An interventional study of TrHCROSS® and Monovisc in Joint Osteoarthritis, Knee Osteoarthristis and Hip Ostearthritis, sponsored by i+Med S.Coop.. Not yet recruiting. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by i+Med S.Coop. · Not applicable, Interventional, and Treatment
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →i+Med S.Coop. is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: TrHCROSS®
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.
Other: Monovisc
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.
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.
Time frame: 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.
Time frame: Baseline to Week 52
Change from Baseline in Joint Function (KOOS, HOOS, or SPADI Score)
Joint function will be evaluated using the KOOS questionnaire for knee osteoarthritis, the HOOS questionnaire for hip osteoarthritis, or the SPADI questionnaire for shoulder disorders. General scores are analyzed according to validated methodology. The outcome measure will be the change from baseline score.
Time frame: Baseline to Week 52
Change from Baseline in Pain Intensity (VAS Score)
Pain intensity in the target joint will be assessed using a 100-mm Visual Analogue Scale (VAS), where 0 represents "no pain" and 100 represents "worst imaginable pain." The outcome measure will be the change from baseline in the VAS score. A negative change indicates an improvement in pain.
Time frame: Baseline to Week 52
Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher index scores indicate a better health status. The outcome measure will be the change from baseline score.
Time frame: Baseline to Week 52
Patient Global Assessment of Treatment Effectiveness
Participants will rate their overall perception of treatment effectiveness on a 5-point Likert scale ranging from "very much worse" to "very much improved." Higher scores indicate greater perceived improvement.
Time frame: Week 52
Investigator Global Assessment of Clinical Improvement
The investigator will evaluate overall clinical improvement using a 5-point Likert scale ranging from "very much worse" to "very much improved." Higher scores indicate greater clinical improvement.
Time frame: Week 52
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2028, 13 months later.
Of 189 industry-sponsored interventional studies with no phase under Osteoarthritis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 13 months is below that.
Counting every sponsor, half of 1,315 studies reached it within 19 months; a quarter within 8 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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i+Med S.Coop.