The Efficacy and Safety of a Single-Dose Hyaluronic Acid Injection in the Treatment of Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorFatih Sultan Mehmet Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • Intra-articular hyaluronic acid injection

    Device

    A 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
5 minutes

Secondary outcomes

1

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."

Time frame
1 minute
2

PGA score

Participants respond using a 5-point Likert scale (0 = very good, 1 = good, 2 = average, 3 = poor, 4 = very poor).

Time frame
1 minute

Other outcomes

Sponsors and contacts

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