Osteoarthritis (OA) of the KneePhase 4NCT06717529
Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis
A Phase 4 study testing Sodium hyaluronate (hyaluronic acid) and Methylprednisolone Acetate Injection in people with Osteoarthritis (OA) of the Knee and Osteoarthritis, run by Edin Mešanović at 1 site in Bosnia and Herzegovina.
Trial summary
The aim of this study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Osteoarthritis, Osteoarthritis in the Knee
- What is being tested?
- Sodium hyaluronate (hyaluronic acid) and Methylprednisolone Acetate Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Jan 2023to 30 Sep 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral knee pain
- same grade of osteoarthritis in both knees
- Kellgren-Lawrence grade 2 or 3 of knee osteoarthritis
- fully completed all follow-up examinations
Who cannot join
- unilateral knee osteoarthritis
- different grade of osteoarthritis between knees based on Kellgren-Lawrence scale
- positive history of previous knee interventions (injections, surgery)
- positive history of additional knee injuries (meniscus, ligament...)
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Cantonal Hospital "dr.Safet Mujic"
Mostar, 88000
About this study
The aim of this study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention.
Read the detailed description
We will include patients with bilateral knee osteoarthritis (Kellgren Lawrence grades 2 and 3). On initial examination, we will measure active and passive range of flexion and extension, presence of swelling, joint effusion, VAS score for each knee separately, and WOMAC score for every knee separately. We will randomly apply hyaluronic acid injection in one knee and steroid injection in the other knee. We will repeat the same examination after week 6, month 3, month 6, and one year after the procedure. The main aim is to check whether there is a significant clinical or functional difference between two groups.
- Conditions
- Osteoarthritis (OA) of the Knee, Osteoarthritis, Osteoarthritis in the Knee, Osteoarthritis of Knee, Osteoarthritis of the Knees, Osteoarthritis of Knee Joint
- Being tested
- Sodium hyaluronate (hyaluronic acid), Methylprednisolone Acetate Injection
- Keywords
- osteoarthritis, hyaluronic acid, steroid injection, kellgren lawrence, oa, arthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate (hyaluronic acid)Other
The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint.
Methylprednisolone Acetate InjectionDrug
The patient will receive 2mL of methylprednisolone acetate solution containing 80 mg of the medicine in other knee joint.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid injection | Experimental | This arm will receive a hyaluronic acid injection in the knee joint. Receives: Other: Sodium hyaluronate (hyaluronic acid) |
| Steroid injection | Active comparator | This arm will receive steroid injection in the knee joint. Receives: Drug: Methylprednisolone Acetate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score
Changes in WOMAC score one year after the intervention compared to the WOMAC score at the initial examination.
Measured: One year after the intervention.
VAS score
Changes in VAS score after one year.
Measured: One year after the intervention.
Range of active knee joint flexion
Changes in the range of active knee joint flexion
Measured: One year after the intervention.
Range of active knee joint extension
Changes in the range of active knee joint extension
Measured: One year after the intervention.
Knee swelling
Presence of knee joint swelling.
Measured: One year after the intervention.
Knee joint effusion
The presence of knee joint effusion.
Measured: One year after the intervention.
Secondary outcomes (18)
WOMAC score after 6 weeks
Changes in WOMAC score compared to the initial examination.
Measured: 6 weeks after the intervention.
VAS score after 6 weeks
Changes in VAS score compared to the initial examination.
Measured: 6 weeks after the intervention.
Range of active knee joint flexion after 6 weeks
Changes in range of active knee joint flexion compared to the initial examination.
Measured: 6 weeks after the intervention.
Range of active knee joint extension after 6 weeks
Changes in the range of knee joint extension compared to the initial examination.
Measured: 6 weeks after the intervention.
Knee swelling after 6 weeks
Changes in the presence of knee swelling compared to the initial examination.
Measured: 6 weeks after the intervention.
Knee joint effusion after 6 weeks
Changes in the presence of knee joint effusion compared to the initial examination.
Measured: 6 weeks after the intervention.
WOMAC score after 3 months
Changes in WOMAC score compared to the initial examination.
Measured: 3 months after the intervention.
VAS score after 3 months
Changes in VAS score compared to the initial examination.
Measured: 3 months after the intervention.
Range of active knee joint flexion after 3 months
Changes in the range of knee joint flexion compared to the initial examination.
Measured: 3 months after the intervention.
Range of active knee joint extension after 3 months
Changes in the range of knee joint extension compared to the initial examination.
Measured: 3 months after the intervention.
Knee swelling after 3 months
Changes in the presence of knee swelling compared to the initial examination.
Measured: 3 months after the intervention.
Knee joint effusion after 3 months
Changes in the presence of knee joint effusion compared to the initial examination.
Measured: 3 months after the intervention.
WOMAC score after 6 months
Changes in WOMAC score compared to the initial examination.
Measured: 6 months after the intervention.
VAS score after 6 months
Changes in VAS score compared to the initial examination.
