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临床试验/NCT02693457
NCT02693457已完成不适用

Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty

Colorado Joint Replacement2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Lower Extremity Isomechanical Dynomometery

研究概览

简要总结

This randomized controlled trial is designed to determine the effect of suction drain usage on the reduction of postoperative swelling following total knee replacement. Furthermore, this study will determine the relationship between postoperative swelling and quadriceps muscle function. This study will be performed in a cohort of patients undergoing bilateral total knee replacement and the suction intra-articular drain will be randomized to one of the two operative knees prior to surgery.

详细描述

This study has two primary aims: 1) to determine the effects of intra-articular suction drain use, placed during total knee arthroplasty (TKA), on postoperative knee joint effusion, which is the collection of fluid in the joint capsule, and lower extremity swelling compared to a TKA without the use of an intra-articular drain and, 2) to describe the relationship between postoperative lower extremity swelling and quadriceps function (strength and activation). The use of intra-articular drains during TKA surgery has been highly disputed, due to the fear of increasing risk of infection from a secondary incision site, however, past studies have found no increased risk of complication from drain use. Furthermore, studies have shown that drain use may reduce the amount of hidden blood loss, or blood that is collected in the intra-articular space. Of interest, effusion may be associated with decreased quadriceps function. Previous research examining the influence of knee effusion on quadriceps function has shown that with laboratory-induced acute knee effusion, quadriceps activation and force production are reduced. However, previous findings lack the ability to inform care for patients following TKA due to the acute nature of the effusion and the inability to translate findings from healthy individuals to a clinical population. This study has the potential to greatly improve care for patients undergoing TKA by informing the surgical procedure while also providing important evidence for the influence of postoperative swelling on quadriceps muscle function.

In order to maintain patient blinding, a non-functional subcutaneous drain will be placed in the non-randomized knee. Patients will be blinded to any fluid output from the intra-articular drain.

A medial parapatellar approach will be utilized for exposure of the knee. All TKAs will be performed using a gap balancing technique with substitution of the posterior collateral ligament (PCL). In all cases, a tensioning device will be used to establish balanced, symmetrical flexion and extension spaces. All TKA procedures will utilize cemented implants. Randomly assigned drains (intra-articular or subcutaneous) will be placed in respective knees before closure. All patients will be treated with Tranexamic Acid intravenously to standardize blood loss and effusion.

All patients will be provided standard rehabilitation protocol during their inpatient stay. After hospital discharge, patients will be encouraged to receive outpatient physical therapy 2-3 times per week for 6 weeks.

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
Single (Participant)

入排标准

年龄范围
— 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≤ 70 years
  • Undergoing bilateral, simultaneous, primary knee replacements

排除标准

  • neurological, vascular or cardiac problems that limit function
  • unstable orthopedic conditions that limit functional performance
  • previous history of inflammatory arthritis or other inflammatory systemic conditions
  • previous history of deep vein thrombosis in either lower extremity
  • lymphedema or other conditions that lead to lower extremity edema that may influence the outcomes of the study.

结局指标

主要结局

Lower Extremity Isomechanical Dynomometery

时间窗: 2 Weeks Post-Operative

Knee Extensor Strength

次要结局

  • Lower Extremity Isomechanical Dynomometery(3 Month Post-Operative)
  • Clinical Quadriceps Activation Battery(3 Months Post-Operative)
  • Knee Pain Measured by Visual Analog Scale(3 Months Post-Operative)
  • Knee Extension Range of Motion(3 Months Post-Operative)
  • Bioelectrical Impedance for Swelling(3 Months Post-Operative)
  • Knee Flexion Range of Motion(3 Months Post Operative)
  • Lower Extremity Hand Held Dyanmometry(48 hours Post-Operative)
  • Circumferential Measure of Swelling(3 Months Post-Operative)
  • Diagnostic Ultrasound Measure of Effusion(3 Months Post-Operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Jennings, MD

Principal Investigator, Orthopedic Surgeon

Colorado Joint Replacement

研究点 (2)

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