Osteoarthritis, KneeNCT04444570
Continuous Glycemia Monitoring in Perioperative Period in Patients Undergoing Total Knee or Hip Arthroplasty
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Medical University of Warsaw.
Trial summary
All across surgery specialties, wound or implant infections constitute rare, yet potentially severe complications of surgical procedure. It is considered, that glucose metabolism disorders, e.g. diabetes, are one of the main risk factors of such condition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Hyperglycemia
- What is being tested?
- Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Power analysis was performed to assess how many patients should be included in the study. Determining effect size was hindered by lack of literature comparing mean values and standard deviations (SD) between groups with and without complications. The effect size can be deemed "large", described numerically as 0.8 by Cohen. However, we decide to be more conservative and used effect size of 0.6, located between "medium" and "large" in Cohen's scale. Standard p value of 0.05, beta value of 0.8 and allocation ratio of 1/1 were used, resulting in total needed sample size of 90 patients. Taking into consideration that 10 % of patients might drop off the follow-up predicted number of participants is 100.
Who may be able to join
- Patients hospitalized in the Department of Orthopedics and Rehabilitation of Medical University of Warsaw
- Willingness to participate in the study
- Qualified for total knee or hip replacement due to the primary osteoarthritis
- Age above 18 years
Who cannot join
- No acceptance to participate in the study
- Qualified for non-surgical treatment
- Patients with other diseases but diabetes mellitus, compensated thyroid disorders and hypertension
- Patients with poorly-controled diabetes mellitus and/or poorly-controlled hypertension
- Patients with diabetes type 1
- Patients from the rest-home
Show all 10Show fewer
- Patients who had previous lower limb surgeries
- Patients who in opinion of research team might be poorly compliant
- Patients during pregnancy
- Patients who are not fluent in polish language
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Continuous Glycemia Monitoring in Perioperative Period in Patients Undergoing Total Knee or Hip Arthroplasty: a Protocol of Observational Study
All across surgery specialties, wound or implant infections constitute rare, yet potentially severe complications of surgical procedure. It is considered, that glucose metabolism disorders, e.g. diabetes, are one of the main risk factors of such condition.
Aim of the study The aim of the study is a prospective evaluation of glucose blood level and its variability during 2 weeks before hospitalization and 2 weeks of postoperative period in patients, that will undergo elective orthopaedic surgeries, and its impact on number of cardiovascular and orthopaedic complications.
Read more
Materials and methods To this study, patients qualified for elective total knee or hip replacement in the single orthopedic center will be recruited. 100 patients will be included in this study. Every patient will be evaluated on the risk of developing diabetes mellitus in 10 years time and on the risk of death in 10 years due to the cardiovascular events. 14 days before procedure patients will have continuous glucose level measurement sensor implemented in subcutaneous tissue. After 14 days, during standard visit for stitches removal, the sensor will be removed and glycemia data will be collected. Next, patients will have their casual glucose blood level checked and surgery outcome, cardiovascular events or surgery complication risk evaluated in 3-, 6- and 12 month follow-up visits.
Expected benefits of the study Results of this study may allow to define impact of orthopaedic treatment on glycemia and possible necessity to modify treatment of hyperglycemia in perioperative period in patients with Diabetes Mellitus type 2 (DM2). Moreover it will allow to specify change of glucose levels and possibly implicating a need to monitor perioperative glycemia in patients without carbohydrate metabolism disorders. Additionally, the study will help to evaluate corelation between perioperative glucose blood level and the risk of cardiovascular events or surgical complications in 1-year after the procedure, which may decrease the risk of such incidents in the future (e.g. by adequate control and effective treatment of hyperglycemia), hence may result in reduction of mortality and lesser lowering of the quality of life in patients with DM2 or high risk of it.
Read the detailed 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 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.
- Being tested
- Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue
- Keywords
- osteoarthritis, hip, knee, diabetes, glycemia
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Hyperglycemia, Diabetes Mellitus, Type 2, Osteoarthritis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissueDevice
14 days before the date of the surgery and after the surgery patient will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected
| Study group | Role | What they receive |
|---|---|---|
| Control group | 14 days before the date of the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom) Receives: Device: Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue | |
| Study group | Right after the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected Receives: Device: Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of glycemia levels during perioperative period
Continuous glycemia level monitoring with use of subcutaneously implanted device
Measured: 4 weeks (14 days preoperatively and 14 postoperatively)
Rate and type cardiovascular events during follow-up
Any cardiovascular events during follow-up (heart stroke, brain stroke, coronal arteries disease, transient ischaemic attack (TIA)
Measured: 12-months postoperatively
Rate and type of complications
Any surgical site and/or implants complications during follow-up
Measured: 12-months postoperatively
Secondary outcomes (2)
Objective functional outcome in Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a questionnaire designed to assess patient-relevant outcomes following knee injury. The KOOS assesses outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. All items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems). Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 14-days, 3-, 6-, and 12- months postoperatively
Cardiovascular events and/or surgical site or implants complications
Correlation of FINDRISC scale results with cardiovascular events and/or surgical site or implants complications
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Dec 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
- Investigators
- Artur Stolarczyk, qMD, PhD, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444570
- Sponsor's protocol ID
- Glycemia / WarsawMU
- Status last verified
- Oct 2021
- First submitted
- 19 Jun 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Owens CD, Stoessel K. Surgical site infections: epidemiology, microbiology and prevention. J Hosp Infect. 2008 Nov;70 Suppl 2:3-10. doi: 10.1016/S0195-6701(08)60017-1.
