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

NCT ID: NCT06975631

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2024-02-14

Brief Summary

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TrHCROSS®

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

Group Type: EXPERIMENTAL

TrHCROSS®

Intervention Type: DEVICE

Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked.

Hyalone®

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

Group Type: ACTIVE_COMPARATOR

Hyalone®

Intervention Type: DEVICE

Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked

Interventions

TrHCROSS®

Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked.

Intervention Type: DEVICE

Hyalone®

Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Araba

OTHER

Sponsor Role: collaborator

Bioaraba

UNKNOWN

Sponsor Role: collaborator

i+Med S.Coop.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Álava

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

Other Identifiers

TrHCROSS-PIC01-2021

Identifier Type: -

Identifier Source: org_study_id