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Standard of Care (SOC) | All participants in the SOC clusters are able to access the nurse-led HIV prevention and treatment services at PHCs in the surveillance area. Standard services include HIV counselling and POCT, with immediate initiation of ART if positive, or PrEP if negative and eligible according to South African National PrEP guidel... | PMC10428543 | ||
Thetha Nami ngithethe nawe | adolescent- | The intervention is a tailored psychosocial support and social mobilisation into community-based SRH and differentiated HIV prevention, including PrEP and UTT. The intervention is provided by 90 (17 men, 73 women aged 18–30) area-based peer navigators and adolescent- and youth-friendly nurse-led SRH mobile clinics that... | PMC10428543 | |
SRH mobile clinic procedures | syphilis, adolescent-, gonorrhoea, chlamydia | HEPATITIS B, STIS, SYPHILIS, GONORRHOEA, ADVERSE EFFECTS | The SRH mobile clinics visit the intervention clusters every 2 weeks. The clinics deliver nurse-led HIV testing, prevention and care including adolescent- and youth-friendly, gender neutral, HIV status neutral, individualized risk assessments for HIV care and PrEP, integrated with SRH services (one stop shops). During ... | PMC10428543 |
Primary outcomes | HIV infection | HIV INFECTION | There are 3 co-primary outcomes: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention, in particular PrEP; 3) cost of transmissible HIV infection averted.We will measure transmissible HIV as the proportion of part... | PMC10428543 |
Secondary outcomes | HIV; mental health as measured by PHQ9, alcohol | Secondary outcomes of the trial include: access to sexual and reproductive health services; STI prevalence; HIV incidence (measured using recency assays); proportion of men and women aged 15–30 at risk of acquiring HIV or transmitting HIV; mental health as measured by PHQ9, alcohol and drug use; and socioeconomic outco... | PMC10428543 | |
Randomisation restriction | The 40 administrative areas were randomly allocated in a 1:1 ratio to early or delayed roll-out of the intervention. Randomisation was restricted to ensure that the trial sequences were reasonably balanced with respect to several key covariates that were thought to be associated with the outcome: the population size of... | PMC10428543 | ||
Randomisation and assignment of intervention | Peer navigators and other key stakeholders were invited to a public randomisation ceremony. The public ceremony ensured transparency and fairness in the randomisation and increased buy-in and engagement of the community. A random subset of 10,000 acceptable allocations was taken from those previously generated to use f... | PMC10428543 | ||
Blinding | BLIND | Investigators, statisticians, research assistants enrolling to the surveys, and laboratory staff will be blind to intervention assignment throughout. Participants, peer navigators and clinical teams cannot be blinded or masked. | PMC10428543 | |
Criteria for discontinuing or modifying allocated interventions | ADVERSE EFFECTS | In the intervention clusters, nurses and/or peer navigators will engage participants throughout the trial, and tailor their HIV prevention to their risk, including stopping and starting PrEP. Participants who experience adverse effects will be referred to a fixed PHC for care if necessary. If anyone seroconverts on PrE... | PMC10428543 | |
Strategies to improve adherence in the intervention clusters | All those who start PrEP, ART or contraception in the intervention clusters are offered peer navigator support as part of their individualized adherence plan and to support the refills and/or appointment scheduling and reminders. Neutral text message reminders are provided for participants who have access to private me... | PMC10428543 | ||
Outcome ascertainment | Data for outcome ascertainment are/will be collected from four sources: i) cross-sectional surveys of random samples of 15–30-year-olds who are resident in the 40 clusters; ii) programme, process, and clinical data; iii) qualitative data collected during the process evaluation; iv) records of resource utilisation (such... | PMC10428543 | ||
