Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. It is also characterized by a decrease of the concentration and molecular weight of the hyaluronic acid in the synovial fluid which ultimately leads to poor viscoelastic properties of synovial fluid and induction of proinflammatory pathways. The intra-articular injection of viscosupplementation gel (mainly exogenous hyaluronic acid) represents one of the most used therapeutic strategies to treat osteoarthritis symptoms. Several studies on knee Osteoarthritis, have shown that one or more weekly injection of viscosupplementation gel significantly relieves articular pain and ameliorates mobility and joint function for at least 6 months and more. Repeated courses of intra-articular injections are an effective and safe treatment for knee osteoarthritis symptoms. Based on studies conducted on intra-articular viscosupplementation gels, the most common side effects expected are local transient and short-lived adverse events such as pain, swelling and arthralgia in the site of administration, which are fully reversible in the days following the injection. Furthermore, such local effects may occur in a minority of cases and are usually treated conservatively with ice, non-steroidal anti-inflammatory drugs, and relative rest.
The study is a pilot, prospective, multicenter, clinical trial that aims to evaluate the safety and efficacy of ABIO3419 for the treatment of knee osteoarthrosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intra-articular injection
Knohenfelds
Riga, Riga, Latvia
KRASTINS
Riga, Riga, Latvia
Incidence of adverse device effects related to ABIO34199 treatment [tolerability] at 3 months
Assessment by the investigators of the occurrence of adverse device effects related to ABIO3419 from the first injection up to the 3-month follow-up
Time frame: Month 3 after the last injection
Incidence of Treatment-Emergent Adverse Events [Safety]
Collection of Adverse Event assessed and recorded by investigators.
Time frame: Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection
Evaluation of the pain of the treated knee when walking on a flat ground.
Assessment by the patient itself of the pain compared to baseline (before initial injection) using a 0-100mm Visual Analogue Scale (0 corresponds to no pain and 100 corresponds to the highest pain that can be felt).
Time frame: Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.
Device related complication rates
Assessment of the proportion of patient with at least one adverse device effect related to ABIO3419 at each time visits
Time frame: Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection
General health status of the treated knee
Assessment by the patient itself of the target-knee functional status using the Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS holds 42 items in 5 separately scored subscales: Pain (nine items); Symptoms (seven items); Function in daily living (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A 5-grade Likert scale is used for all items scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.
Concomitant analgesic consumption
Assessment by the patient of the average weekly consumption (number and dosage) of paracetamol and pain killer drugs using a daily diary.
Time frame: 1 week before the first injection, 1 week and 2 weeks after the first injection then 2 weeks, 1 month and 3 months after the last injection.
Implant card readability
Assessment of the patient of the reading and understanding of the ABIO3419 implant card using a questionnaire on which the text present on the implant card must be identified and reported on the questionnaire.
Time frame: Day 0 (after first injection)
Investigator Global satisfaction
Assessement by the investigator of the handling of the ABIO3419 device with a Usability questionnaire after the third injection with four response possibilities for each item: Very satisfied / Satisfied / Neutral / Not satisfied.
Time frame: Week 2 after first injection
Investigator Global satisfaction
Assessement by the investigator of the overall satisfaction with a satisfaction questionnaire at 6 months with four response possibilities for each item: Very satisfied / Satisfied / Neutral / Not satisfied.
Time frame: Month 6
Patient Global satisfaction
Assessement by the patient of the overall satisfaction with a satisfaction questionnaire at 6 months with four response possibilities for each item: Very satisfied / Satisfied / Neutral / Not satisfied.
Time frame: month 6
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