The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gait analysis with GAITRite software.
研究概览
简要总结
The purpose of this study is to determine the impact of a regular course of treatment with Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three consecutive HA injections will be compared to three consecutive placebo injections to determine whether HA's analgesic effect is greater than that of a placebo injection, and to observe whether HA's viscoelastic properties are manifested in a human knee OA population. We hypothesize that HA injections will relieve pain to a greater extent than placebo injections in knee OA patients, and will afford them with improved walking characteristics, such as increased walking speed, and step length.
详细描述
Knee osteoarthritis (OA) is a severely debilitating disease associated with stiffness and pain in the knee joint, and with a loss of function. Hyaluronic acid (HA) injections are incorporated into non-surgical standard of care for knee OA patients and have been proven to relieve pain in patients who have not received symptomatic relief with other knee OA interventions. HA allows synovial fluid to act as a lubricant and shock absorber for joints, and although this is encouraging ground to advocate for the use of HA treatment in knee OA patients, these properties have yet to be proven in a controlled clinical trial setting. Therefore, we are undertaking this study to observe whether the physiological adaptation in the OA knee joint, initiated by HA injection, will result in biomechanical improvements in human knee OA patients, specifically walking mechanics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 - 80 years old.
- •Mild to moderate knee osteoarthritis:
- •Clinical diagnosis (symptoms).
- •Radiographic diagnosis (Kellgren-Lawrence grade I - III).
- •Must provide provide informed consent and knowledge of all possible benefits and possible adverse events.
- •Available for duration of the study.
- •Not taking any other knee osteoarthritis medications during the study.
排除标准
- •Non - OA arthritides.
- •Hip, ankle, or foot OA.
- •End stage OA.
- •Lower back/extremity pathology.
- •Previous surgery on knee affected by OA (except arthroscopy within the past 12 - 18 months).
- •Neurological/Cardiovascular gait impairment.
- •Pregnant.
- •Cognitively impaired.
- •Not available for duration of study.
- •Taking other knee OA medications at time of study.
- •Gastro-intestinal disturbance.
- •Avian allergy or any other contraindication to intra-articular injections with Hyaluronic acid.
结局指标
主要结局
Gait analysis with GAITRite software.
时间窗: Baseline; after each injection; 3 and 6 months post treatment.
次要结局
- WOMAC OA index (pain, stiffness, function); Six minute walk test (function).(Baseline; after each injection; 3 and 6 months post treatment.)