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

i+Med S.Coop.

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: Hyalone®; Device: TrHCROSS®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06975631

TrHCROSS-PIC01-2021

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

TrHCROSS®

Experimental group

Description:

Class II medical device based on a sterile viscoelastic solution of cross-linked sodium hyaluronate, indicated as an intra-articular viscoelastic supplement for the treatment of osteoarthritis symptoms

Treatment:

Device: TrHCROSS®

Hyalone®

Active Comparator group

Description:

Class II medical device based on a sterile sodium hyaluronate solution that restores the viscoelastic properties of synovial fluid, relieving pain and improving mobility in degenerative joint disorders

Treatment:

Device: Hyalone®