University Hospital of the West Indies
Kingston, Saint Andrew Parish, 00000, Jamaica
NCT Number: NCT07506434
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Kingston, Saint Andrew Parish, 00000, Jamaica
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the use of a pneumatic tourniquet throughout the entire total knee replacement procedure
Time frame: Hb values (pre- and postoperative day 3) will be measured
Calculated using the Haemoglobin Balance method
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.
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
Time frame: Measured at postoperative day 2 and 6 weeks by a physiotherapist blinded to group allocation.
Instrument: Universal goniometer.
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)
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.
Contact information is provided by the study sponsor or research team.
The University of The West Indies
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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