Efficacy of a Single Crosslinked Hyaluronan (HYAJOINT Plus) Combined With a Single Platelet-rich Plasma (PRP) Versus a Single PRP for the Treatment of Knee Osteoarthritis: A Randomized-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- VAS pain score change from baseline
研究概览
简要总结
Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA remained unclear. This study aimed to investigate the efficacy of a single intraarticular hyaluronan (HYAJOINT Plus) combined with a single PRP versus a single intraarticular PRP in patients with knee OA.
详细描述
Intraarticular HA or PRP has been used for knee OA for years. Combined HA and PRP has not been widely used for OA because of lack of clinical evidence. Based on in vitro and animal studies, combining HA and PRP may benefit from their dissimilar biological mechanisms for tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit OA inflammation, modulate the disease process, and improve joint homeostasis in OA. Combination of HA and PRP has much potential for the treatment of OA, but the clinical evidence of this combination remains unclear. The purpose of this study was to investigate the efficacy and safety of combined a single crosslinked HA (HYAJOINT Plus) with a single PRP versus a single PRP alone in patients with knee OA.
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)
盲法说明
Study blinding was accomplished by having an investigator (blinded to the randomization and treatment) perform all the assessments
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-75 years;Symptomatic knee OA > 6 months despite conservative treatment such as oral analgesics, NSAIDs and/or physical therapy;Kellgren-Lawrence grades 2 knee OA on radiographs taken within the previous 6 months;Average pain at walking > 30 mm on a 100-mm visual analog scale (VAS);Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee< 30 mm.
排除标准
- •Previous orthopedic surgery on the spine or lower limbs Disabling OA of either hip or foot Knee instability, apparent joint effusion or marked valgus/varus deformity Known allergy to hyaluronan products Women ascertained or suspected pregnancy or lactating Intraarticular injections into the knee in the past 6 months Any specific medical conditions (rheumatoid arthritis, active infections, severe cardiovascular diseases, autoimmune diseases, hemiparesis, neoplasm, etc.) that would interfere with the assessments
结局指标
主要结局
VAS pain score change from baseline
时间窗: 1,3 and 6 months
. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)
次要结局
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale)(1,3 and 6 months)
- Single-leg stance test (SLS)(1,3 and 6 months)
- satisfaction(1,3 and 6 months)
- consumption of analgesics(1,3 and 6 months)
- Lequesne index(1,3 and 6 months)
研究者
Shu-Fen Sun
Director or Neurorehabilitation
Kaohsiung Veterans General Hospital.