Cross-sectional surveys | For each cross-sectional survey, we will use the surveillance area as a sampling frame to randomly select a sample of young people stratified by sex. Our initial sample size calculations were based on sampling At each survey, the study team will visit the sampled individuals at their homes to give them information abou... | PMC10428543 | ||
Programme and process data | We will collect aggregate data on uptake and retention in the different components of the intervention in all young people aged 15–30 years who are resident in the 40 clusters (around 26,000). We will collect the programme data from the peer navigators’ participants-support management tools. Peer navigators use these t... | PMC10428543 | ||
Qualitative data | Qualitative data will be conducted by a team of research assistants and include in-depth interviews (IDI) with peer navigators ( | PMC10428543 | ||
Costing data | We will work closely with the Health Economics and Epidemiology Research Office to establish the costs of implementing the intervention. We will adapt data collection tools that we have used in previous peer-led trials to measure the costs of the peer navigator intervention to collect bottom-up ingredient-based costs [ | PMC10428543 | ||
Theory of change | It is envisaged that the intervention would reduce the burden of transmissible HIV amongst young people aged 15–30 through a reduced incidence of new cases of HIV and an increase in those with HIV who are virologically suppressed on ART. The Theory of Change (Fig. | PMC10428543 | ||
Sample size | HIV and 0.4 | DECAY | Data from our previous studies and the demographic surveillance suggested 8% of young people aged 15–30 have a transmissible HIV viral load (primary outcome 1), and around 35% are aware of their HIV status and either on PrEP or on ART with undetectable viral load (primary outcome 2). Our original design specified 2000 ... | PMC10428543 |
Data management | Data collected by the peer navigators and clinic staff will be captured electronically on tablets using REDCap software. Automatic checks for invalid values, internal inconsistency and implausible responses will be programmed into REDCap, and additional data validation checks will be run after data collection. Data fro... | PMC10428543 | ||
Statistical analysis | REGRESSION | To quantify the effect of the intervention on sexually transmissible HIV, we will fit a logistic regression model to data from all three survey waves to estimate the odds ratio (OR) and 95% confidence interval (CI), adjusting for design factors and survey wave, acknowledging the clustering of the data through generaliz... | PMC10428543 | |
In-depth interviews | Interviews will be based on a topic guide focusing on the experience and perceptions of the intervention. Interviews will be recorded and transcribed verbatim, with the permission of participants. Data from the IDIs will be managed for analysis using NVIVO software. The software will be used to manage categorization an... | PMC10428543 | ||
Adverse event reporting and harms | ADVERSE EVENTS, ADVERSE EVENT | This is an implementation study and all tests and drugs used are approved for clinical use in South Africa. All clinical care follows South African clinical guideline. The risk of harm is anticipated to be low. Adverse events (AEs) and serious adverse events (SAE) will be captured through the process evaluation, commun... | PMC10428543 | |
Ethics and trial oversight | We assert that all procedures contributing to this study comply with the ethical guidelines and standards of the relevant national and institutional committees on human experimentation and with the Declaration of Helsinki. Ethical approval has been obtained from the University of KwaZulu-Natal Biomedical Research Ethic... | PMC10428543 | ||
Discussion | ’ | The findings of this trial will inform the scale up of peer-led social mobilization into community-based sexual and reproductive health interventions optimized to support the uptake and retention of adolescents and young adults in long term HIV treatment, HIV pre-exposure prophylaxis and other prevention, and contracep... | PMC10428543 | |
Trial registration | NCT05405582 | PMC10428543 | ||
