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

NCT06975631 | Completed

• 1 other identifier: TrHCROSS-PIC01-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

KOA; Osteoarthritis; Knee; Sodium Hyaluronate; WOMAC; VAS; KOOS

Outcome Measures

Primary Outcomes (2)

• Evaluate the effectiveness of TrHCROSS® for pain relief in patients with KOA.

  Comparison of TrHCROSS® with Hyalone®, with significant improvement considered if there was a change of ≥50% and ≥5 points in the WOMAC A pain score. The WOMAC A questionnaire is divided into five items to measure pain, with a scoring range from 0 to 20, where 0 represents the least amount of pain and 20 represents the most intense pain.

  In 24 weeks.

• Serious adverse events.

  Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.

  Through study completion, approximately 52 weeks.

Secondary Outcomes (13)

• Pain relief using WOMAC A.

  At the conclusion of the study, approximately 52 weeks later.

• Stiffness using WOMAC B.

  In 24 weeks and in 52 weeks.

• Functionality using WOMAC C.

  In 24 weeks and in 52 weeks.

• Global Patient Assessment.

  In 24 weeks and in 52 weeks.

• Combined WOMAC and VAS scales.

  At baseline, in 24 weeks and in 52 weeks.

Study Arms (2)

TrHCROSS®

EXPERIMENTAL

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

Device: TrHCROSS®

Hyalone®

ACTIVE COMPARATOR

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

Device: Hyalone®

Interventions

TrHCROSS® DEVICE

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

TrHCROSS®

Hyalone® DEVICE

Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked

Hyalone®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• i+Med S.Coop.: lead
• Hospital Universitario Araba: collaborator
• Bioaraba: collaborator

Study Sites (1)

University Hospital of Álava

Vitoria-Gasteiz, Álava, 01009, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-inferiority, controlled, interventional, randomized, parallel-group, single-blind, and single-center clinical trial

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 16, 2025
• Study Start: June 2, 2022
• Primary Completion: August 10, 2023
• Study Completion: February 14, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

ES (1)