An observational study in Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral) and Doppler Ultrasound Diagnosis, sponsored by SB Istanbul Education and Research Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by SB Istanbul Education and Research Hospital · Observational
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.
Total knee arthroplasty (TKA) is a highly successful surgical intervention for the treatment of end-stage knee osteoarthritis, providing significant pain relief and functional improvement. Despite advances in surgical techniques and perioperative care, postoperative complications-particularly wound healing problems and surgical site infections-remain clinically relevant and may adversely affect patient outcomes.
Chronic venous insufficiency (CVI) is a common vascular condition characterized by venous reflux, venous hypertension, and impaired microcirculation. These pathophysiological changes may lead to tissue edema, reduced oxygenation, and delayed wound healing. Although CVI has been associated with impaired soft tissue healing in various clinical settings, its impact on postoperative outcomes following TKA has not been clearly defined.
The aim of this prospective observational cohort study is to investigate the effect of preoperative CVI on wound healing, functional outcomes, and complication rates after primary TKA. Preoperatively, all patients will undergo a standardized venous assessment including clinical classification using the CEAP system and Doppler ultrasonography to evaluate venous reflux, vein diameter, and the anatomical distribution of insufficiency. Based on these assessments, patients will be stratified into CVI and non-CVI groups.
All procedures will be performed using a standardized surgical technique for primary TKA. Perioperative variables such as operative time, tourniquet use, and comorbidities will be recorded to control for potential confounders.
Postoperative follow-up will be conducted at regular intervals, including early wound assessment at 2 weeks and subsequent evaluations at 6 weeks, 3 months, 6 months, and 12 months. The primary outcome of the study will be wound healing complications in the early postoperative period, including delayed wound healing, wound dehiscence, and surgical site infections. Secondary outcomes will include functional outcomes measured by the Knee Society Score (KSS), patient-reported outcomes assessed by the WOMAC score, length of hospital stay, and overall complication rates.
Statistical analysis will include comparative analyses between groups and multivariate regression models to determine whether CVI is an independent predictor of postoperative complications and functional outcomes. The severity of venous insufficiency, as classified by CEAP, will also be analyzed in relation to clinical outcomes.
This study is expected to provide clinically relevant evidence regarding the role of CVI in TKA outcomes. Identifying CVI as a potential risk factor may improve preoperative risk stratification, guide perioperative management, and ultimately enhance patient outcomes following total knee arthroplasty.
162 studies on the registry are indexed under Venous Insufficiency; 14 are open to participants now.
This study's planned enrollment of 100 is close to the median of 91 across 28 observational studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →SB Istanbul Education and Research Hospital is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Total Knee Arthroplasty patients
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Immunosuppression
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Patients with chronic venous insufficiency (CEAP + Doppler confirmed)
Patients without chronic venous insufficiency on clinical and Doppler evaluation
Wound healing complications
Delayed healing Wound dehiscence Superficial/deep infection
Time frame: Preoperative baseline Postoperative: 2 weeks (wound assessment)
WOMAC score
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): The WOMAC score ranges from 0 to 96 (or 0 to 100 depending on the version used), with higher scores indicating worse pain, stiffness, and functional limitation.
Time frame: Preoperative baseline Postoperative: 6 weeks 6 months 12 months
KNEE SOCIETY SCORE
KSS (Knee Society Score): The Knee Society Score ranges from 0 to 100, with higher scores indicating better knee function and clinical outcome, whereas lower scores reflect poorer function and increased symptoms.
Time frame: Preoperative Postoperative 6th week Postoperative 6th month Postoperative 12nd month
Plan to share: No — Individual participant data will not be shared due to patient privacy and confidentiality considerations. The dataset contains clinical and imaging information collected within a single-center observational study. In accordance with institutional ethics committee regulations and data protection policies, sharing of individual-level data with external parties is not planned.
Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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SB Istanbul Education and Research Hospital