Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

NCT ID: NCT06279507

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-10

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:

* Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
* Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis

Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.

Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants who had been diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria will be enrolled in this study. After the participants receive the information and consent to participate in this study, they will be examined their affected knee by the co-researchers. Ten-milligrams of Triamcinolone will be injected intra-articular into knee joint.

Two-to-four weeks later, the participants will be evaluated for knee pain, stiffness, function and quality of life, as well as knee performance status. Participants whose their knee joint absence of effusion will be allocated in to one treatment group; either Hyaluronic acid or normal saline. After injection, participants will be scheduled for the follow-up visit in 12 and 24 weeks later. In each follow-up visit, they will be evaluated for joint pain, stiffness, function and quality of life, as well as analgesic use and adverse reaction form treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Pain, Joint Stiffness of Knee, Not Elsewhere Classified Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants would be allocated into one treatment group;

* Intervention group : Hyaluronic acid injection
* Placebo group : Normal saline
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participants will not know what treatment they receive. Co-investigators will not know what the participants are injected. Outcome assessor will not know which treatment participant receive.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hyaluronic acid

Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection

Group Type ACTIVE_COMPARATOR

Sodium Hyaluronate

Intervention Type DRUG

Sodium hyaluronate 2% (40 mg/2 mL), with molecular weight of 1-2 million dalton Other active ingredient : Mannitol 0.5% Preparation : Pre-filled syringe

Triamcinolone Acetonide 10mg/mL

Intervention Type DRUG

10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention

Normal saline

Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

0.9% sodium chloride 2 mL prepared in plastic syringe

Triamcinolone Acetonide 10mg/mL

Intervention Type DRUG

10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Hyaluronate

Sodium hyaluronate 2% (40 mg/2 mL), with molecular weight of 1-2 million dalton Other active ingredient : Mannitol 0.5% Preparation : Pre-filled syringe

Intervention Type DRUG

Normal Saline

0.9% sodium chloride 2 mL prepared in plastic syringe

Intervention Type DRUG

Triamcinolone Acetonide 10mg/mL

10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ostenil Plus 0.9% sodium chloride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All participants who had been diagnosed as knee osteoarthritis according to ACR criteria with symptom of knee pain
* Pain visual analog scare of 4 or higher

Exclusion Criteria

* Cognitive impairment
* History of aller to Hyaluronic acid or its component
* History of knee arthropathy
* Concomitant with inflammatory arthritis
* Serious comorbidities or bedridden status
* Current pregnancy or lactation
* Currently use of symptomatic slow acting drugs for osteoarthritis (SYSADOA)
* Communication problem
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chulalongkorn University

OTHER

Sponsor Role collaborator

Khon Kaen University

OTHER

Sponsor Role collaborator

Police General Hospital

OTHER

Sponsor Role collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nis Okuma, Medical

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao College of Medicine and Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nis Okuma, Medical

Role: CONTACT

669-24759900

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Suthee Panichkul

Role: primary

6623547600 ext. 93681

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PMK-00007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.