Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Change in quadriceps activation
研究概览
简要总结
This will be prospective study of patients with knee effusion associated with degenerative osteoarthritis or symptomatic primary total knee arthroplasty that undergo therapeutic joint arthrocentesis. The diagnosis of knee osteoarthritis will be based on knee radiographs (including AP, Rosenburg view, lateral and Merchant views) read and interpreted by one of our clinical providers (PA, Fellow or Surgeon). Patients with at least Grade II Kellgren and Lawrence changes or higher will be included in the osteoarthritis group. Patients in the arthroplasty group must have had a primary total knee arthroplasty without infection (as determined by knee aspirate) to be included. Patients will be clinically evaluated at the time of their visit for presence of a knee effusion using a stroke test and graded on a 5-point scale (zero, trace, 1+, 2+, or 3+) which has shown good interrater reliability. Patients with a mild to severe effusion (1+ to 3+) will considered for the study. Patients having significant pain associated with their effusion will be offered a therapeutic arthrocentesis as part of their treatment plan discussion. This is a pre-post test design in which outcome measures will be collected immediately pre-arthrocentesis and immediately post arthrocentesis. Additionally, there will be an optional 7-10 follow up visit where outcomes measures will be collected again, should the participant choose to return to this visit.
详细描述
Pain and Self-Reported Function
Knee pain will be assessed with an 11-point numeric pain rating scale (NPRS) where 0 represents 'no pain' and 10 represents 'worst imaginable pain'. Self-reported physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for each knee separately. The WOMAC assesses the impact of knee osteoarthritis on multiple domains-pain, stiffness, and disability. A composite score (0-100 scale) will be used for analysis.
Range of Motion
Knee range of motion (ROM) is a direct measure of joint mobility following TKA. Knee ROM will be measured in the supine position both actively and passively using a long-arm goniometer. Goniometry has been shown to be a reliable measure of knee ROM after TKA.
Quadriceps Strength and Activation Testing
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years or older with mild (1+) to severe (3+) knee effusion associated with underlying osteoarthritis (Kellgren and Lawrence grade II or higher) that undergo therapeutic aspiration
- •Patients with symptomatic primary total knee arthroplasty without infection (as verified by prior aspiration) with moderate to severe effusion electing for therapeutic arthrocentesis. Must be minimum of 3 months from index surgery to be included.
排除标准
- •Patients with effusion related to trauma or another underlying condition (ie. fracture, ligamentous injury, hemarthrosis)
- •Patients with known history of gout or with synovial fluid samples testing positive for urate of calcium pyrophosphate crystals
- •Patients with knee effusion associated with septic arthritis or periprosthetic knee infection as determined from knee arthrocentesis.
- •Patients with inflammatory arthritis (ie. JIA, RA, psoriatic arthritis, etc).
- •Patients with revision knee arthroplasty, unicompartmental arthroplasty or other repair/reconstruction surgery
- •Patients with underlying muscular disorder (ie. Stroke, cerebral palsy, multiple sclerosis, polymyalgia, fibromyalgia, muscular dystrophy, etc.)
- •Patients with symptomatic hip pain
- •Patients with active cancer in the area
- •Patients with pacemakers
- •Patients who are pregnant
- •Invasive or injectable therapy within the last 6 months in the involved knee, to include, but not limited to, arthrocentesis, corticosteroid, hyaluronic acid, platelet-rich plasma, prolotherapy, stem cell therapy, or genicular nerve block.
- •Blood clotting disorders, sickle cell disease or trait, or chronic anticoagulation.
结局指标
主要结局
Change in quadriceps activation
时间窗: Immediately pre aspiration (day 0), immediately post aspiration (day 0),optional 7-10 days post aspiration
The change in quadriceps activation prior to and post arthrocentesis will be measured.
次要结局
- Function(Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration)
- Volume of Knee Synovial Fluid Aspirated(Immediately post aspiration (day 0))
- Change in Pain(Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration)
- Range of Motion(Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration)
- Quadriceps Strength(Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration)
- Functional Performance(Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration)
- Bioelectrical Impedance(Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration)
研究者
Jason Jennings
Primary Investigator
Colorado Joint Replacement