Knee OsteoarthritisNCT06975631
Post-market Study on TrHCROSS® in Knee Osteoarthritis After a Single Injection
A study testing TrHCROSS® and Hyalone® in people with Knee Osteoarthritis, run by i+Med S.Coop. at 1 site in Spain.
Trial summary
Double-blind study assessing the safety and efficacy of TrHCROSS® in knee osteoarthritis, compared to Hyalone®, using scales such as WOMAC, VAS, and KOOS. The population includes 60 symptomatic patients with mild to moderate KOA (Kellgren-Lawrence II or III) who have not responded adequately to non-pharmacological… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- TrHCROSS® and Hyalone®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2022to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 18 and 80 years of age.
- Body mass index <40 kg/m².
- Diagnosis of knee osteoarthritis (KOA). The stage must be radiographically confirmed (Kellgren-Lawrence grade II or III) within 6 months prior to study entry.
- Persistent pain reported during the 3 months prior to recruitment and moderate to severe pain when walking on inclines or stairs, or at rest (VAS score ≥40) at baseline.
- History of analgesic use (paracetamol and/or NSAIDs) related to the study condition.
- Willingness and ability to complete questionnaires and understand study instructions.
- Signed informed consent specific to the study.
Who cannot join
- X-rays showing grade IV changes on the Kellgren-Lawrence scale.
- Severe functional impairment in the knee.
- Bilateral involvement (simultaneous involvement of both knees).
- Associated hip osteoarthritis.
- Clinically significant pain in joints other than the knee.
- Psoriasis.
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- Patients with confirmed rheumatic joint disease.
- Active infection.
- Known or suspected use of intra-articular steroids within the previous 3 months, or intra-articular HA or PRP within the 9 months prior to treatment initiation, as well as the use of chondroprotective agents.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-market Study for the Evaluation of the Effectiveness and Safety of Treatment With TrHCROSS by i+Med in Knee Osteoarthritis After a Single Intra-articular Administration
Double-blind study assessing the safety and efficacy of TrHCROSS® in knee osteoarthritis, compared to Hyalone®, using scales such as WOMAC, VAS, and KOOS. The population includes 60 symptomatic patients with mild to moderate KOA (Kellgren-Lawrence II or III) who have not responded adequately to non-pharmacological treatments or simple analgesics.
- Conditions
- Knee Osteoarthritis
- Being tested
- TrHCROSS®, Hyalone®
- Keywords
- KOA, Osteoarthritis, Knee, Sodium Hyaluronate, WOMAC, VAS, KOOS
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrHCROSS®Device
Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked.
Hyalone®Device
Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked
| Study group | Role | What they receive |
|---|---|---|
| TrHCROSS® | Experimental | Class II medical device based on a sterile viscoelastic solution of cross-linked sodium hyaluronate, indicated as an intra-articular viscoelastic supplement for the treatment of osteoarthritis symptoms Receives: Device: TrHCROSS® |
| Hyalone® | Active comparator | Class II medical device based on a sterile sodium hyaluronate solution that restores the viscoelastic properties of synovial fluid, relieving pain and improving mobility in degenerative joint disorders Receives: Device: Hyalone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of TrHCROSS® for pain relief in patients with KOA.
Comparison of TrHCROSS® with Hyalone®, with significant improvement considered if there was a change of ≥50% and ≥5 points in the WOMAC A pain score.
The WOMAC A questionnaire is divided into five items to measure pain, with a scoring range from 0 to 20, where 0 represents the least amount of pain and 20 represents the most intense pain.
Measured: In 24 weeks.
Serious adverse events.
Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.
Measured: Through study completion, approximately 52 weeks.
Secondary outcomes (13)
Pain relief using WOMAC A.
Evaluate the effectiveness of TrHCROSS® in pain relief at 52 weeks using the WOMAC A pain score, and compare it with Hyalone®. The WOMAC A questionnaire consists of five items to assess pain, with a scoring range from 0 to 20, where 0 indicates minimal pain and 20 represents the most severe pain.
Measured: At the conclusion of the study, approximately 52 weeks later.
Stiffness using WOMAC B.
Assess the effectiveness of TrHCROSS® in reducing stiffness at 24 and 52 weeks using the WOMAC B stiffness score, and compare it with Hyalone®. The WOMAC B questionnaire ranges from 0 to 8, where a lower score reflects less stiffness and a higher score indicates more severe stiffness.
