Background. In Japan, idiopathic osteonecrosis of the femoral head (ONFH) is designated as a specified rare and intractable disease in patients for whom medical care is subsidized through the Specified Disease Treatment Research Program. Each patient is approved for the subsidy based upon a prefectural governmental review after filing an application together with a
Using serial CT scans, this project aims to develop a
Most long-term follow-up studies report retrospective data, the quality of which remains limited due to their inherent biases. Prospective databases may overcome these limitations, however, feasibility and costs limit their application. To date there exists a paucity of evidence-based literature on which recommendations can be made for the ideal length of follow-up for spinal deformity research. Therefore, our aim was to evaluate the added value of follow-up of patients beyond 2 years following surgery for AIS. A database registry evaluating surgical outcomes for all consecutive AIS patients with post-op data-points of 6 months, 1 year, 2 year, and 5 year was analysed. Surgeon-reported complications, SRS-22 scores, and radiographic data were evaluated. Complications requiring surgical or medical intervention were compared between patients in whom complications developed within 2 years to those in which newly developed complications occurred between >2–5 years. 536 patients were analysed. SRS-22 scores significantly improved at 2 years post-op with no change at 5-year follow-up. Overall complication rate was 33.2% with majority occurring within 2 years (24.8%). The rate of complications occurring >2–5 years requiring intervention was significantly lower than those requiring intervention within 2 years of surgery (4.7% vs 9.7%, p=0.000), however was not negligible. The most common newly observed complication beyond 2 years was pain (1.9%), followed by surgical site infection (SSI) (1.3%) and implant issues (0.56%). There were no significant differences in the rates of crankshaft (p=0.48), implant issues (p=0.56), pseudarthrosis (p=0.19), and SSI (p=0.13) between the 2 time points. Although majority of complications following AIS surgery occurs within 2 years, a non-negligible rate of newly observed complications occur at >2–5 years post-op. Specifically crankshaft, pseudarthrosis, implant issues, and SSI have similar rates of occurrence at these 2 time points.
Aims. The follow-up interval of a study represents an important aspect that is frequently mentioned in the title of the manuscript. Authors arbitrarily define whether the follow-up of their study is short-, mid-, or long-term. There is no clear consensus in that regard and definitions show a large range of variation. It was therefore the aim of this study to systematically identify
While STS as a group represent a significant portion of all solid tumors in childhood, individual histologic entities are rare due to their extreme heterogeneity. This represents the principal obstacle to clinical trials. A compromise between clinical vs. statistical precision has been necessary in the majority of clinical trials on STS resulting in contradictory conclusions. Clinical trials have to reduce uncertainty but trials, which overlook clinical heterogeneity can even contribute to it. An example is many clinical trials, which have been carried out in the recent decades to answer the question of the role of adjuvant chemotherapy in “Non-RMS-STS”. Majority of these trials have overlooked clinically relevant subgroups. The result is that we still do not have certainty whether and which adjuvant chemotherapy is beneficial. In addition, most clinical trials of treatments for STS rely on the endpoints of survival or event-free survival, so results have taken years to accrue and even longer to report. However, in STS with well defined genetic abnormalities and strong preclinical rationale for activity of a molecular targeted therapy the demonstration of clinical activity in only a few cases might be sufficient. In dermatofibrosarcoma protuberans, a very rare entity, the demonstration of clinical activity of the molecular targeted therapy was very convincing and led to approval of the drug, although the number of cases was very low. International collaboration is necessary to obtain a sufficient number of patients but participation of many different centers with different expertise for a given rare tumor may compromise the quality of patient’s care. It is also difficult for many pediatric departments to open and maintain large numbers of trials with low accrual rates. In conclusion, new methods for
In fractures of proximal humerus, stable fixation of osteoporotic bone fragments poses a significant problem, and wide surgical approach causes damage to blood supply of the humeral head, and to synovial bursae of the shoulder and tendons. These problems cause further permanent unfavourable changes in the shoulder. The least invasive surgical treatment is the percutaneous multi-plane fixation with a bundle of Kirschner wires monitored with fluoroscopy. Stability of these fixations and fixations by tension band, screws and Rush pins were examined in anatomical specimens of porcine humeri and in clinical evaluation. Experimental research concerned the primary stabilisation of various types of Kirschner wires inserted to the proximal part of a porcine humerus, later pulled out using a tensile testing machine, and fixations of 2-part fractures of a porcine proximal humerus fixed with Kirschner wires (various types), tension band, screws and Rush pins. The fixed bones were next torn apart with the same tensile testing machine to examine the strength of the junction. One type of Kirschner wires was designed by us. This type provided the maximum initial strength in the bone and maximum fixation strength, and was next used in surgical treatment of 21 proximal humerus fractures estimated as 2- and 3-part fractures in Neer classification. Follow-up covered a period from 18 months to 10 years. Results were estimated with Neer criteria. Reference comparison group was 50 patients, treated with different methods. Most of the very good and good results (86%) were obtained by fixation with the Kirschner wires of our design. These wires were threaded all over the part which entered the bone.
