Istanbul Fatih Sultan Mehmet Training and Research Hospital
Ataşehir, Istanbul, 34704, Turkey (Türkiye)
NCT Number: NCT07487038
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.
Trial opening soon.
Get Notified40 year–70 year
All sexes
Observational
Ataşehir, Istanbul, 34704, Turkey (Türkiye)
Our study was conducted at the Physical Medicine and Rehabilitation Clinic of Fatih Sultan Mehmet Training and Research Hospital between 2023 and 2025, involving a retrospective review of medical records of patients diagnosed with symptomatic knee osteoarthritis (OA) who were followed up in our outpatient clinics and received a single dose of intra-articular hyaluronic acid (HA) injection (Re-Cross by Reviscon - 4.0 ml, 88 mg sodium hyaluronate).
Our single-center, retrospective study plans to enroll at least 133 knees (Kellgren-Lawrence stages 2-3) with knee OA-related pain that have received HA treatment. Patients included in the study were evaluated before the injection, 30 minutes after the injection, and at 1, 3, 6, and 12 months post-injection. Pre-injection assessments, the injection procedure, and all post-injection evaluations were performed by a physician specializing in physical medicine and rehabilitation.
Patients were assessed for pain, stiffness, and function before injection and at 1, 3, 6, and 12 months post-injection using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Quality of life was also assessed using the Patient General Assessment (PGA) test scores. In the first post-injection assessment, pain intensity was evaluated using the VAS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The presence of significant joint effusion identified by the investigator during a clinical examination and confirmed by an ultrasound examination performed on each patient to determine the presence of effusion
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.
Time frame: 5 minutes
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: 1 minute
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
Participants respond using a 5-point Likert scale (0 = very good, 1 = good, 2 = average, 3 = poor, 4 = very poor).
Contact information is provided by the study sponsor or research team.
Fatih Sultan Mehmet Training and Research Hospital
Other
Efficacy and Safety of a Single-Dose Hyaluronic Acid Injection in Adults With Symptomatic Knee Osteoarthritis: A Retrospective Study
Acronym: ESSDHAITKO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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