmentary compression. The HCSs with cone-shaped proximal ends (HLR and Mini-Acutrak 2) maintained their compression force during over-fastening, whereas the unthreaded central shaft of the Herbert-Whipple screw caused it to lose compression force.


Subject(s)
Bone Screws , Computer Simulation , Fracture Fixation, Internal/methods , Fractures, Bone/surgery , Intra-Articular Fractures/surgery , Biomechanical Phenomena , Humans , Polyurethanes , Pressure
17.
PLoS One ; 12(10): e0184809, 2017.
Article in English | MEDLINE | ID: mdl-29049290

ABSTRACT

Musculoskeletal allografts are now commonly used. To decrease the potential risks of transmission of pathogenic bacteria, fungi, or viruses to the transplant recipients, certain issues regarding the management of patients who receive contaminated allografts need to be addressed. We aimed to clarify the incidence and extent of disease transmission from allografts by analyzing the allografting procedures performed in the bone bank of our hospital over the past 20 years. We retrospectively reviewed the data from our allograft registry center on 3979 allografts that were implanted in 3193 recipients throughout a period of two decades, from July 1991 to June 2011. The source of the allografts, results of all screening tests, dates of harvesting and implantation, and recipients of all allografts were checked. With the help of the Center for Infection Control of our hospital, a strict prospective, hospital-wide, on-site surveillance was conducted, and every patient with healthcare-associated infection was identified. Fisher's exact test was used to compare the infection rate between recipients with sterile allografts and those with contaminated allografts. The overall discard and infection rates were, respectively, 23% and 1.3% in the first decade (1991-2001); and 18.4% and 1.25% in the second decade (2001-2011). The infection rate of contaminated allograft recipients was significantly higher than that of sterile allograft recipients (10% vs. 1.15%, P < 0.01) in the second decade. Both infection and discard rates of our bone bank are comparable with those of international bone banks. Strict allograft processing and adequate prophylactic use of antibiotics are critical to prevent infection and disease transmission in such cases.


Subject(s)
Allografts , Bone Banks , Hospitals , Quality Control , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Retrospective Studies , Taiwan , Young Adult
18.
J Orthop Res ; 34(2): 240-8, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26222735

ABSTRACT

Osteoporosis and osteoarthritis commonly coexist in the elderly. In patients undergoing prosthetic total knee arthroplasty (TKA), the bone quality around the knee joint may affect the safety of prosthetic implantation and consequently satisfaction with the surgical outcome. We recruited 50 postmenopausal women undergoing TKA for primary osteoarthritis; 43 completed the study protocol. The bone quality parameters of the operated knee, including bone mineral density assessed using dual-energy X-ray absorptiometry and microarchitecture variables assessed using micro-computed tomography, were determined. Surgical outcomes were assessed according to immediate (<1 week) postoperative pain quantified using the visual analog scale and knee function quantified using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 and 6 months postoperatively. The influence of bone quality parameters on surgical outcomes was analyzed using simple and multiple regression analyses. Volumetric bone mineral density (R(2) = 0.187-0.234, p < 0.01), the structural model index (R(2) = 0.103-0.181, p < 0.05), and trabecular separation (R(2) = 0.289-0.424, p < 0.05) were significantly associated with postoperative pain and improvement according to the KOOS. In conclusion, local bone quality, including mineral content and microarchitecture, affects the surgical outcome of TKA.


Subject(s)
Arthroplasty, Replacement, Knee/statistics & numerical data , Bone Density , Osteoarthritis, Knee/surgery , Osteoporosis, Postmenopausal/complications , Aged , Female , Humans , Knee Joint/diagnostic imaging , Knee Prosthesis , Middle Aged , Osteoarthritis, Knee/complications , Pain, Postoperative/epidemiology , Prospective Studies , Radiography , Taiwan/epidemiology , Treatment Outcome
19.
Biomed Res Int ; 2013: 140237, 2013.
Article in English | MEDLINE | ID: mdl-24222895

ABSTRACT

An understanding of the activities of enzymes could help to elucidate the metabolic pathways of thousands of chemical reactions that are catalyzed by enzymes in living systems. Sophisticated applications such as drug design and metabolic reconstruction could be developed using accurate enzyme reaction annotation. Because accurate enzyme reaction annotation methods create potential for enhanced production capacity in these applications, they have received greater attention in the global market. We propose the enzyme reaction prediction (ERP) method as a novel tool to deduce enzyme reactions from domain architecture. We used several frequency relationships between architectures and reactions to enhance the annotation rates for single and multiple catalyzed reactions. The deluge of information which arose from high-throughput techniques in the postgenomic era has improved our understanding of biological data, although it presents obstacles in the data-processing stage. The high computational capacity provided by cloud computing has resulted in an exponential growth in the volume of incoming data. Cloud services also relieve the requirement for large-scale memory space required by this approach to analyze enzyme kinetic data. Our tool is designed as a single execution file; thus, it could be applied to any cloud platform in which multiple queries are supported.


Subject(s)
Computational Biology , Enzymes/chemistry , Software , Enzymes/metabolism , Kinetics , Molecular Sequence Annotation
20.
Int J Genomics ; 2013: 456356, 2013.
Article in English | MEDLINE | ID: mdl-23738320

ABSTRACT

Severe gastroenteritis and foodborne illness caused by Noroviruses (NoVs) during the winter are a worldwide phenomenon. Vulnerable populations including young children and elderly and immunocompromised people often require hospitalization and may die. However, no efficient vaccine for NoVs exists because of their variable genome sequences. This study investigates the infection processes in protein-protein interactions between hosts and NoVs. Protein-protein interactions were collected from related Pfam NoV domains. The related Pfam domains were accumulated incrementally from the protein domain interaction database. To examine the influence of domain intimacy, the 7 NoV domains were grouped by depth. The number of domain-domain interactions increased exponentially as the depth increased. Many protein-protein interactions were relevant; therefore, cloud techniques were used to analyze data because of their computational capacity. The infection relationship between hosts and NoVs should be used in clinical applications and drug design.

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