Acknowledgements | Sibonelo, Zethu, Mbali, Mfekayi, Nombuso Mtshali, Nompumelelo | The authors acknowledge the Thetha Nami ngithethe nawe implementation and research team including the research assistants (Mthobisi Zikhali, Sibongseni Xulu, Xolani Ngwenya, Zakhele Zikhali), clinical team (Funanai Shange, Hlengiwe Ncanana, Lethiwe Mlambo, Monsley Myeni, Ndumiso Vilane, Nokwazi Ntombela, Nolwazi Ngcobo... | PMC10428543 | |
Authors’ contributions | JJ | MS conceived the study. MS, AC, KB, NC, TZ, JD, CH, NO, JB, and JS designed the study. JB and MS wrote the first draft of the manuscript. JB, MS, AC, KB, LS, JS, SH, GH, JM, CH, NC, TZ, TS, and JJ read and critically revised the manuscript. All authors read and approved the final manuscript. | PMC10428543 | |
Funding | This trial was made possible through funding from Bill and Melinda Gates Foundation (INV-033650); US National Institute of Health (NIH) R01 (5R01MH114560-03); Africa Health Research Institute is the trial sponsor and is supported by core funding from the Wellcome Trust (Core grant number (082384/Z/07/Z). MS is an NIHR ... | PMC10428543 | ||
Availability of data and materials | Data sharing is not applicable to this article as no datasets are reported. However, following completion of the study all the datasets generated and/or analysed during the current trial will be made available in the AHRI repository at the time of publication of the primary outcome paper. Access to the datasets generat... | PMC10428543 | ||
Declarations | PMC10428543 | |||
Ethics approval and consent to participate | We assert that all procedures contributing to this study comply with the ethical guidelines and standards of the relevant national and institutional committees on human experimentation and with the Declaration of Helsinki. Ethical approval has been obtained from the University of KwaZulu-Natal Biomedical Research Ethic... | PMC10428543 | ||
Consent for publication | Not applicable. | PMC10428543 | ||
Competing interests | The authors declare no competing interests. | PMC10428543 | ||
References | PMC10428543 | |||
Introduction | dysphagia, palate, mastication and deglutition | DYSPHAGIA, POSTERIOR | The tongue heavily interacts with the hard and soft palate during speech production as well as mastication and deglutition, cooperating with the lips, mandible, pharynx, and larynx. Therefore, tongue function impairment negatively influences speech production, masticatory, and swallowing movements, leading to dysphagia... | PMC9968309 |
Methods | PMC9968309 | |||
Ethical considerations | This single-arm study was conducted per the Declaration of Helsinki of 1975, revised in 2013, and was approved by the Ethics Committee of the Tokyo Medical and Dental University (D2020-023). Written informed consent was obtained from all participants. | PMC9968309 | ||
Participants | dysphagia | DYSPHAGIA | Patients who visited a university dental hospital between September 2020 and September 2021 and had dysphagia were enrolled in this study. The inclusion criteria were as follows: (1) at least three of the six anterior teeth in the upper jaw remained, (2) at least two of the five molars on both the right and left sides ... | PMC9968309 |
Intervention | PMC9968309 | |||
Tongue right positioner | TONGUE | The TRP (Tongue Lab Japan, Kyoto, Japan), patented by Tongue Lab., Paris, France, was provided to all participants. It is a custom-made removable oral device consisting of a resin button and a transverse arch (Fig. | PMC9968309 | |
Outcome | SECONDARY | The outcome variables were assessed at the beginning of the study and at the 2-month follow-up visit. In this study, TP was the primary outcome, and the secondary outcomes were tongue and lip movement speed, peak nasal inspiratory flow (PNIF), and ultrasound assessment of swallowing-related muscles. | PMC9968309 | |
Measurement | dysphagia | DYSPHAGIA | The measurements were performed by dentists who belong to the department of dysphagia rehabilitation in a university hospital and are accustomed to using the measurement devices. Before the measurements, the dentists calibrated the usage of all measurement devices employed in this study. | PMC9968309 |
