Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 130
- 试验地点
- 16
- 主要终点
- Knee Range of Motion After Manipulation Under Anesthesia
研究概览
简要总结
Compare the outcome following manipulation under anesthesia for stiffness in a randomized controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone.
Outcomes will include pain, range of motion, as well as subjective outcome scores.
详细描述
Stiffness is a potential complication following Total Knee Arthroplasty (TKA). While a variety of factors have been cited as possible causes, such as component malrotation or improper soft-tissue balancing, however, an etiology is not always appreciated. Histologic and arthroscopic evidence of fibrosis suggests that an inflammatory process may contribute to loss of knee range of motion following surgery. Manipulation under anesthesia remains standard of care for stiffness following TKA. Manipulation shows improved range of motion for stiffness after total knee arthroplasty, however, patients do not always achieve full range of motion. Furthermore, repeat manipulation and manipulation greater than 8 weeks post-surgically have shown limited improvements. Given a possible role of the host inflammatory response and the importance of early gains in knee range of motion following total knee arthroplasty, limiting the inflammatory response at the time of manipulation may improve outcomes. Investigators would like to assess the role of anti-inflammatory medications to optimize range of motion and outcome for manipulation under anesthesia for stiffness following TKA.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.
- •MUA's scheduled between 6-10 weeks postoperatively
排除标准
- •Intolerance to NSAIDs
- •Renal dysfunction
- •Age < 18 or > 90 years
- •Primary diagnosis of rheumatoid arthritis
- •Patients with a Glomerular Filtration Rate (GFR) <60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)
研究组 & 干预措施
MUA with dexamethasone and celecoxib
For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
干预措施: Dexamethasone (Drug)
MUA with dexamethasone and celecoxib
For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
干预措施: Celecoxib (Drug)
结局指标
主要结局
Knee Range of Motion After Manipulation Under Anesthesia
时间窗: 1 year from the date of the manipulation
Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score(6 weeks after MUA, 1 year after MUA)
- Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score(6 weeks after MUA, 1 year after MUA)
- Knee Society Functional Score(6 weeks after the MUA, and 1 year after the MUA)
- Knee Society Knee Score(6 weeks after the MUA, and 1 year after the MUA)
- PROMIS-29 Outcome Form: Physical Function(6 weeks after the MUA, and 1 year after the MUA)
- PROMIS-29 Outcome Form: Anxiety(6 weeks after MUA, and 1 year after MUA)
- PROMIS-29 Outcome Form: Depression(6 weeks after MUA, and 1 year after MUA)
- PROMIS-29 Outcome Form: Fatigue(6 weeks after MUA, and 1 year after MUA)
- PROMIS-29 Outcome Form: Sleep Disturbance(6 weeks after MUA, and 1 year after MUA)
- PROMIS-29 Outcome Form: Social Activities(6 weeks after MUA, and 1 year after MUA)
- PROMIS-29 Outcome Form: Pain Interference(6 weeks after MUA, 1 year after MUA)
- Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life(6 weeks after MUA, 1 year after MUA)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)(6 weeks after the MUA, and 1 year after the MUA)
- Short Form Survey 12-item Version 2 (SF-12v2): Physical Health(6 weeks after the MUA, and 1 year after the MUA)
- Short Form Survey 12-item Version 2 (SF-12v2): Mental Health(6 weeks after MUA, 1 Year after MUA)
- Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score(6 weeks after the MUA, and 1 year after the MUA)
- Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score(6 weeks after the MUA, and 1 year after the MUA)
研究者
Matthew P. Abdel, M.D.
Consultant - Knee Surgery
Mayo Clinic