跳至主要内容
临床试验/NCT06909760
NCT06909760进行中(未招募)不适用

A Myth Orthopaedic Implant Pain in Cold Weather

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
210
试验地点
1
主要终点
Pain on the extremity which was operated

研究概览

简要总结

In daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. However, when the literature is examined, there is only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. In this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.

详细描述

Fractures and degenerative joint diseases are common medical problems that many people experience throughout their lives. Orthopaedic implants are widely manufactured and used worldwide to replace a degenerated joint or to reduce a fractured bone and promote healing (1). In a 1988 incidence study, it was estimated that 4.9 million people in the USA had fixation material (2). Today, this rate is thought to increase much more due to increasing population, developing and increasing number of motorised vehicles and increasing surgical indications. Although the removal of these implants is a very controversial issue in the literature, most surgeons do not recommend routine removal of implants unless there are complications (3). In a study, it was reported that the reasons for implant removal were osteomyelitis and persistent pain in only 28% of patients, but the reason for removal was 'patient request' in 72% of patients who had implants removed (4).

In daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. However, when the literature was examined, there was only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. In this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients aged ≥ 18 years with orthopaedic implants due to orthopaedic trauma.

排除标准

  • •Patients <18 years of age
  • •Patients with incomplete fracture union
  • •Patients with joint prosthesis (knee, hip, shoulder prosthesis, etc.)
  • •Patients with complications in the operated extremity (implant infection, implant failure, etc.)
  • •Acute or chronic infection (bacterial or viral infection) of any body site
  • •Patients diagnosed with neuropathy (diabetic, alcoholism, autoimmune, nutritional deficiency, infectious)

结局指标

主要结局

Pain on the extremity which was operated

时间窗: Patients are called for follow up twice a year with 6 months interval

Pain will be assessed with "Visual Analogue Scale". Patients will be asked if they have pain on their extremity with orthopedic implant both in cold and hot weather conditions.

次要结局

  • range of motion of the affected joints(Patients are called for follow up twice a year with 6 months interval)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ahmet Berkay Girgin

Supervisor İnvestigator

Ankara Etlik City Hospital

研究点 (1)

Loading locations...

相似试验