PubMed 19022115de Oliveira AC, Sarmento Gama C. Surgical site infection prevention: An analysis of compliance with good practice in a teaching hospital. J Infect Prev. 2017 Nov;18(6):301-306. doi: 10.1177/1757177417703190. Epub 2017 Apr 27.
PubMed 29344100Ata A, Lee J, Bestle SL, Desemone J, Stain SC. Postoperative hyperglycemia and surgical site infection in general surgery patients. Arch Surg. 2010 Sep;145(9):858-64. doi: 10.1001/archsurg.2010.179.
PubMed 20855756Martin ET, Kaye KS, Knott C, Nguyen H, Santarossa M, Evans R, Bertran E, Jaber L. Diabetes and Risk of Surgical Site Infection: A Systematic Review and Meta-analysis. Infect Control Hosp Epidemiol. 2016 Jan;37(1):88-99. doi: 10.1017/ice.2015.249. Epub 2015 Oct 27.
PubMed 26503187Kharroubi AT, Darwish HM. Diabetes mellitus: The epidemic of the century. World J Diabetes. 2015 Jun 25;6(6):850-67. doi: 10.4239/wjd.v6.i6.850.
PubMed 26131326Skyler JS, Bakris GL, Bonifacio E, Darsow T, Eckel RH, Groop L, Groop PH, Handelsman Y, Insel RA, Mathieu C, McElvaine AT, Palmer JP, Pugliese A, Schatz DA, Sosenko JM, Wilding JP, Ratner RE. Differentiation of Diabetes by Pathophysiology, Natural History, and Prognosis. Diabetes. 2017 Feb;66(2):241-255. doi: 10.2337/db16-0806. Epub 2016 Dec 15.
PubMed 27980006Lubbeke A, Silman AJ, Barea C, Prieto-Alhambra D, Carr AJ. Mapping existing hip and knee replacement registries in Europe. Health Policy. 2018 May;122(5):548-557. doi: 10.1016/j.healthpol.2018.03.010. Epub 2018 Mar 17.
PubMed 29598886Pijls BG, Meessen JMTA, Tucker K, Stea S, Steenbergen L, Marie Fenstad A, Makela K, Cristian Stoica I, Goncharov M, Overgaard S, de la Torre JA, Lubbeke A, Rolfson O, Nelissen RGHH. MoM total hip replacements in Europe: a NORE report. EFORT Open Rev. 2019 Jun 3;4(6):423-429. doi: 10.1302/2058-5241.4.180078. eCollection 2019 Jun.
PubMed 31210979Ackerman IN, Dieppe PA, March LM, Roos EM, Nilsdotter AK, Brown GC, Sloan KE, Osborne RH. Variation in age and physical status prior to total knee and hip replacement surgery: a comparison of centers in Australia and Europe. Arthritis Rheum. 2009 Feb 15;61(2):166-73. doi: 10.1002/art.24215.
PubMed 19177522Kheir MM, Tan TL, Kheir M, Maltenfort MG, Chen AF. Postoperative Blood Glucose Levels Predict Infection After Total Joint Arthroplasty. J Bone Joint Surg Am. 2018 Aug 15;100(16):1423-1431. doi: 10.2106/JBJS.17.01316.
PubMed 30106824Maeda Y, Nakamura N, Tsujimoto T, Sugano N. Higher blood glucose and larger fluctuations detected postoperatively using continuous glucose monitoring: a preliminary study following total knee or hip arthroplasty. J Exp Orthop. 2019 Apr 1;6(1):15. doi: 10.1186/s40634-019-0181-9.
PubMed 30937670Kitsios K, Tsapas A, Karagianni P. Glycemia and cardiovascular risk: challenging evidence based medicine. Hippokratia. 2011 Jul;15(3):199-204.
PubMed 22435015Kishore P, Kim SH, Crandall JP. Glycemic control and cardiovascular disease: what's a doctor to do? Curr Diab Rep. 2012 Jun;12(3):255-64. doi: 10.1007/s11892-012-0268-5.
PubMed 22467273Brand-Miller J, Dickinson S, Barclay A, Celermajer D. The glycemic index and cardiovascular disease risk. Curr Atheroscler Rep. 2007 Dec;9(6):479-85. doi: 10.1007/s11883-007-0064-x.
PubMed 18377788Giorgino F, Leonardini A, Laviola L. Cardiovascular disease and glycemic control in type 2 diabetes: now that the dust is settling from large clinical trials. Ann N Y Acad Sci. 2013 Apr;1281(1):36-50. doi: 10.1111/nyas.12044. Epub 2013 Feb 6.
