Osteoarthritis, KneePhase 2/3DR-HAKOANCT07352540
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
A Phase 2/3 study testing Three intra-articular hyaluronic acid (HA) injections and One intra-articular hyaluronic acid (HA) injection in people with Osteoarthritis, Knee, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The goal of this clinical trial is to directly compare two hyaluronic acid injection protocols in adults with knee osteoarthritis: a single intra-articular injection of Innoryos 2.5% (Single-Shot) and a three-week injection series of Innoryos 2.2% (Triple-Shot). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Three intra-articular hyaluronic acid (HA) injections and One intra-articular hyaluronic acid (HA) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2026to 31 Dec 2026
- Phase
- Phase 2/3
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-70 years
- Radiographically confirmed moderate to severe knee osteoarthritis
- Knee pain for ≥3 months
- Pain on ≥50% of days in past 30 days
- Able to provide informed consent
Who cannot join
- Grade 4 osteoarthritis (full-thickness cartilage loss)
- Non-osteoarthritic knee pain
- Other rheumatic diseases (e.g., rheumatoid arthritis, fibromyalgia)
- HA injection <6 months or corticosteroid injection <3 months in target knee
- Recent trauma or surgery of affected knee (<6 months)
- Coagulopathy or bleeding disorder
Show all 12Show fewer
- Autoimmune or relevant systemic disease
- Dermatologic infection at injection site
- Pregnancy or lactation
- Opioid or oral corticosteroid use
- Contraindications to MRI (pacemaker, intracorporeal metal, claustrophobia)
- Expected absence during study period or noncompliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Radiology, University Hospital Erlangen
Erlangen, 91052
About this study
Official title: Effects and Safety of Single Versus Triple Hyaluronic Acid Injections in the Treatment of Knee Osteoarthritis
The goal of this clinical trial is to directly compare two hyaluronic acid injection protocols in adults with knee osteoarthritis: a single intra-articular injection of Innoryos 2.5% (Single-Shot) and a three-week injection series of Innoryos 2.2% (Triple-Shot). The study aims to determine whether the single injection provides comparable safety, pain relief, and improvement in knee function to the triple-injection protocol.
The main questions are:
Read more
- How do the single-shot and triple-shot protocols compare in terms of pain reduction and functional improvement?
- How do their safety and tolerability profiles compare?
- What medical problems occur with each protocol? Participants (n = 46) will receive either the single 4.8 ml injection or three weekly 2 ml injections. They will attend clinic visits at baseline, Week 6, Week 12, and Week 24 for assessments including WOMAC score, 7-day pain diary, functional and strength tests, and MRI scans of the knee.
This single-center, partially blinded, randomized study will provide a direct comparison of the two HA injection protocols, assessing whether the single-shot approach is as safe and effective as the triple-shot regimen, while potentially offering a more convenient, patient-friendly treatment.
Read the detailed description
Background:
Knee osteoarthritis (gonarthrosis) is a prevalent degenerative joint disease characterized by cartilage loss, joint pain, stiffness, and functional impairment, which significantly affects mobility and quality of life. Intra-articular injections of hyaluronic acid (HA) are a well-established conservative therapy to reduce pain, improve function, and potentially delay surgical interventions. Various HA formulations and injection protocols exist, differing in molecular weight, concentration, and dosing schedules. Optimizing treatment in terms of efficacy, safety, patient convenience, and cost-effectiveness remains a key clinical goal.
Objective:
This study aims to compare the safety, tolerability, and efficacy of a single intra-articular injection of Innoryos 2.5% (Single-Shot) with a standard three-week injection regimen of Innoryos 2.2% (Triple-Shot) in adults with moderate to severe knee osteoarthritis. The primary focus is on safety and pain reduction, with secondary outcomes including functional improvement, leg muscle strength, and structural assessment of the knee joint via MRI.
Study Design:
This is a single-center, randomized, partially blinded, parallel-group clinical intervention study including 46 participants. Patients are randomized using block randomization stratified by baseline WOMAC total score to ensure balanced distribution of baseline pain and functional impairment. Patients and treating physicians are aware of treatment allocation, while all personnel performing functional tests, MRI assessments, data entry, and statistical analyses are blinded to minimize bias.
Participants:
Adults aged 40-70 years with radiographically confirmed moderate to severe knee osteoarthritis, experiencing knee pain for at least three months and on at least 50% of days in the prior month. Key exclusion criteria include grade 4 osteoarthritis, non-osteoarthritic knee pain, other rheumatic diseases, recent HA or corticosteroid injections, recent trauma or surgery, coagulopathies, autoimmune disorders, pregnancy or lactation, and contraindications for MRI.
