Joint OsteoarthritisNCT07870031
Clinical Evaluation of TrHCROSS® for Different Joints
A study testing TrHCROSS® and Monovisc in people with Joint Osteoarthritis and Knee Osteoarthristis, run by i+Med S.Coop..
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Joint Osteoarthritis, Knee Osteoarthristis, Hip Ostearthritis
- What is being tested?
- TrHCROSS® and Monovisc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Presence of signs and symptoms consistent with active osteoarthritis (symptomatic flare), defined by joint pain and at least one of the following:
- Morning joint stiffness lasting less than 30 minutes.
- Functional limitation of the affected joint.
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- Tenderness or pain on joint movement.
- Decreased range of motion of the affected joint.
- Previous treatment with non-pharmacological conservative therapy, including one or more of the following measures, as deemed appropriate by the physician: physiotherapy, therapeutic exercise, patient education, or physical activity modifications, and/or inadequate response, intolerance, or contraindication to conventional analgesic treatment, including paracetamol and/or non-steroidal anti-inflammatory drugs (NSAIDs), administered for the management of osteoarthritis symptoms prior to enrollment.
- Willingness and ability to complete study questionnaires and understand study instructions.
Who cannot join
- 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.
- History of allergy or intolerance to hyaluronic acid.
- Patients with autoimmune diseases or severe metabolic disorders.
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- Planned hip, shoulder, or knee replacement surgery, or previous surgical treatment of the hip, shoulder, or knee.
- History of thrombocytopenia or current use of anticoagulant therapy.
- Women of childbearing potential, pregnant women, or breastfeeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Post-Marketing Clinical Investigation to Evaluate the Safety and Effectiveness of the Certified Medical Device TrHCROSS® for Use in Different Joints
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.
- Being tested
- TrHCROSS®, Monovisc
- Keywords
- TrHCROSS®, Osteoarthritis, Viscosupplementation, Intra-articular Injection, Knee Osteoarthritis, Hip Osteoarthritis, Shoulder Osteoarthritis, Hyaluronic Acid
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrHCROSS®Other
Single intra-articular injection of TrHCROSS® for the treatment of osteoarthritis-related symptoms in the target joint.
MonoviscOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TrHCROSS® | Experimental | 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. Receives: Other: TrHCROSS® |
| MONOVISC® | Active comparator | 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. Receives: Other: Monovisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 52
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Responsible party
- Sponsor
- Investigators
- Alberto Gómez, Dr, Principal investigator, Centro Médico Complutense Grupo Virtus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870031
- Sponsor's protocol ID
- TrHCROSS-PIC01-2025
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No