Clinical Evaluation of TrHCROSS® for Different Joints
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
Sponsori+Med S.Coop.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects aged 55 years or older.
Diagnosis of symptomatic osteoarthritis of the knee, hip, or shoulder (Kellgren-Lawrence (KL) II o III)
Presence of pain in the affected joint for at least 3 months prior to screening, with a pain intensity of ≥40 mm on a 0-100 Visual Analog Scale (VAS), or equivalent, at the baseline visit.
Morning joint stiffness lasting less than 30 minutes.
Disqualifiers
Clinically significant pain in joints other than the shoulder, hip, or knee.
Patients with documented rheumatic joint disease.
Active infection around the injection site.
Known or suspected use of intra-articular corticosteroids within the previous 3 months, or intra-articular hyaluronic acid (HA) or platelet-rich plasma (PRP) within the previous 9 months before treatment initiation, as well as the use of chondroprotective agents.
Trial design
Design model
Parallel
Treatments tested in this trial
TrHCROSS®
Other interventionSingle intra-articular injection of TrHCROSS® for the treatment of osteoarthritis-related symptoms in the target joint.
Monovisc
Other interventionSingle 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: TrHCROSS®Experimental treatment 1 intervention
Group B: MONOVISC®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 242
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 52Secondary outcomes
1
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 522
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 523
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 524
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 52Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
i+Med S.Coop.
Lead sponsor
Dr. Goya Análisis, SL.
Collaborator
Source ClinicalTrials.gov
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