Measured: In 24 weeks and in 52 weeks.
Functionality using WOMAC C.
Evaluate the effectiveness of TrHCROSS® in improving functionality at 24 and 52 weeks using the WOMAC C functionality score, and compare it with Hyalone®. The WOMAC C questionnaire has a scoring range from 0 to 68, where a lower score indicates less difficulty and a higher score indicates greater difficulty.
Measured: In 24 weeks and in 52 weeks.
Global Patient Assessment.
Analyze the global patient assessment after administration of the study treatment with VAS and compare it with the one obtained after administration of Hyalone®.
The Visual Analogue Scale (VAS) allows for the assessment of the patient's overall evaluation, ranging from 0 to 100 mm, with 0 indicating the best outcome and 100 the worst outcome.
Measured: In 24 weeks and in 52 weeks.
Combined WOMAC and VAS scales.
Evaluate the combined WOMAC and VAS scales from baseline at all follow-up visits (weeks 24 and 52). The VAS is measured in mm (from 0 to 100), while the WOMAC uses a Likert scale to provide a total score.
Measured: At baseline, in 24 weeks and in 52 weeks.
Improvement in pain score.
Analyze the improvement in pain scores (WOMAC A) from baseline (at least 40% and ≥5 points) in each treatment group separately. The WOMAC A questionnaire consists of five items to assess pain, with a scoring range from 0 to 20, where 0 indicates minimal pain and 20 represents the most severe pain.
Measured: At baseline, in 24 weeks and in 52 weeks.
Improvement in KOOS scores.
Analyze the significant improvement in KOOS scores from baseline in each treatment group separately.
The KOOS scale is divided into subscales that are scored individually: Pain, Other Symptoms, Daily Activities, Function, Sports/Recreational Activities, and Quality of Life. A Likert scale is used, and all items have five possible options ranging from 0 (No problems) to 4 (Extreme problems). Each of the five scores is calculated as the sum of the items included
Measured: At baseline, in 24 weeks and in 52 weeks.
Treatment response rate.
Calculate the treatment response rate at all follow-up visits (weeks 24 and 52) according to the OMERACT-OARSI criteria and compare it with Hyalone®. A responder is defined as having at least a 50% improvement and an absolute change of ≥20mm in pain or functionality, or improvement in two of the three subscales with ≥20% and ≥10mm change in the VAS scales for pain, functionality, and overall patient evaluation.
Measured: At baseline, in 24 weeks and in 52 weeks.
Patient satisfaction with treatment.
Evaluate patient satisfaction with the treatment using a Likert scale with 5 options: Very satisfied, Satisfied, Slightly satisfied, Indifferent, and Dissatisfied. The percentage of patients who rate their satisfaction as 'Very satisfied,' 'Satisfied,' and 'Slightly satisfied' will be calculated.
Measured: At the conclusion of the study, approximately 52 weeks later.
Other adverse events.
Analyze and record the incidence of other adverse events to ensure it does not exceed the pre-established threshold of 18%.
Measured: Through study completion, approximately 52 weeks.
Analgesic use.
Monitor the need for analgesic use.
Measured: Through study completion, approximately 52 weeks.
Joint mobility.
Evaluate joint mobility by measuring the joint range with a goniometer and assess its progression from baseline to the follow-up visits.
Measured: At baseline, in 24 weeks and in 52 weeks.
Investigator´s global assessment.
For the overall treatment evaluation by the investigator, a Likert scale with 5 options will be used: Significant improvement, Improvement, Slight improvement, No change, and Worsening. Patients classified by the investigator as having a perceived global change after treatment of 'slight improvement,' 'improvement,' or 'significant improvement' will be identified as having a clinically relevant improvement.
Measured: At the conclusion of the study, approximately 52 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start2 Jun 2022
- Primary completion10 Aug 2023
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Model description
- Non-inferiority, controlled, interventional, randomized, parallel-group, single-blind, and single-center clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Araba, Bioaraba Health Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975631
- Sponsor's protocol ID
- TrHCROSS-PIC01-2021
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study for the Evaluation of the Effectiveness and Safety of Treatment With TrHCROSS by i+Med in Knee Osteoarthritis After a Single Intra-articular Administration
- ClinicalTrials.gov ID
- NCT06975631
- Acronym / sponsor ID
- TrHCROSS-PIC01-2021
- Conditions
- Knee Osteoarthritis
- Keywords
- KOA, Osteoarthritis, Knee, Sodium Hyaluronate, WOMAC, VAS, KOOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Araba, Bioaraba Health Research Institute
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 16 May 2025 (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.
