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

12. maj 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Total Knee Arthroplasty patients

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wound healing complications
Tidsramme: Preoperative baseline Postoperative: 2 weeks (wound assessment)
Delayed healing Wound dehiscence Superficial/deep infection
Preoperative baseline Postoperative: 2 weeks (wound assessment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
WOMAC score
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TKA-CVI-2026
  • not yet assigned (Anden identifikator: Istanbul Education and Research Hospital)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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