AIMS: This project aimed to improve physicians' adherence to evidence-based practices regarding the selection and administration of intra-articular knee injections for patients with osteoarthritis. The project also aimed to empower patients by increasing their awareness of these evidence-based practices. INTRODUCTION: In the management of knee osteoarthritis, intra-articular injections are commonly used when initial treatments prove inadequate. However, issues such as patients' demand for rapid relief and variability in physicians' familiarity with optimal practices often lead to suboptimal treatment decisions and potential adverse outcomes. METHODS: This project followed the JBI Evidence Implementation Framework, which is grounded in an audit, feedback, and re-audit process. Initially, physicians were surveyed on the topic under consideration, and hospital records were reviewed. Subsequently, targeted interventions were implemented, including briefings and the distribution of informative flyers. RESULTS: The baseline audit indicated low adherence with all audit criteria. Various parameters, such as adherence to best clinical practices, informed decision-making by patients, and the recommendation of alternative treatment modalities, were significantly lacking. Following the interventions, substantial improvements were observed, including higher rates of adherence to best clinical practices by physicians for multiple criteria, such as stepwise referral to conservative therapy options and the content of intra-articular injections. CONCLUSIONS: Adherence to best clinical practices can be improved through educational briefings for physicians on the most current evidence-based treatment practices for injectable substances in knee osteoarthritis. The active engagement of patients, facilitated by informative flyers and physician assistance, contributed to better involvement in their treatment choices. However, the participation of health care institutions and providers as well as lifelong education practices may be necessary for more comprehensive and sustainable changes. SPANISH ABSTRACT: http://links.lww.com/IJEBH/A277.
- MeSH
- artróza kolenních kloubů * farmakoterapie MeSH
- dodržování směrnic * MeSH
- injekce intraartikulární MeSH
- lékařská praxe - způsoby provádění statistika a číselné údaje MeSH
- lékařská praxe založená na důkazech MeSH
- lidé MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Corticosteroids are among the few effective treatments for knee osteoarthritis, but short duration of action limits their utility. EP-104IAR, a long-acting formulation of fluticasone propionate for intra-articular injection, optimises the action of fluticasone propionate through novel diffusion-based extended-release technology. The SPRINGBOARD trial assessed the efficacy, safety, and pharmacokinetics of EP-104IAR in people with knee osteoarthritis. METHODS: SPRINGBOARD was a randomised, vehicle-controlled, double-blind, phase 2 trial done at 12 research sites in Denmark, Poland, and Czech Republic. We recruited adults aged 40 years or older with primary knee osteoarthritis (Kellgren-Lawrence grade 2-3) who reported Western Ontario and McMaster Universities Osteoarthritis Arthritis Index (WOMAC) pain scores of at least 4 and no more than 9 out of 10. Participants were randomly assigned (1:1) to receive one intra-articular dose of 25 mg EP-104IAR or vehicle control. Randomisation was done via interactive web-based access to a central predefined computer-generated list with block size of six (allocated by clinical site). Participants and assessors were masked to treatment allocation. Participants were followed up for 24 weeks. The primary outcome was the difference between groups in change in WOMAC pain score from baseline to week 12, analysed in all participants who were randomly assigned and received treatment. Safety, including laboratory analyses, and pharmacokinetics from quantification of fluticasone propionate in peripheral blood were assessed in all participants who received a dose of randomly assigned treatment. A person with lived experience of knee osteoarthritis was involved in study interpretation and writing of the report. This trial is registered with ClinicalTrials.gov, NCT04120402, and the EU Clinical Trials Register, EudraCT 2021-000859-39, and is complete. FINDINGS: Between Sept 10, 2021, and Nov 16, 2022, 1294 people were screened for eligibility, and 319 were randomly assigned to EP-104IAR (n=164) or vehicle control (n=155). One participant in the EP-104IAR group was excluded from all analyses because treatment was not administered due to an adverse event. 318 participants (135 [42%] male and 183 [58%] female, 315 [99%] White) received randomly assigned treatment and were included in the primary analysis and safety analysis (EP-104IAR, n=163; vehicle control, n=155). At week 12, least squares mean change in WOMAC pain score from baseline was -2·89 (95% CI -3·22 to -2·56) in the EP-104IAR group and -2·23 (-2·56 to -1·89) in the vehicle control group, with a between-group difference of -0·66 (-1·11 to -0·21; p=0·0044); a significant between-group difference persisted to week 14. 106 (65%) of 163 participants in the EP-104IAR group had one or more treatment-emergent adverse event compared with 89 (57%) of 155 participants in the vehicle control group. Effects on serum glucose and cortisol concentrations were minimal and transient. There were no treatment-emergent deaths or treatment-related serious adverse events. Plasma concentrations of fluticasone propionate showed a blunted initial peak with terminal half-life of approximately 18-20 weeks. INTERPRETATION: These phase 2 results suggest that EP-104IAR has the potential to offer clinically meaningful pain relief in knee osteoarthritis for an extended period of up to 14 weeks, longer than published data for currently marketed corticosteroids. There were minimal effects on glucose and cortisol, and stable fluticasone propionate concentrations in plasma. The safety and efficacy of EP-104IAR will be further evaluated in phase 3 trials, including the possibility of bilateral and repeat dosing with EP-104IAR. FUNDING: Eupraxia Pharmaceuticals. TRANSLATION: For the Danish translation of the abstract see Supplementary Materials section.
