Arthroplasty, Replacement, KneeNCT07905495
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
A study testing Simultaneous Bilateral Total Knee Replacement with Tourniquet and Simultaneous Bilateral Total Knee Replacement without Tourniquet in people with Arthroplasty, Replacement, Knee and Blood Loss, Surgical, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
This randomized controlled trial compared early outcomes after replacement of both knees during the same operation, with and without tourniquet use. A tourniquet was an inflatable cuff placed around the upper thigh and tightened during surgery to temporarily restrict blood flow. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Blood Loss, Surgical, Pain, Postoperative
- What is being tested?
- Simultaneous Bilateral Total Knee Replacement with Tourniquet and Simultaneous Bilateral Total Knee Replacement without Tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 30 Jan 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-80 years scheduled for simultaneous bilateral primary total knee replacement.
- Both male and female.
- American Society of Anesthesiologists (ASA) class I-III, medically optimized for elective surgery.
Who cannot join
- Revision arthroplasty, prior major realignment or ligament reconstruction on either knee, unicompartmental or staged bilateral procedures, or concomitant procedures altering perioperative blood loss profiles.
- Active local or systemic infection, chronic osteomyelitis, or recent septic arthritis; skin compromise over planned incisions.
- Inflammatory arthropathies with active systemic disease, crystal arthropathy flare, or post-infective arthritis are likely to confound pain or bleeding metrics.
- Coagulopathy (congenital/acquired), platelets <150×10⁹/L, hemoglobin <11.0 g/dL, INR >1.3, or requirement for anticoagulant/antiplatelet therapy that cannot be safely interrupted per protocol.
- Recent venous thromboembolism (<6 months) or hypercoagulable states (e.g., antiphospholipid syndrome) not fully anticoagulated/optimized.
- Significant uncontrolled comorbidity: NYHA III-IV heart failure, recent myocardial infarction (<6 months) or LVEF <35%; severe pulmonary disease with resting hypoxemia; CKD stage 4-5 (eGFR <30 mL/min/1.73 m²); Child-Pugh B/C liver disease.
- Cognitive impairment precluding valid pain scoring.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Shifa International Hospital, Islamabad
Islamabad, Fedral, 44000
About this study
This randomized controlled trial compared early outcomes after replacement of both knees during the same operation, with and without tourniquet use. A tourniquet was an inflatable cuff placed around the upper thigh and tightened during surgery to temporarily restrict blood flow. The study tested the hypothesis that tourniquet use would reduce blood loss during and after surgery, preserve hemoglobin levels, and reduce early postoperative pain. Hemoglobin was the protein in red blood cells that carried oxygen.
The study was designed to include 84 patients aged 40-80 years at the Department of Orthopedic Surgery, Shifa International Hospital, Islamabad. Patients were randomly assigned to two equal groups of 42. One group underwent replacement of both knees with tourniquet use, while the other underwent the same procedure without tourniquet inflation. Both groups received standardized surgical care, pain management, blood clot prevention, and rehabilitation.
The outcomes assessed were blood loss during surgery, blood collected through drains from both knees during the first 24 hours after surgery, hemoglobin levels at 24 hours, and the decrease from preoperative hemoglobin levels. Pain in each knee was assessed at 24 and 48 hours using a scale from 0, indicating no pain, to 10, indicating the worst possible pain. These measurements were compared between the two groups to assess the effect of tourniquet use on early recovery.
- Being tested
- Simultaneous Bilateral Total Knee Replacement with Tourniquet, Simultaneous Bilateral Total Knee Replacement without Tourniquet
- Keywords
- Bilateral total knee arthroplasty, Pneumatic thigh tourniquet, Intraoperative blood loss, Postoperative hemoglobin level, Postoperative pain
- Medical subject headings
- Blood Loss, Surgical, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Bilateral Total Knee Replacement with TourniquetProcedure or surgery
Both knees were replaced during a single anesthetic session using cemented components. A pneumatic tourniquet was placed around the proximal thigh of each limb and inflated to 100 mmHg above systolic blood pressure immediately before the incision for that limb. Tourniquet release and hemostasis followed the standardized surgical protocol.
Simultaneous Bilateral Total Knee Replacement without TourniquetProcedure or surgery
Both knees were replaced during a single anesthetic session using cemented components. Tourniquet cuffs were not inflated. Hemostasis was maintained throughout surgery using electrocautery and standard surgical techniques.
| Study group | Role | What they receive |
|---|---|---|
| Group A-With Tourniquet | Experimental | Patients underwent simultaneous bilateral total knee replacement with pneumatic thigh tourniquets. Standardized perioperative care, pain management, thromboprophylaxis, and rehabilitation were provided. Receives: Procedure: Simultaneous Bilateral Total Knee Replacement with Tourniquet |
| Group B-Without Tourniquet | Active comparator | Patients underwent simultaneous bilateral total knee replacement without tourniquet inflation. Standardized perioperative care, pain management, thromboprophylaxis, and rehabilitation were provided. Receives: Procedure: Simultaneous Bilateral Total Knee Replacement without Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood Loss
Blood loss was calculated as the volume collected in suction canisters minus irrigation fluid, plus blood absorbed in surgical gauzes. Gauze blood content was estimated from the difference between preoperative and postoperative weights, using 1 gram as equivalent to 1 milliliter. Blood loss from both knee procedures was combined and recorded in milliliters per patient.
Measured: During surgery, from skin incision to skin closure for both knee procedures.
Secondary outcomes (3)
Postoperative Hemoglobin Level
Hemoglobin concentration was measured in a venous blood sample and reported in grams per deciliter. Values were compared between the tourniquet and non-tourniquet groups.
Measured: At 24 hours after completion of surgery.
