Knee OsteoarthritisNCT04786613
The Effectiveness of Different Doses of Hyaluronic Acid Injections in Knee Osteoarthritis.
A study testing Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection, Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection and Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection in people with Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective, randomized, controlled multi-centre study is to compare the effectiveness and safety of three and five injections of standard linear hyaluronic acid (HA) versus single HA injection in terms of pain intensity and functional status in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection, Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection and Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2021to 7 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral symptomatic knee pain for at least three months
- Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
- Functional ambulation scale stage 4-5
- Being able to attend injection and control examinations
Who cannot join
- Intra-articular knee injection within the last six months
- History of severe trauma to the knee within the past six months
- Concomitant severe meniscus or ligament injury, surgery applied to the knee area
- Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
- Having a bleeding disorder and / or using warfarin
- Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
Show all 10Show fewer
- Presence of cardiac or systemic disease that may affect exercise
- The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
- Body Mass Index ≥35 kg / m²
- Allergy to hyaluranic acid products
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34034
About this study
Official title: The Efficacy and Safety of Intra-articular Injections of 48 mg, 32 mg and 20 mg Linear Hyaluronic Acid in Patients With Knee Osteoarthritis: A Multicenter Randomized Single-Blind Clinical Trial
The aim of this prospective, randomized, controlled multi-centre study is to compare the effectiveness and safety of three and five injections of standard linear hyaluronic acid (HA) versus single HA injection in terms of pain intensity and functional status in patients with knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is the most common form of chronic joint disease. A treatment option for patients diagnosed with knee osteoarthritis is intra-articular hyaluronic acid therapy. In this prospective, randomized controlled, single blind, interventional study, a total of 90 patients with stage 2-3 knee osteoarthritis according to the kellgren lawrence classification who meet the eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the three groups using computer-generated random numbers. In the first group, 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions, in the second group 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions and in the third group 2.4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in a single sessions will be applied. Participants are going to evaluate before injection, at the 1-month follow-up, at the 3-month follow-up and 6-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change in pain, stiffness and physical function score, the change in the Timed Up and Go Test (TUG) time and the change in the patient's daily activities with the numerical global patient assessment scale.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection, Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection, Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection
- Keywords
- Knee Osteoarthritis, Linear Hyaluronic Acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular 20 mg, 1.0% Hyaluronic Acid InjectionOther
Intra-articular 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions will be applied.
As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
Intra-articular 32 mg, 1.6% Hyaluronic Acid InjectionOther
Intra-articular 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions will be applied.
As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
Intra-articular 48 mg, 2.0% Hyaluronic Acid InjectionOther
Intra-articular 2,4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in single session will be applied.
As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| 20 mg, 1.0% hyaluronic acid injection groups | Active comparator | In the first group, 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions will be applied. Receives: Other: Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection |
| 32 mg, 1.6% hyaluronic acid injection groups | Active comparator | In the second group, 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions will be applied. Receives: Other: Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection |
| 48 mg, 2.0% hyaluronic acid injection groups | Active comparator | In the third group 2.4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in a single sessions will be applied. Receives: Other: Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline activity pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month
Secondary outcomes (4)
Change from baseline rest pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline night pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Night pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline functional balance at 1-months, 3-months and 6-months
The Timed Up and Go test requires the person to stand up from a standard chair in which they are sitting, walk 3 m at a comfortable speed to the marked place on the floor, turn around, walk backwards to the starting point and return to the sitting position in the chair. The time taken for the person to complete the test is measured in seconds. The timing of the test is related to the function.
Measured: Baseline, 1-month, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start10 Mar 2021
- Primary completion7 Oct 2021
- Study completion7 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Sezikli, Istanbul University
- Investigators
- Demirhan Diracoglu, Prof., Principal investigator, Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786613
- Sponsor's protocol ID
- Istanbul University HA
- Status last verified
- Oct 2022
- First submitted
- 3 Mar 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Intra-articular Injections of 48 mg, 32 mg and 20 mg Linear Hyaluronic Acid in Patients With Knee Osteoarthritis: A Multicenter Randomized Single-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04786613
- Acronym / sponsor ID
- Istanbul University HA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Linear Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Nov 2021 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective, randomized, controlled multi-centre study is to compare the effectiveness and safety of three and five injections of standard linear hyaluronic acid (HA) versus single HA injection in terms of pain intensity and functional status in patients with knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is the most common form of chronic joint disease. A treatment option for patients diagnosed with knee osteoarthritis is intra-articular hyaluronic acid therapy. In this prospective, randomized controlled, single blind, interventional study, a total of 90 patients with stage 2-3 knee osteoarthritis according to the kellgren lawrence classification who meet the eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the three groups using computer-generated random numbers. In the first group, 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions, in the second group 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions and in the third group 2.4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in a single sessions will be applied. Participants are going to evaluate before injection, at the 1-month follow-up, at the 3-month follow-up and 6-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change in pain, stiffness and physical function score, the change in the Timed Up and Go Test (TUG) time and the change in the patient's daily activities with the numerical global patient assessment scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 mg, 1.0% hyaluronic acid injection groups | Active comparator | Other: Intra-articular 20 mg, 1.0% Hyaluronic Acid InjectionIn the first group, 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions will be applied. |
| 32 mg, 1.6% hyaluronic acid injection groups | Active comparator | Other: Intra-articular 32 mg, 1.6% Hyaluronic Acid InjectionIn the second group, 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions will be applied. |
| 48 mg, 2.0% hyaluronic acid injection groups | Active comparator | Other: Intra-articular 48 mg, 2.0% Hyaluronic Acid InjectionIn the third group 2.4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in a single sessions will be applied. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral or bilateral symptomatic knee pain for at least three months
- Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
- Functional ambulation scale stage 4-5
- Being able to attend injection and control examinations
Key exclusion criteria (10 listed)
- Intra-articular knee injection within the last six months
- History of severe trauma to the knee within the past six months
- Concomitant severe meniscus or ligament injury, surgery applied to the knee area
- Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
- Having a bleeding disorder and / or using warfarin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular 20 mg, 1.0% Hyaluronic Acid InjectionIntra-articular 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions. | Other | 20 mg, 1.0% hyaluronic acid injection groups |
| Intra-articular 32 mg, 1.6% Hyaluronic Acid InjectionIntra-articular 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions. | Other | 32 mg, 1.6% hyaluronic acid injection groups |
| Intra-articular 48 mg, 2.0% Hyaluronic Acid InjectionIntra-articular 2,4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in single session will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions. | Other | 48 mg, 2.0% hyaluronic acid injection groups |
Primary outcome
Change from baseline activity pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
4 secondary outcomes
Change from baseline rest pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline night pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline functional balance at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demirhan Diracoglu, Prof. principal investigator
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection, Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection and Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection in people with Knee Osteoarthritis, run by Istanbul University 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 4 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: finished, as of the sponsor's last update on 18 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline activity pain score at 1-months, 3-months and 6-months (time frame: Baseline, 1-month, 3-month, 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2022.