Postoperative Hyperglycemia After Knee Primary Knee Arthroplasty Surgery

NCT03830931 | Completed

• 1 other identifier: SKAR1
• Study Type: observational
• Target: 1,448
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperglycemia

Keywords

Hyperglycemia, arthroplasty , complication

Outcome Measures

Primary Outcomes (1)

• The presence of postoperative hyperglycemia after primary knee arthroplasty surgery

  fP-Glucose

  The postoperative fP-Glucose will be assessed 1 day after primary knee arthroplasty surgery

Secondary Outcomes (2)

• The presence of adverse events after primary knee arthroplasty surgery

  90-days after primary knee arthroplasty surgery

• The presence of prosthetic joint infection (PJI) after primary knee arhroplasty surgery

  within 1 year after primary knee arthroplasty surgery

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients operated on with a primary knee arthroplasty from Three hospitals in Sweden

You may qualify if:

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

You may not qualify if:

• Not approved to participate in the study.

Sponsors & Collaborators

• Lund University: lead
• Ministry of Health and Social Affairs, Sweden: collaborator

Study Sites (1)

The Swedish Knee Arthroplasty Register

Lund, Skåne County, 24651, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Annette W-Dahl, Ass prof

  The Swedish Knee Arthroplasty Register

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 5, 2019
• Study Start: January 1, 2019
• Primary Completion: September 28, 2021
• Study Completion: October 31, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)