Total Knee AnthroplastyVENOUS-TKANCT07577141
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
An observational study of Total Knee Anthroplasty and Venous Insufficiency (Chronic)(Peripheral), run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral), Doppler Ultrasound Diagnosis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Total Knee Arthroplasty patients
Who may be able to join
- Patients undergoing primary total knee arthroplasty
- Age ≥ 50 years
- Ability to provide informed consent
Who cannot join
- Revision TKA
- Peripheral arterial disease (ABI < 0.9)
- Active infection
- History of deep vein thrombosis within 6 months
- Immunosuppressive therapy
- Severe uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Educaiton and Research Hospital
Istanbul
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral), Doppler Ultrasound Diagnosis
- Keywords
- total knee arthroplasty, chronic venous insufficiency, doppler, wound
- Medical subject headings
- Venous Insufficiency, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CVI Group | Patients with chronic venous insufficiency (CEAP + Doppler confirmed) | |
| Non-CVI Group | Patients without chronic venous insufficiency on clinical and Doppler evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing complications
Delayed healing Wound dehiscence Superficial/deep infection
Measured: Preoperative baseline Postoperative: 2 weeks (wound assessment)
Secondary outcomes (2)
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.
Measured: Preoperative baseline Postoperative: 6 weeks 6 months 12 months
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.
Measured: Preoperative Postoperative 6th week Postoperative 6th month Postoperative 12nd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start30 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris Acar, SB Istanbul Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577141
- Sponsor's protocol ID
- TKA-CVI-2026
- Other IDs
- not yet assigned
- Acronym
- VENOUS-TKA
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34464986Cansabuncu 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.
PubMed 33409562Robin 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.
PubMed 37286057
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chronic Venous Insufficiency on Postoperative Outcomes and Wound Healing After Total Knee Arthroplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07577141
- Acronym / sponsor ID
- VENOUS-TKA / TKA-CVI-2026
- Conditions
- Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral), Doppler Ultrasound Diagnosis
- Keywords
- total knee arthroplasty, chronic venous insufficiency, doppler, wound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVI Group | – | –Patients with chronic venous insufficiency (CEAP + Doppler confirmed) |
| Non-CVI Group | – | –Patients without chronic venous insufficiency on clinical and Doppler evaluation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Total Knee Arthroplasty patients
Key inclusion criteria (3 listed)
- Patients undergoing primary total knee arthroplasty
- Age ≥ 50 years
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Revision TKA
- Peripheral arterial disease (ABI < 0.9)
- Active infection
- History of deep vein thrombosis within 6 months
- Immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound healing complications
Time frame: Preoperative baseline Postoperative: 2 weeks (wound assessment)
Delayed healing Wound dehiscence Superficial/deep infection
2 secondary outcomes
WOMAC score
Time frame: Preoperative baseline Postoperative: 6 weeks 6 months 12 months
KNEE SOCIETY SCORE
Time frame: Preoperative Postoperative 6th week Postoperative 6th month Postoperative 12nd month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 34464986Summers 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.
- Background: PubMed 33409562Cansabuncu 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.
- Background: PubMed 37286057Robin 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Anthroplasty and Venous Insufficiency (Chronic)(Peripheral), run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing complications (time frame: Preoperative baseline Postoperative: 2 weeks (wound assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07577141, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.