Clinical study

Peri-Operative STress and immune-response in Orthopaedic patients

Background: Annually around 9.000 patients in Denmark are having total knee arthroplasty surgery (TKA). All surgeries lead to a surgical stress response, which may be associated with postoperative complications. The Dex-2-TKA examines if dexamethasone could improve pain and other clinical outcomes after TKA. In addition, blood samples were collected in DEX-2-TKA patients at Næstved hospital for a biobank for future research in the immunological and inflammatory reactions concerning TKA and the influence hereon of dexamethasone.

Objectives: Evaluate the immunological and inflammatory response to dexamethasone and total knee arthroplasty.

Design: Analysis of blood samples collected pre-and postoperatively during the blinded, randomized, three-arm, clinical trial Dex-2-TKA (ethics committee registration SJ695).

Inclusion and exclusion criteria: Patients were included if they participated in the Dex-2-TKA-study and gave written, informed consent to collect blood samples for a biobank for future research. Exclusion criteria for the biobank were either refusal or lack of informed consent.

Description of experimental and control intervention: Evaluation of a biobank for future research collected in a cohort of patients undergoing total knee arthroplasty while receiving either placebo or 1 or 2 doses of 24mg dexamethasone perioperatively and 24 hours after surgery.

Primary and secondary outcomes: The difference in gene-expression profile (mRNA levels) and cytokine levels preoperatively and 24hour postoperatively after perioperative 24mg dexamethasone or placebo.
Secondary outcomes are the difference between 1 and 2 doses of dexamethasone. As an exploratory outcome, the gene expression and mRNA levels will be related to the clinical outcome (i.e., pain and function).

Trial size: Blood samples of 252 patients were stored as plasma/serum aliquots in a biobank for future research. In addition, 64 patients also donated Pax-gene tubes.