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

NCT07487038 | Not Yet Recruiting

• 1 other identifier: FSMHA
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthristis; Hyaluronic Acid

Outcome Measures

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.

  5 minutes

Secondary Outcomes (2)

• VAS score

  1 minute

• PGA score

  1 minute

Interventions

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.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic knee osteoarthritis (Kellgren-Lawrence stages 2-3)

You may qualify if:

• 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).
• Baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score (sum of five 100-mm components) between 200 and 400 mm.
• Individuals deemed by the investigator to be able to adhere to the visit schedule.
• Discontinuation of all NSAIDs, corticosteroids, and other pain relievers, including over-the-counter medications, herbal treatments, or chondroprotective agents prior to injection, and no use of these during the study follow-up period (except for acetaminophen).
• Patients who have not received another intra-articular injection in the knee or participated in a physical therapy program during the follow-up period.

You may not qualify if:

• 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).
• 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
• 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).
• Surgical intervention on the symptomatic knee within the previous 12 months (including joint replacement) or arthroscopy of the symptomatic knee within the past 3 months (note: joint replacement of the contralateral knee is permitted if performed more than 12 months prior and the participant does not report pain of ≥ 20 mm on the WOMAC pain subscale).
• Intra-articular (IA) injections in both knees within the past 4 weeks (e.g., corticosteroids, chondroprotective agents).
• Changes to current medications or the addition of new medications to treat knee OA within the past 4 weeks (i.e., a change in dose or regimen lasting at least 4 weeks).
• Regular use of opioid pain relievers for pain management. Use of long-acting pain relievers such as analgesic patches, methadone, and levorphanol at any time

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Fatih Sultan Mehmet Training and Research Hospital

Ataşehir, Istanbul, 34704, Turkey (Türkiye)

Location

Related Publications (3)

• van der Weegen W, Wullems JA, Bos E, Noten H, van Drumpt RA. No difference between intra-articular injection of hyaluronic acid and placebo for mild to moderate knee osteoarthritis: a randomized, controlled, double-blind trial. J Arthroplasty. 2015 May;30(5):754-7. doi: 10.1016/j.arth.2014.12.012. Epub 2014 Dec 13.

  PMID: 25548079 BACKGROUND

• Petterson SC, Plancher KD. Single intra-articular injection of lightly cross-linked hyaluronic acid reduces knee pain in symptomatic knee osteoarthritis: a multicenter, double-blind, randomized, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1992-2002. doi: 10.1007/s00167-018-5114-0. Epub 2018 Aug 29.

  PMID: 30159738 BACKGROUND

• Kawasaki T, Kurosawa H, Ikeda H, Takazawa Y, Ishijima M, Kubota M, Kajihara H, Maruyama Y, Kim SG, Kanazawa H, Doi T. Therapeutic home exercise versus intraarticular hyaluronate injection for osteoarthritis of the knee: 6-month prospective randomized open-labeled trial. J Orthop Sci. 2009 Mar;14(2):182-91. doi: 10.1007/s00776-008-1312-9. Epub 2009 Apr 1.

  PMID: 19337810 BACKGROUND

Study Officials

• Yunus Emre DOĞAN, MD

  Istanbul Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Aslınur KELEŞ ERCİŞLİ, MD

  Istanbul Fatih Sultan Mehmet Training and Research Hospital

  STUDY CHAIR

• Arzu ATICI, MD, Assoc. Prof.

  Istanbul Fatih Sultan Mehmet Training and Research Hospital

  STUDY CHAIR

• Meryem YILMAZ KAYSIN, MD

  Istanbul Fatih Sultan Mehmet Training and Research Hospital

  STUDY CHAIR

• İlknur AKTAŞ, MD, Prof.

  Istanbul Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

• Feyza ÜNLÜ ÖZKAN, MD, Prof.

  Istanbul Fatih Sultan Mehmet Training and Research Hospital

  STUDY CHAIR

• Aylin REZVANİ, MD, Prof.

  Medipol University

  STUDY CHAIR

Central Study Contacts

Yunus Emre Doğan, MD

CONTACT

+90 506 051 25 00; ynsemredgn91@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)