The presentation is based on the results of the nursing intervention program by using telephone contact to elderly patients with hip replacement after discharge.
To establish the utility of adding the laboratory-based synovial alpha-defensin immunoassay to the traditional diagnostic work-up of a prosthetic joint infection (PJI). A group of four physicians evaluated 158 consecutive patients who were worked up for PJI, of which 94 underwent revision arthroplasty. Each physician reviewed the diagnostic data and decided on the presence of PJI according to the 2014 Musculoskeletal Infection Society (MSIS) criteria (yes, no, or undetermined). Their initial randomized review of the available data before or after surgery was blinded to each alpha-defensin result and a subsequent randomized review was conducted with each result. Multilevel logistic regression analysis assessed the effect of having the alpha-defensin result on the ability to diagnose PJI. Alpha-defensin was correlated to the number of synovial white blood cells (WBCs) and percentage of polymorphonuclear cells (%PMN).Aims
Methods
Traditionally, informed consent for clinical
research involves the patient reading an approved Participant Information
Sheet, considering the information presented and having as much time
as they need to discuss the study information with their friends
and relatives, their clinical care and the research teams. This
system works well in the ‘planned’ or ‘elective’ setting. But what
happens if the patient requires urgent treatment for an injury or emergency? This article reviews the legal framework which governs informed
consent in the emergency setting, discusses how the approach taken
may vary according to the details of the emergency and the treatment
required, and reports on the patients’ view of providing consent
following a serious injury. We then provide some practical tips
for managing the process of informed consent in the context of injuries
and emergencies. Cite this article:
The aim was to examine the descriptive epidemiology of Slipped Capital Femoral Epiphysis, with respect to geography and time. We extracted all children with a diagnosis of Slipped Capital Femoral Epiphysis from the
Aims. The aim of this study was to develop a core outcome set of what to measure in all future
Aims. Preprint servers allow authors to publish full-text manuscripts or interim findings prior to undergoing peer review. Several preprint servers have extended their services to biological sciences,
The interleukin-6/gp130-associated Janus Kinases/STAT3 axis is known to play an important role in mediating inflammatory signals, resulting in production of matrix metalloproteinase-3 (MMP-3). The hip joints with rapidly destructive coxopathy (RDC) demonstrate rapid chondrolysis, probably by increased production of MMP-3 observed in the early stage of RDC. In the recent study, no apparent activation of STAT3 has been shown in the synovial tissues obtained from the osteoarthritic joint at operation. However, no data are currently available on STAT3 activation in the synovial tissues in the early stage of RDC. This study aimed to elucidate STAT3 activation in the synovial tissues in the early stage of RDC. Synovial tissues within 7 months from the disease onset were obtained from four RDC patients with femoral head destruction and high serum levels of MMP-3. RDC synovial tissues showed the synovial lining hyperplasia with an increase of CD68-positive macrophages and CD3-positive T lymphocytes. STAT3 phosphorylation was found in the synovial tissues by immunohistochemistry using anti-phospho-STAT3 antibody. The majority of phospho-STAT3-positive cells were the synovial lining cells and exhibited negative expression of macrophage or T cell marker. Treatment with tofacitinib, a Janus Kinase inhibitor, resulted in a decrease in phospho-STAT3-positive cells, especially with high intensity, indicating effective suppression of STAT3 activation in RDC synovial tissues. Inhibitory effect of tofacitinib could act through the Janus Kinase/STAT3 axis in the synovial tissues in the early stage of RDC. Therefore, STAT3 may be a potential therapeutic target for prevention of joint structural damage in RDC. Acknowledgements: This study was supported by Katakami Foundation for
Osteosarcoma is a highly malignant primary tumor of bone tissue. The 5-year survival rate of patients with metastasis is below 20% and this scenario is unchanged in the last two decades, despite great efforts in pre-clinical and
