Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

NCT06279507 | Recruiting Phase 4 DMC

• 1 other identifier: PMK-00007
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Hyaluronic acid; Adjunctive treatment

Outcome Measures

Primary Outcomes (3)

• Pain outcome measurement

  The comparison between Hyaluronic acid and normal saline injection in the change of joint pain after the injection, by using visual analog scale and pain domain assessment in Western Ontario and McMaster University (WOMAC) scale (scale 0-10, which higher scale reflects worse symptom)

  12 and 24 weeks after injection

• Joint stiffness and function measurement

  The comparison between Hyaluronic acid and normal saline injection in the change of joint stiffness and function after the injection, by using WOMAC scale (scale 0-10, which higher scale reflects worse symptom or function)

  12 and 24 weeks after injection

• Overall symptom assessment

  The comparison between Hyaluronic acid and normal saline injection in the change of overall symptom after the injection, by using patient's global assessment (scale 0-10, which higher scale reflects worse condition)

  12 and 24 weeks after injection

Secondary Outcomes (2)

• Knee performance evaluation

  12 and 24 weeks after injection

• Quality of life assessment

  12 and 24 weeks after injection

Study Arms (2)

Hyaluronic acid

ACTIVE COMPARATOR

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

Drug: Sodium Hyaluronate; Drug: Triamcinolone Acetonide 10mg/mL

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal Saline; Drug: Triamcinolone Acetonide 10mg/mL

Interventions

Sodium Hyaluronate 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

Also known as: Ostenil Plus

Hyaluronic acid

Normal Saline DRUG

0.9% sodium chloride 2 mL prepared in plastic syringe

Also known as: 0.9% sodium chloride

Normal saline

Triamcinolone Acetonide 10mg/mL DRUG

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

Hyaluronic acid; Normal saline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead
• Chulalongkorn University: collaborator
• Khon Kaen University: collaborator
• Police General Hospital: collaborator

Study Sites (1)

Phramongkutklao Hospital

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthralgia

Interventions

Hyaluronic Acid; Saline Solution; Sodium Chloride; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nis Okuma, Medical

  Phramongkutklao College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nis Okuma, Medical

CONTACT

669-24759900; nitzumo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants would be allocated into one treatment group; * Intervention group : Hyaluronic acid injection * Placebo group : Normal saline

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: February 28, 2024
• Study Start: February 10, 2024
• Primary Completion: January 31, 2025
• Study Completion: June 30, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)