Double-blind study assessing the safety and efficacy of TrHCROSS® in knee osteoarthritis, compared to Hyalone®, using scales such as WOMAC, VAS, and KOOS. The population includes 60 symptomatic patients with mild to moderate KOA (Kellgren-Lawrence II or III) who have not responded adequately to non-pharmacological treatments or simple analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Non-inferiority, controlled, interventional, randomized, parallel-group, single-blind, and single-center clinical trial
| Arm | Type | Receives |
|---|---|---|
| TrHCROSS® | Experimental | Device: TrHCROSS®Class II medical device based on a sterile viscoelastic solution of cross-linked sodium hyaluronate, indicated as an intra-articular viscoelastic supplement for the treatment of osteoarthritis symptoms |
| Hyalone® | Active comparator | Device: Hyalone®Class II medical device based on a sterile sodium hyaluronate solution that restores the viscoelastic properties of synovial fluid, relieving pain and improving mobility in degenerative joint disorders |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women between 18 and 80 years of age.
- Body mass index <40 kg/m².
- Diagnosis of knee osteoarthritis (KOA). The stage must be radiographically confirmed (Kellgren-Lawrence grade II or III) within 6 months prior to study entry.
- Persistent pain reported during the 3 months prior to recruitment and moderate to severe pain when walking on inclines or stairs, or at rest (VAS score ≥40) at baseline.
- History of analgesic use (paracetamol and/or NSAIDs) related to the study condition.
Key exclusion criteria (10 listed)
- X-rays showing grade IV changes on the Kellgren-Lawrence scale.
- Severe functional impairment in the knee.
- Bilateral involvement (simultaneous involvement of both knees).
- Associated hip osteoarthritis.
- Clinically significant pain in joints other than the knee.
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 injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked. | Device | TrHCROSS® |
| Hyalone®Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked | Device | Hyalone® |
Primary outcome
Evaluate the effectiveness of TrHCROSS® for pain relief in patients with KOA.
Time frame: In 24 weeks.
Comparison of TrHCROSS® with Hyalone®, with significant improvement considered if there was a change of ≥50% and ≥5 points in the WOMAC A pain score. The WOMAC A questionnaire is divided into five items to measure pain, with a scoring range from 0 to 20, where 0 represents the least amount of pain and 20 represents the most intense pain.
Serious adverse events.
Time frame: Through study completion, approximately 52 weeks.
Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.
13 secondary outcomes
Pain relief using WOMAC A.
Time frame: At the conclusion of the study, approximately 52 weeks later.
Stiffness using WOMAC B.
Time frame: In 24 weeks and in 52 weeks.
Functionality using WOMAC C.
Time frame: In 24 weeks and in 52 weeks.
Global Patient Assessment.
Time frame: In 24 weeks and in 52 weeks.
Combined WOMAC and VAS scales.
Time frame: At baseline, in 24 weeks and in 52 weeks.
Improvement in pain score.
Time frame: At baseline, in 24 weeks and in 52 weeks.
Improvement in KOOS scores.
Time frame: At baseline, in 24 weeks and in 52 weeks.
Treatment response rate.
Time frame: At baseline, in 24 weeks and in 52 weeks.
Patient satisfaction with treatment.
Time frame: At the conclusion of the study, approximately 52 weeks later.
Other adverse events.
Time frame: Through study completion, approximately 52 weeks.
Analgesic use.
Time frame: Through study completion, approximately 52 weeks.
Joint mobility.
Time frame: At baseline, in 24 weeks and in 52 weeks.
Investigator´s global assessment.
Time frame: At the conclusion of the study, approximately 52 weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrHCROSS® and Hyalone® in people with Knee Osteoarthritis, run by i+Med S.Coop. at 1 site in Spain.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of TrHCROSS® for pain relief in patients with KOA. (time frame: In 24 weeks.). 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 21 May 2025.