Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pneumatic tourniquet.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis (OA), Total Knee Anthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jamaica
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device pneumatic tourniquet
the use of a pneumatic tourniquet throughout the entire total knee replacement procedure
Primary outcome measures
- Total perioperative blood loss [Time frame: Hb values (pre- and postoperative day 3) will be measured]
Secondary outcome measures (5)
- Bone-cement interface quality [Time frame: Taken Intraoperatively]
- Postoperative pain [Time frame: 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.]
- 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.]
- Perioperative complications [Time frame: Recorded up to 6 weeks postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Jamaica · 1 center
- University Hospital of the West Indies — Kingston
Identifiers
NCT: NCT07506434 · CREC-MN.065,2025/2026