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

NCT07506434 | Not Yet Recruiting

• 1 other identifier: CREC-MN.065,2025/2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis (OA); Total Knee Anthroplasty

Keywords

tourniquet use

Outcome Measures

Primary Outcomes (1)

• Total perioperative blood loss

  Calculated using the Haemoglobin Balance method

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

Secondary Outcomes (5)

• Bone-cement interface quality

  Taken Intraoperatively

• Postoperative pain

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

• Knee range of motion

  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

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

• Perioperative complications

  Recorded up to 6 weeks postoperatively

Study Arms (2)

Tourniquet Group

ACTIVE COMPARATOR

Total knee arthroplasty performed with the use of a pneumatic tourniquet throughout the entire procedure

Device: pneumatic tourniquet

No-Tourniquet Group

NO INTERVENTION

Total knee arthroplasty performed without the use of a pneumatic tourniquet

Interventions

pneumatic tourniquet DEVICE

the use of a pneumatic tourniquet throughout the entire total knee replacement procedure

Tourniquet Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University Hospital of the West Indies

Kingston, Saint Andrew Parish, 00000, Jamaica

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Maxim Christmas, DM (Orthopaedics), FACS, FCCS

  University of the West Indies, Mona Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic Landell, MBBS

CONTACT

+18763257551; d.landell@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JA (1)