NCT05735847

Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA)

Does Surgery-Induced Trauma Influence Postoperative Safety and Outcome Comparing Total vs. Medial Unicompartmental Knee Arthroplasty (SITA): A Prospective Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) is the most common type of arthritis, characterized by pain and physical disability. More than 10% of persons \> 55 years have symptomatic OA, primarily involving the knees. Knee arthroplasty is considered a successful orthopaedic procedure in progressed knee OA (KOA) with severe pain and disability where non-surgical treatments have been tried. It has long been recognized that injury to the body, either from trauma or surgery causes an inflammatory response. As TKA is considered a more invasive procedure compared with UKA, TKA and UKA may not trigger inflammatory reactions of the same magnitude. Differences in inflammatory response between TKA and UKA could help explain why differences in outcome are present, despite both procedures being technically successful. Even though knee arthroplasty is a very common and successful procedure, there are no existing studies comparing the invasiveness of TKA and UKA. As morbidity and mortality rates differ between the groups, the aim of this prospective cohort study is to investigate whether the post-operative inflammatory responses differ between TKA and UKA, and secondarily whether this difference can explain the difference in outcome between the two procedures. The investigators hypothesize that TKA generates a larger postoperative systemic inflammatory response compared with UKA due to more extensive periarticular soft tissue and bone trauma. The study's primary outcome is C-reactive Protein (CRP) measured in blood 24 hours after surgery (22-26 hours after surgery \~ day 1). Participants which are candidates for either a TKA or a UKA will through serial blood test measurement have their postoperative systemic inflammatory response measured. This further will be correlated to the clinical and functional outcomes over a 2-years postoperative follow-up period.

Conditions

• Knee Osteoarthritis
• Arthritis
• Surgery
• Total Knee Arthroplasty
• Unicompartmental Knee Arthroplasty

Interventions

Type	Name	Description
PROCEDURE	Total Knee Arthroplasty (TKA)	The choice between TKA and UKA is based on the radiological presentation of the knee KOA on an x-ray. A surgery with TKA involves the replacement of both the medial and lateral compartments of the knee.
PROCEDURE	Unicompartmental Knee Arthroplasty (UKA)	The choice between TKA and UKA is based on the radiological presentation of the knee KOA on an x-ray. A surgery with UKA involves the replacement of one compartment.

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-03-30
• Completion: 2026-03-30
• First posted: 2023-02-21
• Last updated: 2024-10-08

Locations

1 site across 1 country: Denmark