Tongue pressure | incisors, palate | TP was evaluated using a JMS tongue pressure measurement device (JMS Co. Ltd., Hiroshima, Japan). Participants in the sitting position were asked to place the balloon in their mouth and hold the plastic pipe with their upper and lower central incisors with their lips closed. A dentist held the probe in the correct posi... | PMC9968309 | |
Tongue and lip movement speed | The tongue and lip movements were evaluated using oral diadochokinesis (ODK). ODK was measured using the KENKO-KUN Handy, an oral function-measuring device (Takei Scientific Co., Ltd., Niigata, Japan). Participants were asked to pronounce a monosyllable as quickly as possible for 5 s. The device recorded the number of ... | PMC9968309 | ||
Ultrasonographic assessment of swallowing-related muscles | The cross-sectional area of the geniohyoid muscle (CSA of the GH) and the thickness of the tongue were evaluated using an ultrasonic measuring device (SonoSite M-turbo, Fujifilm, Tokyo, Japan) in B modeThe intraclass correlation coefficients (ICC) (1,1) and (2,1) were calculated to evaluate the reliability of the exami... | PMC9968309 | ||
Peak nasal inspiratory flow | A previous report | PMC9968309 | ||
Other measurements | dysphagia, DSS | DYSPHAGIA | The Barthel index (BI), the functional oral intake scale (FOIS) scores, and the dysphagia severity scale (DSS) of the participants were recorded. The BI is an index of daily living activities consisting of 10 questions, with scores between 0 and 100. A higher score was associated with a higher physical function | PMC9968309 |
Statistical analysis | The Shapiro–Wilk test was used to test the normality of all data, after which the paired | PMC9968309 | ||
Ethics approval | This single-arm study was conducted per the Declaration of Helsinki of 1964, revised in 2013, and was approved by the Ethics Committee of the Tokyo Medical and Dental University (D2020-023). | PMC9968309 | ||
Consent to participate | Written informed consent was obtained from all participants. | PMC9968309 | ||
Discussion | dysphagia, DSS | DYSPHAGIA, DISEASE, NEUROMUSCULAR DISEASES, DISEASES, CEREBRAL INFARCTION | The TRP was employed for patients with dysphagia for the first time, showing that TP increased after 2-month use. Interestingly, although three participants had progressive disease, TP increased. Therefore, the device can serve as a valuable tool for functional rehabilitation of the tongue in patients with such disease... | PMC9968309 |
Author contributions | All authors contributed to the study’s conception and design. Material preparation, data collection, and analysis were performed by R.Y., K.H., C.N., T.O., and A.S. The first draft of the manuscript was written by R.Y., and all authors commented on previous versions of the manuscript. All authors read and approved the ... | PMC9968309 | ||
Funding | TONGUE | Fifty percent of the cost for proofreading by Editage and article publishing charges were paid for by Tongue Lab Japan, Kyoto, Japan. In addition, eight tongue right positioner devices and one peak nasal inspiratory flow meter were provided by Tongue Lab Japan for this study. | PMC9968309 | |
Data availability | The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request. | PMC9968309 | ||
Competing interests | The authors declare no competing interests. | PMC9968309 | ||
References | PMC9968309 | |||
Background | Aphthous stomatitis | MUCOSAL DISEASE, DISEASE, MINOR, RECURRENT APHTHOUS STOMATITIS, APHTHOUS STOMATITIS | Aphthous stomatitis is one of the most common oral mucosal diseases. Due to the commonness of recurrent aphthous stomatitis and considering the anti-inflammatory, analgesic, and tissue regenerative properties of atorvastatin and the lack of a study on the effect of statins on minor recurrent aphthous stomatitis, this s... | PMC10182658 |
Methods | pain | This study is a randomized, double-blinded clinical trial. Patients were divided into two groups, atorvastatin and, placebo; each of the patients received three mucoadhesive tablets daily in the morning, noon, and night. Finally, the patients were examined on days 0 (baseline), 3, 5, and 7 to determine the diameter of ... | PMC10182658 | |
Results | pain | The halo diameter did not significantly differ between the two groups on baseline (P > 0.05). However, on the study’s third, fifth, and seventh days, the difference between the two groups was remarkable, so in the atorvastatin group, the size of the lesions decreased in shorter healing time (P < 0.05). In addition, the... | PMC10182658 | |
