Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.
详细描述
Information collected during your office visits:
The patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. A member of our research team will ask the patient a series of questions about his/her knee. The patient will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten your knee at these 4 office visits. We will have the patient rate the pain in his/her knee and ask the patient if he/she is satisfied with the surgery. If the patients have any complications, those will also be recorded. The patient will also have X-rays taken of the knee at the postoperative follow-up visits. This is the normal routine following total knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.
Injection during total knee replacement surgery:
All patients will receive an injection containing bupivicaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline that will be placed directly into the knee during surgery. In addition, approximately half of the patients in the study will also receive methylprednisolone acetate as part of the injection.
Information being collected during your hospital stay:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages of 18 and 95
- •Has elected to undergo total knee replacement
排除标准
- •Allergy to any of the medications used in the protocol
- •History of kidney disease
- •Rheumatoid arthritis
- •Any systemic conditions associated with chronic pain
- •History of deep knee sepsis in the affected extremity
- •Unable to understand the questions used to obtain the Knee Society Score
- •Minors and prisoners will be excluded from the study
研究组 & 干预措施
Control
Patients in the active comparator group will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
干预措施: active comparator (Drug)
Corticosteroid
Patients in the Corticosteroid group will have the same medications as the Control Group with the addition of a corticosteroid (methylprednisolone acetate)
干预措施: methylprednisolone acetate (Drug)
结局指标
主要结局
Length of Hospital Stay
时间窗: days after surgery
Knee Range of Motion
时间窗: 3 months
Knee Society Scores
时间窗: 3 months postoperative
The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.
Amount of Pain Medication Taken Per Day
时间窗: Average of 3 days after surgery
Patient Satisfaction
时间窗: 6 weeks, 3 months, and 1 year postoperative
Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
时间窗: any point during the first postoperative year
次要结局
未报告次要终点