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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
University Hospital of Álava
Vitoria-Gasteiz, Álava, Spain
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.
Time frame: In 24 weeks.
Serious adverse events.
Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.
Time frame: Through study completion, approximately 52 weeks.
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.
Time frame: 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.
Time frame: 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.
Time frame: In 24 weeks and in 52 weeks.
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: Through study completion, approximately 52 weeks.
Analgesic use.
Monitor the need for analgesic use.
Time frame: 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.
Time frame: 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.
Time frame: At the conclusion of the study, approximately 52 weeks later.