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临床试验/NCT02907047
NCT02907047已完成不适用

Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

Rothman Institute Orthopaedics2 个研究点 分布在 1 个国家开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
试验地点
2
主要终点
timed up and go (TUG) score

研究概览

简要总结

The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.

研究设计

研究类型
Interventional
干预模型
Parallel

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion
  • Diagnosis of osteoarthritis

排除标准

  • Revision surgery
  • Bilateral knee surgery
  • Age <18 or >80
  • Baseline lower extremity strength less than 5/5
  • Vascular calcifications
  • History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
  • Functionally limiting spine disease
  • Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
  • Patients who cannot perform the baseline functional tests
  • Allergy/contraindication to protocol medications
  • Post-traumatic arthritis
  • Inflammatory arthritis
  • Patients receiving care as part of a worker's compensable injury

研究组 & 干预措施

No tourniquet

Other

These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure

干预措施: tourniquet not inflated (Other)

Tourniquet

Active Comparator

These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure

干预措施: tourniquet inflated (Other)

结局指标

主要结局

timed up and go (TUG) score

时间窗: 4 weeks following surgery

Stair Climb test

时间窗: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

time, in seconds, to climb one flight of nine stairs

Visual Analog Scale: Pain

时间窗: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

次要结局

  • surgical field visualization(intra-operative)
  • blood loss(intra-operative)
  • range of motion(in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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