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Knee OsteoarthristisESSDHAITKONCT07487038

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

An observational study of Knee Osteoarthristis and Hyaluronic Acid, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Knee Osteoarthristis, Hyaluronic Acid
What is being tested?
Intra-articular hyaluronic acid injection
How many people
133 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2026to 15 May 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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).
  • Clinical findings of hip osteoarthritis (OA) and/or hip joint replacement on the same side as the affected knee. Hip joint replacement on the opposite side of the affected knee is not exclusionary, provided the patient does not have symptomatic hip OA.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yunus Emre Doğan, MD contact

+90 506 051 25 00

ynsemredgn91@gmail.com

Turkey (Türkiye)1 site

  • Istanbul Fatih Sultan Mehmet Training and Research Hospital

    Ataşehir, Istanbul, 34704

    İlknur AKTAŞ, MD, Prof., +90 533 714 63 52, iaktas@hotmail.com

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Intra-articular hyaluronic acid injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-articular hyaluronic acid injectionDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 minutes

Secondary outcomes (2)

  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."

    Measured: 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).

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion15 May 2026 (estimated)
  4. Study completion15 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
133 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07487038
Sponsor's protocol ID
FSMHA
Acronym
ESSDHAITKO
Status last verified
Mar 2026
First submitted
17 Mar 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25548079

  • 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.

    PubMed 30159738

  • 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.

    PubMed 19337810

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthristis and Hyaluronic Acid, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yunus Emre Doğan, MD (+90 506 051 25 00, ynsemredgn91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC score (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07487038, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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