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Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy

Expert Rev Med Devices. 2025 Jan 1. doi: 10.1080/17434440.2024.2449504. Online ahead of print.

ABSTRACT

INTRODUCTION: The Mobi-C Cervical Disc Replacement is a motion preserving alternative to anterior cervical discectomy and fusion in properly indicated patients. In 2013, Mobi-C became the first cervical disc in the United States approved to treat more than one level of the cervical spine. The FDA determined Mobi-C to be statistically superior to fusion at 2 levels, based on the primary endpoint of a prospective, concurrently controlled and randomized multicenter clinical trial.

AREAS COVERED: The history of Mobi-C and cervical disc arthroplasty are discussed. The unique biomechanics and structure of Mobi-C, the clinical results, the long term follow up, the disc’s biomechanics, and cost effectiveness research are described. The competitive landscape is overviewed.

EXPERT OPINION: The evidence in this article supports the use of the Mobi-C cervical disc prosthesis as a viable alternative to fusion surgery in selected patients. Mobi-C has a relatively long track record compared to most other cervical discs prostheses. Thus far, Mobi-C is a very good option for preserving cervical motion based on long term follow-up, for achieving favorable clinical outcomes, and for maintaining patient safety. The Mobi-C cervical disc prosthesis is generally viewed positively, supported by clinical experience and research findings.

PMID:39743533 | DOI:10.1080/17434440.2024.2449504

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A joint analysis of single cell transcriptomics and proteomics using transformer

NPJ Syst Biol Appl. 2025 Jan 2;11(1):1. doi: 10.1038/s41540-024-00484-9.

ABSTRACT

CITE-seq provides a powerful method for simultaneously measuring RNA and protein expression at the single-cell level. The integrated analysis of RNA and protein expression in identical cells is crucial for revealing cellular heterogeneity. However, the high experimental costs associated with CITE-seq limit its widespread application. In this paper, we propose scTEL, a deep learning framework based on Transformer encoder layers, to establish a mapping from sequenced RNA expression to unobserved protein expression in the same cells. This computation-based approach significantly reduces the experimental costs of protein expression sequencing. We are now able to predict protein expression using single-cell RNA sequencing (scRNA-seq) data, which is well-established and available at a lower cost. Moreover, our scTEL model offers a unified framework for integrating multiple CITE-seq datasets, addressing the challenge posed by the partial overlap of protein panels across different datasets. Empirical validation on public CITE-seq datasets demonstrates scTEL significantly outperforms existing methods.

PMID:39743530 | DOI:10.1038/s41540-024-00484-9

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Possible association between Sever’s disease and attention deficit hyperactivity disorder. a prospective observational study

J Orthop Surg Res. 2025 Jan 2;20(1):1. doi: 10.1186/s13018-024-05435-y.

ABSTRACT

BACKGROUND: Sever’s disease is among the most common causes of foot pain in childhood.The etiology of Sever’s disease is still under debate.The objective of this prospective study is to investigate the relationship between Sever’s disease and attention deficit hyperactivity disorder(ADHD).

METHODS: The study was prospectively conducted for 1 year between 2023-2024.Of 238 children admitted to our clinic with foot pain, 88 children diagnosed with Sever’s disease were included in the study.A control group including 90 individuals was employed.Patients diagnosed with Sever’s disease in the orthopedics outpatient clinic and healthy control group were evaluated by a pediatric psychiatrist in terms of ADHD based on the DSM-4 diagnostic criteria.

RESULTS: Fifty-seven patients were male, and 31 were female.While 45 male patients were diagnosed with ADHD, 12 of them did not have ADHD.While 17 female patients were diagnosed with ADHD, 14 did not have ADHD. ADHD was detected in 12 (13.3%) of 90 patients in the control group, comprising 9 boys and 3 girls. The prevalence of ADHD in the Sever’s disease cohort was 62 (70.5%) out of 88, significantly higher than the control group’s 12 (13.3%) out of 90 patients (p < 0.01). The high number of the patients diagnosed with ADHD among the Sever’s patients who were not engaged in sports was found to be statistically significant(p < 0.01).The diagnosis of ADHD was found to be statistically more significant in boys with Sever’s disease compared to girls(p < 0.018).

