Knee OsteoarthritisNCT06141018
Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)
A study testing Cross-linked intra-articular hyaluronic acid in people with Knee Osteoarthritis, run by Semikal Technology at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cross-linked intra-articular hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and over, both male and female
- Diagnosed with clinical knee osteoarthritis according to the American College of
- Rheumatology (ACR) criteria, with Kellgren \& Lawrence stage II and III osteoarthritic findings on antero-posterior knee radiographs
- Able to provide written informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Safety and Effectiveness of Intra-articular Injection of a Cross-linked Sodium Hyaluronate in Knee Osteoarthritis: A Randomized, Prospective, Double-blind, Placebo-controlled, Cross-over, Post-marketing Clinical Follow-up Study
The goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis.
Primary objectives: The aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of SEMICAL GEL B-CROSS, produced and marketed by Semical Biosurgery incorporated company, in knee osteoarthritis patients.
It is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. Participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (SEMICAL GEL-B CROSS); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.
Read the detailed description
The study is a randomized controlled, double-blind, two-armed, single-center and cross-over study. After a maximum screening period of 28 days, patients with Kellgren \& Lawrence Stage II and III knee osteoarthritis will be randomly assigned to one of the two treatment arms on the day of injection, which is considered Day 0. These treatment arms are:
Group 1: Treatment Arm - Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)
Group 2: Control Arm - Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) A safety visit will be made 7-10 days after administration of the treatment injection and the injection site will be visually evaluated for local reactions. In addition, an inquiry for injection-related adverse events will also be conducted.
Treatment responses of patients in both groups will be evaluated by a separate researcher blinded to study treatment with predefined objective response criteria.
At the 3rd month visit, the patients in both groups will be crossed-over and those who received a placebo at baseline will receive a hyaluronic acid injection at the 3rd month, while those who receive a hyaluronic acid injection at baseline will receive a placebo at the 3rd month. Efficacy evaluations will continue to be made at every three months for one year.
- Conditions
- Knee Osteoarthritis
- Being tested
- Cross-linked intra-articular hyaluronic acid, Placebo
- Keywords
- knee osteoarthritis, hyaluronic acid, intraarticular injection, viscosupplementation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-linked intra-articular hyaluronic acidDevice
Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.
PlaceboOther
Also called 3 ml isotonic saline solution
Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.
| Study group | Role | What they receive |
|---|---|---|
| Cross-linked intra-articular hyaluronic acid | Active comparator | Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid) Receives: Device: Cross-linked intra-articular hyaluronic acid |
| Placebo | Placebo comparator | Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) at the same dose as the treatment arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores
The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary outcomes (11)
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score
The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee functions
The alteration in function arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee flexor muscle strength
Knee flexor muscle strength assessed by myometer
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee extensor muscle strength
Knee extensor muscle strength assessed by myometer
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee functions during 5 times sit to stand test
5 times sit to stand test
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee functions by 6MWT (6 Minute Walking Test)
6 minute walking test
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in the need for analgesic drug from pre-treatment to post-treatment
Will be assessed by patient diary
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in quality of life
Will be assessed by 36-item Short Form Survey
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in knee pain during movement and rest
Will be assessed by Visual Analogue Scale 1-10 (1: no pain, 10: very much pain)
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Local reactions in the injection site
A safety visit will be performed 7-10 days after administration of the treatment injection and the injection site will be visually assessed for local reactions.
Measured: 7-10 days post-injection
Adverse events throughout the entire study period
Adverse events will be questioned throughout the entire study period
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start15 Jan 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semikal Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Antalya Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- Aslıhan Kara, Study director, Semikal Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141018
- Sponsor's protocol ID
- SEM-ART1
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol will be published as an article.
