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

N/ANot Yet RecruitingNCT07506434

The University of The West Indies30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total perioperative blood loss

Calculated using the Haemoglobin Balance method

Time frame: Hb values (pre- and postoperative day 3) will be measured

Secondary Outcomes

Bone-cement interface quality

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: Taken Intraoperatively

Postoperative pain

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: Patients will be asked to mark their pain level at 24 and 48 hours postoperatively.

Knee range of motion

Instrument: Universal goniometer.

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

Instrument: Standardized questionnaire Scored as raw sum (0-28) and converted to 0-100 interval scale (higher = better function)

Time frame: Administered at postoperative day 2 and 6 weeks by the research coordinator.

Perioperative complications

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.

Time frame: Recorded up to 6 weeks postoperatively

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts