Effects and Safety of Single Versus Triple Hyaluronic Acid Injections in the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to directly compare two hyaluronic acid injection protocols in adults with knee osteoarthritis: a single intra-articular injection of Innoryos 2.5% (Single-Shot) and a three-week injection series of Innoryos 2.2% (Triple-Shot). The study aims to determine whether the single injection provides comparable safety, pain relief, and improvement in knee function to the triple-injection protocol.
The main questions are:
- How do the single-shot and triple-shot protocols compare in terms of pain reduction and functional improvement?
- How do their safety and tolerability profiles compare?
- What medical problems occur with each protocol? Participants (n = 46) will receive either the single 4.8 ml injection or three weekly 2 ml injections. They will attend clinic visits at baseline, Week 6, Week 12, and Week 24 for assessments including WOMAC score, 7-day pain diary, functional and strength tests, and MRI scans of the knee.
This single-center, partially blinded, randomized study will provide a direct comparison of the two HA injection protocols, assessing whether the single-shot approach is as safe and effective as the triple-shot regimen, while potentially offering a more convenient, patient-friendly treatment.
详细描述
Background:
Knee osteoarthritis (gonarthrosis) is a prevalent degenerative joint disease characterized by cartilage loss, joint pain, stiffness, and functional impairment, which significantly affects mobility and quality of life. Intra-articular injections of hyaluronic acid (HA) are a well-established conservative therapy to reduce pain, improve function, and potentially delay surgical interventions. Various HA formulations and injection protocols exist, differing in molecular weight, concentration, and dosing schedules. Optimizing treatment in terms of efficacy, safety, patient convenience, and cost-effectiveness remains a key clinical goal.
Objective:
This study aims to compare the safety, tolerability, and efficacy of a single intra-articular injection of Innoryos 2.5% (Single-Shot) with a standard three-week injection regimen of Innoryos 2.2% (Triple-Shot) in adults with moderate to severe knee osteoarthritis. The primary focus is on safety and pain reduction, with secondary outcomes including functional improvement, leg muscle strength, and structural assessment of the knee joint via MRI.
Study Design:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40-70 years
- •Radiographically confirmed moderate to severe knee osteoarthritis
- •Knee pain for ≥3 months
- •Pain on ≥50% of days in past 30 days
- •Able to provide informed consent
排除标准
- •Grade 4 osteoarthritis (full-thickness cartilage loss)
- •Non-osteoarthritic knee pain
- •Other rheumatic diseases (e.g., rheumatoid arthritis, fibromyalgia)
- •HA injection <6 months or corticosteroid injection <3 months in target knee
- •Recent trauma or surgery of affected knee (<6 months)
- •Coagulopathy or bleeding disorder
- •Autoimmune or relevant systemic disease
- •Dermatologic infection at injection site
- •Pregnancy or lactation
- •Opioid or oral corticosteroid use
- •Contraindications to MRI (pacemaker, intracorporeal metal, claustrophobia)
- •Expected absence during study period or noncompliance