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

Study acronym: SITA
StatusTerminated
PhaseNot specified
Started
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Record History

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  1. Stopped Trial terminated Sponsor's reason: The study was terminated due to poor participant accrual. Recruitment was limited by competing clinical studies at the participating site, and the resources required to prolong the recruitment period were not available.
    • Study completion date changed from estimate of Mar 30, 2026 to Feb 28, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 13 of 30 entries
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 29
    • Site details revised
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 14, 2023 to Feb 20, 2023
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05735847
Lead Sponsor Hvidovre University Hospital
Collaborators: Frederiksberg University Hospital, Parker Research Institute
Conditions
(from sponsor)
Knee Osteoarthritis, Arthritis, Surgery, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty
Related terms Arthritis, Osteoarthritis, Knee
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov