Safety and Effectiveness of Intra-articular Injection of a Cross-linked Sodium Hyaluronate in Knee Osteoarthritis: A Randomized, Prospective, Double-blind, Placebo-controlled, Cross-over, Post-marketing Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis.
Primary objectives: The aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of SEMICAL GEL B-CROSS, produced and marketed by Semical Biosurgery incorporated company, in knee osteoarthritis patients.
It is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. Participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (SEMICAL GEL-B CROSS); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.
详细描述
The study is a randomized controlled, double-blind, two-armed, single-center and cross-over study. After a maximum screening period of 28 days, patients with Kellgren & Lawrence Stage II and III knee osteoarthritis will be randomly assigned to one of the two treatment arms on the day of injection, which is considered Day 0. These treatment arms are:
Group 1: Treatment Arm - Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)
Group 2: Control Arm - Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) A safety visit will be made 7-10 days after administration of the treatment injection and the injection site will be visually evaluated for local reactions. In addition, an inquiry for injection-related adverse events will also be conducted.
Treatment responses of patients in both groups will be evaluated by a separate researcher blinded to study treatment with predefined objective response criteria.
At the 3rd month visit, the patients in both groups will be crossed-over and those who received a placebo at baseline will receive a hyaluronic acid injection at the 3rd month, while those who receive a hyaluronic acid injection at baseline will receive a placebo at the 3rd month. Efficacy evaluations will continue to be made at every three months for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and over, both male and female
- •Diagnosed with clinical knee osteoarthritis according to the American College of
- •Rheumatology (ACR) criteria, with Kellgren & Lawrence stage II and III osteoarthritic findings on antero-posterior knee radiographs
- •Able to provide written informed consent
排除标准
- 未提供
研究组 & 干预措施
Cross-linked intra-articular hyaluronic acid
Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)
干预措施: Cross-linked intra-articular hyaluronic acid (Device)
Placebo
Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) at the same dose as the treatment arm
干预措施: Placebo (Other)
结局指标
主要结局
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores
时间窗: Baseline, 3 months, 6 months, 9 months, and 12 months.
The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.
次要结局
- Changes in knee flexor muscle strength(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Changes in knee functions(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in the need for analgesic drug from pre-treatment to post-treatment(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in quality of life(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Local reactions in the injection site(7-10 days post-injection)
- Changes in knee extensor muscle strength(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in knee pain during movement and rest(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Changes in knee functions during 5 times sit to stand test(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Changes in knee functions by 6MWT (6 Minute Walking Test)(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Adverse events throughout the entire study period(Through study completion, an average of 1 year.)