Conclusion | pain | MINOR, RECURRENT APHTHOUS STOMATITIS | Atorvastatin mucoadhesive tablets effectively reduce the pain of patients with minor recurrent aphthous stomatitis and reduce the size and healing time of the lesions, so their application should be considered in treating minor recurrent aphthous stomatitis. The present study was approved by the Medical Ethics Committe... | PMC10182658 |
Keywords | PMC10182658 | |||
Background | itching, burning, herpetic, inflammation, ulcerative, aphthous stomatitis, necrotic, pain, palate, cardiovascular problems, ulcer | RECURRENT APHTHOUS STOMATITIS, ULCER, HYPERLIPIDEMIA, INFLAMMATION, MINOR, ULCERATIVE, APHTHOUS STOMATITIS, ULCERS, NECROTIC, DISEASE, ADVERSE EFFECTS, ADHESION, RECURRENT APHTHOUS STOMATITIS, HYPERTENSION, APHTHOUS STOMATITIS, TYPE 2 DIABETES | Recurrent aphthous stomatitis (RAS) is an ulcerative and painful lesion with a prevalence of 5–60%, which can interfere with an individual’s nutrition, speech, and oral hygiene due to its painful nature, which in turn can affect the patient’s quality of life [Aphthous stomatitis is clinically divided into minor, major,... | PMC10182658 |
Methods | COMPLICATIONS | This randomized, double-blinded clinical trial was approved by the Medical Ethics Committee of Mazandaran University of Medical Sciences (Moral Code: IR.MAZUMS.REC.1400.8346).All patients received a sufficient explanation about the treatment process and possible complications; then signed a consent form before entering... | PMC10182658 | |
Participants and inclusion criteria | aphthous lesions, Behcet’s syndrome, stomatitis, urticaria, myopathy | MUSCULAR DISORDERS, STOMATITIS, LIVER FAILURE, MINOR, URTICARIA, SYNDROMES, RECURRENT APHTHOUS STOMATITIS, APHTHOUS ULCERS, MYOPATHY, SKIN AUTOIMMUNE DISEASE | According to the study conducted by Babaei et al. with the mean and standard deviation of the lesion diameter on the seventh day in the control group of 0.60 ± 0.69 and the intervention group of 1.29 ± 0.66 with a confidence level of 95%, a test power of 90%, and for the two-way test, by using the formula for comparing... | PMC10182658 |
Developing mucoadhesive tablets | Mucoadhesive tablets were produced in the laboratory of Mazandaran medical university (Faculty of pharmacy). 10-mg atorvastatin mucoadhesive tablets were prepared with different proportions of the medicine and bioadhesive polymers such as HPMC or CMC. Tablets were prepared by direct compression method after weighing an... | PMC10182658 | ||
Study protocol | aphthous, pain | In this study, the evaluator and all patients in both groups were blinded. The patients were informed to visit the dental clinic during the first 24 h after the occurrence of aphthous lesions, and their first visit was regarded as the baseline (day 0). During the initial visit, patients were firstly assured about the s... | PMC10182658 | |
Data analysis | pain | After completing the data and information collection, the acquired data was entered into SPSS 24 software. Then, quantitative variables were reported using the mean ± standard deviation. A Chi-square test was used to compare gender distribution between the two groups. The normal distribution of quantitative variables w... | PMC10182658 | |
Results | pain | This study was conducted as a double-blinded clinical trial. Somehow, 44 patients who met the inclusion criteria of the study were selected from those who were referred to the dental clinic of Mazandaran University of Medical Sciences (18 men and 26 women) and completed the treatment and study period. At the same time,... | PMC10182658 | |
Inflammatory halo diameter | pain | STILL | Based on Friedman’s test, an intra-group comparison of the results showed that halo diameter decreased significantly during the study period in both the intervention and control groups. Still, the intensity of the decrease was faster and more noticeable in the atorvastatin group (P = 0.000) (Table
comparison of halo d... | PMC10182658 |
