NCT07487038

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

Efficacy and Safety of a Single-Dose Hyaluronic Acid Injection in Adults With Symptomatic Knee Osteoarthritis: A Retrospective Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 133 (estimated)
• Sponsor: Fatih Sultan Mehmet Training and Research Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Knee Osteoarthristis
• Hyaluronic Acid

Interventions

Type	Name	Description
DEVICE	Intra-articular hyaluronic acid injection	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.

Timeline

• Start date: 2026-03-20
• Primary completion: 2026-04-20
• Completion: 2026-04-20
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Turkey (Türkiye)