Knee Injection RCT

赞助:

合作者:

信息的提供 (责任方):

Mohamad Halawi，UConn Health

追踪信息

首次提交日期 ^ICMJE

August 16, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

July 5, 2018

预计主要完成日期

February 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Visual Analogue Pain Scale (VAS)[ Time Frame: 3 months post injection ]

average knee pain 3 months following injection

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[ Time Frame: 3 and 6 months post injection ]
self-reported pain, stiffness and functioning
Oxford Knee questionnaire[ Time Frame: 3 and 6 months post injection ]
self-reported pain, stiffness and functioning
Koos, Jr. Knee Survey[ Time Frame: 3 and 6 months post injection ]
self-reported pain, stiffness and functioning
Visual Analogue Pain Scale (VAS)[ Time Frame: 6 months ]
average knee pain 6 months following injection
Patient Satisfaction[ Time Frame: 3 and 6 months post injection ]
satisfaction with treatment rated as "Yes" or "No"
Non-routine visits due to inadequate pain relief or complications[ Time Frame: 3 months post injection ]
Any additional visits due to inadequate pain relief or complications
Cost of Intervention[ Time Frame: 3 months post injection ]
cost of each injection

描述性信息

简略标题 ^ICMJE

Knee Injection RCT

正式标题 ^ICMJE

Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study

简要概况

Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (OA) compared to steroids and viscosupplementation. Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in the nonsurgical management of symptomatic OA compared to injections with corticosteroids and viscosupplements.

详细说明

The purpose of this research study is to examine the effectiveness of intra-articular (inside the joint) ketorolac injection compared to injection with either corticosteroid or hyaluronic acid for the treatment of painful knee osteoarthritis. Patients will be randomly assigned to receive either ketorolac (a nonsteroidal anti-inflammatory drug, methylprednisolone (a steroid), hyaluronic acid (a substance that is naturally present in the human body).

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Ketorolac Tromethamine Injection
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Drug: Methylprednisolone Acetate Injection
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Drug: Hylan G-F 20
One knee injection of Hylan G-F 20 (Synvisc-One)

研究工具

Experimental: Ketorolac
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Active Comparator: Corticosteroid
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Active Comparator: Hyaluronic Acid
One knee injection of Hylan G-F 20 (Synvisc-One)

招募信息

招募状态 ^ICMJE

Enrolling by invitation

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

February 2019

预计主要完成日期

February 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief. Exclusion Criteria: - Prior injections into the same knee within the past 6 months, - Pregnant and/or lactating women, - Inflammatory joint disease including rheumatoid or psoriatic arthritis, - Concurrent use of anti-rheumatic drugs, - Allergy or hypersensitivity to the study medications, - Patients on an active pain management contract, - Patients with insurance that requires pre-certification for any of the study drugs, - Inability to make own decisions regarding the informed consent, - Inability to read and/or understand English, - Patients who are unable to return for follow-up or be reached by phone.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Mohamad Halawi，UConn Health

研究赞助商 ^ICMJE

UConn Health

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Mohamad J. Halawi, MD UConn Health

PRS 账户

UConn Health

验证日期

August 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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