Interventions:
- Single-Shot Group: One intra-articular injection of Innoryos 2.5% (4.8 ml)
- Triple-Shot Group: Three intra-articular injections of Innoryos 2.2% (2 ml each) at weekly intervals
Outcomes:
The primary outcome is total WOMAC score. Secondary outcomes include WOMAC subscales, VAS pain diary, functional performance, leg muscle strength, MRI-detected structural changes, and safety/tolerability parameters.
Assessments:
Participants are assessed at baseline, Week 6, Week 12, and Week 24.
- WOMAC questionnaire (baseline, Week 6, Week 12, and Week 24): Pain, stiffness, and functional limitation
- Pain diary (VAS) (baseline, Week 6, Week 12, and Week 24): Daily for 7 days at each assessment (~1 min/day)
- Functional and strength tests (baseline, Week 6, Week 12): Chair Stand Test, Timed Up and Go Test, isokinetic leg press (~30 min per session)
- MRI (baseline, Week 6, Week 12): Baseline and Week 12 for structural assessment (~90 min including functional tests)
- Safety monitoring: Adverse events, medication use, compliance, drop-outs
Significance:
This study provides high-quality evidence for the direct comparison of single-shot versus triple-shot HA injection protocols in knee osteoarthritis. By using stratified randomization based on baseline WOMAC total score and blinded assessment of outcomes, the trial ensures unbiased evaluation. Demonstration of comparable safety and efficacy of the single-shot regimen could offer a more convenient, patient-friendly, and potentially safer therapeutic option, optimizing conservative management for patients with knee osteoarthritis.
intra-articular injection of Innoryos 2.5% (Single-Shot) with a standard three-week injection regimen of Innoryos 2.2% (Triple-Shot) in adults with moderate to severe knee osteoarthritis. The primary focus is on safety and pain reduction, with secondary outcomes including functional improvement, leg muscle strength, and structural assessment of the knee joint via MRI.
Study Design:
This is a single-center, randomized, partially blinded, parallel-group clinical intervention study including 46 participants. Patients are randomized using block randomization stratified by baseline WOMAC total score to ensure balanced distribution of baseline pain and functional impairment. Patients and treating physicians are aware of treatment allocation, while all personnel performing functional tests, MRI assessments, data entry, and statistical analyses are blinded to minimize bias.
Participants:
Adults aged 40-70 years with radiographically confirmed moderate to severe knee osteoarthritis, experiencing knee pain for at least three months and on at least 50% of days in the prior month. Key exclusion criteria include grade 4 osteoarthritis, non-osteoarthritic knee pain, other rheumatic diseases, recent HA or corticosteroid injections, recent trauma or surgery, coagulopathies, autoimmune disorders, pregnancy or lactation, and contraindications for MRI.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Three intra-articular hyaluronic acid (HA) injections, One intra-articular hyaluronic acid (HA) injection
- Keywords
- osteoarthritis, Hyaluronic-acid, injection, safety, feasibility
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three intra-articular hyaluronic acid (HA) injectionsDrug
Therapy with intra-articular injections of hyaluronic acid (HA). Three intra-articular injections of Innoryos 2.2% (2 ml per injection) administered into the affected knee joint at weekly intervals.
One intra-articular hyaluronic acid (HA) injectionDrug
Therapy with a single intra-articular injection of hyaluronic acid (HA). One intra-articular injection of Innoryos 2.5% (4.8 ml per injection) administered into the affected knee joint at weekly intervals.
| Study group | Role | What they receive |
|---|---|---|
| Three intra-articular HA injections | Active comparator | Three intra-articular injections of Innoryos 2.2% (2 ml each) in the knee joint at weekly intervals Receives: Drug: Three intra-articular hyaluronic acid (HA) injections |
| One intra-articular HA injection | Experimental | One intra-articular injection of Innoryos 2.5% (4.8 ml) in the knee joint Receives: Drug: One intra-articular hyaluronic acid (HA) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC questionnaire total score
Total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), assessing overall pain, stiffness, and physical function of the knee joint
Measured: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
Secondary outcomes (7)
WOMAC questionnaire pain subscore
Pain subscore of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), assessing pain of the knee joint
Measured: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
WOMAC questionnaire stiffness subscore
Stiffness subscore of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), assessing stiffness of the knee joint
Measured: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
WOMAC questionnaire physical function subscore
Physical function subscore of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), assessing pain of the knee joint
Measured: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
7-day pain assessment using visual analog scale (VAS)
Participants will record their knee pain daily using a Visual Analog Scale (VAS) as part of a 7-day pain diary at each assessment period. The VAS is a straight 100 mm line, anchored by "no pain" at 0 mm and "worst imaginable pain" at 100 mm. Participants indicate their current knee pain intensity each day by marking a point on the line that best represents their pain.
