Knee Osteoarthritis (OA)NCT07506434
Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies
A study testing pneumatic tourniquet in people with Knee Osteoarthritis (OA) and Total Knee Anthroplasty, run by The University of The West Indies at 1 site in Jamaica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis (OA), Total Knee Anthroplasty
- What is being tested?
- pneumatic tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJamaica
- Study dates
- Jun 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jamaica1 site
University Hospital of the West Indies
Kingston, Saint Andrew Parish, 00000
Dominic Landell, MBBS, 8763257551, d.landell@hotmail.com
d.landell@hotmail.com
About this study
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
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.
Read more
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
- Being tested
- pneumatic tourniquet
- Keywords
- tourniquet use
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumatic tourniquetDevice
the use of a pneumatic tourniquet throughout the entire total knee replacement procedure
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet Group | Active comparator | Total knee arthroplasty performed with the use of a pneumatic tourniquet throughout the entire procedure Receives: Device: pneumatic tourniquet |
| No-Tourniquet Group | No intervention | Total knee arthroplasty performed without the use of a pneumatic tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total perioperative blood loss
Calculated using the Haemoglobin Balance method
Measured: Hb values (pre- and postoperative day 3) will be measured
Secondary outcomes (5)
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.
Measured: 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
Measured: Patients will be asked to mark their pain level at 24 and 48 hours postoperatively.
Knee range of motion
Instrument: Universal goniometer.
Measured: 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)
Measured: Administered at postoperative day 2 and 6 weeks by the research coordinator.
Perioperative complications
Measured outcomes:
- 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.
- Neurovascular injury - documented by clinical exam postoperatively.
Measured: Recorded up to 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxim Christmas, DM (Orthopaedics), FACS, FCCS, Principal investigator, University of the West Indies, Mona Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506434
- Sponsor's protocol ID
- CREC-MN.065,2025/2026
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07506434
- Acronym / sponsor ID
- CREC-MN.065,2025/2026
- Conditions
- Knee Osteoarthritis (OA), Total Knee Anthroplasty
- Keywords
- tourniquet use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet Group | Active comparator | Device: pneumatic tourniquetTotal knee arthroplasty performed with the use of a pneumatic tourniquet throughout the entire procedure |
| No-Tourniquet Group | No intervention | –Total knee arthroplasty performed without the use of a pneumatic tourniquet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age ≥ 18 years.
Key exclusion criteria (7 listed)
- • Revision TKA or bilateral simultaneous TKA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumatic tourniquetthe use of a pneumatic tourniquet throughout the entire total knee replacement procedure | Device | Tourniquet Group |
Primary outcome
Total perioperative blood loss
Time frame: Hb values (pre- and postoperative day 3) will be measured
Calculated using the Haemoglobin Balance method
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maxim Christmas, DM (Orthopaedics), FACS, FCCS principal investigator
University of the West Indies, Mona Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumatic tourniquet in people with Knee Osteoarthritis (OA) and Total Knee Anthroplasty, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Landell, MBBS (+18763257551, d.landell@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total perioperative blood loss (time frame: Hb values (pre- and postoperative day 3) will be measured). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.