Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorSB Istanbul Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients undergoing primary total knee arthroplasty

Age ≥ 50 years

Ability to provide informed consent

Disqualifiers

Revision TKA

Peripheral arterial disease (ABI < 0.9)

Active infection

History of deep vein thrombosis within 6 months

Trial population

Total Knee Arthroplasty patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: CVI Group
Group B: Non-CVI Group

Trial outcomes

Primary outcomes

1

Wound healing complications

Delayed healing Wound dehiscence Superficial/deep infection

Time frame
Preoperative baseline Postoperative: 2 weeks (wound assessment)

Secondary outcomes

1

WOMAC score

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.

Time frame
Preoperative baseline Postoperative: 6 weeks 6 months 12 months
2

KNEE SOCIETY SCORE

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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