Pain intensity | Pain, pain | Based on Friedman’s test results, intragroup comparison of patient pain intensity (VAS) showed a significant decrease from day one to seven in both intervention and control groups (P = 0.000) (Table In the inter-group comparison of pain intensity, no significant difference was found between the two groups on the first,... | PMC10182658 | |
Discussion | aphthous lesions, granuloma, bone loss, Tahamtan, trauma, inflammation, cancer, blood lipid disorders, periodontitis, arthritis, pain, aphthous, aphthous ulcers, ulcer, orthodontic, Alzheimer | GRANULOMA, BONE LOSS, ULCER, SECONDARY INFECTION, INFLAMMATION, DISEASES, CANCER, PERIODONTITIS, ARTHRITIS, EPITHELIALIZATION, CHRONIC PERIODONTITIS, PROLIFERATIVE, APHTHOUS ULCERS, CHRONIC INFLAMMATION, OXIDATIVE STRESS, ACUTE AND CHRONIC INFLAMMATION, PATHOGENESIS, ALZHEIMER | This study examined the effect of atorvastatin mucoadhesive tablets on the diameter of the inflammatory halo and the pain intensity of aphthous ulcers in patients. This study was conducted as a double-blinded clinical trial on 44 patients participating in the study (22 patients in the atorvastatin group and 22 patients... | PMC10182658 |
Conclusion | aphthous, pain | RECURRENCE, RECURRENT APHTHOUS STOMATITIS | The results of this study show that the atorvastatin mucoadhesive tablets effectively reduce the pain and discomfort of patients and cause the healing and size reduction of aphthous lesions. So these tablets may be effective in the treatment of patients with recurrent aphthous stomatitis due to their anti-inflammatory ... | PMC10182658 |
Acknowledgements | We would like to thank all participants who contributed to this study, the research center of Mazandaran University of Medical Sciences, and all who helped in the completion of this study. | PMC10182658 | ||
Funding | No funding resources were used in this research. | PMC10182658 | ||
Data availability | All data generated or analyzed during this study are included in this published article. | PMC10182658 | ||
Declarations | PMC10182658 | |||
Ethics approval and consent to participate | All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all subjects and/or their legal guardian(s).The present study was approved by the Medical Ethics Committee of Mazandaran University of Medical Sciences with the ethics code IR.MAZUMS.REC.1400.8346. Al... | PMC10182658 | ||
Consent for publication | Not applicable. | PMC10182658 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10182658 | ||
Abbreviations | Aphthous | Visual Analogue ScaleRecurrent Aphthous StomatitisGeneralized Estimated Equations | PMC10182658 | |
References | PMC10182658 | |||
Introduction | fractures, Cut-out | Cut-out is the most frequently reported mechanical failure of internal fixation of pertrochanteric fractures. The purpose of this study was to examine if hydroxyapatite-coated screw thread on a sliding hip screw (SHS) could reduce screw migration within the femoral head in patients with stable pertrochanteric fractures... | PMC10503211 | |
Materials and methods | fracture, pertrochanteric fracture | EVANS | In a double-blinded randomized controlled study, 37 patients at mean age 78 (range 56–96), with pertrochanteric fracture (Evans I, II, IV) received surgery with a SHS with a hydroxyapatite-coated or a non-coated lag screw thread. Radiostereometry and standard radiographs were obtained 1 day, 6 weeks, 3- and 6 months po... | PMC10503211 |
Results | There was similar and small screw migration in the femoral head between the two groups at 6 weeks, 3- and 6 months ( | PMC10503211 | ||
Conclusion | fracture, fractures | There was no clinical benefit of hydroxyapatite coating on lag screw migration in this patient cohort. Migration of the pertrochanteric fractures was higher with poor fracture reposition but fractures generally stabilized after 6 weeks follow-up. The study was registered at ClinicalTrials.gov (NCT05677061). | PMC10503211 | |
Highlights | fracture, fractures | FRACTURE COMPRESSION |
Hydroxyapatite coating on the screw thread did not improve screw fixation in the femoral head of a sliding hip screw in pertrochanteric fractures.Displacement of pertrochanteric fractures operated with a sliding hip screw was primarily a fracture compression across the screw axis.Pertrochanteric fractures operated wit... | PMC10503211 |
Keywords | PMC10503211 | |||
