Tourniquet PalsyNCT06521593
Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study
A study testing Applying a tourniquet for either a short or long time during total knee replacement in people with Tourniquet Palsy, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Total knee arthroplasty (TKA) is an effective treatment in severe osteoarthritis. We aim to compare the advantages and disadvantages related to the duration of tourniquet application in TKA surgeries. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Tourniquet Palsy
- What is being tested?
- Applying a tourniquet for either a short or long time during total knee replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- We included symptomatic grade IV knee primary osteoarthritis cases who were candidates for TKA surgery
Who cannot join
- we excluded patients with a history of post-infection or traumatic osteoarthritis, knee deformity, hematological diseases, currant infection focus, immune-suppression, or inflammatory arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Total knee arthroplasty (TKA) is an effective treatment in severe osteoarthritis. We aim to compare the advantages and disadvantages related to the duration of tourniquet application in TKA surgeries.
Read the detailed description
Total knee arthroplasty (TKA) is considered an effective method in relieving pain and regaining function in severe osteoarthritis patients; however, it is associated with increased blood loss risk which can increase the need for blood transfusion. Tourniquet use during surgery is controversial as it provides a clear visualization which decreases the blood loss and ensures proper cementation which makes it used frequently during TKA. However, its use is associated with complications like nerve palsy, thigh pain, swelling, joint stiffness, wound complications, subcutaneous fat necrosis, vascular injury, deep venous thrombosis (DVT), and prolonged duration of quadriceps recovery.
The proper duration of tourniquet application is also controversial as it affects TKA postoperative outcomes as increasing tourniquet application duration can aggravate the complications risk because of the increased tissue exposure to ischemia. Therefore, minimization of the tourniquet application duration is important which makes researchers investigate if tourniquet application during the cementation process only in TKA could decrease the complications and fasten the recovery.
Limited tourniquet application during TKA decreased swelling and joint pain while it was not associated with blood loss, recovery, or operation time. While applying a tourniquet only in cementation could reduce blood loss, fasten the recovery period, and reduce pain after TKA surgery.
However, decreasing tourniquet application to be only during cementation was associated with increased blood transfusion risk which indicated that this approach was impractical if there was not any improvement in recovery. Therefore, a balance should exist between the increased blood loss and blood transfusion risk during cementation tourniquet application. Therefore, the application time of a tourniquet during cementation in TKA is controversial and no meta-analysis compared using a tourniquet only to the long tourniquet use in TKA surgeries.
Therefore, randomized controlled trials (RCTs) are needed to compare which strategy is better which made us perform this study to compare both strategies regarding pain, Oxford Knee Score (OKS), hospital stay, pain, Knee Society Score (KSS), blood loss, and range of motion (ROM).
- Conditions
- Tourniquet Palsy
- Being tested
- Applying a tourniquet for either a short or long time during total knee replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying a tourniquet for either a short or long time during total knee replacementProcedure or surgery
All patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation finishing of bone cementation while in group two who underwent short duration application of a tourniquet, the tourniquet was only applied just before cementation, was inflated also to 150 mmHg above the systolic blood pressure of the patients, and was deflated after bone cementation.
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent short duration applying of tourniquet. | Active comparator | All patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation just before cementing Receives: Procedure: Applying a tourniquet for either a short or long time during total knee replacement |
| patients who underwent long duration applying of tourniquet. | Experimental | All patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation finishing of bone cementation Receives: Procedure: Applying a tourniquet for either a short or long time during total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
We measured the intraoperative blood loss by subtracting saline volume used in washing from the whole suction volume which was added to the value resulting from subtracting dry foments weight from the wet foments weight used in managing bleeding.
Measured: immediately post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Nov 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourniquet PalsyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521593
- Sponsor's protocol ID
- N-414-2021
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study
- ClinicalTrials.gov ID
- NCT06521593
- Acronym / sponsor ID
- N-414-2021
- Conditions
- Tourniquet Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 26 Jul 2024 (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.
Total knee arthroplasty (TKA) is an effective treatment in severe osteoarthritis. We aim to compare the advantages and disadvantages related to the duration of tourniquet application in TKA surgeries.
Detailed description
Total knee arthroplasty (TKA) is considered an effective method in relieving pain and regaining function in severe osteoarthritis patients; however, it is associated with increased blood loss risk which can increase the need for blood transfusion. Tourniquet use during surgery is controversial as it provides a clear visualization which decreases the blood loss and ensures proper cementation which makes it used frequently during TKA. However, its use is associated with complications like nerve palsy, thigh pain, swelling, joint stiffness, wound complications, subcutaneous fat necrosis, vascular injury, deep venous thrombosis (DVT), and prolonged duration of quadriceps recovery.
The proper duration of tourniquet application is also controversial as it affects TKA postoperative outcomes as increasing tourniquet application duration can aggravate the complications risk because of the increased tissue exposure to ischemia. Therefore, minimization of the tourniquet application duration is important which makes researchers investigate if tourniquet application during the cementation process only in TKA could decrease the complications and fasten the recovery.
Limited tourniquet application during TKA decreased swelling and joint pain while it was not associated with blood loss, recovery, or operation time. While applying a tourniquet only in cementation could reduce blood loss, fasten the recovery period, and reduce pain after TKA surgery.
However, decreasing tourniquet application to be only during cementation was associated with increased blood transfusion risk which indicated that this approach was impractical if there was not any improvement in recovery. Therefore, a balance should exist between the increased blood loss and blood transfusion risk during cementation tourniquet application. Therefore, the application time of a tourniquet during cementation in TKA is controversial and no meta-analysis compared using a tourniquet only to the long tourniquet use in TKA surgeries.
Therefore, randomized controlled trials (RCTs) are needed to compare which strategy is better which made us perform this study to compare both strategies regarding pain, Oxford Knee Score (OKS), hospital stay, pain, Knee Society Score (KSS), blood loss, and range of motion (ROM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who underwent short duration applying of tourniquet. | Active comparator | Procedure: Applying a tourniquet for either a short or long time during total knee replacementAll patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation just before cementing |
| patients who underwent long duration applying of tourniquet. | Experimental | Procedure: Applying a tourniquet for either a short or long time during total knee replacementAll patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation finishing of bone cementation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We included symptomatic grade IV knee primary osteoarthritis cases who were candidates for TKA surgery
Key exclusion criteria (1 listed)
- we excluded patients with a history of post-infection or traumatic osteoarthritis, knee deformity, hematological diseases, currant infection focus, immune-suppression, or inflammatory arthritis.
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 |
|---|---|---|
| Applying a tourniquet for either a short or long time during total knee replacementAll patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation finishing of bone cementation while in group two who underwent short duration application of a tourniquet, the tourniquet was only applied just before cementation, was inflated also to 150 mmHg above the systolic blood pressure of the patients, and was deflated after bone cementation. | Procedure or surgery | patients who underwent long duration applying of tourniquet., patients who underwent short duration applying of tourniquet. |
Primary outcome
Blood loss
Time frame: immediately post operative
We measured the intraoperative blood loss by subtracting saline volume used in washing from the whole suction volume which was added to the value resulting from subtracting dry foments weight from the wet foments weight used in managing bleeding.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Undecided. May be shared upon reasonable request
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applying a tourniquet for either a short or long time during total knee replacement in people with Tourniquet Palsy, run by Kasr El Aini Hospital at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
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?
Blood loss (time frame: immediately post operative). 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 26 Jul 2024.