The diary is completed for seven consecutive days to capture fluctuations in pain intensity during daily activities. The daily VAS scores are recorded and later averaged to calculate a weekly mean pain score.
Measured: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
Maximum isokinetic leg extension strength
Participants' leg muscle strength and functional performance are assessed using an isokinetic leg press (Physiomed, Laipersdorf, Germany). Before testing, participants complete a 5-minute warm-up on a cross-trainer to prepare the muscles and reduce injury risk.
Following the warm-up, two maximal test sessions are conducted, each consisting of 6 repetitions at a velocity of 0.6 meters per second (m/s). During each attempt, participants perform the leg press extension movement with maximal effort. The highest peak force achieved during the extension in each session is recorded and used for analysis.
Measured: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
30-Second Chair Stand Test (30s CST) - Assessment of Lower Limb Function:
The 30-Second Chair Stand Test measures lower body strength, endurance, and functional mobility. Participants sit on a standard chair with arms crossed over the chest. When instructed, they stand up fully and sit back down repeatedly for 30 seconds.
The total number of full stands completed within 30 seconds is recorded. A higher number of repetitions indicates better lower limb strength and functional performance.
Measured: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
Knee MRI and T2 Mapping - Assessment of Joint Structures
Magnetic Resonance Imaging (MRI) is used to assess structural changes in the knee joint and evaluate the integrity of cartilage and other joint tissues. Participants undergo a non-invasive, radiation-free MRI scan of the affected knee at baseline and 12 weeks after treatment.
The MRI protocol includes high-resolution imaging of joint structures, such as cartilage, menisci, ligaments, and subchondral bone. Additionally, T2 mapping is performed to quantify the T2 relaxation time of articular cartilage, which reflects the water content and collagen organization. Areas of increased T2 values indicate cartilage degeneration or changes in cartilage composition, while decreases or stabilization suggest maintenance or improvement of cartilage health.
Measured: At baseline, at 12 weeks, at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Jan 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Responsible party
- Sponsor
- Investigators
- Simon von Stengel, PhD, Principal investigator, Institute of Radiology, University Hospital Erlangen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352540
- Sponsor's protocol ID
- 25-275_1-Bm
- Acronym
- DR-HAKOA
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared publicly in order to comply with data protection regulations in Germany (GDPR) and the study's data protection consent. Only aggregated and anonymized results will be reported in publications or study summaries. No personal identifiers, contact information, or sensitive participant data will be disclosed.
Publications
Kast S, Kemmler W, Roemer FW, Kohl M, Culvenor AG, Mobasheri A, Uder M, von Stengel S. Effectiveness of whole-body electromyostimulation on knee pain and physical function in knee osteoarthritis: a randomized controlled trial. Sci Rep. 2024 Sep 6;14(1):20804. doi: 10.1038/s41598-024-71552-7.
PubMed 39242729Roemer FW, Kast S, Kemmler W, Collins JE, Engelke K, Guermazi A, Uder M, von Stengel S. Structural effects of whole body electromyostimulation on knee osteoarthritis: the EMSOAT Study. Skeletal Radiol. 2025 Nov;54(11):2579-2588. doi: 10.1007/s00256-025-04984-5. Epub 2025 Jul 22.
PubMed 40694090Hofweber, L., von Stengel, S., Nürnberger, J., & Kemmler, W. (2024). Effectiveness and safety of the hyaluronic acid INNORYOS 2.2% in patients with early to advanced knee osteoarthritis. A prospective non-interventional randomized clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Safety of Single Versus Triple Hyaluronic Acid Injections in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07352540
- Acronym / sponsor ID
- DR-HAKOA / 25-275_1-Bm
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, Hyaluronic-acid, injection, safety, feasibility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (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 directly compare two hyaluronic acid injection protocols in adults with knee osteoarthritis: a single intra-articular injection of Innoryos 2.5% (Single-Shot) and a three-week injection series of Innoryos 2.2% (Triple-Shot). The study aims to determine whether the single injection provides comparable safety, pain relief, and improvement in knee function to the triple-injection protocol.
The main questions are:
- How do the single-shot and triple-shot protocols compare in terms of pain reduction and functional improvement?
- How do their safety and tolerability profiles compare?