Low back pain (LBP) is the main cause of disability worldwide and is primarily triggered by intervertebral disc degeneration (IDD). Although several treatment options exist, no therapeutic tool has demonstrated to halt the progressive course of IDD. Therefore, several clinical trials are being conducted to investigate different strategies to regenerate the intervertebral disc, with numerous studies not reaching completion nor being published. The aim of this study was to analyze the publication status of clinical trials on novel regenerative treatments for IDD by funding source and identify critical obstacles preventing their conclusion. Prospective clinical trials investigating regenerative treatments for IDD and registered on . ClinicalTrials.gov. were included. Primary outcomes were publication status and investigational treatment funding. Fisher's exact test was utilized to test the association for categorical variables between groups. 25 clinical trials were identified. Among these, only 6 (24%) have been published. The most common source of funding was university (52%), followed by industry (36%) and private companies (12%). Investigational treatments included autologous (56%) or allogeneic (12%) products alone or in combination with a carrier or delivery system (32%). The latter were more likely utilized in industry or privately funded studies (Fig. 1, p=0.0112). No significant difference was found in terms of funding regarding the publication status of included trials (Table 1, p=0.9104). Most clinical trials investigating regenerative approaches for the treatment of IDD were never completed nor published. This is likely due to multiple factors, including difficult enrollment, high dropout rate, and publication bias. 3. More accurate design and technical support from stakeholders and
Objectives. Open fracture classification systems are limited in their use. Our objective was to classify open tibia and femur fractures using the OTS classification system in a region with high incidence of gunshot fractures. One hundred and thirty-seven patients with diaphyseal tibia and femur open fractures were identified from a prospectively collected cohort of patients. This database contained all cases (closed and open fractures) of tibial and femoral intramedullary nailed patients older than 18 years old during the period of September 2017 to May 2021. Exclusion criteria included closed fractures, non-viable limbs, open fractures > 48 hours to first surgical debridement and patients unable to follow up over a period of 12 months (a total of 24). Open fractures captured and classified in the HOST study using the Gustilo-Anderson classification, were reviewed and reclassified using the OTS open fracture classification system, analysing gunshot fractures in particular. Ninety percent were males with a mean age of 34. Most common mechanism was civilian gunshot wounds (gsw) in 54.7% of cases. In 52.6% of cases soft tissue management was healing via secondary intention, these not encompassed in the classification. Fracture classification was OTS Simple in 23.4%, Complex B in 24.1% and 52.6% of cases unclassified. The OTS classification system was not comprehensive in the classification of open tibia and femur fractures in a setting of high incidence of gunshot fractures. An amendment has been proposed to alter acute management to appropriate wound care and to subcategorise Simple into A and B subdivisions; no soft tissue intervention and primary closure respectively. This will render the OTS classification system more inclusive to all open fractures of all causes with the potential to better guide patient care and
Aims. The extended wait that most patients are now experiencing for hip and knee arthroplasty has raised questions about whether reliance on waiting time as the primary driver for prioritization is ethical, and if other additional factors should be included in determining surgical priority. Our Prioritization of THose aWaiting hip and knee ArthroplastY (PATHWAY) project will explore which perioperative factors are important to consider when prioritizing those on the waiting list for hip and knee arthroplasty, and how these factors should be weighted. The final product will include a weighted benefit score that can be used to aid in surgical prioritization for those awaiting elective primary hip and knee arthroplasty. Methods. There will be two linked work packages focusing on opinion from key stakeholders (patients and surgeons). First, an online modified Delphi process to determine a consensus set of factors that should be involved in patient prioritization. This will be performed using standard Delphi methodology consisting of multiple rounds where following initial individual rating there is feedback, discussion, and further recommendations undertaken towards eventual consensus. The second stage will then consist of a Discrete Choice Experiment (DCE) to allow for priority setting of the factors derived from the Delphi through elicitation of weighted benefit scores. The DCE consists of several choice tasks designed to elicit stakeholder preference regarding included attributes (factors). Results. The study is co-funded by the University of Aberdeen Knowledge Exchange Commission (Ref CF10693-29) and a Chief Scientist Office (CSO) Scotland