- MeSH
- artróza kolenních kloubů * farmakoterapie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- flutikason * aplikace a dávkování farmakokinetika terapeutické užití škodlivé účinky MeSH
- injekce intraartikulární MeSH
- léky s prodlouženým účinkem MeSH
- lidé středního věku MeSH
- lidé MeSH
- měření bolesti MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Česká republika MeSH
- Dánsko MeSH
- Polsko MeSH
PURPOSE OF THE STUDY: Our aim was to compare the effects of intraarticular and intravenous (IV) tranexemic acid (TXA) application on bleeding and complication rates in patients who underwent total knee arthroplasty (TKA). MATERIAL AND METHODS: Between 2017 and 2021, 406 patients who underwent TKA with 2 g of IV TXA and retrograde 1.5 g of TXA applied through the drain were included in the study. Of the patients, 206 were in the IV TXA group. Preoperative and postoperative hemoglobin levels, drain output, BMI, ASA score, blood loss, and the number of transfused patients were recorded. Complications such as symptomatic venous thromboembolism were also recorded. RESULTS: There was no significant difference between the two groups in terms of age, sex, American Society of Anesthesiologists (ASA) score, or BMI (p = 0.68, 0.54, 0.28, 0.45). Total drain output and blood loss were significantly higher in the IV TXA group than in the intraarticular TXA group (p < 0.0001, p < 0.0001). Eighteen patients in the IV TXA group and 1 patient in the intraarticular TXA group received a blood transfusion (p < 0.0001). There was no difference between the two groups in terms of preoperative hemoglobin or platelet count (p = 0.24). However, postoperative hemoglobin level was higher in the patients who received intraarticular TXA (p=0.0005). More thromboembolism events were seen in the IV TXA group (p < 0.0001). CONCLUSIONS: Intraarticular TXA application reduces blood loss more than IV application, reduces the blood transfusion rate, and causes fewer complications. KEY WORDS: tranexemic acid, total knee arthroplasty, intraarticular injection, blood loss, blood transfusion.
- MeSH
- antifibrinolytika * aplikace a dávkování MeSH
- injekce intraartikulární MeSH
- intravenózní podání MeSH
- konstrikce MeSH
- krevní transfuze statistika a číselné údaje MeSH
- krvácení při operaci * prevence a kontrola MeSH
- kyselina tranexamová * aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační krvácení prevence a kontrola etiologie MeSH
- retrospektivní studie MeSH
- senioři MeSH
- totální endoprotéza kolene * metody škodlivé účinky MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
- Klíčová slova
- ChondroGrid, MD přípravky,
- MeSH
- injekce intraartikulární * MeSH
- kolagen * aplikace a dávkování farmakologie terapeutické užití MeSH
- lidé MeSH
- osteoartróza * farmakoterapie klasifikace patofyziologie MeSH
- výchova a vzdělávání metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- zprávy MeSH
- Klíčová slova
- ChondroGrid,
- MeSH
- injekce intraartikulární metody MeSH
- klinická studie jako téma MeSH
- kolagen * aplikace a dávkování farmakologie terapeutické užití MeSH
- lidé MeSH
- rotátorová manžeta * patofyziologie MeSH
- tendinopatie * etiologie farmakoterapie patologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Geografické názvy
- Itálie MeSH
10 stran : ilustrace ; 27 cm
Publikace se zaměřuje na injekční kolagenovou terapii gonartrózy. Určeno odborné veřejnosti.