Publications
Filiz MB, Hekim HH, Bal A, Kara A. Effectiveness and safety of intra-articular hyaluronic acid SEMICAL GEL-B CROSS therapy in knee osteoarthritis (SEM-ART1): Study protocol for a randomized, placebo controlled, double-blind, cross-over clinical trial. PLoS One. 2026 Jul 9;21(7):e0353120. doi: 10.1371/journal.pone.0353120. eCollection 2026.
PubMed 42424346
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Intra-articular Injection of a Cross-linked Sodium Hyaluronate in Knee Osteoarthritis: A Randomized, Prospective, Double-blind, Placebo-controlled, Cross-over, Post-marketing Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT06141018
- Acronym / sponsor ID
- SEM-ART1
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, hyaluronic acid, intraarticular injection, viscosupplementation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Semikal TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Antalya Training and Research Hospital
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 21 Nov 2023 (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 goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis.
Primary objectives: The aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of SEMICAL GEL B-CROSS, produced and marketed by Semical Biosurgery incorporated company, in knee osteoarthritis patients.
It is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. Participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (SEMICAL GEL-B CROSS); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.
Detailed description
The study is a randomized controlled, double-blind, two-armed, single-center and cross-over study. After a maximum screening period of 28 days, patients with Kellgren \& Lawrence Stage II and III knee osteoarthritis will be randomly assigned to one of the two treatment arms on the day of injection, which is considered Day 0. These treatment arms are:
Group 1: Treatment Arm - Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)
Group 2: Control Arm - Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) A safety visit will be made 7-10 days after administration of the treatment injection and the injection site will be visually evaluated for local reactions. In addition, an inquiry for injection-related adverse events will also be conducted.
Treatment responses of patients in both groups will be evaluated by a separate researcher blinded to study treatment with predefined objective response criteria.
At the 3rd month visit, the patients in both groups will be crossed-over and those who received a placebo at baseline will receive a hyaluronic acid injection at the 3rd month, while those who receive a hyaluronic acid injection at baseline will receive a placebo at the 3rd month. Efficacy evaluations will continue to be made at every three months for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-linked intra-articular hyaluronic acid | Active comparator | Device: Cross-linked intra-articular hyaluronic acidCross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid) |
| Placebo | Placebo comparator | Other: PlaceboIntra-articular isotonic saline solution (3 ml 0.9% isotonic saline) at the same dose as the treatment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 and over, both male and female
- Diagnosed with clinical knee osteoarthritis according to the American College of
- Rheumatology (ACR) criteria, with Kellgren \& Lawrence stage II and III osteoarthritic findings on antero-posterior knee radiographs
- Able to provide written informed consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Cross-linked intra-articular hyaluronic acidPatients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month. | Device | Cross-linked intra-articular hyaluronic acid |
| PlaceboAlso: 3 ml isotonic saline solutionPatients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month. | Other | Placebo |
Primary outcome
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.
11 secondary outcomes
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee functions
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee flexor muscle strength
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee extensor muscle strength
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee functions during 5 times sit to stand test
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Changes in knee functions by 6MWT (6 Minute Walking Test)
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in the need for analgesic drug from pre-treatment to post-treatment
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in quality of life
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in knee pain during movement and rest
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Local reactions in the injection site
Time frame: 7-10 days post-injection
Adverse events throughout the entire study period
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 42424346Filiz MB, Hekim HH, Bal A, Kara A. Effectiveness and safety of intra-articular hyaluronic acid SEMICAL GEL-B CROSS therapy in knee osteoarthritis (SEM-ART1): Study protocol for a randomized, placebo controlled, double-blind, cross-over clinical trial. PLoS One. 2026 Jul 9;21(7):e0353120. doi: 10.1371/journal.pone.0353120. eCollection 2026.
- Individual participant dataSharing planned: No. Study protocol will be published as an article.
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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.
Aslıhan Kara study director
Semikal Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-linked intra-articular hyaluronic acid in people with Knee Osteoarthritis, run by Semikal Technology 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 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
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 in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores (time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.). 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 NCT06141018, which also lists 1 linked publication.
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 21 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.