跳至主要内容
临床试验/CTRI/2024/02/063386
CTRI/2024/02/063386尚未招募不适用

Examination of primary total hip and knee arthroplasty tissues

Dr Arunava Kumar Bhuyan1 个研究点 分布在 1 个国家目标入组 1,394 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,394
试验地点
1
主要终点
Histological and microbiological sample reports routinely sent intraoperatively

研究概览

简要总结

Permission shall be taken from Medical Superintendent of KH and Orthopedic Surgeons in the Department of Orthopaedics, KMC Manipal to use the medical records of their patients. All demographic data collected shall be kept anonymous. Samples will be selected from hospital records and selection of samples will be done based on above mentioned inclusion and exclusion criteria. Patient data will be collected from EMR and MRD. Pre-operative tests reports and intra operative histopathological and microbiological test results will be collected. Patient records will be utilized to analyse whether the patient underwent any change in antibiotic therapy based on microbiological reports and the course of the patients follow up and progress will be followed for atleast 1 year through hospital records in EMR to ascertain the outcome of the post operative period and whether the patient developed PJI at any time post op. A negative intraoperative culture report with post operative PJI will be considered as a insignificant result. The total number of insignificant studies will be multiplied by the mean cost of the microbiologcal analysis(over the past 10 years) to obain the approximate financial burden of microbiological analysis to the patients over the past 10 years in Kasturba Hospital. Histological reports will be analysed and grouped whether they were concordant (similar),  discordant (different but not warranting change in treatment plan) or discrepant (different and warranting change in treatment plan) as compared to the preoperative clinicoradiological diagnosis of the Orthopedic surgeon. Every concordant match will be considered as a non-significant result and the total non-significant results will be tabulated and multiplied by the mean cost of histological analysis (over the past 10 years) to obtain the approximate financial burden of histological analysis to the patients over the past 10 years in Kasturba Hospital. All these data collected will be tabulated in excel

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • No known hip/knee pathology/infection preop apart from diagnosis.

排除标准

  • Revision arthroplasty surgeries.

结局指标

主要结局

Histological and microbiological sample reports routinely sent intraoperatively

时间窗: Histological and microbiological sample reports routinely sent intraoperatively

次要结局

  • Significance of sending these routine investigations(End of study)
  • If not significant, overall economic burden of the same(End of study)

研究者

发起方
Dr Arunava Kumar Bhuyan
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Arunava Kumar Bhuyan

Kasturba Medical College, MAHE, Manipal

研究点 (1)

Loading locations...

相似试验