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Completed

NCT Number: NCT06975631

Post-market Study on TrHCROSS® in Knee Osteoarthritis After a Single Injection

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Álava

Vitoria-Gasteiz, Álava, 01009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pain relief using WOMAC A.

    Time frame: At the conclusion of the study, approximately 52 weeks later.

    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.

  2. Stiffness using WOMAC B.

    Time frame: In 24 weeks and in 52 weeks.

    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.

  3. Functionality using WOMAC C.

    Time frame: In 24 weeks and in 52 weeks.

    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.

  4. Global Patient Assessment.

    Time frame: In 24 weeks and in 52 weeks.

    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.

  5. Combined WOMAC and VAS scales.

    Time frame: At baseline, in 24 weeks and in 52 weeks.

    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.

  6. Improvement in pain score.

    Time frame: At baseline, in 24 weeks and in 52 weeks.

    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.

  7. Improvement in KOOS scores.

    Time frame: At baseline, in 24 weeks and in 52 weeks.

    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

  8. Treatment response rate.

    Time frame: At baseline, in 24 weeks and in 52 weeks.

    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.

  9. Patient satisfaction with treatment.

    Time frame: At the conclusion of the study, approximately 52 weeks later.

    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.

  10. Other adverse events.

    Time frame: Through study completion, approximately 52 weeks.

    Analyze and record the incidence of other adverse events to ensure it does not exceed the pre-established threshold of 18%.

  11. Analgesic use.

    Time frame: Through study completion, approximately 52 weeks.

    Monitor the need for analgesic use.

  12. Joint mobility.

    Time frame: At baseline, in 24 weeks and in 52 weeks.

    Evaluate joint mobility by measuring the joint range with a goniometer and assess its progression from baseline to the follow-up visits.

  13. Investigator´s global assessment.

    Time frame: At the conclusion of the study, approximately 52 weeks later.

    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.

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Collaborators

  • Bioaraba Health Research Institute
  • Hospital Universitario Araba

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 16, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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