Post-Marketing Clinical Investigation to Evaluate the Safety and Effectiveness of the Certified Medical Device TrHCROSS® for Use in Different Joints
Sponsor study identifier
interventional
150
0 countries
N/A
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2026
Actual (reported)October 13, 2026
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from Baseline in Joint-Specific Functional Score (WOMAC or SPADI)
Clinical effectiveness will be assessed using joint-specific validated patient-reported outcome measures. For knee and hip osteoarthritis, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to evaluate pain, stiffness, and physical function. For shoulder osteoarthritis, the Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability. For both instruments, the primary endpoint will be the change from baseline in the total score at Week 24. Greater reductions in score indicate an improvement in symptoms and functional status.
Baseline to Week 24
Incidence of Device-Related Serious Adverse Events (SAEs)
The number and proportion of participants experiencing device-related serious adverse events during the study period will be recorded and analyzed.
Baseline to Week 52
Participants will receive a single intra-articular injection of TrHCROSS® according to the approved Instructions for Use and the investigator's clinical judgment. The treated joint may be the knee, hip, or shoulder, depending on the patient's osteoarthritis localization.
Participants will receive a single intra-articular injection of a commercially available CE-marked hyaluronic acid viscosupplement used as the reference treatment, administered according to its approved Instructions for Use and the investigator's clinical judgment. The treated joint may be the knee, hip, or shoulder, depending on the patient's osteoarthritis localization.
Single intra-articular injection of TrHCROSS® for the treatment of osteoarthritis-related symptoms in the target joint.
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.
Alberto Gómez, Dr
Centro Médico Complutense Grupo Virtus
First Submitted
October 6, 2026
First Posted
October 13, 2026
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 1, 2028
MONOVISC for Shoulder Joint Pain Relief Due to Osteoarthritis
Change from Baseline in Joint Function (KOOS, HOOS, or SPADI Score)
Baseline to Week 52
Change from Baseline in Pain Intensity (VAS Score)
Baseline to Week 52
Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)
Baseline to Week 52
Patient Global Assessment of Treatment Effectiveness
Week 52
Investigator Global Assessment of Clinical Improvement
Week 52
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 13, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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