Post-market Study on TrHCROSS® in Knee Osteoarthritis After a Single Injection

Post-market Study for the Evaluation of the Effectiveness and Safety of Treatment With TrHCROSS by i+Med in Knee Osteoarthritis After a Single Intra-articular Administration

Double-blind study assessing the safety and efficacy of TrHCROSS® in knee osteoarthritis, compared to Hyalone®, using scales such as WOMAC, VAS, and KOOS. The population includes 60 symptomatic patients with mild to moderate KOA (Kellgren-Lawrence II or III) who have not responded adequately to non-pharmacological treatments or simple analgesics.

Inclusion Criteria:

• Men or women between 18 and 80 years of age.
• Body mass index <40 kg/m².
• Diagnosis of knee osteoarthritis (KOA). The stage must be radiographically confirmed (Kellgren-Lawrence grade II or III) within 6 months prior to study entry.
• Persistent pain reported during the 3 months prior to recruitment and moderate to severe pain when walking on inclines or stairs, or at rest (VAS score ≥40) at baseline.
• History of analgesic use (paracetamol and/or NSAIDs) related to the study condition.
• Willingness and ability to complete questionnaires and understand study instructions.
• Signed informed consent specific to the study.

Exclusion Criteria:

• X-rays showing grade IV changes on the Kellgren-Lawrence scale.
• Severe functional impairment in the knee.
• Bilateral involvement (simultaneous involvement of both knees).
• Associated hip osteoarthritis.
• Clinically significant pain in joints other than the knee.
• Psoriasis.
• Patients with confirmed rheumatic joint disease.
• Active infection.
• Known or suspected use of intra-articular steroids within the previous 3 months, or intra-articular HA or PRP within the 9 months prior to treatment initiation, as well as the use of chondroprotective agents.
• Pregnant women.