- Konspekt
- Farmacie. Farmakologie
- NLK Obory
- farmacie a farmakologie
- ortopedie
PURPOSE OF THE STUDY: Hip osteoarthritis (OA) has a prevalence of around 6.4% and is the second most commonly affected joint. This review aims to assess the clinical outcomes of intra-articular high molecular weight hyaluronic acid (HMWHA) in the management of hip osteoarthritis. MATERIAL AND METHODS: We conducted a comprehensive search across PubMed, Google Scholar, and the Cochrane Library for randomised trials investigating the effectiveness of high molecular weight hyaluronic acid (HMWHA) in the treatment of hip osteoarthritis. Quality and risk of bias assessments were performed using the Cochrane RoB2 tool. To synthesise the data, we utilised the Standardised Mean Difference (SMD) for assessing pain relief through the Visual Analogue Scale (VAS) and the Lequesne index (LI) for evaluating functional outcomes. Risk Ratio (RR) was calculated to assess the occurrence of complications. RESULTS: A total of four studies involving HMWHA and control groups were included. The standardised mean difference (SMD) for the Visual Analogue Scale (VAS) (SMD -0.056; 95% CI; -0.351, 0.239; p = 0.709) and the Lequesne index (SMD -0.114; 95% CI; -0.524, 0.296; p = 0.585) were not statistically significant. Analysis for complications demonstrated an overall relative risk ratio (RR) of 0.879 (95% CI; 0.527, 1.466; p = 0.622), and was not statistically significant. DISCUSSION AND CONCLUSIONS: Intra-articular HMWHA in hip OA can significantly reduce pain and improve functional recovery when compared with the condition before treatment. However, there is no significant difference between HMWHA, or saline, or other therapeutic treatments. Currently, available evidence indicates that intra-articular HMWHA in hip OA would not increase the risk of adverse events. KEY WORDS: hip osteoarthritis, hyaluronic acid, intra-articular, molecular weight, viscosupplementation.
- MeSH
- artróza kyčelních kloubů * farmakoterapie komplikace MeSH
- injekce intraartikulární MeSH
- kyselina hyaluronová * terapeutické užití škodlivé účinky MeSH
- lidé MeSH
- měření bolesti MeSH
- molekulová hmotnost MeSH
- randomizované kontrolované studie jako téma * MeSH
- viskosuplementace * metody MeSH
- viskosuplementy * aplikace a dávkování terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- systematický přehled MeSH
- Klíčová slova
- sysadoa,
- MeSH
- antiflogistika nesteroidní aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- hormony kůry nadledvin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- kolagen aplikace a dávkování terapeutické užití MeSH
- konzervativní terapie MeSH
- kyselina hyaluronová aplikace a dávkování terapeutické užití MeSH
- lidé MeSH
- osteoartróza * diagnóza patofyziologie terapie MeSH
- plazma bohatá na destičky MeSH
- rehabilitace MeSH
- viskosuplementace MeSH
- Check Tag
- lidé MeSH
OBJECTIVE: Injection of the tibiotalar (TT) joint is commonly performed in clinical practice under ultrasound (US) guidance using an anteromedial approach. However, in some patients, this approach may be technically challenging due to post-traumatic and/or degenerative bony changes. Therefore, the aim of this cadaveric investigation was to demonstrate the feasibility of the ultrasound-guided (USG) injection of the ankle joint via the anterolateral sulcus (ALS) by confirming the dye placement/distribution inside the articular space. Likewise, the safety of the procedure has also been evaluated by measuring the distance between the needle and the intermediate dorsal cutaneous nerve of the foot. DESIGN: A descriptive laboratory study with eight embalmed cadaveric ankles using the Fix for Life (F4L) method was performed at the setting of an academic institution. The interventional technique and the related anatomical findings were illustrated. During the injection, the needle was advanced into the TT joint through the ALS under US guidance, i.e., in-plane anterior-to-posterior approach. With the objective to confirm its correct placement, the needle was kept in situ and-to demonstrate the location of the dye inside the articular space-all eight ankles were injected with 3 mL of green color dye. Thereafter, a layer-by-layer anatomical dissection was performed on all four cadavers. RESULTS: The position of the needle's tip within the ALS was confirmed in all specimens. Accurate placement of the dye inside the articular space of the ankle was confirmed in seven of the eight cadaveric ankles, with 87.5% of accuracy. Herewith, unintentional spilling of the dye within the superficial soft tissues was reported in two of the eight ankles (25.0%). The mean distance between the needle and the intermediate dorsal cutaneous nerve of the foot, measured in all eight procedures, was 3 cm. CONCLUSION: USG injection of the ALS using the in-plane, anterior-to-posterior approach can accurately place the injectate inside the articular space. CLINICAL RELEVANCE: This cadaveric investigation described the accuracy and potential pitfalls of USG injection of the ankle via the anterolateral approach which represents an alternative technique in patients with reduced accessibility of the anteromedial recess due to degenerative and/or post-traumatic bony changes.
- MeSH
- hlezenní kloub * diagnostické zobrazování MeSH
- injekce intraartikulární metody MeSH
- intervenční ultrasonografie metody MeSH
- lidé MeSH
- mrtvola MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH