Knee Osteoarthritis (Knee OA)KOALANCT06839222
Knee OsteoArthritis Long-term Assessment
A study testing Hydrogel OA 2% and Hyaluronic Acid (Durolane) in people with Knee Osteoarthritis (Knee OA), run by Allegro NV/SA at 5 sites in Belgium.
Trial summary
The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Hydrogel OA 2% and Hyaluronic Acid (Durolane)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesBelgium
- Study dates
- May 2025to Nov 2026
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
- Unilateral symptomatic tibiofemoral KOA confirmed by a "standing knee" X-ray. In case of bilateral KOA on X-ray only one knee (indexed knee) presents symptomatic OA pain.
- Age 35 ≤ 75 years.
- BMI 20 ≤ 35.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25-85.
- Radiological Kellgren and Lawrence (K\&L) grade II and III from a standing knee radiograph with minimum joint space of 1 mm in the study knee.
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- Fully ambulatory for functional assessments.
- Willingness to refrain from taking any pain medication for 48 hours prior to each study visit.
- Female subjects must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device), if not surgically sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year. Females must show a negative pregnancy test at the treatment visit.
Who cannot join
- Bilateral tibiofemoral KOA where the non-symptomatic knee presents worse radiological grade of KOA.
- Radiological K\&L grade 0, I, or IV from a standing knee radiograph assessed during the screening visit, using the most recent x-ray taken either immediately or within the past 3 months. Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
- Extension deficit of the index knee of higher than 5 degrees.
- Bilateral symptomatic tibiofemoral KOA or a combined unilateral symptomatic tibiofemoral knee and hip OA.
- Clinical signs of significant effusion with noticeable swelling and/or inflammation related severe pain during the treatment visit.
- Evidence of active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma).
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- Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment.
- Synovial infection, skin infections or any skin diseases in the area of the injection site.
- History of autoimmune diseases that cause chronic joint pain and inflammation in the knee joint, including rheumatoid arthritis, psoriasis arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, gout, pseudogout, systemic sclerosis, Sjögren's disease, adult-onset still's disease.
- Known or suspected generalized chronic pain disorder.
- Severe alteration of mobility preventing any functional assessment.
- Allergy or hypersensitivity to any of the product components.
- Conditions (orthopedic, rheumatologic, musculoskeletal or inflammatory) causing symptomatic and/or radiating pain in the lower extremities that might interfere with the symptomatic OA knee pain, including hip OA assessed by physical examination by the physician.
- Symptomatic patellofemoral knee OA.
- Oral corticotherapy ≥4 mg/day (in prednisone equivalent) in the last 3 months before injection.
- Severe acute illness within 14 days prior to investigational device administration.
- Any intra-articular injection (hyaluronan, hydrogel, soft implant, corticosteroid, platelet-rich plasma, local anesthetic etc.) arthroscopy, surgery in the treated knee; or cell-based therapy or an invasive procedure on the treated knee in the last 6 months before screening visit.
- Anticipated need for any surgical or other invasive procedure throughout the course of the clinical investigation, including prosthesis in the treatment knee, any concurrent OA treatments including alternative treatments (e.g., acupuncture, ultrasound, magnetic resonance etc.).
- Any investigator-assessed clinically significant condition that may represent a substantial risk to the patient or may have an impact on the study assessments.
- Participation in another clinical trial in the last 3 months before injection.
- Pregnancy and breastfeeding.
- Legal incapacity or limited legal capacity to consent.
- Trauma of the treatment knee in the last 6 months before the treatment visit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
More Institute
Antwerp
AZ Sint Jan Brugge
Bruges
UZ Antwerpen
Edegem
CHU Liège
Liège
AZ DELTA
Roeselare
About this study
Official title: Randomized Controlled Single-Blind Multi-Centre Evaluation of the Safety and Performance of an Injection of Hydrogel OA 2% in Subjects With Knee Osteoarthritis
The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. The main question it aims to answer is:
- How many study participants will experience side effects related to Hydrogel OA 2% during the study when compared to Hyaluronic Acid (Durolane)?
All study participants will receive either one Hydrogel OA 2% or Hyaluronic Acid (Durolane) injection in their knee during the clinical study. Study participants will not know which treatment they have received. Study participants will also receive a call from the researchers and visit the clinic three times to report whether they have experienced any side effects, and complete a questionnaire that will ask questions on whether their symptoms have improved since they received an injection.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Hydrogel OA 2%, Hyaluronic Acid (Durolane)
- Keywords
- Hydrogel OA 2%, Knee Osteoarthritis, Knee Injury and Osteoarthritis Outcome Score (KOOS), Safety, Hyaluronic acid
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel OA 2%Device
Hydrogel OA 2% is a sterile, nonpyrogenic viscoelastic hydrogel suspension, designed using highly purified biopolymers in a phosphate-buffered saline solution. The main component is a cross-linked protein (ultra-pure bovine gelatin). The other main component is a polysaccharide cellulose nanocrystal (CNC) that acts as the crosslinker. Hydrogel OA 2% is supplied in pre-filled 2.25ml Luer lock syringe. Each package contains one syringe containing 2.0 mL Hydrogel OA 2%. Hydrogel OA 2% is designed to provide symptomatic relief by restoring joint lubrication and cushioning, potentially leading to reduced pain and improved joint function. The device is suitable for use in early and moderate OA (Kellgren and Lawrence, K\&L, II-III).
