The Effects of a Tourniquet on Implant Migration and Muscle Strength and Function in Patients Operated With Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Nerve growth factor (NGF)
研究概览
简要总结
About 5000 total knee arthroplasties (TKA) are performed annually in Norway. Pain and reduced physical function is present in patients operated with TKA up to a year after surgery and about one of five patients are not satisfied with the outcome from TKA surgery. The use of tourniquet during surgery may also have impact on pain and physical function. Whether TKA surgery should be performed with or without the use of tourniquet, is a much-debated issue in orthopedic surgery today, and there is still no consensus in this field. This study will investigate early muscle strength and power recovery, neuromuscular recordings, neuronal changes and patient reported outcome measures after surgery with tourniquet versus not tourniquet.The findings in this study are expected to have implications for rehabilitation and the outcome of the TKA surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthrosis qualifying for total knee arthroplasty
排除标准
- •Coagulation disease
- •Rheumatoid arthritis
- •Peripheral vascular disease
- •Malign disease
- •Pregnancy
- •On-going infection
- •Not able to understand written and oral information in Norwegian
研究组 & 干预措施
No tourniquet
No use of tourniquet during surgery
Tourniquet
Use of tourniquet during surgery. The cuff will be inflated to 300mmHg
干预措施: Tourniquet (Device)
结局指标
主要结局
Nerve growth factor (NGF)
时间窗: Change from during surgery to 8 weeks postoperative
Analysis from muscle biopsies harvested from the m. vastus lateralis
Mmax
时间窗: Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris
Forgotten Joint Score
时间窗: Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
The stair climbing test measures the time (in seconds) to ascend, turn around and descend a regular stairway of 11 steps. The patients are asked to perform the test as quickly as possible.
次要结局
- Maximal leg strength(Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative)
- Maximal knee extension strength(Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative)
- Rate of force development, voluntary activation and muscle contractility(Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative)
- Daily physical activity(Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement))
- EuroQual 5D-L(Preoperative, 8 weeks, 1 year postoperative)
- Numeric Rating Scale (NRS)(Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative)
- Hemoglobin values(Preoperatively, day 1 postoperative)
- Volume of bleeding(During surgery and day 1 postoperative)
- Length of hospital stay(From day of surgery until 10 days postoperative)
- Knee circumference(Preoperative and day 1 postoperative)
- Knee joint range of motion(Preoperative, 1 day, 8 weeks,1 year postoperative)
- Forgotten Joint Score(Preoperative, 8 weeks, 1 year postoperative)
- Gene expression analyses. RT-PCR for expression levels for VEGF, NGF, SP, CGRP, IL-6, IL-1, TNF-alpha, Bad, Bax, Bid, Bim, Fas, Fas-ligand, Bcl-2, Mcl, and FLIP. Results will be normalized to GAPDH expression levels.(Peroperative and 8 weeks postoperative)
- Neuronal markers; PGP, GAP-43(During surgery and 8 weeks postoperative)
- Neuromediators; SP, CGRP, glutamate(During surgery and 8 weeks postoperative)
- Pain receptors; glutamate receptors(During surgery and 8 weeks postoperative)