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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serious adverse events.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: TrHCROSS® (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
干预措施: Hyalone® (Device)
结局指标
主要结局
Serious adverse events.
时间窗: Through study completion, approximately 52 weeks.
Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.
Evaluate the effectiveness of TrHCROSS® for pain relief in patients with KOA.
时间窗: 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.
次要结局
- Pain relief using WOMAC A.(At the conclusion of the study, approximately 52 weeks later.)
- Stiffness using WOMAC B.(In 24 weeks and in 52 weeks.)
- Functionality using WOMAC C.(In 24 weeks and in 52 weeks.)
- Global Patient Assessment.(In 24 weeks and in 52 weeks.)
- Combined WOMAC and VAS scales.(At baseline, in 24 weeks and in 52 weeks.)
- Improvement in pain score.(At baseline, in 24 weeks and in 52 weeks.)
- Improvement in KOOS scores.(At baseline, in 24 weeks and in 52 weeks.)
- Treatment response rate.(At baseline, in 24 weeks and in 52 weeks.)
- Patient satisfaction with treatment.(At the conclusion of the study, approximately 52 weeks later.)
- Other adverse events.(Through study completion, approximately 52 weeks.)
- Analgesic use.(Through study completion, approximately 52 weeks.)
- Joint mobility.(At baseline, in 24 weeks and in 52 weeks.)
- Investigator´s global assessment.(At the conclusion of the study, approximately 52 weeks later.)