- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07577141
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty (VENOUS-TKA)
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
CVI Group
Patients with chronic venous insufficiency (CEAP + Doppler confirmed)
|
|
Non-CVI Group
Patients without chronic venous insufficiency on clinical and Doppler evaluation
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Wound healing complications
Časové okno: Preoperative baseline Postoperative: 2 weeks (wound assessment)
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Delayed healing Wound dehiscence Superficial/deep infection
|
Preoperative baseline Postoperative: 2 weeks (wound assessment)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
WOMAC score
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- TKA-CVI-2026
- not yet assigned (Jiný identifikátor: Istanbul Education and Research Hospital)
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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