Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty

NCT07577141 | Not Yet Recruiting

• 2 other identifiers: TKA-CVI-2026not yet assigned
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Total Knee Anthroplasty; Venous Insufficiency (Chronic)(Peripheral); Doppler Ultrasound Diagnosis

Keywords

total knee arthroplasty; chronic venous insufficiency; doppler; wound

Outcome Measures

Primary Outcomes (1)

• Wound healing complications

  Delayed healing Wound dehiscence Superficial/deep infection

  Preoperative baseline Postoperative: 2 weeks (wound assessment)

Secondary Outcomes (2)

• WOMAC score

  Preoperative baseline Postoperative: 6 weeks 6 months 12 months

• KNEE SOCIETY SCORE

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

Study Arms (2)

CVI Group

Patients with chronic venous insufficiency (CEAP + Doppler confirmed)

Non-CVI Group

Patients without chronic venous insufficiency on clinical and Doppler evaluation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Total Knee Arthroplasty patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• SB Istanbul Education and Research Hospital: lead

Related Publications (3)

• 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.

  PMID: 34464986 BACKGROUND

• 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.

  PMID: 33409562 BACKGROUND

• 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.

  PMID: 37286057 BACKGROUND

MeSH Terms

Conditions

Venous Insufficiency; Wounds and Injuries

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share