Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks
研究概览
简要总结
This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.
详细描述
Tourniquets are widely accepted as "safe" for up to two hours of continued use, despite known risks and a paucity of literature supporting this duration. Complications of tourniquets include tourniquet site pain, increased surgical site pain and swelling from reperfusion, neuropraxia, vascular injury, functional weakness, and decreased muscle endurance. Similar to compartment syndrome, tourniquets eliminate the tissue perfusion gradient necessary for oxygen, glucose, and lactic acid exchange. Lack of molecular exchange within the tissue is thought to result in tissue anoxia and acidosis, leading to cellular death of skeletal muscle and nerves. This study randomizes patients undergoing ankle fracture surgery to tourniquet or no-tourniquet arms and studies outcomes including continuous intramuscular pH during and after surgery, and patient-reported outcomes and functional measures up to 3 months postoperatively.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU
排除标准
- •other significant long bone or internal injuries (including ipsilateral limb injuries).
结局指标
主要结局
Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks
时间窗: Collected preoperatively and 12 weeks postoperatively
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) subscale, a Patient Reported Outcome survey used widely in orthopaedic literature, will be obtained and reported in points. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). A score of 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For example a score of 40 is one SD lower than the mean of the reference population where as a score of 60 is one SD higher than the mean of the reference population. Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeks
时间窗: Collected preoperatively and 12 weeks postoperatively
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) subscale, a Patient Reported Outcome survey used widely in orthopaedic literature, will be obtained and reported in points. A score of 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For example a score of 40 is one SD lower than the mean of the reference population where as a score of 60 is one SD higher than the mean of the reference population. Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
Change from Baseline Foot and Ankle Ability Measure at 12 weeks
时间窗: Collected preoperatively and 12 weeks postoperatively
Foot and Ankle Ability Measure (FAAM), a Patient Reported Outcome survey used widely in orthopaedic Foot and Ankle literature, will be obtained and reported in points. Scores range from 0% (least function) to 100% (most function).
次要结局
- Pain Score(Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively)
- Mobility(Collected at 6 weeks and 12 weeks postoperatively)
- Fatigability(Collected at 6 weeks and 12 weeks postoperatively)
- Malleolar circumference(Collected at 6 weeks and 12 weeks postoperatively)
- Limb pH(Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively)
- Ankle range of motion(Collected at 6 weeks and 12 weeks postoperatively)
- Calf girth(Collected at 6 weeks and 12 weeks postoperatively)
- Proximal and distal lower extremity strength(Collected at 6 weeks and 12 weeks postoperatively)
- Single-limb stance time(Collected at 6 weeks and 12 weeks postoperatively)
- Y-balance test scores(Collected at 6 weeks and 12 weeks postoperatively)
研究者
Lara Atwater
Associate Professor
Oregon Health and Science University