Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes Mellitus - Type 2
  • Hyperglycemia
  • Osteoarthritis Hip
  • Osteoarthritis (Knee)
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

In every surgical subspeciality surgical site or implants infections are not common but potentially devastating for patients health. One of the most known risk factors of such state is glucose metabolism disorders. Such pathologies, containing diabetes mellitus, are considered one of the most epidem...

In every surgical subspeciality surgical site or implants infections are not common but potentially devastating for patients health. One of the most known risk factors of such state is glucose metabolism disorders. Such pathologies, containing diabetes mellitus, are considered one of the most epidemic health-related problems in XXI century. Diabetes is a civilization disease, caused mainly by obesity, unhealthy eating habits and lack of physical activity. It was concerning about 108 million people in 1980, while in next 40 years this number grew 4-times and is expecting to reach almost 600 million people in 2035. Total joint arthroplasty is considered the most effective way of treating the end-stage osteoarthritis of hip and knee joints. It is estimated that every year more that one million total joint replacements are performed in Europe. It is believed that our community is getting older and that is the reason why the number of total joint replacements will be growing, as well as patients expectations towards it. Even though total knee and hip replacement have wonderful outcome and are improving significantly patients life and its quality, there are several potential side effect that might lower patients limb function. There were several studies confirming increased risk of surgical site or implants infections in patients undergoing total joint replacements such as knee or hip, who had perioperative poor glycemic control or had treated diabetes mellitus. However, there is lack of literature concerning analysis of continuous glycemia measurements before and after hospital stay. There are some promises that glycemic disturbances during postoperative period might also increase risk of cardiovascular events in this time and more frequent periods of hypoglycemia, which might result in higher risk of unconsciousness and falls. What is more higher cardiovascular risk is corelated with higher risk of disability and death. Results of this research will allow to investigate influence of orthopedic surgery on glycemia and possible modifications of hyperglycemia treatment in perioperative period in patients with diabetes or glucose intolerance. What is more it will allow to investigate changes of glycemia in patients with normal glycemia metabolism, potentially protecting them from hypoglycemia during hospital stay and increasing their awareness of potentially suffering diabetes mellitus in the future. Additionally, this study will allow to corelate perioperative glycemia levels with risk of cardiovascular events in one year follow-up, and its influence on surgical site and implants complications. Thanks to these findings surgeons will be able to lower the risk of such complications in the future, hence lowering mortality and quality of life, especially in patients with diabetes mellitus and from the group with high risk of developing this disorder. Nowadays, with technological development concerning our every day life, also devices used in medicine are getting more and more sophisticated and are making patients lifes easier. One of the most prominent examples of such device are the "discs" implanted into the subcutaneous tissue which might measure patients glycemia level. Thanks to it patients no longer need to measure it with traditional glucometers, which action relayed on blood samples collected from the tip of the finger. It was associated with every day unpleasant needling. Nowadays modern solution allow patients to get the result from their devices on their smartphones by only sliding it above the place of the implanted device. Taking into considerations, such a wide spread of diabetes mellitus in our population it is obvious, that among patients qualified for total hip or knee arthroplasty many of them will have this disease. Adding to it common risk factors of diabetes and osteoarthritis, such as obesity, it seems that number of patients with such diseases is much bigger than it seems. According to the literature mentioned above it is obvious that microangiopathic changes, as well as hyperglycemia, have negative influence on wound healing, surgery itself and might increase the risk of periprosthetic infections. It is worthy to look for ways to optimize patients care in perioperative period. Additional good side of this study is a fact, that it contains patients without recognized diabetes mellitus to assess their glycemia fluctuations, without carbohydrate metabolism disorders. Such knowledge might improve and allow to develop the algorithm of perioperative care for the high number of patients, who in such demanding for their body period are exposed to significant glycemia fluctuations. What is more, it must be admitted that this study has unique model (described below), in which glycemia monitoring will contain both pre- and postoperative period of every included patient. Such way of analyzing patients allows to produce "perfect control group", because every measurements after the surgery has its counterpart before the surgery. The aim of this project is to prospectively evaluate the level of glycemia and its variability in patients undergoing elective orthopedic surgeries during one month (two weeks before the surgery and two weeks postoperatively) and its influence on the number of cardiovascular and orthopedic complications. What is more the investigators want to evaluate its influence on objective functional outcome of the surgery in one year follow-up. It seems that long bone surgery as a stress factor might increase the risk of developing diabetes or glucose intolerance, what might increase the risk of cardiovascular diseases and number of complications. To this prospective observational study, patients qualified for elective total knee or hip replacement in the Department of Orthopedics and Rehabilitation in Miedzyleski Specialist Hospital in Warsaw will be recruited. 100 patients will be included. There were several studies confirming increased risk of surgical site or implants infections in patients undergoing total joint replacements such as knee or hip, who had perioperative poor glycemic control or had treated diabetes mellitus. However, there is lack of literature concerning analysis of continuous glycemia measurements before and after hospital stay. There are some premises that glycemic disturbances during postoperative period might also increase risk of cardiovascular events in this time and more frequent periods of hypoglycemia, which might result in higher risk of unconsciousness and falls. What is more higher cardiovascular risk is corelated with higher risk of disability and death. Results of this research will allow to investigate influence of orthopedic surgery on glycemia and possible modifications of hyperglycemia treatment in perioperative period in patients with diabetes or glucose intolerance. What is more it will allow to investigate changes of glycemia in patients with normal glycemia metabolism, potentially protecting them from hypoglycemia during hospital stay and increasing their awareness of potentially suffering diabetes mellitus in the future. Additionally, this study will allow to corelate perioperative glycemia levels with risk of cardiovascular events in one year follow-up, and its influence on surgical site and implants complications. Thanks to these findings surgeons will be able to lower the risk of such complications in the future, hence lowering mortality and quality of life, especially in patients with diabetes mellitus and from the group with high risk of developing this disorder. Nowadays, with technological development concerning our every day life, also devices used in medicine are getting more and more sophisticated and are making patients lifes easier. One of the most prominent examples of such device are the "discs" implanted into the subcutaneous tissue which might measure patients glycemia level. Thanks to it patients no longer need to measure it with traditional glucometers, which action relayed on blood samples collected from the tip of the finger. It was associated with every day unpleasant needling.

Tracking Information

NCT #
NCT04444570
Collaborators
Not Provided
Investigators
Study Chair: Artur Stolarczyk, qMD, PhD Medical University of Warsaw