- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
CVI Group
Patients with chronic venous insufficiency (CEAP + Doppler confirmed)
|
|
Non-CVI Group
Patients without chronic venous insufficiency on clinical and Doppler evaluation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound healing complications
Tidsram: Preoperative baseline Postoperative: 2 weeks (wound assessment)
|
Delayed healing Wound dehiscence Superficial/deep infection
|
Preoperative baseline Postoperative: 2 weeks (wound assessment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
WOMAC score
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TKA-CVI-2026
- Not yet assigned (Istanbul Education and Research Hospital)
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