Knee Osteoarthritis (OA), Total Knee Anthroplasty
Conditions
Keywords
tourniquet use
Brief summary
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
DEVICEpneumatic tourniquet
the use of a pneumatic tourniquet throughout the entire total knee replacement procedure
Sponsors
The University of The West Indies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total perioperative blood loss | Hb values (pre- and postoperative day 3) will be measured | Calculated using the Haemoglobin Balance method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone-cement interface quality | 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. |
| Postoperative pain | 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 |
| Knee range of motion | Measured at postoperative day 2 and 6 weeks by a physiotherapist blinded to group allocation. | Instrument: Universal goniometer. |
| Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS JR) Survey score | 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) |
| Perioperative complications | 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. |
Countries
Jamaica
Contacts
CONTACTDominic Landell, MBBS
PRINCIPAL_INVESTIGATORMaxim Christmas, DM (Orthopaedics), FACS, FCCS
University of the West Indies, Mona Campus
Outcome results
None listed