CONCLUSION: Children with Sever’s disease can be the candidates for attention deficit hyperactivity disorder.It is thought that evaluating children, especially male children, diagnosed with calcaneal apophysitis within the framework of attention deficit hyperactivity disorder will be valuable.

PMID:39743527 | DOI:10.1186/s13018-024-05435-y

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Efficacy of the cross-union protocol in the treatment of congenital tibial pseudarthrosis: a comparative study

BMC Musculoskelet Disord. 2025 Jan 2;26(1):3. doi: 10.1186/s12891-024-08257-5.

ABSTRACT

BACKGROUND: Congenital Pseudarthrosis of the Tibia (CPT) is a rare pediatric condition presenting substantial challenges for orthopedic surgeons. Aiming to achieve bone union, with subsequent complications such as refractures being common. The aim of the present study is to evaluate the results of our intentional cross-union protocol and to compare these outcomes with those obtained from our previously used techniques.

MATERIALS AND METHODS: Sixteen patients, with a mean age of 4.8 years (range: 1-13.3 years), who were treated with the intentional cross-union protocol were included in Group (A) Eleven patients, with a mean age of 3.5 years (range: 1.3-7.6 years), who primarily underwent intramedullary rodding with bone graft, were included in Group (B) The intentional cross-union protocol involved cross-union of the tibia and fibula, autogenous iliac bone grafting, and the insertion of bone morphogenetic protein 2 (BMP-2) aimed at achieving tibia-fibula cross-union. Retrospective evaluation of serial radiographs was conducted, and the outcomes regarding union and any subsequent complications were analyzed.

RESULTS: A total of 27 patients with CPT were included in the study. All 16 patients (100%) in Group A successfully achieved primary union. Among the 11 patients in Group B, only 4 cases achieved primary union, with a primary healing rate of 36.4%. Seven cases with delayed healing required 2-4 revision surgeries for final healing. The time to union was significantly shorter in Group A (3.37 ± 0.64 months) compared to Group B (8.67 ± 3.0 months). The cross-sectional area of union was also significantly larger in Group A (6.71 ± 0.58 cm²) compared to Group B (1.18 ± 0.19 cm²). In Group A, there were no cases of refracture, whereas in Group B, 7 cases (77.8%) experienced refracture, indicating a statistically significant difference.

CONCLUSIONS: Our study demonstrates that the Cross-union protocol is highly effective for achieving union and preventing refracture in CPT. With such significant improvement, it has notably altered the prognosis of this challenging condition.

LEVEL OF EVIDENCE: IV.

PMID:39743526 | DOI:10.1186/s12891-024-08257-5

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Neurocognition and affective temperament in first-degree relatives of patients with bipolar disorder in south India: a cross-sectional study

East Asian Arch Psychiatry. 2024 Dec;34(4):122-127. doi: 10.12809/eaap2445.

ABSTRACT

BACKGROUND: Endophenotypes aid in studying the complex genetic basis of bipolar disorder. We aimed to compare first-degree relatives of patients with bipolar I disorder in a hospital in India with unrelated healthy controls in terms of neurocognition and affective temperament METHODS. This cross-sectional study was conducted between August and November 2012 at a tertiary hospital in India. First-degree relatives (parents, siblings, and children) of patients with bipolar I disorder were included; they were aged 18 to 50 years and had education level of at least eighth grade. Additionally, matched healthy controls were recruited from the general population. Sociodemographic data were collected using a semi-structured proforma. Participants were assessed for verbal and visual working memory, executive function (including cognitive flexibility, response inhibition, as well as concept formation, abstract reasoning, and set-shifting abilities), and affective temperament by a single investigator.

RESULTS: Of the 52 first-degree relatives of patients diagnosed with bipolar I disorder, 30 were included in the analysis. Additionally, 30 matched healthy controls from the general population were included for comparison. Compared with healthy controls, first-degree relatives performed significantly poorer in all tests and had significantly higher scores for cyclothymic, hyperthymic, and anxious temperaments.

