Actively Recruiting
New Treatment of Knee Osteoarthritis
Led by Symatese · Updated on 2025-02-26
134
Participants Needed
2
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. It is also characterized by a decrease of the concentration and molecular weight of the hyaluronic acid in the synovial fluid which ultimately leads to poor viscoelastic properties of synovial fluid and induction of proinflammatory pathways. The intra-articular injection of viscosupplementation gel (mainly exogenous hyaluronic acid) represents one of the most used therapeutic strategies to treat osteoarthritis symptoms. Several studies on knee Osteoarthritis, have shown that one or more weekly injection of viscosupplementation gel significantly relieves articular pain and ameliorates mobility and joint function for at least 6 months and more. Repeated courses of intra-articular injections are an effective and safe treatment for knee osteoarthritis symptoms. Based on studies conducted on intra-articular viscosupplementation gels, the most common side effects expected are local transient and short-lived adverse events such as pain, swelling and arthralgia in the site of administration, which are fully reversible in the days following the injection. Furthermore, such local effects may occur in a minority of cases and are usually treated conservatively with ice, non-steroidal anti-inflammatory drugs, and relative rest.
CONDITIONS
Official Title
New Treatment of Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily given informed consent to participate and allow data recording and verification.
- Male or female aged 35 to 85 years inclusive.
- Diagnosed with knee osteoarthritis by American College of Rheumatology clinical and radiographic criteria.
- Non-severe Grade 2 to 3 knee osteoarthritis confirmed by X-rays within 6 months before screening.
- Experiencing knee osteoarthritis symptoms in the target knee for at least 6 months prior to screening.
- Knee pain on walking on flat ground between 40 mm and 80 mm measured on a 0-100 mm visual analog scale at baseline.
- Treatment failure with first-line oral NSAIDs.
- Women of childbearing potential must have a negative urine pregnancy test before each injection.
- Able to comply with study requirements as judged by the Investigator.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Bilateral knee osteoarthritis if the non-target knee has VAS pain greater than 30 mm, KL score greater than 2, or uses dedicated pain relief medicine.
- Severe or progressive diseases or other pathologies interfering with study evaluation, including diabetes, autoimmune diseases, cardiac conditions, liver deficiency, epilepsy, porphyria, rheumatoid arthritis, or systemic inflammatory conditions.
- History of severe multiple allergies, angioedema, or anaphylactic shock.
- Allergy or hypersensitivity to hyaluronic acid or bovine collagen.
- History or active streptococcal infection.
- Infections, inflammation, or skin disease at the injection site.
- Disorders affecting wound healing such as connective tissue or immunosuppressive disorders.
- Received chemotherapy or immunosuppressive drugs within the past 3 months.
- Bleeding disorders or use of antiplatelet or anticoagulant medication within 24 hours before injections.
- Received intra-articular steroid injections within 60 days or oral corticosteroids within 4 weeks before or during study.
- Use of chondroitinsulphate, glucosamine sulphate, diacereine, bisphosphonates, or MMP inhibitors within 30 days before baseline.
- Received viscosupplementation in the target knee within 6 months before baseline.
- Use of any pain relief medicine or NSAIDs within 24 hours before baseline.
- KL grade 4 patellofemoral osteoarthritis or higher patellofemoral grade than femorotibial.
- Coxarthrosis.
- Knee surgery in the target knee within 6 months before screening or planned during study.
- Previous knee arthroplasty in the target knee.
- Diagnostic or surgical knee arthroscopy or lavage in the target knee within 6 months before screening.
- Candidate for knee replacement during the study period.
- Body mass index over 35 kg/m2.
- Large intra-articular effusion, venous or lymphatic stasis, inflammatory flare-up, or local inflammation in the target knee.
- History of septic osteoarthritis of any joint.
- Significant pain outside the target knee including hip, back pain, or fibromyalgia.
- Clinically significant knee deformities, ligament laxity, or meniscal instability.
- Other musculoskeletal conditions affecting target knee assessment.
- Current malignancy or treatment for malignancy except non-melanoma skin cancer.
- Drug or alcohol abuse.
- Legal or administrative deprivation of freedom.
- Living in social or sanitary establishments.
- Current or recent participation in another investigational drug study within 3 months.
- Other conditions preventing participation or compliance as judged by the Investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
IRIS CRO
Mtskheta, Georgia, Georgia, 3300
Not Yet Recruiting
2
IRIS CRO
Riga, Latvia, Latvia, 1002
Actively Recruiting
Research Team
C
Carla LIPPENS
CONTACT
S
Sébastien GUYON
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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