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临床试验/NCT07010809
NCT07010809进行中(未招募)不适用

Assessing Bone Thermal Damage in Knee Arthroplasty: Burring vs Sawing

East Suffolk and North Essex NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月28日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
The measure of temperature generated by burr and saw cutting devices during total knee arthroplasty.

研究概览

简要总结

We will assess the temperatures achieved during bone cutting in total knee replacements, comparing burr and saw techniques. Our study involves recruiting 20 patients from East Suffolk and North Essex NHS Foundation Trust (Colchester site). Patients will be recruited from the orthopaedic outpatient clinic, with 10 undergoing Robotic total knee arthroplasty (burr cutting) and 10 undergoing conventional total knee arthroplasty (saw cutting). Temperatures will be measured using a visual infrared thermometer placed outside the surgical field while a consultant surgeon performs the procedure. Importantly, these temperature recordings will have no impact on which treatment the patient received as the standard of care.

详细描述

Patients will be recruited from elective orthopaedic outpatient clinics. All patients over the age of 18 with symptomatic osteoarthritis (OA), and due to undergo robotic assisted rTKA, with burr cutting, or cTKA, with saw cutting, will be considered for trial inclusion. Both devices are considered the standard of care for TKA.

This is an observational trial and the decision to undergo rTKA or cTKA is determined by patient factors, availability of equipment, and following consultation with the surgeon. The trial will not influence which patients undergo rTKA or cTKA.

10 patients undergoing cTKA and 10 patients undergoing rTKA will be recruited. During the procedure, a thermal imaging camera (Thermovision A320, Flir Systems Inc., Wilsonville, Oregon, USA) will be setup 2 metres outside the sterile operating field to record temperatures reached during the distal femoral cut.

  • Patients diagnosed with osteoarthritis follow a streamlined pathway to consult an orthopaedic surgeon. Initially, during the first clinic visit, the diagnosis is verified through both imaging and clinical examinations. After confirming the diagnosis, the patient is then scheduled for surgery, which could be either a robotic-assisted or a conventional total knee replacement, depending on their needs.
  • Approximately 1-2 weeks prior to the surgery, patients attend a consent clinic. During this session, if they meet the inclusion criteria, they are provided with detailed study information and invited to participate. For those needing more time to decide, the option to take the consent form home is available. This gives them at least 1-2 weeks to consider their enrolment before the surgery.
  • This study will not in any way impact the high standard of care provided to our patients. It is essential for researchers to ensure that enrolled patients have a comprehensive understanding of the trial procedures, the utilization of pseudo anonymized data, and contact addresses for any questions.
  • The study includes no direct intervention- it is an observational study.
  • A thermal imaging camera (Thermovision A320, Flir Systems Inc., Wilsonville, Oregon, USA) will be used to monitor temperature at the bone interface from exposure of distal femur until the distal femoral cut has been completed.
  • The camera will be positioned 2 meters away from the operative site out of the sterile operating field and will be operated by a trained members of staff who are members of the direct clinical care team.
  • All measurements throughout the study will be captured with the same camera, calibrated to the ambient room temperature and humidity prior to use in accordance with the manufacturer's instructions.
  • The camera will be connected to a password protected ESNEFT laptop computer, running the software application required to control and record from the thermal imaging camera (ThermaCAM Researcher Pro, version 2.8, Flir Systems Inc., Wilsonville, Oregon, USA, http://www.flir.com/).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Symptomatic knee osteoarthritis
  • 18+ years old
  • Scheduled for TKA as part of standard of care

排除标准

  • Distorted bone anatomy
  • Previous knee surgery
  • Diagnosed disease affected bone quality (e.g. Rheumatoid arthritis, Paget's disease, Osteomalacia)

研究组 & 干预措施

Robotic Total Knee Arthroplasty

With burr cutting

Conventional Total Knee Arthroplasty

With saw cutting

结局指标

主要结局

The measure of temperature generated by burr and saw cutting devices during total knee arthroplasty.

时间窗: During surgery

Temperature will be measured in degrees centigrade

次要结局

  • Duration of temperature above 47 degrees centigrade in burr and saw cutting groups.(During surgery.)

研究者

发起方
East Suffolk and North Essex NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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