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Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty (VENOUS-TKA)

12 de mayo de 2026 actualizado por: Baris Acar, SB Istanbul Education and Research Hospital

The Impact of Chronic Venous Insufficiency on Postoperative Outcomes and Wound Healing After Total Knee Arthroplasty: A Prospective Observational Study

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

100

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

Total Knee Arthroplasty patients

Descripción

Inclusion Criteria:

  • Patients undergoing primary total knee arthroplasty
  • Age ≥ 50 years
  • Ability to provide informed consent

Exclusion Criteria:

  • Revision TKA
  • Peripheral arterial disease (ABI < 0.9)
  • Active infection
  • History of deep vein thrombosis within 6 months
  • Immunosuppressive therapy
  • Severe uncontrolled diabetes mellitus

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
CVI Group
Patients with chronic venous insufficiency (CEAP + Doppler confirmed)
Non-CVI Group
Patients without chronic venous insufficiency on clinical and Doppler evaluation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Wound healing complications
Periodo de tiempo: Preoperative baseline Postoperative: 2 weeks (wound assessment)
Delayed healing Wound dehiscence Superficial/deep infection
Preoperative baseline Postoperative: 2 weeks (wound assessment)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
WOMAC score
Periodo de tiempo: Preoperative baseline Postoperative: 6 weeks 6 months 12 months

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.

Preoperative baseline Postoperative: 6 weeks 6 months 12 months
KNEE SOCIETY SCORE
Periodo de tiempo: Preoperative Postoperative 6th week Postoperative 6th month Postoperative 12nd month

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.

Preoperative Postoperative 6th week Postoperative 6th month Postoperative 12nd month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • TKA-CVI-2026
  • Not yet assigned (Istanbul Education and Research Hospital)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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