- What medical problems occur with each protocol? Participants (n = 46) will receive either the single 4.8 ml injection or three weekly 2 ml injections. They will attend clinic visits at baseline, Week 6, Week 12, and Week 24 for assessments including WOMAC score, 7-day pain diary, functional and strength tests, and MRI scans of the knee.
This single-center, partially blinded, randomized study will provide a direct comparison of the two HA injection protocols, assessing whether the single-shot approach is as safe and effective as the triple-shot regimen, while potentially offering a more convenient, patient-friendly treatment.
Detailed description
Background:
Knee osteoarthritis (gonarthrosis) is a prevalent degenerative joint disease characterized by cartilage loss, joint pain, stiffness, and functional impairment, which significantly affects mobility and quality of life. Intra-articular injections of hyaluronic acid (HA) are a well-established conservative therapy to reduce pain, improve function, and potentially delay surgical interventions. Various HA formulations and injection protocols exist, differing in molecular weight, concentration, and dosing schedules. Optimizing treatment in terms of efficacy, safety, patient convenience, and cost-effectiveness remains a key clinical goal.
Objective:
This study aims to compare the safety, tolerability, and efficacy of a single intra-articular injection of Innoryos 2.5% (Single-Shot) with a standard three-week injection regimen of Innoryos 2.2% (Triple-Shot) in adults with moderate to severe knee osteoarthritis. The primary focus is on safety and pain reduction, with secondary outcomes including functional improvement, leg muscle strength, and structural assessment of the knee joint via MRI.
Study Design:
This is a single-center, randomized, partially blinded, parallel-group clinical intervention study including 46 participants. Patients are randomized using block randomization stratified by baseline WOMAC total score to ensure balanced distribution of baseline pain and functional impairment. Patients and treating physicians are aware of treatment allocation, while all personnel performing functional tests, MRI assessments, data entry, and statistical analyses are blinded to minimize bias.
Participants:
Adults aged 40-70 years with radiographically confirmed moderate to severe knee osteoarthritis, experiencing knee pain for at least three months and on at least 50% of days in the prior month. Key exclusion criteria include grade 4 osteoarthritis, non-osteoarthritic knee pain, other rheumatic diseases, recent HA or corticosteroid injections, recent trauma or surgery, coagulopathies, autoimmune disorders, pregnancy or lactation, and contraindications for MRI.
Interventions:
- Single-Shot Group: One intra-articular injection of Innoryos 2.5% (4.8 ml)
- Triple-Shot Group: Three intra-articular injections of Innoryos 2.2% (2 ml each) at weekly intervals
Outcomes:
The primary outcome is total WOMAC score. Secondary outcomes include WOMAC subscales, VAS pain diary, functional performance, leg muscle strength, MRI-detected structural changes, and safety/tolerability parameters.
Assessments:
Participants are assessed at baseline, Week 6, Week 12, and Week 24.
- WOMAC questionnaire (baseline, Week 6, Week 12, and Week 24): Pain, stiffness, and functional limitation
- Pain diary (VAS) (baseline, Week 6, Week 12, and Week 24): Daily for 7 days at each assessment (~1 min/day)
- Functional and strength tests (baseline, Week 6, Week 12): Chair Stand Test, Timed Up and Go Test, isokinetic leg press (~30 min per session)
- MRI (baseline, Week 6, Week 12): Baseline and Week 12 for structural assessment (~90 min including functional tests)
- Safety monitoring: Adverse events, medication use, compliance, drop-outs
Significance:
This study provides high-quality evidence for the direct comparison of single-shot versus triple-shot HA injection protocols in knee osteoarthritis. By using stratified randomization based on baseline WOMAC total score and blinded assessment of outcomes, the trial ensures unbiased evaluation. Demonstration of comparable safety and efficacy of the single-shot regimen could offer a more convenient, patient-friendly, and potentially safer therapeutic option, optimizing conservative management for patients with knee osteoarthritis.
intra-articular injection of Innoryos 2.5% (Single-Shot) with a standard three-week injection regimen of Innoryos 2.2% (Triple-Shot) in adults with moderate to severe knee osteoarthritis. The primary focus is on safety and pain reduction, with secondary outcomes including functional improvement, leg muscle strength, and structural assessment of the knee joint via MRI.
Study Design:
This is a single-center, randomized, partially blinded, parallel-group clinical intervention study including 46 participants. Patients are randomized using block randomization stratified by baseline WOMAC total score to ensure balanced distribution of baseline pain and functional impairment. Patients and treating physicians are aware of treatment allocation, while all personnel performing functional tests, MRI assessments, data entry, and statistical analyses are blinded to minimize bias.
Participants:
Adults aged 40-70 years with radiographically confirmed moderate to severe knee osteoarthritis, experiencing knee pain for at least three months and on at least 50% of days in the prior month. Key exclusion criteria include grade 4 osteoarthritis, non-osteoarthritic knee pain, other rheumatic diseases, recent HA or corticosteroid injections, recent trauma or surgery, coagulopathies, autoimmune disorders, pregnancy or lactation, and contraindications for MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three intra-articular HA injections | Active comparator | Drug: Three intra-articular hyaluronic acid (HA) injectionsThree intra-articular injections of Innoryos 2.2% (2 ml each) in the knee joint at weekly intervals |
| One intra-articular HA injection | Experimental | Drug: One intra-articular hyaluronic acid (HA) injectionOne intra-articular injection of Innoryos 2.5% (4.8 ml) in the knee joint |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 40-70 years
- Radiographically confirmed moderate to severe knee osteoarthritis
- Knee pain for ≥3 months
- Pain on ≥50% of days in past 30 days
- Able to provide informed consent
Key exclusion criteria (12 listed)
- Grade 4 osteoarthritis (full-thickness cartilage loss)
- Non-osteoarthritic knee pain
- Other rheumatic diseases (e.g., rheumatoid arthritis, fibromyalgia)
- HA injection <6 months or corticosteroid injection <3 months in target knee
- Recent trauma or surgery of affected knee (<6 months)
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 |
|---|---|---|
| Three intra-articular hyaluronic acid (HA) injectionsTherapy with intra-articular injections of hyaluronic acid (HA). Three intra-articular injections of Innoryos 2.2% (2 ml per injection) administered into the affected knee joint at weekly intervals. | Drug | Three intra-articular HA injections |
| One intra-articular hyaluronic acid (HA) injectionTherapy with a single intra-articular injection of hyaluronic acid (HA). One intra-articular injection of Innoryos 2.5% (4.8 ml per injection) administered into the affected knee joint at weekly intervals. | Drug | One intra-articular HA injection |
Primary outcome
WOMAC questionnaire total score
Time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
Total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), assessing overall pain, stiffness, and physical function of the knee joint
7 secondary outcomes
WOMAC questionnaire pain subscore
Time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
WOMAC questionnaire stiffness subscore
Time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
WOMAC questionnaire physical function subscore
Time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
7-day pain assessment using visual analog scale (VAS)
Time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
Maximum isokinetic leg extension strength
Time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
30-Second Chair Stand Test (30s CST) - Assessment of Lower Limb Function:
Time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks
Knee MRI and T2 Mapping - Assessment of Joint Structures
Time frame: At baseline, at 12 weeks, at 24 weeks
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 6 Nov 2026.
- Background: PubMed 39242729Kast S, Kemmler W, Roemer FW, Kohl M, Culvenor AG, Mobasheri A, Uder M, von Stengel S. Effectiveness of whole-body electromyostimulation on knee pain and physical function in knee osteoarthritis: a randomized controlled trial. Sci Rep. 2024 Sep 6;14(1):20804. doi: 10.1038/s41598-024-71552-7.
- Background: PubMed 40694090Roemer FW, Kast S, Kemmler W, Collins JE, Engelke K, Guermazi A, Uder M, von Stengel S. Structural effects of whole body electromyostimulation on knee osteoarthritis: the EMSOAT Study. Skeletal Radiol. 2025 Nov;54(11):2579-2588. doi: 10.1007/s00256-025-04984-5. Epub 2025 Jul 22.
- BackgroundHofweber, L., von Stengel, S., Nürnberger, J., & Kemmler, W. (2024). Effectiveness and safety of the hyaluronic acid INNORYOS 2.2% in patients with early to advanced knee osteoarthritis. A prospective non-interventional randomized clinical trial.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared publicly in order to comply with data protection regulations in Germany (GDPR) and the study's data protection consent. Only aggregated and anonymized results will be reported in publications or study summaries. No personal identifiers, contact information, or sensitive participant data will be disclosed.
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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.
Simon von Stengel, PhD principal investigator
Institute of Radiology, University Hospital Erlangen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Three intra-articular hyaluronic acid (HA) injections and One intra-articular hyaluronic acid (HA) injection in people with Osteoarthritis, Knee, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 5 inclusion and 12 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 6 Nov 2026. 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 Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
WOMAC questionnaire total score (time frame: At baseline, at 6 weeks, at 12 weeks, at 24 weeks). 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 NCT07352540, which also lists 3 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 6 Nov 2026.