Measured: 6 months after the intervention.
Range of active knee joint flexion after 6 months
Changes in the range of knee joint flexion compared to the initial examination.
Measured: 6 months after the intervention.
Range of active knee joint extension after 6 months
Changes in the range of knee joint extension compared to the initial examination.
Measured: 6 months after the intervention.
Knee swelling after 6 months
Changes in the presence of knee swelling compared to the initial examination.
Measured: 6 months after the intervention.
Knee joint effusion after 6 months
Changes in the presence of knee effusion compared to the initial examination.
Measured: 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jan 2023
- Primary completion15 Nov 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with bilateral knee osteoarthritis will receive hyaluronic acid injection in one knee and steroid injection in the other knee.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edin Mešanović
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edin Mešanović, Cantonal Hospital Dr. Safet Mujic Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717529
- Sponsor's protocol ID
- 01-1-1-5469/23-01
- Status last verified
- Nov 2024
- First submitted
- 30 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication.
Publications
Ko NY, Chang CN, Cheng CH, Yu HK, Hu GC. Comparative Effectiveness of Focused Extracorporeal versus Radial Extracorporeal Shockwave Therapy for Knee Osteoarthritis-Randomized Controlled Study. Int J Environ Res Public Health. 2022 Jul 24;19(15):9001. doi: 10.3390/ijerph19159001.
PubMed 35897371Mitra, S., Seenappa, H., & Madhavan, P. (2021). A clinical evaluation study of single spin vs double spin intra-articular prp injection in patients with bilateral early oa knee: a novel technique. International Journal of Orthopaedics Sciences, 7(3), 01-06. https://doi.org/10.22271/ortho.2021.v7.i3a.2718
Rahman, S., Narhari, P., Sharifudin, M., & Aa, S. (2020). Western ontario and mcmaster universities (womac) osteoarthritis index as an assessment tool to indicate total knee arthroplasty in patients with primary knee osteoarthritis. Iium Medical Journal Malaysia, 19(3). https://doi.org/10.31436/imjm.v19i3.1664
Wang SZ, Wu DY, Chang Q, Guo YD, Wang C, Fan WM. Intra-articular, single-shot co-injection of hyaluronic acid and corticosteroids in knee osteoarthritis: A randomized controlled trial. Exp Ther Med. 2018 Sep;16(3):1928-1934. doi: 10.3892/etm.2018.6371. Epub 2018 Jun 29.
PubMed 30186420Metcalfe AJ, Andersson ML, Goodfellow R, Thorstensson CA. Is knee osteoarthritis a symmetrical disease? Analysis of a 12 year prospective cohort study. BMC Musculoskelet Disord. 2012 Aug 22;13:153. doi: 10.1186/1471-2474-13-153.
PubMed 22917179Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.
PubMed 25136689Cotofana S, Wirth W, Pena Rossi C, Eckstein F, Gunther OH. Contralateral knee effect on self-reported knee-specific function and global functional assessment: data from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2015 Mar;67(3):374-81. doi: 10.1002/acr.22495.
PubMed 25302424
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06717529
- Acronym / sponsor ID
- 01-1-1-5469/23-01
- Conditions
- Osteoarthritis (OA) of the Knee, Osteoarthritis, Osteoarthritis in the Knee, Osteoarthritis of Knee, Osteoarthritis of the Knees, Osteoarthritis of Knee Joint
- Keywords
- osteoarthritis, hyaluronic acid, steroid injection, kellgren lawrence, oa, arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Edin MešanovićUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 5 Dec 2024 (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 study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention.
Detailed description
We will include patients with bilateral knee osteoarthritis (Kellgren Lawrence grades 2 and 3). On initial examination, we will measure active and passive range of flexion and extension, presence of swelling, joint effusion, VAS score for each knee separately, and WOMAC score for every knee separately. We will randomly apply hyaluronic acid injection in one knee and steroid injection in the other knee. We will repeat the same examination after week 6, month 3, month 6, and one year after the procedure. The main aim is to check whether there is a significant clinical or functional difference between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients with bilateral knee osteoarthritis will receive hyaluronic acid injection in one knee and steroid injection in the other knee.
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid injection | Experimental | Other: Sodium hyaluronate (hyaluronic acid)This arm will receive a hyaluronic acid injection in the knee joint. |
| Steroid injection | Active comparator | Drug: Methylprednisolone Acetate InjectionThis arm will receive steroid injection in the knee joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- bilateral knee pain
- same grade of osteoarthritis in both knees
- Kellgren-Lawrence grade 2 or 3 of knee osteoarthritis
- fully completed all follow-up examinations
Key exclusion criteria (4 listed)
- unilateral knee osteoarthritis
- different grade of osteoarthritis between knees based on Kellgren-Lawrence scale
- positive history of previous knee interventions (injections, surgery)
- positive history of additional knee injuries (meniscus, ligament...)