PubMed 23387439
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glycemia Monitoring in Perioperative Period in Patients Undergoing Total Knee or Hip Arthroplasty: a Protocol of Observational Study
- ClinicalTrials.gov ID
- NCT04444570
- Acronym / sponsor ID
- Glycemia / WarsawMU
- Keywords
- osteoarthritis, hip, knee, diabetes, glycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All across surgery specialties, wound or implant infections constitute rare, yet potentially severe complications of surgical procedure. It is considered, that glucose metabolism disorders, e.g. diabetes, are one of the main risk factors of such condition.
Aim of the study The aim of the study is a prospective evaluation of glucose blood level and its variability during 2 weeks before hospitalization and 2 weeks of postoperative period in patients, that will undergo elective orthopaedic surgeries, and its impact on number of cardiovascular and orthopaedic complications.
Materials and methods To this study, patients qualified for elective total knee or hip replacement in the single orthopedic center will be recruited. 100 patients will be included in this study. Every patient will be evaluated on the risk of developing diabetes mellitus in 10 years time and on the risk of death in 10 years due to the cardiovascular events. 14 days before procedure patients will have continuous glucose level measurement sensor implemented in subcutaneous tissue. After 14 days, during standard visit for stitches removal, the sensor will be removed and glycemia data will be collected. Next, patients will have their casual glucose blood level checked and surgery outcome, cardiovascular events or surgery complication risk evaluated in 3-, 6- and 12 month follow-up visits.
Expected benefits of the study Results of this study may allow to define impact of orthopaedic treatment on glycemia and possible necessity to modify treatment of hyperglycemia in perioperative period in patients with Diabetes Mellitus type 2 (DM2). Moreover it will allow to specify change of glucose levels and possibly implicating a need to monitor perioperative glycemia in patients without carbohydrate metabolism disorders. Additionally, the study will help to evaluate corelation between perioperative glucose blood level and the risk of cardiovascular events or surgical complications in 1-year after the procedure, which may decrease the risk of such incidents in the future (e.g. by adequate control and effective treatment of hyperglycemia), hence may result in reduction of mortality and lesser lowering of the quality of life in patients with DM2 or high risk of it.
Detailed 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Device: Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue14 days before the date of the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom) |
| Study group | – | Device: Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissueRight after the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Power analysis was performed to assess how many patients should be included in the study. Determining effect size was hindered by lack of literature comparing mean values and standard deviations (SD) between groups with and without complications. The effect size can be deemed "large", described numerically as 0.8 by Cohen. However, we decide to be more conservative and used effect size of 0.6, located between "medium" and "large" in Cohen's scale. Standard p value of 0.05, beta value of 0.8 and allocation ratio of 1/1 were used, resulting in total needed sample size of 90 patients. Taking into consideration that 10 % of patients might drop off the follow-up predicted number of participants is 100.
Key inclusion criteria (4 listed)
- Patients hospitalized in the Department of Orthopedics and Rehabilitation of Medical University of Warsaw
- Willingness to participate in the study
- Qualified for total knee or hip replacement due to the primary osteoarthritis
- Age above 18 years
Key exclusion criteria (10 listed)
- No acceptance to participate in the study
- Qualified for non-surgical treatment
- Patients with other diseases but diabetes mellitus, compensated thyroid disorders and hypertension
- Patients with poorly-controled diabetes mellitus and/or poorly-controlled hypertension
- Patients with diabetes type 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue14 days before the date of the surgery and after the surgery patient will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected | Device | Control group, Study group |
Primary outcome
Changes of glycemia levels during perioperative period
Time frame: 4 weeks (14 days preoperatively and 14 postoperatively)
Continuous glycemia level monitoring with use of subcutaneously implanted device
Rate and type cardiovascular events during follow-up
Time frame: 12-months postoperatively
Any cardiovascular events during follow-up (heart stroke, brain stroke, coronal arteries disease, transient ischaemic attack (TIA)
Rate and type of complications
Time frame: 12-months postoperatively
Any surgical site and/or implants complications during follow-up
2 secondary outcomes
Objective functional outcome in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 14-days, 3-, 6-, and 12- months postoperatively
Cardiovascular events and/or surgical site or implants complications
Time frame: 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 19022115Owens CD, Stoessel K. Surgical site infections: epidemiology, microbiology and prevention. J Hosp Infect. 2008 Nov;70 Suppl 2:3-10. doi: 10.1016/S0195-6701(08)60017-1.
- Background: PubMed 29344100de Oliveira AC, Sarmento Gama C. Surgical site infection prevention: An analysis of compliance with good practice in a teaching hospital. J Infect Prev. 2017 Nov;18(6):301-306. doi: 10.1177/1757177417703190. Epub 2017 Apr 27.
- Background: PubMed 20855756Ata A, Lee J, Bestle SL, Desemone J, Stain SC. Postoperative hyperglycemia and surgical site infection in general surgery patients. Arch Surg. 2010 Sep;145(9):858-64. doi: 10.1001/archsurg.2010.179.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Artur Stolarczyk, qMD, PhD study chair
Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Medical University of Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartosz M. Maciąg, MD (+48 881568144, bartosz.maciag94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of glycemia levels during perioperative period (time frame: 4 weeks (14 days preoperatively and 14 postoperatively)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444570, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.