New Treatment of Knee Osteoarthritis
Eligible age
35–85 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Symatese
You may qualify if…
- ✓ 1\. Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- ✓ 2\. Male and female subjects, aged 35 to 85 years (inclusive).
- ✓ 3\. Subjects affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for OA of the knee, and meeting the following conditions:
- ✓ 1. Non-severe Grade 2 to 3 osteoarthritis of the knee according to the Kellgren-Lawrence (KL) classification, confirmed by an extension face X-rays shot, supported by flexion face X-rays shot (optional) obtained within 6 months from the screening visit.
- ✓ 2. Subjects suffering from OA symptoms of the target knee for at least 6 months prior to the screening visit.
- ✓ 4\. Pain during walking on flat ground in the target knee of at least 40 mm and maximum 80 mm on a 0-100 mm VAS at the baseline visit (Visit 2).
- ✓ 5\. Subjects in treatment failure of first line treatment with oral NSAIDS
- ✓ 6\. Women of childbearing potential must have a negative urine pregnancy test prior to each injection.
You may not qualify if…
- ✕ \- 1. Pregnant and breastfeeding women
- ✕ 2\. Subject with bilateral OA of the knees is excluded if one of the following points is present on the non-targeted knee has:
- ✕ a visual analog scale (VAS) score greater than 30mm (\> 30mm),
- ✕ a KL score is greater than 2 (\>2)
- ✕ a dedicated pain relief medicine consumption.
- ✕ 3\. Subject suffering from a severe or progressive disease or any other pathology which, according to the investigator, may interfere with evaluation of the results of the study: diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria, rheumatoid arthritis or other systemic inflammatory process.
- ✕ 4\. Subject who has a known history of severe multiple allergies, angioedema or anaphylactic shock according to the investigator opinion.
- ✕ 5\. Subject with a known allergy or hypersensitivity to Hyaluronic Acid or bovine collagen.
Where it's recruiting
Mtskheta
Source: ClinicalTrials.gov · NCT06611098 · last updated 2025-02-26