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 |
|---|---|---|
| Sodium hyaluronate (hyaluronic acid)The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint. | Other | Hyaluronic acid injection |
| Methylprednisolone Acetate InjectionThe patient will receive 2mL of methylprednisolone acetate solution containing 80 mg of the medicine in other knee joint. | Drug | Steroid injection |
Primary outcome
WOMAC score
Time frame: One year after the intervention.
Changes in WOMAC score one year after the intervention compared to the WOMAC score at the initial examination.
VAS score
Time frame: One year after the intervention.
Changes in VAS score after one year.
Range of active knee joint flexion
Time frame: One year after the intervention.
Changes in the range of active knee joint flexion
Range of active knee joint extension
Time frame: One year after the intervention.
Changes in the range of active knee joint extension
Knee swelling
Time frame: One year after the intervention.
Presence of knee joint swelling.
Knee joint effusion
Time frame: One year after the intervention.
The presence of knee joint effusion.
18 secondary outcomes
WOMAC score after 6 weeks
Time frame: 6 weeks after the intervention.
VAS score after 6 weeks
Time frame: 6 weeks after the intervention.
Range of active knee joint flexion after 6 weeks
Time frame: 6 weeks after the intervention.
Range of active knee joint extension after 6 weeks
Time frame: 6 weeks after the intervention.
Knee swelling after 6 weeks
Time frame: 6 weeks after the intervention.
Knee joint effusion after 6 weeks
Time frame: 6 weeks after the intervention.
WOMAC score after 3 months
Time frame: 3 months after the intervention.
VAS score after 3 months
Time frame: 3 months after the intervention.
Range of active knee joint flexion after 3 months
Time frame: 3 months after the intervention.
Range of active knee joint extension after 3 months
Time frame: 3 months after the intervention.
Knee swelling after 3 months
Time frame: 3 months after the intervention.
Knee joint effusion after 3 months
Time frame: 3 months after the intervention.
WOMAC score after 6 months
Time frame: 6 months after the intervention.
VAS score after 6 months
Time frame: 6 months after the intervention.
Range of active knee joint flexion after 6 months
Time frame: 6 months after the intervention.
Range of active knee joint extension after 6 months
Time frame: 6 months after the intervention.
Knee swelling after 6 months
Time frame: 6 months after the intervention.
Knee joint effusion after 6 months
Time frame: 6 months after the intervention.
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 5 Dec 2024.
- Background: PubMed 35897371Ko NY, Chang CN, Cheng CH, Yu HK, Hu GC. Comparative Effectiveness of Focused Extracorporeal versus Radial Extracorporeal Shockwave Therapy for Knee Osteoarthritis-Randomized Controlled Study. Int J Environ Res Public Health. 2022 Jul 24;19(15):9001. doi: 10.3390/ijerph19159001.
- BackgroundMitra, S., Seenappa, H., & Madhavan, P. (2021). A clinical evaluation study of single spin vs double spin intra-articular prp injection in patients with bilateral early oa knee: a novel technique. International Journal of Orthopaedics Sciences, 7(3), 01-06. https://doi.org/10.22271/ortho.2021.v7.i3a.2718
- BackgroundRahman, S., Narhari, P., Sharifudin, M., & Aa, S. (2020). Western ontario and mcmaster universities (womac) osteoarthritis index as an assessment tool to indicate total knee arthroplasty in patients with primary knee osteoarthritis. Iium Medical Journal Malaysia, 19(3). https://doi.org/10.31436/imjm.v19i3.1664
- Background: PubMed 30186420Wang SZ, Wu DY, Chang Q, Guo YD, Wang C, Fan WM. Intra-articular, single-shot co-injection of hyaluronic acid and corticosteroids in knee osteoarthritis: A randomized controlled trial. Exp Ther Med. 2018 Sep;16(3):1928-1934. doi: 10.3892/etm.2018.6371. Epub 2018 Jun 29.
- Background: PubMed 22917179Metcalfe AJ, Andersson ML, Goodfellow R, Thorstensson CA. Is knee osteoarthritis a symmetrical disease? Analysis of a 12 year prospective cohort study. BMC Musculoskelet Disord. 2012 Aug 22;13:153. doi: 10.1186/1471-2474-13-153.
- Background: PubMed 25136689Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.
- Background: PubMed 25302424Cotofana S, Wirth W, Pena Rossi C, Eckstein F, Gunther OH. Contralateral knee effect on self-reported knee-specific function and global functional assessment: data from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2015 Mar;67(3):374-81. doi: 10.1002/acr.22495.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium hyaluronate (hyaluronic acid) and Methylprednisolone Acetate Injection in people with Osteoarthritis (OA) of the Knee and Osteoarthritis, run by Edin Mešanović at 1 site in Bosnia and Herzegovina.
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 4 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 5 Dec 2024. 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 Bosnia and Herzegovina. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
WOMAC score (time frame: One year after the intervention.). The study lists 6 primary outcomes in all. 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 NCT06717529, which also lists 7 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 5 Dec 2024.