CONCLUSION: Impairments in working memory, executive function, and certain affective temperaments are potential endophenotypes for bipolar I disorder. Working memory and executive function are most important cognitive domains for social, occupational, and interpersonal functioning. These potential markers could be used to trace susceptible genes for bipolar disorder and thus enhance our understanding of the complex genetics of mood disorders.

PMID:39743486 | DOI:10.12809/eaap2445

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Suicidal behaviours in Pakistani Urdu television dramas: a 12-year media content analysis

East Asian Arch Psychiatry. 2024 Dec;34(4):115-121. doi: 10.12809/eaap2440.

ABSTRACT

BACKGROUND: Pakistani television dramas often depict scenes involving suicide that may affect the psychological wellbeing of viewers. We aimed to examine the effects of suicide depiction in Pakistani television dramas on their viewers.

METHODS: In April 2023, we searched the YouTube website for Urdu-language television dramas released between 2011 and 2022 that contained scenes of suicidal behaviours (both attempts and completed suicides) using the keywords ‘suicide in Pakistani dramas’. Data extracted included details of the characters involved including age group, sex, role, occupation, religion, and marital status, as well as details of the suicidal behaviours including method, reason/trigger, and place of suicide.

RESULTS: In total, 49 incidents of suicidal behaviours from 46 characters in 40 Urdu-language television dramas were included in the analysis. Of the 40 dramas, 42.5% were released in 2021 and 2022, and 57.5% were released between 2011 and 2020. Among the 46 characters with suicidal behaviour, 50.0% were male, 54.3% were young adults, 52.2% were married, 26.1% were housewives, 100% were Muslim, and 34.8% were in a leading role. Of the 49 incidents of suicidal behaviour, 29 were suicide, 19 were suicide attempts, and one was homicide-suicide. Common methods of suicidal behaviour depicted were gun shooting (30.6%), wrist cutting (18.3%), self-poisoning (12.2%), and jumping from height (12.2%). Common reasons for suicidal behaviour were failure in love (24.4%), familial issues (24.4%), and others (26.5%); 69.4% of suicidal behaviour occurred in home.

CONCLUSION: Television dramas with scenes involving suicidal behaviours may negatively affect the general population, particularly adolescents. These scenes should be censored to prevent imitation or identification among vulnerable young people. Television dramas should provide psychoeducational messages to promote help-seeking rather than suicide for emotional problems.

PMID:39743485 | DOI:10.12809/eaap2440

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State Medicaid Policies Governing Access to Medications for Opioid Use Disorder (MOUD) and MOUD Treatment Use in a Large Sample of People Who Inject Drugs in 20 U.S. States

Subst Use Misuse. 2024 Dec 31:1-11. doi: 10.1080/10826084.2024.2440365. Online ahead of print.

ABSTRACT

BACKGROUND: People who inject drugs (PWID) are especially vulnerable to harms from opioid use disorder (OUD). Medications for OUD (MOUD) effectively reduce overdose and infectious disease transmission risks.

OBJECTIVE: We investigate whether state Medicaid coverage for methadone and buprenorphine is related to past-year MOUD use among PWID using cross-sectional, multilevel analyses with individual-level data on PWID from the Centers for Disease Control and Prevention’s 2018 National HIV Behavioral Surveillance. The sample included 8,142 PWID aged 18-64 who reported daily opioid use from 22 U.S. metropolitan areas. Our outcome was any self-reported MOUD use in the past 12 months. Exposures were state Medicaid coverage and prior authorization requirements for methadone and buprenorphine. We interacted these exposures with PWID race/ethnicity, insurance status, and spatial access to treatment and harm reduction resources.

RESULTS: Compared with PWID in states without Medicaid methadone coverage, odds of past-year MOUD use were 73% (p<0.05) higher among PWID in states with methadone coverage requiring prior authorization and 80% (p<0.05) higher among PWID in states with coverage without prior authorization. Insured PWID were twice as likely to report MOUD use than uninsured PWID, with no statistically significant differences between Medicaid versus other insurance. Medicaid prior authorization requirements for buprenorphine were not significantly associated with MOUD use. Non-Hispanic Black PWID were significantly less likely to use MOUD than non-Hispanic White and Hispanic PWID.

