Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies

March 27, 2026 updated by: The University of The West Indies

Is Routine Tourniquet Use Still Warranted? A Randomized Controlled Equivalence Trial Comparing Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies

The goal of this clinical trial is to determine whether performing total knee replacement surgery (total knee arthroplasty, TKA) without a tourniquet is clinically equivalent to performing the procedure with a tourniquet in adults with symptomatic knee osteoarthritis.

A tourniquet is commonly used during surgery to reduce bleeding and improve the surgeon's view. However, some studies suggest it may be associated with certain complications. It is currently unclear whether using a tourniquet meaningfully changes outcomes compared to not using one. This study aims to assess whether both approaches result in similar outcomes within a clinically acceptable range.

The main question this study aims to answer is:

Is total blood loss during surgery equivalent between TKA performed with a tourniquet and TKA performed without a tourniquet, within a predefined margin of ±100 mL?

Additional questions include:

Are surgical field quality, postoperative pain, functional recovery, and complication rates comparable between the two techniques?

Researchers will compare:

TKA performed with a pneumatic tourniquet TKA performed without a tourniquet

to determine whether outcomes between the two approaches are equivalent rather than whether one is superior to the other.

Participants will:

Be randomly assigned to one of the two surgical groups using a computer-generated process Undergo standard total knee replacement surgery and routine perioperative care Have blood loss assessed during and after surgery Be monitored for pain, recovery of function, wound healing, and complications during hospital stay and follow-up visits

This study is designed as a randomized controlled equivalence trial to determine whether both surgical approaches produce comparable outcomes within clinically acceptable limits, in a standardized local setting.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Age ≥ 18 years.

    • Clinical and radiographic diagnosis of knee osteoarthritis requiring primary unilateral Total Knee Arthroplasty.
    • Medically fit for elective surgery (typically ASA I-III).
    • Able to provide informed consent.

Exclusion Criteria:

  • • Revision TKA or bilateral simultaneous TKA.

    • Preexisting coagulopathy or active anticoagulation that cannot be perioperatively managed per protocol.
    • Known allergy or contraindication to tranexamic acid.
    • Active infection or immunosuppression.
    • Severe peripheral vascular disease in the operative limb.
    • BMI > 45 kg/m²
    • Inability to provide informed consent or comply with follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tourniquet Group
Total knee arthroplasty performed with the use of a pneumatic tourniquet throughout the entire procedure
Device: pneumatic tourniquet
the use of a pneumatic tourniquet throughout the entire total knee replacement procedure
No Intervention: No-Tourniquet Group
Total knee arthroplasty performed without the use of a pneumatic tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total perioperative blood loss
Time Frame: Hb values (pre- and postoperative day 3) will be measured
Calculated using the Haemoglobin Balance method
Hb values (pre- and postoperative day 3) will be measured

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone-cement interface quality
Time Frame: Taken Intraoperatively

Standardized digital photographs will be taken at approximately 30 cm from the operating field, using the same camera, technique, and exposure settings for all cases. The quality of the bloodless surgical field on the tibial and femoral cutting surfaces will then be evaluated. The tibial cutting surface will be divided into four equal sections (25% each) and the femoral cutting surface into eight equal sections (12.5% each). A bloodless surgical field will be defined as the absence of visible bloodstain on the cancellous bone surfaces.

Two independent physicians, blinded to the intervention and not involved in the surgery, will grade the images. Discrepancies between assessors will be resolved by consensus or adjudicated by a third blinded reviewer.
Taken Intraoperatively
Postoperative pain
Time Frame: Patients will be asked to mark their pain level at 24 and 48 hours postoperatively.
Instrument: Visual Analog Scale (VAS, 10 cm line; score 0-100). Personnel: Research coordinator or ward nurse (blinded to allocation) will administer and record scores
Patients will be asked to mark their pain level at 24 and 48 hours postoperatively.
Knee range of motion
Time Frame: Measured at postoperative day 2 and 6 weeks by a physiotherapist blinded to group allocation.
Instrument: Universal goniometer.
Measured at postoperative day 2 and 6 weeks by a physiotherapist blinded to group allocation.
Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS JR) Survey score
Time Frame: Administered at postoperative day 2 and 6 weeks by the research coordinator.
Instrument: Standardized questionnaire Scored as raw sum (0-28) and converted to 0-100 interval scale (higher = better function)
Administered at postoperative day 2 and 6 weeks by the research coordinator.
Perioperative complications
Time Frame: Recorded up to 6 weeks postoperatively

Measured outcomes:

i. Perioperative transfusion rates (from transfusion records) ii. Tourniquet-related complications (wound seepage, infection, subcutaneous hematoma/ecchymosis, tension blisters), to be assessed during ward rounds and recorded by blinded surgical team members.

iii. Thromboembolic events - confirmed via venous Doppler ultrasound or CT pulmonary angiogram as clinically indicated.

iv. Wound complications (infection, delayed healing) - assessed at follow-up visits by blinded clinic staff.

v. Neurovascular injury - documented by clinical exam postoperatively.
Recorded up to 6 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Investigators

  • Principal Investigator: Maxim Christmas, DM (Orthopaedics), FACS, FCCS, University of the West Indies, Mona Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC-MN.065,2025/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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