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

NCT06975631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-21

No results posted yet for this study

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

Interventions

DEVICE

TrHCROSS®

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

DEVICE

Hyalone®

Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked

Sponsors & Collaborators

  • Hospital Universitario Araba

    collaborator OTHER

  • Bioaraba

    collaborator UNKNOWN

  • i+Med S.Coop.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-02
Primary Completion
2023-08-10
Completion
2024-02-14

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975631 on ClinicalTrials.gov