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Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty

Study acronym: VENOUS-TKA
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruiting Show 4 more changesShow less
    • Start date changed from estimate of Jun 2026 to Jun 30, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 3 of 3 entries
  2. Minor Secondary endpoints: 1 to 2v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Total knee arthroplasty (TKA) is an effective treatment for end-stage knee osteoarthritis; however, postoperative complications-particularly wound healing problems-remain a significant concern. Chronic venous insufficiency (CVI) is associated with venous hypertension, impaired microcirculation, and tissue hypoxia, which may negatively affect wound healing and increase complication rates. This prospective observational cohort study aims to evaluate the impact of preoperative CVI on postoperative outcomes following TKA. Patients will be assessed preoperatively using the CEAP classification and Doppler ultrasonography to identify and stratify venous insufficiency. Participants will be followed for 12 months postoperatively. The primary outcome will be wound healing complications in the early postoperative period. Secondary outcomes will include functional outcomes assessed by the Knee Society Score (KSS), patient-reported outcomes using the WOMAC score, and overall complication rates. The findings of this study are expected to clarify the role of venous insufficiency as a potential risk factor in TKA and may contribute to improved preoperative risk stratification and postoperative management strategies.
Trial Details
NCT Number NCT07577141
Lead Sponsor SB Istanbul Education and Research Hospital
Conditions
(from sponsor)
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral), Doppler Ultrasound Diagnosis
Related terms Venous Insufficiency, Wounds and Injuries
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov