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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of The West Indies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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