BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).

Introduction Diverse musculo-skeletal pathology can be treated conservatively by different types of injections and in most cases, results are significantly better if the existing inflammatory fluid is aspirated prior to injection of medication solutions. The present study analyses an original technique which uses infusion therapy accessories to create two types of closed sterile double syringe systems, and compares the benefits of using such a system in aspiration/injection procedures to classic aspiration injection technique that implies changing and connecting multiple syringes to the same needle, thus increasing the risk for septic complications. The aim of the present study is to minimize therapeutic risk of iatrogenic septic complications during aspiration/injection procedures. Methods 1024 patients underwent aspiration/injection procedures in our clinic using the double syringe system between 2015 and 2020. During the early stages of the study, the second type of assembly was rendered impractical so the study continued with analyzing a single type of double syringe system using a three way infusion therapy device which is readily available, and allows the assembly of a closed sterile system with a single, two-step procedure technique. Iatrogenic local septic complications were followed by means of a six week clinical follow-up evaluation with additional investigations only if necessary. Results In 1024 procedures we report 0% incidence of iatrogenic septic complications, or other types of complications and recommend this technique in a vast array of rheumatic, orthopedic or traumatic conditions that require aspiration/injection procedures. Discussion The double syringe system is practical, easy to use, it completely eliminates the risk of iatrogenic infection due to manipulation errors, and significantly simplifies the technique for sonography guided aspiration/injection procedures for musculo-skeletal pathology.