CONCLUSIONS: State Medicaid methadone coverage was strongly associated with higher odds that PWID utilized MOUD, suggesting that expanding methadone insurance coverage could improve MOUD treatment in a vulnerable population.

PMID:39741378 | DOI:10.1080/10826084.2024.2440365

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The system can change: a feasibility study of a doula-clinician collaborative at a large tertiary hospital in the United States

Implement Sci Commun. 2024 Dec 31;5(1):144. doi: 10.1186/s43058-024-00682-w.

ABSTRACT

BACKGROUND: Doulas, non-clinical professionals who provide support throughout the perinatal period, can positively impact patient experiences and clinical outcomes during birth. Doulas often support hospital-based births without being employed by the hospital system, resulting in varied relationships with hospitals and clinicians. Systems-level changes are needed to maximize collaboration between hospitals and doulas to ensure facilitation of, and not barriers to, doula support. We implemented and evaluated a new program, called the “Supportive Birth Collaborative,” to maximize effectiveness of doula support in hospital settings.

METHODS: We conducted a single-site feasibility study of the use of implementation mapping to make systemic changes to clinician-doula collaboration for labor and delivery. Implementation mapping consisted of five steps: developing a collaborative of program implementers and knowledge holders, conducting a needs assessment, developing a logic model, applying implementation strategies, and evaluating changes in outcomes. To evaluate change, process data were collected throughout, and implementation outcomes were measured in 2022 and again after one year of implementation via online surveys to all clinicians who provided labor and delivery care. Descriptive statistics were calculated and change over time was analyzed in Stata using log-binomial regression models with clustering to account for respondents who completed both surveys.

RESULTS: The “Supportive Birth Collaborative” (SBC) was founded in November 2021. The first meeting included 19 people, who were obstetricians, anesthesiologists, nurses, doulas, students, social workers, administrators, researchers, and individuals who had given birth at the study hospital. From 2022-2023, the SBC adopted 11 implementation strategies and piloted or fully implemented 10 of them. Implementation strategies ranged from making training dynamic, to changes in the physical environment, to changes in formal policy. In 2022, 104 clinicians participated in the survey; 97 participated in 2023. There was significant improvement in clinician-reported trust in doulas (0.23, 95% CI: 0.12, 0.34) and doula-clinician communication (0.25, 95% CI: 0.12, 0.38). Clinicians had a limited understanding of the doula’s role, and that understanding did not significantly improve.

CONCLUSIONS: Using implementation mapping as a guide to collaborative work can lead to meaningful health system changes. Regular review of implementation outcomes could allow for adaptation and tailoring of implementation strategies.

PMID:39741364 | DOI:10.1186/s43058-024-00682-w

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The efficacy of platelet-rich plasma in ankle disease: a systematic review and meta-analysis

J Orthop Surg Res. 2024 Dec 31;19(1):895. doi: 10.1186/s13018-024-05420-5.

ABSTRACT

OBJECTIVE: Ankle osteoarthritis is a debilitating condition that significantly impairs patients’ quality of life. Platelet-rich plasma has emerged as a novel cellular therapy in clinical practice. This study evaluates the clinical efficacy of platelet-rich plasma (PRP) after intervention in ankle disorders, so as to provide strong evidence in support of clinical treatment.

METHODS: A comprehensive and systematic search of PubMed, the Cochrane Library, Embase and web of science databases was performed, and studies that met the requirements according to the inclusion criteria were analyzed using Review Manager and STATA version 14.0. Quality assessment was performed using the Cochrane Collaboration Risk of Bias 2.0 tool. The outcome indicators were the American Orthopaedic Foot and Ankle Society Rating Scale (AOFAS) and Visual Analog Scale (VAS) scores used to evaluate the efficacy of platelet-rich plasma.

