ClinicalTrials.gov
ClinicalTrials.gov Menu

Postoperative Hyperglycemia After Knee Primary Knee Arthroplasty Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03830931
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Ministry of Health and Social Affairs, Sweden
Information provided by (Responsible Party):
Lund University

Brief Summary:
Patients in three hospitals in Sweden who will have knee arthroplasty surgery for the first time are invited to participate in the study, approximately 2000 patients. The fasting glucose value (fP-glucose) is obtained via a blood sample the day after the knee arthroplasty surgery. The sample is analyzed and the glucose value obtained is documented and sent to the Swedish Knee Arthroplasty Register (SKAR). In the SKAR there is information on patient characteristics, diagnosis, prosthesis, anesthetic form and primary and secondary operations, etc. The unique personal numbers of the included patients are submitted to the National Board of Health and Welfare, which matches the cohort with the Patient Register to identify adverse events, re-admission and death in a year after the surgery. SKAR has carried out several interactions with the National Board of Health and Welfare, and possesses clinical expertise as well as registers and biostatistics expertise. Incidence calculation of the proportion that develops elevated glucose levels after surgery and Cox regression for group comparison (elevated glucose vs. non-elevated) taking into account factors within groups such as age, gender, etc. This is a register-based observation study. Since the incidence of elevated glucose value after a knee prosthesis operation is not known, we are planning for a representative selection from three major prosthetic clinics in Sweden. Regarding the secondary purposes, our ability to answer these depends on the presence of elevated glucose levels. The inclusion start in January 2019 and lasts for one year. Incidence calculations can be made as soon as all patients are included, but 90-day data from the patient register can reasonably be completed

Condition or disease
Hyperglycemia

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Hyperglycemia in Knee Arthroplasty Surgery
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Primary knee arthroplasty patients
Fasting Plasma Glucose test will be obtained the morning after surgery and the frequency of hyperglycemia in non diabetic and diabetic patients will be evaluated



Primary Outcome Measures :
  1. postoperative hyperglycemia [ Time Frame: the morning after primary knee arthroplasty surgery ]
    fP-Glucose


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 90-days after primary knee arthroplasty surgery ]
    complications, readmission, death

  2. Prosthetic joint infection (PJI) [ Time Frame: within 1 year after primary knee arthroplasty surgery ]
    infection after primary knee arthroplasty surgery


Biospecimen Retention:   Samples Without DNA
Blood sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients operated on with a primary knee arthroplasty from Three hospitals in Sweden
Criteria

Inclusion Criteria:

  • Patients operated on with a primary knee arthroplasty in 3 hospitals in Sweden.
  • Approved to participate in the study.

Exclusion Criteria:

  • Not approved to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830931


Contacts
Contact: Annette W-Dahl, Ass prof +46704240410 annette.w-dahl@med.lu.se
Contact: Otto Robertsson, PhD +46704968183 otto.robertsson@med.lu.se

Locations
Sweden
The Swedish Knee Arthroplasty Register Recruiting
Lund, Skane, Sweden, 24651
Contact: Annette W-Dahl, Ass prof    +46704240410    annette.w-dahl@med.lu.se   
Contact: Otto Robertsson, PhD    +46704968183    otto.robertsson@med.lu.se   
Principal Investigator: Annette W-Dahl, Ass prof         
Sponsors and Collaborators
Lund University
Ministry of Health and Social Affairs, Sweden
Investigators
Principal Investigator: Annette W-Dahl, Ass prof The Swedish Knee Arthroplasty Register

Additional Information:

Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03830931     History of Changes
Other Study ID Numbers: SKAR1
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lund University:
Hyperglycemia, knee arthroplasty surgery, adverse events

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases