Daily Activity Quantification and Gait Pattern Analysis Before and After Intra-articular Injection of Viscosupplement Among Hip Osteoarthritis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in hip flexion-extension range of motion
研究概览
简要总结
The objective of this study is to assess the changes in daily physical activity and gait pattern, following a viscosupplement injection among a population who is suffering from hip osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36 (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology affects the quality of life, will be use.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From 45 years old to 65 years old
- •Clinically symptomatic moderate or severe hip osteoarthritis (Tönnis Grade II to III)
- •Capacity to keep steady upright position and walking during 15 minutes
- •Body mass index < 40kg/m2
排除标准
- •Bilateral hip osteoarthritis
- •No broken hip or leg during the last 12 months
- •Bone necrosis
- •Rheumatoid arthritis, articular chondrocalcinosis, metabolic bone disease, psoriasis, gout, active infection
- •Per os corticosteroid treatment
- •Corticosteroid injection < 3 months
- •Viscosupplement injection < 6 months
- •Hypersensitivity to hyaluronic acid products
- •Planed surgery during study duration
- •Physical or mental disability to fill in questionnaires and/or to participate to follow-up
研究组 & 干预措施
Hyaluronan
Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection
干预措施: Hyaluronan (Drug)
Bupivacaine
one Marcain extra-capsular injection
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Change in hip flexion-extension range of motion
时间窗: Change from Baseline at 6 months
Subtraction between maximum and minimum flexion measured with motion capture system during gait
Change in daily physical activity
时间窗: Change from Baseline at 6 months
Intensity and duration of the daily physical activity measured with pedometer
次要结局
- Change in hip pain(change from Baseline at 6 months)
- Change in quality of life(Change from Baseline at 6 months)
- Change in walking cadence(Change from Baseline at 6 months)