Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis (Pain+Stiffness)
2021年8月10日 更新者：Hospital for Special Surgery, New York
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty.
There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity.
This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications.
Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.
研究概览
研究类型
观察性的
注册 (实际的)
179
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
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New York
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New York、New York、美国
- Hospital for Special Surgery
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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
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.
描述
Inclusion Criteria:
- Elective primary unilateral total knee arthroplasty
- Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
- Patients of surgeons who have agreed to participate in the study
- Age > 18 years
- American Society of Anesthesiologists (ASA) Physical Status 1-3
- Regional anesthesia
- Epidural patient-controlled analgesia (PCA) for postoperative pain
- Adductor canal block for postoperative pain
Exclusion Criteria:
- Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
- Use of general anesthesia
- History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
- Preoperative oral steroid use in the past 6 months
- Intra-articular steroid injection within one month of scheduled surgery in affected joint
- Non-English speakers
- Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
- Peri-articular injections or infusions for postoperative pain
- Diagnosis of crystalline arthropathy
- Diagnosis of osteonecrosis
- Active infection or use of antibiotics
- Pregnant women
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Total knee arthroplasty patients
Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study.
Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.
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Patients will undergo total unilateral knee arthroplasty for osteoarthritis.
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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 |
|---|---|---|
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Presence of persistent postoperative pain using the numeric rating scale (NRS)
大体时间：6 months after date of surgery
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Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint
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6 months after date of surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of postoperative joint stiffness
大体时间：6 weeks after date of surgery
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Number of patients that experience postoperative joint stiffness, defined as ≤95 degrees range of motion.
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6 weeks after date of surgery
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Postoperative knee range of motion
大体时间：6 weeks after date of surgery
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Range of motion at 6 weeks postoperative.
Measured as flexion minus extension.
Measured in degrees.
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6 weeks after date of surgery
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NRS pain at rest on POD1
大体时间：1 day after surgery
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NRS pain at rest on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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1 day after surgery
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NRS pain with movement on POD1
大体时间：1 day after surgery
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NRS pain with movement on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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1 day after surgery
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Worst NRS pain on POD1
大体时间：1 day after surgery
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Worst NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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1 day after surgery
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Least NRS pain on POD1
大体时间：1 day after surgery
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Least NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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1 day after surgery
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NRS pain at rest on POD2
大体时间：2 days after surgery
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NRS pain at rest on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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2 days after surgery
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NRS pain with movement on POD2
大体时间：2 days after surgery
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NRS pain with movement on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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2 days after surgery
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Worst NRS pain on POD2
大体时间：2 days after surgery
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Worst NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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2 days after surgery
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Least NRS pain on POD2
大体时间：2 days after surgery
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Least NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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2 days after surgery
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NRS pain at rest 4 weeks after surgery
大体时间：4 weeks after surgery
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NRS pain at rest on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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4 weeks after surgery
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NRS pain with movement 4 weeks after surgery
大体时间：4 weeks after surgery
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NRS pain with movement on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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4 weeks after surgery
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Worst NRS pain 4 weeks after surgery
大体时间：4 weeks after surgery
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Worst NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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4 weeks after surgery
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Least NRS pain 4 weeks after surgery
大体时间：4 weeks after surgery
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Least NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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4 weeks after surgery
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NRS pain at rest 3 months after surgery
大体时间：3 months after surgery
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NRS pain at rest 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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3 months after surgery
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NRS pain with movement 3 months after surgery
大体时间：6 weeks after date of surgery
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NRS pain with movement 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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6 weeks after date of surgery
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Worst NRS pain 3 months after surgery
大体时间：6 weeks after date of surgery
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Worst NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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6 weeks after date of surgery
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Least NRS pain 3 months after surgery
大体时间：6 weeks after date of surgery
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Least NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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6 weeks after date of surgery
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NRS pain at rest 6 months after surgery
大体时间：6 weeks after date of surgery
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NRS pain at rest 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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6 weeks after date of surgery
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Least NRS pain 6 months after surgery
大体时间：6 weeks after date of surgery
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Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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6 weeks after date of surgery
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Worst NRS pain 6 months after surgery
大体时间：6 weeks after date of surgery
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Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
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6 weeks after date of surgery
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Postoperative knee range of motion
大体时间：6 weeks after date of surgery
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Range of motion (extension minus flexion) at patients postoperative 6 week appointment.
Measured by the surgeon or surgical staff.
Measured in degrees.
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6 weeks after date of surgery
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Postoperative KOOS scores
大体时间：4 weeks, 3 months, and 6 months after date of surgery
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4 weeks, 3 months, and 6 months after date of surgery
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Postoperative painDETECT scores
大体时间：4 weeks, 3 months, and 6 months after date of surgery
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Neuropathic pain assessment
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4 weeks, 3 months, and 6 months after date of surgery
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Time to attainment of inpatient physical therapy goals
大体时间：During inpatient hospital stay, approximately 3 days after date of surgery
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Goals include ambulation of 40 feet and independent transfer.
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During inpatient hospital stay, approximately 3 days after date of surgery
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Types of postoperative medications
大体时间：1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery
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Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.
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1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery
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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：Meghan Kirksey, MD, PhD、Hospital for Special Surgery, New York
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)
2015年12月1日
初级完成 (预期的)
2022年7月1日
研究完成 (预期的)
2022年7月1日
研究注册日期
首次提交
2015年12月8日
首先提交符合 QC 标准的
2015年12月9日
首次发布 (估计)
2015年12月10日
研究记录更新
最后更新发布 (实际的)
2021年8月11日
上次提交的符合 QC 标准的更新
2021年8月10日
最后验证
2021年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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