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治疗性关节穿刺术对膝骨性关节炎患者疼痛和股四头肌功能的影响

2026年11月3日 更新者:Jason Jennings、Colorado Joint Replacement

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.

研究概览

地位

完全的

条件

详细说明

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

Maximum voluntary isometric quadriceps strength and quadriceps activation will be assessed before surgery and at week 3 using an electromechanical dynamometer (Humac Norm, CSMI) and a doublet interpolation test. Patients will be seated on the electromechanical dynamometer with their hips flexed to approximately 85° and their knees flexed to 60°. Two 3" by 5" self-adhesive neuromuscular stimulation electrodes will be placed over the motor points of the rectus femoris and the vastus medialis. A Grass S48 stimulator with a Grass Model SIU8T stimulus isolation unit will be used to deliver 600 µs doublet pulses. A Biopac MP150WSW system will be used for data acquisition during testing with sampling frequency of 300 Hz.

Following two warm-up contractions, a practice maximal voluntary isometric contraction (MVIC) will be performed against the dynamometer's force transducer. Visual torque targets will be set on the feedback monitor at slightly higher torques than produced during the practice MVIC trial. Trials will be repeated until maximal torque is within 5% of the previous attempt. Torque from quadriceps MVIC will be normalized to body weight for between-subject comparisons.

Voluntary activation of the quadriceps muscle will be assessed using the doublet interpolation technique, where a supramaximal stimulus will be applied by a Grass S48 stimulator during an MVIC and immediately afterwards while the quadriceps muscle is at

rest. Normalization of the force from the superimposed doublet to the resting doublet allows for comparisons of quadriceps activation across individuals and lower extremities.

Timed-Up-and-Go

The timed-up-and-go (TUG) test is a responsive, valid, and reliable functional measure of basic mobility and dynamic balance. The examiner measures the time, in seconds, required by the patient to a) rise from an arm chair; b) walk 3 meters; c) turn and walk back to the arm chair; and d) return to the seated position.

30-second Sit-to-Stand Test

The 30-second Sit-to-Stand test (30STS) is a responsive, valid, and reliable functional measure of lower extremity strength after TKA. This test counts the number of times a patient can rise to a full standing position in 30 seconds. The test starting position is sitting on an armless chair with seat plate 17 inches from the floor. Patients rise from this position with hands placed on opposite shoulders. If the patient must use his/her arms to stand, the test is stopped. If the patient is over halfway to a standing position when 30 seconds have lapsed, this counts as a stand.

Bioimpedance Spectroscopy

Bioimpedance spectroscopy (BIS) is a reliable, responsive measure of swelling that has been validated in observational studies of individuals after TKA. The RJL Systems Quantum® (Clinton Township, MI) bioelectrical impedance device delivers a 2.5 µA alternating current at a frequency of 50 kHz. The tissue impedance to this current is displayed in Ohms (Ω) and is recorded at a precision of 1 Ω. The level of impedance met by the current reflects the composition of the tissue, but will also fluctuate with the presence of swelling in the lower extremity. Lower levels of impedance represent the increased fluid content present with greater levels of swelling. Measuring the impedance of both the involved and uninvolved limb allows for calculation of a ratio (W-involved limb: W-uninvolved limb). To measure impedance, a four-wire measurement method will be used. The most proximal electrode pair will be placed 10 and 20 centimeters above the superior patellar pole. The most distal electrode pair will be placed at a point bisecting the medial and lateral malleolus, and also 10 cm distal to that point along the second ray of the foot. New electrodes will be used for each testing session, and skin will be cleaned with an alcohol swab prior to electrode placement.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Denver
      • Denver、Colorado、美国、80210
        • Colorado Joint Replacement

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 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
  2. 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.

Exclusion Criteria:

  1. Patients with effusion related to trauma or another underlying condition (ie. fracture, ligamentous injury, hemarthrosis)
  2. Patients with known history of gout or with synovial fluid samples testing positive for urate of calcium pyrophosphate crystals
  3. Patients with knee effusion associated with septic arthritis or periprosthetic knee infection as determined from knee arthrocentesis.
  4. Patients with inflammatory arthritis (ie. JIA, RA, psoriatic arthritis, etc).
  5. Patients with revision knee arthroplasty, unicompartmental arthroplasty or other repair/reconstruction surgery
  6. Patients with underlying muscular disorder (ie. Stroke, cerebral palsy, multiple sclerosis, polymyalgia, fibromyalgia, muscular dystrophy, etc.)
  7. Patients with symptomatic hip pain
  8. Patients with active cancer in the area
  9. Patients with pacemakers
  10. Patients who are pregnant
  11. 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.
  12. Blood clotting disorders, sickle cell disease or trait, or chronic anticoagulation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Primary Osteoarthritis

Patients with native knees and effusions will participate in this arm.

Patients will receive a joint arthrocentesis to remove fluid from the joint.

实验性的:Primary TKA

Patients with total knee replacements will participate in this arm.

Patients will receive a joint arthrocentesis to remove fluid from the joint.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in quadriceps activation
大体时间: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.

Immediately pre aspiration (day 0), immediately post aspiration (day 0),optional 7-10 days post aspiration

次要结果测量

结果测量
措施说明
大体时间
Change in Pain
大体时间:Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

Self reported pain scores

Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Function
大体时间:Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

Self reported function will be collected

Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Range of Motion
大体时间:Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

Range of motion will be measured

Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Quadriceps Strength
大体时间:Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

This will be measured using the Humac Norm chair

Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Functional Performance
大体时间:Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

This will be assessed with standardized functional tests (30 STS, TUG)

Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Volume of Knee Synovial Fluid Aspirated
大体时间:Immediately post aspiration (day 0)

We will look at the volume of fluid drawn off the knee

Immediately post aspiration (day 0)
Bioelectrical Impedance
大体时间:Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

This will be measured with The RJL Systems Quantum®

Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jason Jennings, MD、Colorado Joint Replacement

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月5日

初级完成 (实际的)

2022年8月31日

研究完成 (实际的)

2024年4月10日

研究注册日期

首次提交

2019年10月28日

首先提交符合 QC 标准的

2019年10月29日

首次发布 (实际的)

2019年10月31日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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