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临床试验/NCT04786379
NCT04786379终止不适用

Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial

Texas Tech University Health Sciences Center, El Paso1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年4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
终止
发起方
入组人数
10
试验地点
1
主要终点
Number of surgeries to obtain lasting clinical resolution

研究概览

简要总结

Surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. However, there has been considerable debate over the optimal modality. Most surgeons perform an open arthrotomy or arthroscopic debridement, although serial aspiration can be considered as an option in very limited circumstances with patients who cannot tolerate surgery. While open arthrotomy has been often utilized, there has been an increasing number of proponents for arthroscopic treatment citing lower re-infection rates and better functional outcomes. However, there has been a lack of well-designed prospective studies comparing surgical treatment modalities for native knee septic arthritis. The goals of this present study are to determine if arthroscopic management of septic arthritis in the native knee resulted in a lower number of surgeries and a shorter length of stay compared to open arthrotomy. Secondary outcomes included differences in postoperative pain and improvements in Lysholm knee scores.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Adults (>18 years old)
  • •Have a diagnosis of septic arthritis of the native knee (synovial WBC >50k or acrystalline elevated synovial WBC >25,000 with high clinical suspicion)
  • •Willingness to participate in the study

排除标准

  • •Unwilling to participate in the study
  • •Acrystalline elevated synovial WBC < 25,000
  • •Crystalline arthropathy with elevated synovial WBC but < 50,000
  • •Have a history of a prior knee prosthesis (hemiarthroplasty, total knee arthroplasty)

研究组 & 干预措施

Patients with confirmed septic arthritis of the native knee

Experimental

干预措施: Arthroscopic Irrigation and Debridement (Procedure)

Patients with confirmed septic arthritis of the native knee

Experimental

干预措施: Open Arthrotomy with irrigation and debridement (Procedure)

结局指标

主要结局

Number of surgeries to obtain lasting clinical resolution

时间窗: Through time period of initial admission (days; expected under 14 days)

The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.

Hospital length of stay

时间窗: Through time period of initial admission (days; expected under 14 days)

The total number of days in which the patient is initially admitted in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.

次要结局

  • Post Operative Pain Scores(Through time period of initial admission (days; expected under 14 days))
  • Post Operative Opioid Use(Through time period of initial admission (days; expected under 14 days))
  • Lysholm Knee Scale(Through anticipated follow up period of 3 month post operative appointment.)

研究者

发起方
Texas Tech University Health Sciences Center, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Wells

Principal Investigator

Texas Tech University Health Sciences Center, El Paso

研究点 (1)

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