Hemoglobin Decline
Hemoglobin decline was calculated by subtracting the hemoglobin concentration measured 24 hours after surgery from the preoperative concentration. The difference was reported in grams per deciliter.
Measured: From the preoperative assessment to 24 hours after completion of surgery.
Postoperative Pain at 24 Hours
Pain was assessed separately for each knee using a 10-centimeter visual analog scale, ranging from 0, indicating no pain, to 10, indicating the worst possible pain. The average of the right and left knee scores was calculated for each patient. Higher scores indicated greater pain.
Measured: At 24 hours after completion of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jul 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnain Ali, Shifa International Hospital
- Investigators
- Ammara Khalil, Principal investigator, Shifa International Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905495
- Sponsor's protocol ID
- SIH2
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
- ClinicalTrials.gov ID
- NCT07905495
- Acronym / sponsor ID
- SIH2
- Keywords
- Bilateral total knee arthroplasty, Pneumatic thigh tourniquet, Intraoperative blood loss, Postoperative hemoglobin level, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 29 Oct 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.
This randomized controlled trial compared early outcomes after replacement of both knees during the same operation, with and without tourniquet use. A tourniquet was an inflatable cuff placed around the upper thigh and tightened during surgery to temporarily restrict blood flow. The study tested the hypothesis that tourniquet use would reduce blood loss during and after surgery, preserve hemoglobin levels, and reduce early postoperative pain. Hemoglobin was the protein in red blood cells that carried oxygen.
The study was designed to include 84 patients aged 40-80 years at the Department of Orthopedic Surgery, Shifa International Hospital, Islamabad. Patients were randomly assigned to two equal groups of 42. One group underwent replacement of both knees with tourniquet use, while the other underwent the same procedure without tourniquet inflation. Both groups received standardized surgical care, pain management, blood clot prevention, and rehabilitation.
The outcomes assessed were blood loss during surgery, blood collected through drains from both knees during the first 24 hours after surgery, hemoglobin levels at 24 hours, and the decrease from preoperative hemoglobin levels. Pain in each knee was assessed at 24 and 48 hours using a scale from 0, indicating no pain, to 10, indicating the worst possible pain. These measurements were compared between the two groups to assess the effect of tourniquet use on early recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-With Tourniquet | Experimental | Procedure: Simultaneous Bilateral Total Knee Replacement with TourniquetPatients underwent simultaneous bilateral total knee replacement with pneumatic thigh tourniquets. Standardized perioperative care, pain management, thromboprophylaxis, and rehabilitation were provided. |
| Group B-Without Tourniquet | Active comparator | Procedure: Simultaneous Bilateral Total Knee Replacement without TourniquetPatients underwent simultaneous bilateral total knee replacement without tourniquet inflation. Standardized perioperative care, pain management, thromboprophylaxis, and rehabilitation were provided. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 40-80 years scheduled for simultaneous bilateral primary total knee replacement.
- Both male and female.
- American Society of Anesthesiologists (ASA) class I-III, medically optimized for elective surgery.
Key exclusion criteria (7 listed)
- Revision arthroplasty, prior major realignment or ligament reconstruction on either knee, unicompartmental or staged bilateral procedures, or concomitant procedures altering perioperative blood loss profiles.
- Active local or systemic infection, chronic osteomyelitis, or recent septic arthritis; skin compromise over planned incisions.
- Inflammatory arthropathies with active systemic disease, crystal arthropathy flare, or post-infective arthritis are likely to confound pain or bleeding metrics.
- Coagulopathy (congenital/acquired), platelets <150×10⁹/L, hemoglobin <11.0 g/dL, INR >1.3, or requirement for anticoagulant/antiplatelet therapy that cannot be safely interrupted per protocol.
- Recent venous thromboembolism (<6 months) or hypercoagulable states (e.g., antiphospholipid syndrome) not fully anticoagulated/optimized.
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 |
|---|---|---|
| Simultaneous Bilateral Total Knee Replacement with TourniquetBoth knees were replaced during a single anesthetic session using cemented components. A pneumatic tourniquet was placed around the proximal thigh of each limb and inflated to 100 mmHg above systolic blood pressure immediately before the incision for that limb. Tourniquet release and hemostasis followed the standardized surgical protocol. | Procedure or surgery | Group A-With Tourniquet |
| Simultaneous Bilateral Total Knee Replacement without TourniquetBoth knees were replaced during a single anesthetic session using cemented components. Tourniquet cuffs were not inflated. Hemostasis was maintained throughout surgery using electrocautery and standard surgical techniques. | Procedure or surgery | Group B-Without Tourniquet |
Primary outcome
Intraoperative Blood Loss
Time frame: During surgery, from skin incision to skin closure for both knee procedures.
Blood loss was calculated as the volume collected in suction canisters minus irrigation fluid, plus blood absorbed in surgical gauzes. Gauze blood content was estimated from the difference between preoperative and postoperative weights, using 1 gram as equivalent to 1 milliliter. Blood loss from both knee procedures was combined and recorded in milliliters per patient.
3 secondary outcomes
Postoperative Hemoglobin Level
Time frame: At 24 hours after completion of surgery.
Hemoglobin Decline
Time frame: From the preoperative assessment to 24 hours after completion of surgery.
Postoperative Pain at 24 Hours
Time frame: At 24 hours after completion of surgery.
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 29 Oct 2026.
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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.
Ammara Khalil principal investigator
Shifa International Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Bilateral Total Knee Replacement with Tourniquet and Simultaneous Bilateral Total Knee Replacement without Tourniquet in people with Arthroplasty, Replacement, Knee and Blood Loss, Surgical, run by Shifa International Hospital at 1 site in Pakistan.
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 3 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 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 Pakistan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Blood Loss (time frame: During surgery, from skin incision to skin closure for both knee procedures.). 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 29 Oct 2026.