MedTrace Logo

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

NCT07506434 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-01

No results posted yet for this study

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

Interventions

DEVICE

pneumatic tourniquet

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

Sponsors & Collaborators

  • The University of The West Indies

    lead OTHER

Principal Investigators

  • Maxim Christmas, DM (Orthopaedics), FACS, FCCS · University of the West Indies, Mona Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • Jamaica

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07506434 on ClinicalTrials.gov