About this trial
HA therapy typically consists of several intra-articular injections administered at weekly intervals. A single-dose IA-HA treatment offers patients and physicians a treatment option that involves both lower costs and fewer clinic visits. Furthermore, considering the administration procedure, we believe that single-dose therapy helps reduce the risk of potential side effects.
In light of this information, our study aims to retrospectively evaluate the efficacy and safety of HA in patients with symptomatic knee OA who have received a single-dose intra-articular HA injection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who have provided written informed consent.
Male and female participants aged 40 to 70.
Bilateral or unilateral, painful, primary knee osteoarthritis.
Knee pain lasting at least 4 weeks while standing, walking, and/or moving, and the presence of at least one of the following features on an X-ray taken within the last 3 months: tibiofemoral osteophytes, femoral or tibial endplate osteosclerosis, or narrowing of the joint space (Kellgren-Lawrence grade 2-3).
Disqualifiers
Participants hospitalized in the hospital.
Participants with inflammatory knee conditions other than OA (e.g., rheumatoid arthritis, chronic hemochromatosis, sickle cell anemia, and/or chondrocalcinosis, as well as arthropathies associated with systemic diseases such as gout and hemophilia, and infectious joint disease).
Body mass index (BMI) >35 kg/m²
Severe misalignment of the knee axis (i.e., >12° severe varus or valgus deformity and/or clinically significant moderate to severe instability).
Trial population
Patients with symptomatic knee osteoarthritis (Kellgren-Lawrence stages 2-3)
Trial design
Case-only
Retrospective
Treatments tested in this trial
Intra-articular hyaluronic acid injection
DeviceA single-dose intra-articular hyaluronic acid (HA) injection (Re-Cross by Reviscon-containing 88 mg of sodium hyaluronate in 4.0 ml) was administered to patients with symptomatic knee osteoarthritis using the lower lateral patellar approach with the knee flexed at 90 degrees.
Treatment groups
Trial outcomes
Primary outcomes
WOMAC score
The WOMAC Index 3.1 (Sections A-B-C) must be completed by participants using a 5-point Likert scale. Participants are asked about pain, stiffness, and function in their knees (the study joint) due to osteoarthritis over the past 24 hours.
Secondary outcomes
VAS score
The Visual Analog Scale (VAS) is a validated subjective measure for acute and chronic pain. Scores are recorded by marking a 10-centimeter line with a handwritten mark, representing a continuum from "no pain" to "worst pain."
PGA score
Participants respond using a 5-point Likert scale (0 = very good, 1 = good, 2 = average, 3 = poor, 4 = very poor).
Sponsors and contacts
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