Triamcinolone Ketorolac (TriKe) Knee Trial Evaluating the Effectiveness and Possible Superiority of Ketorolac vs. Cortisone When Injected Intra-Articular in Subjects With Osteoarthrosis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in patient reported outcomes as measured by Modified KOOS scores
研究概览
简要总结
Cortisone injections are commonly used in the treatment of osteoarthrosis of the knee, but there are known detriments to cortisone including localized tissue atrophy near the injection site and acceleration of joint degeneration, as well as contraindications, such as uncontrolled diabetes. Ketorolac is a non-steroidal anti-inflammatory with decades of clinical data that is most commonly injected intramuscularly. There is rising interest in using ketorolac as an intra-articular injectant substitute or adjunctive to cortisone. This may potentially improve clinical outcomes or decrease adverse effects. Although intra-articular use of ketorolac is increasing in orthopedics and sports medicine, there is limited data in the literature comparing these two injectants in prospective, randomized trials, and no data that evaluates combining the two injectants. Primary objectives are to evaluate the efficacy of intra-articular ketorolac compared to cortisone on knee osteoarthrosis and to evaluate whether the combination of ketorolac and cortisone is superior to either alone.
详细描述
Charts will be prescreened for diagnosis or suspicion of osteoarthritis of the knee by the study staff. Those charts identified will be flagged for possible inclusion in the study. The receptionist will give the prospective subject a copy of the consent to read while they are in the waiting room. Once they are taken back to the room, the investigator will review the study with them. If they are agreeable, they will sign the consent and a copy will be given to them and a copy will be scanned into the Electronic Medical Record (EMR). The investigator will then notify the unblinded investigator, who will randomize the subject and prepare the medication in a blinded fashion. The subject will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into the affected knee joint/s. The subject will be asked to complete a survey prior to receiving the injection, and again at 1 week, 6 weeks, and 12 weeks post injection. If necessary, an additional survey will be completed at 24 weeks post injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All staff working with the study subjects will be blinded. Once the subject signs consent, an unblinded study doctor will, using a special method, draw up the appropriate medication and blind the syringe so the the staff giving the medication will not know what is being given.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee pain with diagnosis of osteoarthritis/osteoarthrosis
- •Weight-bearing x-rays within the last year adequate to assess Kellgran-Lawrence OA stage
- •Age > 21
- •English proficiency sufficient to complete surveys
- •Willing to complete follow-up surveys
排除标准
- •Prior knee injection in last 3 months
- •Knee surgery within the last year
- •Contraindications to Cortisone, Ketorolac, or local anesthetic
- •Uncontrolled diabetes
- •Systemic steroid use in last 3 months
- •BMI > 50
- •Non-ambulatory
- •Known kidney disease
- •Current opioid use
研究组 & 干预措施
Triamcinolone acetonide - Ropivacaine - Normal Saline
Subject would receive:
Triamcinolone acetonide, 40 mg/mL. 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization
干预措施: Triamcinolone acetonide-Ketorolac-Ropivacaine (Drug)
Ketorolac - Ropivacaine - Normal Saline
Subject would receive:
Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization
干预措施: Triamcinolone acetonide-Ketorolac-Ropivacaine (Drug)
Triamcinolone acetonide - Ketorolac - Ropivacaine
Subject would receive:
Triamcinolone acetonide, 40 mg/mL Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization
干预措施: Triamcinolone acetonide-Ketorolac-Ropivacaine (Drug)
结局指标
主要结局
Change in patient reported outcomes as measured by Modified KOOS scores
时间窗: 12 -24 weeks
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better \[0-100\]).
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS
时间窗: 12 -24 weeks
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better \[0-100\])
次要结局
- Change in patient reported outcomes as measured by VAS(12 -24 weeks)
- Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS(12 -24 weeks)
研究者
Stanley Hunter
Director, UHSH Concussion Center
United Health Services Hospitals, Inc.