Introduction | femoral neck fractures, fracture, fractures | Hip fractures come at a high cost for the patient, the healthcare system, and for society [The failure rate of pertrochanteric fracture fixation has been reported from 2% and up to 20% [Radiostereometric analysis (RSA) have proven useful, accurate and precise for three-dimensional measurement of the displacement of fem... | PMC10503211 | |
Patients and methods | fracture | EVANS, WEST, MINOR, DETACHMENT | The study was designed as a double-blinded randomized clinical trial, with blinding for patients and outcome assessors but not to the surgeons. Between December 2008 and January 2013, 37 patients were enrolled having sustained a stable pertrochanteric fracture with an intact greater trochanter and lateral femoral wall,... | PMC10503211 |
Criteria | fracture, fractures | The inclusion criteria were: patients > 50 years of age admitted with a stabile pertrochanteric fracture, able to speak Danish and sign the written consent, and expected to be able to complete the postoperative controls. The exclusion criteria were: patients who were unable to follow the standard hip fracture regime, w... | PMC10503211 | |
Sample size | A power analysis was performed using the y-translation screw migration measure of the first 4 patients (pilot group) after 6 months follow-up. Expecting a 40% loss of fixation with NON-coated screws [ | PMC10503211 | ||
Implants | All patients received a 4-hole 135° SHS plate (HipLOC™, Biomet, Warsaw, IN, USA). All lag screws were marked preoperatively with 4 tantalum beads in a specific predetermined pattern (Fig. Sliding hip screw marked with 4 tantalum markers. | PMC10503211 | ||
Surgery | thrombosis, femoral head position | THROMBOSIS, BLOOD, AIDS | All surgeries were performed by or under direct supervision of an orthopedic surgeon. The procedure was performed under general anesthesia with the leg under traction using an approximately 10 cm lateral thigh incision and with the vastus lateralis muscle held anteriorly. A k-wire was placed using a 135° guide and fluo... | PMC10503211 |
Radiostereometric analysis | The first RSA recording was performed within 24 h after surgery and after the patient had been weight-bearing. A standard RSA system with 2 synchronized ceiling fixed roentgen tubes angled 40° towards each other and a uniplanar calibration box (Carbon Box 19, RSAcore, Leiden, The Netherlands) was used [RSA analysis was... | PMC10503211 | ||
RSA precision | The condition number (CN), describing the dispersion of the marker model, was mean 298 (SD 346) in the greater/lesser trochanter, mean 126 (SD 16) for the screw, and mean 120 (SD 61) for the head/neck segment. The rigid body error for marker stability was set at 0.35 mm. When accepting CN higher than 150, the verificat... | PMC10503211 | ||
Radiographic evaluation | fracture | EVANS | An experienced surgeon classified the pertrochanteric fracture according to Evans classification [ | PMC10503211 |
Patient reported and clinical outcomes | fracture, NMS | NMS | Patient evaluation was performed pre-operatively asking patients to recall their status before the fracture self-reported mobility level with new mobility score (NMS) (0–9 points) [ | PMC10503211 |
Statistics | fracture | IMPACTION | Normality of the data distribution was assessed by probability plots. Data following a normal distribution was reported with 95% confidence intervals (CI 95%) and data with non-normal distribution was reported as median values with interquartile range (IQR). Hypotheses of no difference for clinical, patient reported, a... | PMC10503211 |
Ethics, registration and funding | MAY | The study was approved by the Danish National Scientific Committee on Research Ethics (H-KF-298036, issue date May 3rd, 2006) and Data Protection Agency (2008-41-2757, issue date March 3rd, 2006) and was performed in agreement with the Helsinki ll declaration. The study was registered at ClinicalTrials.gov (NCT05677061... | PMC10503211 | |
Results | PMC10503211 | |||
Demographics | The consort study flowchart and the baseline patient demographics are shown in Fig. Demographics at baselineASA score: American Society of Anesthesiology physical classification score system, | PMC10503211 |
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