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Postoperative Hyperglycemia After Knee Primary Knee Arthroplasty Surgery

NCT03830931 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1448

Last updated 2021-11-11

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Ministry of Health and Social Affairs, Sweden

    collaborator OTHER_GOV

  • Lund University

    lead OTHER

Principal Investigators

  • Annette W-Dahl, Ass prof · The Swedish Knee Arthroplasty Register

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-09-28
Completion
2021-10-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03830931 on ClinicalTrials.gov