Hyaluronic Acid (Durolane)Device
DUROLANE contains 20 mg/mL of stabilized non-animal hyaluronic acid in buffered physiological sodium chloride solution pH 7. DUROLANE is a sterile, transparent viscoelastic gel supplied in a 3 mL glass syringe.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogel OA 2% | Experimental | treatment arm Receives: Device: Hydrogel OA 2% |
| Hyaluronic Acid (Durolane) | Active comparator | control arm Receives: Device: Hyaluronic Acid (Durolane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Hydrogel OA 2% in subjects with symptomatic KOA
The primary aim of this study is to test the safety of Hydrogel OA 2% in patients with symptomatic KOA. Specifically, the aim is to demonstrate that the proportion of patients experiencing Hydrogel OA 2%-related AEs is equal to the the proportion of patients experiencing Durolane-related AEs .
Measured: From the treatment to the end of the follow up at 26 weeks
Secondary outcomes (1)
The improvement in the Knee Injury and Osteoarthritis Outcome Score (KOOS) 'Pain' score at 26 weeks after treatment
The aim is to show that the change in Knee Injury and Osteoarthritis Outcome Score (KOOS) 'Pain' score in the treatment group is at least equal to the control group at 26 weeks after treatment
Measured: From the treatment to the end of the follow up at 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: Change in scope
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- Parallel groups
- Model description
- A randomized controlled, single-blind, multi-center, prospective first-inhuman clinical investigation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegro NV/SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QbD Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839222
- Sponsor's protocol ID
- DHF-001-DVaP-001-03
- Acronym
- KOALA
- Status last verified
- Oct 2025
- First submitted
- 17 Feb 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Single-Blind Multi-Centre Evaluation of the Safety and Performance of an Injection of Hydrogel OA 2% in Subjects With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06839222
- Acronym / sponsor ID
- KOALA / DHF-001-DVaP-001-03
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Hydrogel OA 2%, Knee Osteoarthritis, Knee Injury and Osteoarthritis Outcome Score (KOOS), Safety, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in scope
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allegro NV/SAIndustry (pharma, biotech, devices)
- Collaborators
- QbD Clinical
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Feb 2025 (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 study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. The main question it aims to answer is:
- How many study participants will experience side effects related to Hydrogel OA 2% during the study when compared to Hyaluronic Acid (Durolane)?
All study participants will receive either one Hydrogel OA 2% or Hyaluronic Acid (Durolane) injection in their knee during the clinical study. Study participants will not know which treatment they have received. Study participants will also receive a call from the researchers and visit the clinic three times to report whether they have experienced any side effects, and complete a questionnaire that will ask questions on whether their symptoms have improved since they received an injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled, single-blind, multi-center, prospective first-inhuman clinical investigation.
| Arm | Type | Receives |
|---|---|---|
| Hydrogel OA 2% | Experimental | Device: Hydrogel OA 2%treatment arm |
| Hyaluronic Acid (Durolane) | Active comparator | Device: Hyaluronic Acid (Durolane)control arm |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
- Unilateral symptomatic tibiofemoral KOA confirmed by a "standing knee" X-ray. In case of bilateral KOA on X-ray only one knee (indexed knee) presents symptomatic OA pain.
- Age 35 ≤ 75 years.
- BMI 20 ≤ 35.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25-85.
Key exclusion criteria (23 listed)
- Bilateral tibiofemoral KOA where the non-symptomatic knee presents worse radiological grade of KOA.
- Radiological K\&L grade 0, I, or IV from a standing knee radiograph assessed during the screening visit, using the most recent x-ray taken either immediately or within the past 3 months. Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
- Extension deficit of the index knee of higher than 5 degrees.
- Bilateral symptomatic tibiofemoral KOA or a combined unilateral symptomatic tibiofemoral knee and hip OA.
- Clinical signs of significant effusion with noticeable swelling and/or inflammation related severe pain during the treatment visit.
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 |
|---|---|---|
| Hydrogel OA 2%Hydrogel OA 2% is a sterile, nonpyrogenic viscoelastic hydrogel suspension, designed using highly purified biopolymers in a phosphate-buffered saline solution. The main component is a cross-linked protein (ultra-pure bovine gelatin). The other main component is a polysaccharide cellulose nanocrystal (CNC) that acts as the crosslinker. Hydrogel OA 2% is supplied in pre-filled 2.25ml Luer lock syringe. Each package contains one syringe containing 2.0 mL Hydrogel OA 2%. Hydrogel OA 2% is designed to provide symptomatic relief by restoring joint lubrication and cushioning, potentially leading to reduced pain and improved joint function. The device is suitable for use in early and moderate OA (Kellgren and Lawrence, K\&L, II-III). | Device | Hydrogel OA 2% |
| Hyaluronic Acid (Durolane)DUROLANE contains 20 mg/mL of stabilized non-animal hyaluronic acid in buffered physiological sodium chloride solution pH 7. DUROLANE is a sterile, transparent viscoelastic gel supplied in a 3 mL glass syringe. | Device | Hyaluronic Acid (Durolane) |
Primary outcome
Safety of Hydrogel OA 2% in subjects with symptomatic KOA
Time frame: From the treatment to the end of the follow up at 26 weeks
The primary aim of this study is to test the safety of Hydrogel OA 2% in patients with symptomatic KOA. Specifically, the aim is to demonstrate that the proportion of patients experiencing Hydrogel OA 2%-related AEs is equal to the the proportion of patients experiencing Durolane-related AEs .
1 secondary outcome
The improvement in the Knee Injury and Osteoarthritis Outcome Score (KOOS) 'Pain' score at 26 weeks after treatment
Time frame: From the treatment to the end of the follow up at 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogel OA 2% and Hyaluronic Acid (Durolane) in people with Knee Osteoarthritis (Knee OA), run by Allegro NV/SA at 5 sites in Belgium.
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 9 inclusion and 23 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: withdrawn, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety of Hydrogel OA 2% in subjects with symptomatic KOA (time frame: From the treatment to the end of the follow up at 26 weeks). 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 13 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.