Comparison of intraoperative surgical field visualization between the use of a tourniquet and without a tourniquet in primary total knee arthroplasty : a randomized controlled, non-inferiority trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260407011

Enrollment

110

Registered

2026-04-07

Start date

2026-03-31

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative surgical field visualization score between tourniquet and without a tourniquet in primary total knee arthroplasty intraoperative surgical field visualization score, surgical field visualization score, field visualization score, visualization score, tourniquet, without a tourniquet, non tourniquet, without tourniquet, TKA, primary total knee arthroplasty, total knee arthroplasty, total knee replacement

Interventions

All patients have their thighs covered with a tourniquet. Inflate or deflate based on the assigned group. the tourniquet will not be inflated for patients in the non tourniquet group (Without tourniqu

s blood pressure and thigh circumference. This procedure will be performed for patients in the tourniquet group (Tourniquet TKA).

Experimental Procedure/Surgery,Experimental Procedure/Surgery

Without tourniquet TKA,Tourniquet TKA

Eligibility

Sex/Gender

All

Age

55 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged between 55-80 years 2.Patients diagnosed with primary osteoarthritis of the knee 3.Patients who admitted for primary unilateral TKA at our institution

Exclusion criteria

Exclusion criteria: 1.Risk of venous thromboembolism (e.g. history of deep vein thrombosis [DVT], pulmonary embolism, hypercoagulability, chronic venous insufficiency, active malignancy, hormone replacement therapy, oral contraceptive therapy) 2.Bleeding disorders 3.Peripheral arterial disease 4.History of previous knee surgery in the operated knee. 5.Inflammatory arthritis : Gout, CPPD, Rheumatoid arthritis

Design outcomes

Primary

Measure	Time frame
Intraoperative surgical field visualization score At the end of operation Category scale adapted from Fromme and Boezaart et al	—

Secondary

Measure	Time frame
Postoperative pain score 24 hours and 72 hours after TKA Verbal numerical pain score,Leg circumference at Day 72 hours after TKA Measure thigh (10 cm proximal to the superior border of the patella), knee (midpoint of the patella), and calf (20 cm proximal to the medial malleolus) circumference in centimeters,Incidence of wound complications and thigh ecchymosis During hospitalization Wound grading according to the Southampton Scoring System and observation of thigh ecchymosis,Total blood loss Before surgery and 48 hours after TKA Measured by Gross formula use hematocrit	—

Measure

Time frame

Postoperative pain score 24 hours and 72 hours after TKA Verbal numerical pain score,Leg circumference at Day 72 hours after TKA Measure thigh (10 cm proximal to the superior border of the patella), knee (midpoint of the patella), and calf (20 cm proximal to the medial malleolus) circumference in centimeters,Incidence of wound complications and thigh ecchymosis During hospitalization Wound grading according to the Southampton Scoring System and observation of thigh ecchymosis,Total blood loss Before surgery and 48 hours after TKA Measured by Gross formula use hematocrit

—

Countries

Thailand

Contacts

Public ContactPasit Kiattimanaroj

Vajira hospital

pasit.kia@nmu.ac.th0982737610

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026