RESULTS: A total of 10 studies met the inclusion criteria. Regarding the AOFAS score, a meta-analysis that included five randomized controlled trials (each study extracted the score results at the last follow-up time) showed no statistically significant differences between the platelet-rich plasma intervention group and the control group, and there was a great deal of heterogeneity in the results, with subgroup analyses based on disease type. (Mean Difference = 4.14, 95% CI=-0.60-8.87, p = 0.09, I2 = 86%). Subgroup analysis showed a more significant effect in patients with talar cartilage injuries (Mean Difference = 8.66, 95%CI = 6.61-10.71, p < 0.00001, I2 = 0%). And the treatment effect of PRP remained effective in long-term follow-up (Mean Difference = 7.83, 95% CI = 5.57-10.09, p = 0.46, I2 = 0%). For VAS scores, PRP relieved patients’ pain (Standardized Mean Difference=-0.62, 95%CI=-1.13-0.10, p = 0.02, I2 = 77%) but showed a greater advantage in patients with cartilage injuries of the talus (Standardized Mean Difference=-1.24, 95%CI=-1.68-0.81, p < 0.00001, I2 = 0%). Subgroup analyses according to different disease types and different follow-up times showed that PRP had significant efficacy in talar cartilage injuries in both the short and long term. A meta-analysis of single-arm studies showed that PRP was helpful in improving patients’ pain before and after the intervention (Standardized Mean Difference = -1.76, 95% CI = -2.85 to -0.67, p = 0.002, I^2 = 87%).However, the high level of heterogeneity may be due to the large differences between the inclusion criteria of the single-arm studies.

CONCLUSION: More clinical studies are needed to further confirm the efficacy of platelet-rich plasma in ankle disorders, and the current study only suggests that platelet-rich plasma may be more effective in talus cartilage injuries than in other types of ankle disorders.

PMID:39741342 | DOI:10.1186/s13018-024-05420-5

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Association of continuous renal replacement therapy downtime with fluid balance gap and clinical outcomes: a retrospective cohort analysis utilizing EHR and machine data

J Intensive Care. 2024 Dec 31;12(1):55. doi: 10.1186/s40560-024-00772-w.

ABSTRACT

BACKGROUND: Fluid balance gap (FBgap-prescribed vs. achieved) is associated with hospital mortality. Downtime is an important quality indicator for the delivery of continuous renal replacement therapy (CRRT). We examined the association of CRRT downtime with FBgap and clinical outcomes including mortality.

METHODS: This is a retrospective cohort study of critically ill adults receiving CRRT utilizing both electronic health records (EHR) and CRRT machine data. FBgap was calculated as achieved minus prescribed fluid balance. Downtime, or percent treatment time loss (%TTL), was defined as CRRT downtime in relation to the total CRRT time. Data collection stopped upon transition to intermittent hemodialysis when applicable. Linear and logistic regression models were used to analyze the association of %TTL with FBgap and hospital mortality, respectively. Covariates included demographics, Sequential Organ Failure Assessment (SOFA) score at CRRT initiation, use of organ support devices, and the interaction between %TTL and machine alarms.

RESULTS: We included 3630 CRRT patient-days from 500 patients with a median age of 59.5 years (IQR 50-67). Patients had a median SOFA score at CRRT initiation of 13 (IQR 10-16). Median %TTL was 8.1% (IQR 4.3-12.5) and median FBgap was 17.4 mL/kg/day (IQR 8.2-30.4). In adjusted models, there was a significant positive relationship between FBgap and %TTL only in the subgroup with higher alarm frequency (6 + alarms per CRRT-day) (β = 0.87 per 1% increase, 95%CI 0.48-1.26). No association was found in the subgroups with lower alarm frequency (0-2 and 3-5 alarms). There was no statistical evidence for an association between %TTL and hospital mortality in the adjusted model with the interaction term of alarm frequency.

CONCLUSIONS: In critically ill adult patients undergoing CRRT, %TTL was associated with FBgap only in the subgroup with higher alarm frequency, but not in the other subgroups with lower alarms. No association between %TTL and mortality was observed. More frequent alarms, possibly indicating unexpected downtime, may suggest compromised CRRT delivery and could negatively impact FBgap.

PMID:39741337 | DOI:10.1186/s40560-024-00772-w