Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty
Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty
研究概览
详细说明
Postoperative pain is often moderate to severe following unicompartmental knee arthroplasty. In order to reduce postoperative pain and improve mobilization the minimal invasive technique was developed. After a 8-10 cm skin incision, a medial parapatellar capsule incision in made. The rectus tendon or the vastus medialis are not incised and the patella is not everted.
In recent years The Local Infiltration Analgesia (LIA) technique has been developed to reduce postoperative pain. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.
The aim of this study is to investigate if Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Orebro、瑞典、SE-70185
- 招聘中
- Dept. of Orthopedic Surgery
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首席研究员：
- Kjell Axelsson, Professor
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接触：
- Per Essving, MD
- 电话号码：+46196021000
- 邮箱：per.essving@orebroll.se
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接触：
- Kjell Axelsson, Professor
- 电话号码：+46196021000
- 邮箱：kjell.axelsson@orebroll.se
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients scheduled for unicompartmental knee arthroplasty
- Aged 20-80 yrs
- ASA physical status I-III and mobility indicating normal postoperative mobilization
Exclusion Criteria:
- Known allergy or intolerance to local anesthetics, ASA or NSAID
- Serious liver-, heart- or renal decease
- Rheumatoid arthritis
- Chronic pain or bleeding disorder
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Group MIS
Minimal Invasive Surgery
|
After a 8-10 cm skin incision, a medial parapatellar capsule incision is made.
The vastus medialis muscle or the rectus tendon are not incised, nor is the patella everted.
The patella is merely pushed slightly aside when the bone cuts are made and the prostheses are cemented in place.
Local Infiltration Analgesia is used.
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有源比较器：Conventional Exposure
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After a 15-20 cm midline skin incision is made, a medial parapatellar capsule incision is made.
The incision is carried up through the insertion of the vastus medialis and into the rectus tendon.
The patella is everted.
The bone cuts are made and the prostheses are cemented in place.
Local Infiltration Analgesia is used.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Time to fulfilling discharge criteria
大体时间：0-2 weeks
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0-2 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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疼痛强度
大体时间：0-3个月
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0-3个月
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膝关节功能
大体时间：0-3个月
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0-3个月
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|
住院
大体时间：0-2周
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0-2周
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患者满意度
大体时间：0-3个月
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0-3个月
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Morphine consumption
大体时间：0-48 hours
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0-48 hours
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合作者和调查者
调查人员
- 首席研究员：Kjell Axelsson, Professor、Region Örebro County
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
膝骨性关节炎的临床试验
Minimal Invasive Surgery的临床试验
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Regenstrief Institute, Inc.Merck Sharp & Dohme LLC; National Sleep Foundation未知
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的