VENOUS-TKA
The Impact of Chronic Venous Insufficiency on Postoperative Outcomes and Wound Healing After Total Knee Arthroplasty: A Prospective Observational Study
Sponsor study identifier
Secondary identifiers
OTHER · Istanbul Education and Research Hospital
observational
100
1 country
1
Study Start
June 30, 2026
Actual (reported)Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2026
Actual (reported)May 11, 2026
Actual (reported)June 30, 2026
Actual (reported)May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Wound healing complications
Delayed healing Wound dehiscence Superficial/deep infection
Preoperative baseline Postoperative: 2 weeks (wound assessment)
WOMAC score
Preoperative baseline Postoperative: 6 weeks 6 months 12 months
KNEE SOCIETY SCORE
Preoperative Postoperative 6th week Postoperative 6th month Postoperative 12nd month
Patients with chronic venous insufficiency (CEAP + Doppler confirmed)
Patients without chronic venous insufficiency on clinical and Doppler evaluation
Total Knee Arthroplasty patients
İstanbul Educaiton and Research Hospital
Istanbul, Turkey (Türkiye)
Summers S, Yakkanti R, Ocksrider J, Haziza S, Mannino A, Roche M, Hernandez VH. Effects of Venous Insufficiency in Patients Undergoing Primary Total Knee Arthroplasty: An Analysis of 1.2 Million Patients. J Knee Surg. 2023 Feb;36(3):322-328. doi: 10.1055/s-0041-1733901. Epub 2021 Aug 31.
Cansabuncu G, Gumus F. Pre-operative predictors of lower extremity swelling following total knee arthroplasty in patients with venous insufficiency and osteoarthritis. Int Orthop. 2021 Oct;45(10):2561-2567. doi: 10.1007/s00264-020-04888-0. Epub 2021 Jan 7.
First Submitted
May 4, 2026
First Posted
May 11, 2026
Study Start
June 30, 2026
Actual (reported)Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Robin KJ, Maier MA, Leslie LJ, Dasa V, Krause PC, Jones DG, Chapple AG. Severity of Chronic Venous Insufficiency on Primary Total Knee Arthroplasty Outcomes. J Arthroplasty. 2023 Nov;38(11):2324-2327.e4. doi: 10.1016/j.arth.2023.05.040. Epub 2023 Jun 5.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-05
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.
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Source: ClinicalTrials.gov.
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