Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Universitario Araba | OTHER |
| Bioaraba Health Research Institute | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrHCROSS® | Device | Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | In 24 weeks. |
| Serious adverse events. | Evaluate the safety of the treatment, in terms of the incidence of serious adverse events. | Through study completion, approximately 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the conclusion of the study, approximately 52 weeks later. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Álava | Vitoria-Gasteiz | Álava | 01009 | Spain |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Non-inferiority, controlled, interventional, randomized, parallel-group, single-blind, and single-center clinical trial
Not provided
Not provided
Not provided
| Hyalone® | Device | Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked |
|
| 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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%. | Through study completion, approximately 52 weeks. |
| Analgesic use. | Monitor the need for analgesic use. | 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. | 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. | At the conclusion of the study, approximately 52 weeks later. |