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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Investigation to Evaluate the Safety and Effectiveness of the Certified Medical Device TrHCROSS® for Use in Different Joints
- ClinicalTrials.gov ID
- NCT07870031
- Acronym / sponsor ID
- TrHCROSS-PIC01-2025
- Keywords
- TrHCROSS®, Osteoarthritis, Viscosupplementation, Intra-articular Injection, Knee Osteoarthritis, Hip Osteoarthritis, Shoulder Osteoarthritis, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TrHCROSS® | Experimental | Other: TrHCROSS®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. |
| MONOVISC® | Active comparator | Other: MonoviscParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrHCROSS®Single intra-articular injection of TrHCROSS® for the treatment of osteoarthritis-related symptoms in the target joint. | Other | TrHCROSS® |
| MonoviscSingle 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. | Other | MONOVISC® |
Primary outcome
Change from Baseline in Joint-Specific Functional Score (WOMAC or SPADI)
Time frame: Baseline to Week 24
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.
Incidence of Device-Related Serious Adverse Events (SAEs)
Time frame: Baseline to Week 52
The number and proportion of participants experiencing device-related serious adverse events during the study period will be recorded and analyzed.
5 secondary outcomes
Change from Baseline in Joint Function (KOOS, HOOS, or SPADI Score)
Time frame: Baseline to Week 52
Change from Baseline in Pain Intensity (VAS Score)
Time frame: Baseline to Week 52
Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)
Time frame: Baseline to Week 52
Patient Global Assessment of Treatment Effectiveness
Time frame: Week 52
Investigator Global Assessment of Clinical Improvement
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberto Gómez, Dr principal investigator
Centro Médico Complutense Grupo Virtus
Questions about this trial
What is this clinical trial studying?
A study testing TrHCROSS® and Monovisc in people with Joint Osteoarthritis and Knee Osteoarthristis, run by i+Med S.Coop..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josune Torrecilla, Dr (+34945561134, jtorrecilla@imasmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Joint-Specific Functional Score (WOMAC or SPADI) (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.