Comparative study between Lower versus Higher tourniquet pressure in bilateral Subvastus total knee arthroplasty; A prospective Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260125005

Enrollment

Registered

2026-01-25

Start date

2024-11-01

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

Primary Hypothesis Patients in the low-pressure tourniquet group experience less pain at the tourniquet site and the surgical wound compared to those in the high-pressure tourniquet group. Secondary Hypothesis Patients in the low-pressure tourniquet group have greater knee range of motion than those in the high-pressure tourniquet group Primary osteoarthritis of knee, Bilateral total knee arthroplasty, Subvastus approach, Tourniquet pressure, Post operative care

Interventions

Systolic blood pressure (SBP) plus 75 mmHg,Systolic blood pressure (SBP) plus 150 mmHg

Experimental Procedure/Surgery,Experimental Procedure/Surgery

Lower pressure tourniquet,Higher pressure tourniquet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Male or female patients 2.Thai nationality 3.Able to understand and provide informed consent to participate in the study 4.Diagnosed with bilateral knee osteoarthritis in which conservative treatment was unsuccessful, requiring surgical intervention 5.Underwent bilateral total knee arthroplasty (BTKA) using the Subvastus approach

Exclusion criteria

Exclusion criteria: 1.Patients with severe knee deformity requiring customized prostheses 2.Patients with obesity (BMI > 35) 3.Patients with uncontrolled hypertension 4.Patients with contraindications to tourniquet use, such as peripheral vascular disease, history of coronary artery bypass graft (CABG) using leg vessels, or revision total knee arthroplasty (TKA)

Design outcomes

Primary

Measure	Time frame
Pain at tourniquet site pre-operative, 1day post-operative, 2day post-operative, 3day post-operative, 4day post-operative, 5day post-operative, 2week post-operative Questionnaire, content/case record form : Visual analog sclae	—

Secondary

Measure	Time frame
Pain at surgical site pre-operative, 1day post-operative, 2day post-operative, 3day post-operative, 4day post-operative, 5day post-operative, 2week post-operative Questionnaire, content/case record form : Visual analog sclae,Range of motion pre-operative, 1day post-operative, 2day post-operative, 3day post-operative, 4day post-operative, 5day post-operative, 2week post-operative Universal gloniometer	—

Measure

Time frame

Pain at surgical site pre-operative, 1day post-operative, 2day post-operative, 3day post-operative, 4day post-operative, 5day post-operative, 2week post-operative Questionnaire, content/case record form : Visual analog sclae,Range of motion pre-operative, 1day post-operative, 2day post-operative, 3day post-operative, 4day post-operative, 5day post-operative, 2week post-operative Universal gloniometer

—

Countries

Thailand

Contacts

Public ContactSurasun Saiyat

police general hospital

Yusurasun2@gmail.com0985257787

Outcome results

None listed

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