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Clinical Evaluation of TrHCROSS® for Different Joints
Sponsor: i+Med S.Coop.
Summary
This post-market clinical investigation is designed to evaluate the safety and effectiveness of TrHCROSS®, a CE-marked cross-linked hyaluronic acid viscosupplement, in patients with mild to moderate osteoarthritis of the knee, hip, or shoulder who have experienced an inadequate response to conservative treatments and standard analgesic therapy. The study is a prospective, randomized, single-blind, active-controlled, non-inferiority trial enrolling 150 participants, who will receive a single intra-articular injection of either TrHCROSS® or a reference viscosupplement and will be followed for 12 months. The primary effectiveness endpoint is pain reduction at 24 weeks, while safety will be assessed through the incidence of treatment-related serious adverse events. Secondary and exploratory assessments will evaluate changes in pain, joint function, mobility, quality of life, patient satisfaction, investigator global assessment, rescue medication use, and the occurrence of adverse events over 52 weeks. Outcomes will be measured using validated, joint-specific instruments, including WOMAC and KOOS for knee osteoarthritis, WOMAC and HOOS for hip osteoarthritis, and SPADI and WOSI for shoulder osteoarthritis. The results of this investigation are intended to generate post-market clinical evidence supporting the safety and clinical performance of TrHCROSS® across different joint indications and to further characterize its benefit-risk profile in routine clinical practice.
Official title: Post-Marketing Clinical Investigation to Evaluate the Safety and Effectiveness of the Certified Medical Device TrHCROSS® for Use in Different Joints
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-12-01
Completion Date
2028-01-30
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
TrHCROSS®
Single intra-articular injection of TrHCROSS® for the treatment of osteoarthritis-related symptoms in the target joint.
Monovisc
Single intra-articular injection of a CE-marked hyaluronic acid viscosupplement used as the active comparator for the treatment of osteoarthritis-related symptoms in the target joint.