Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Key facts
- Who runs it
- University of Erlangen-Nürnberg Medical School
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2/3
- People taking part
- 46 people enrolled
- Started
- 15 Jan 2026
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Three intra-articular hyaluronic acid (HA) injections
- One intra-articular hyaluronic acid (HA) injection
- Record updated
- 6 November 2026
Who can take part
- Age
- 40 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- HA injection <6 months or corticosteroid injection <3 months in target knee
- Recent trauma or surgery of affected knee (<6 months)
- Opioid or oral corticosteroid use
- Other rheumatic diseases (e.g., rheumatoid arthritis, fibromyalgia)
- Coagulopathy or bleeding disorder
- Autoimmune or relevant systemic disease
- Dermatologic infection at injection site
- Grade 4 osteoarthritis (full-thickness cartilage loss)
- Non-osteoarthritic knee pain
- Pregnancy or lactation
- Contraindications to MRI (pacemaker, intracorporeal metal, claustrophobia)
- Expected absence during study period or noncompliance
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Three intra-articular HA injectionsExisting treatment, for comparison
Three intra-articular injections of Innoryos 2.2% (2 ml each) in the knee joint at weekly intervals
Treatment: Three intra-articular hyaluronic acid (HA) injections
- One intra-articular HA injectionTreatment being tested
One intra-articular injection of Innoryos 2.5% (4.8 ml) in the knee joint
Treatment: One intra-articular hyaluronic acid (HA) injection
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects and Safety of Single Versus Triple Hyaluronic Acid Injections in the Treatment of Knee Osteoarthritis
- Record updated
- 6 November 2026