Quadriceps Muscle AtrophyNCT05926154
Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
A study testing Surgical tourniquet pressure selection in people with Quadriceps Muscle Atrophy and Tourniquet, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare two differential tourniquet pressure in lower extremity surgery cases. The main questions it aims to answer are: What are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet? Are the effects of two different… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quadriceps Muscle Atrophy, Tourniquet, EMG
- What is being tested?
- Surgical tourniquet pressure selection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to Jan 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operation planning in the foot and ankle area
Who cannot join
- Having a history of previous foot and ankle surgery,
- Having a history of previous knee surgery or spinal surgery,
- Diagnosis of diabetes mellitus,
- Having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.),
- Having a diagnosis of a disease affecting the known peripheral vascular system (Peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency),
- Having a disease that affects the ideal tourniquet application (Chronic Lymphedema, BMI>35, Stage 3 and above chronic renal failure, uncontrollable hypertension),
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- Having been diagnosed with a known coagulation disorder,
- History of pulmonary embolism or deep vein thrombosis.
- ASA score above 3
- Surgery time to be less than 80 minutes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey
Istanbul, Fatih-Topkapı, 34080
Ahmet M YILDIRIM, Assistant, 090 212 414 2000 ext. 31516, ahmet.yildirim.93@istanbul.edu.tr
About this study
The goal of this clinical trial is to compare two differential tourniquet pressure in lower extremity surgery cases. The main questions it aims to answer are:
- What are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet?
- Are the effects of two different tourniquet pressures on neuromonitoring significantly different?
- Can the ideal time of the reperfusion interval be evaluated by neuromonitoring?
- Are the effects of two different tourniquet pressures on the quadriceps denervation significantly different from each other? Participants meeting the inclusion criteria will be evaluated for parameters to be used preoperatively. It will be evaluated in the 1st day, 1st week and 1-month follow-ups in the postoperative period.
The investigators will compare two different tourniquet pressure ( Limb occlusion pressure +50 mmHg / + 100 mmHg) to see if it will be evaluated whether there is a significant difference in terms of quadriceps denervation, vas scores, total blood estimate volume loss, intraoperative MEP decrease, and recovery times, quadriceps tendon thickness, thigh circumfrences.
Read the detailed description
As a result of the power analysis for this study, the number of samples was determined as 24. The study was started after the approval of the ethics committee.
Participants who met the inclusion and exclusion criteria were randomized in terms of tourniquet pressure to be applied and divided into two groups. It was planned to evaluate quadriceps tendon thickness by USG and MRI, thigh circumference, VAS scores, CBC, and CK in blood samples in the preoperative period of all patients. It was planned to obtain parameters related to MEP by using intraoperative neuromonitorization during the surgery. In the postoperative period, all parameters that were evaluated preoperatively on the 1st day, 1st week, and 1st month were re-evaluated. Finally, EMG evaluation was planned for 1 month.
- Conditions
- Quadriceps Muscle Atrophy, Tourniquet, EMG
- Being tested
- Surgical tourniquet pressure selection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical tourniquet pressure selectionProcedure or surgery
Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure. One group is LOP + 50 mm Hg and other one is LOP + 100 mmHg
| Study group | Role | What they receive |
|---|---|---|
| LOP + 50 mmHg | Experimental | As a result of randomization, the surgical tourniquet pressure is 50 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure Receives: Procedure: Surgical tourniquet pressure selection |
| LOP + 100 mmHg | Experimental | As a result of randomization, the surgical tourniquet pressure is 100 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure Receives: Procedure: Surgical tourniquet pressure selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP 50% reduction in intraoperative neuromonitorization
Time with more than 50% reduction in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
Measured: Intraoperative
MEP full recovery intraoperative neuromonitorization
Time with full recovery in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
Measured: Intraoperative
Secondary outcomes (7)
Quadriceps Tendon Thickness-USG
In the study, quadriceps tendon thickness measurements will be performed in B Mode using the Clarius Portable L7 HD3 Linear Ultrasound device (13-4 MHz).The measurements of the patients will be performed in the supine position with the knee flexed to 30 degrees with a pillow placed in the popliteal web to prevent anisotropy in the quadriceps. The USG probe will be parallel to the long axis of the femur in the sagittal plane, and the patella will be placed at the midpoint of the proximal pole with its distal part. Quadiceps tendon thickness was measured at three different levels, 5-10-15 mm from the proximal patella. The quadriceps tendon borders were determined as the first hyperechoic region, superficial and deep.
Measured: Preoperative, Postoperative 1st day and 4th week will be evaluated
Quadriceps Tendon Thickness-MRI
In the study, the thickness of the quadriceps tendon will also be evaluated with MRI. In the sagittal T1 sequence of knee MRI images, the portion with the largest diameter 1.5 and 3 cm proximal to the superior pole of the patella will be taken as the tendon thickness.
Measured: Preoperative, Postoperative third month
Thigh Diameter
Thigh diameters were measured comparatively with a non-flexible 7 mm tape measure from 10 cm proximal to the midpoint of the proximal patella. As the leg length, the distance from the level of the tibial plateau to the medial malleolus type was measured.
Measured: Preoperative, Postoperative 1st day, first week and 4th week will be evaluated
Total Blood Estimate Volume Loss
Total blood volume will be calculated with the formula Nadler previously presented in the literature. Total blood volume loss will be calculated using preoperative and postoperative hemogram and hematocrit parameters.
Measured: Preoperative, Postoperative 1st day
CK levels
Creatinine kinase, one of the blood parameters showing muscle degradation, will be evaluated by taking blood samples from the patients before and after the surgery.
Measured: Preoperative, Postoperative 1st day, Postoperative 1 st month
EMG
ENMG is an electrophysiological study often used to evaluate nerve injuries. Permanent nerve damage will be evaluated with a nerve conduction study performed by an experienced neurologist comparing both extremities at the first postoperative month of the participants. Peroneal and tibial nerves as motor nerves, sural and s.peroneal nerves as sensory nerves will be evaluated. The latency, amplitude and nerve conduction velocities of the nerves will be compared.
Measured: Postoperative 1 st month
Surgical Area Pain
The pain of the surgical area will be evaluated over the VAS score.
Measured: Preoperative, Postoperative 1st day, Postoperative 1 st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jan 2023
- Primary completionNov 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quadriceps Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET MUCTEBA YILDIRIM, Istanbul University
- Investigators
- Serkan BAYRAM, Ass. Prof., Study director, Istanbul University Medicine Faculty Orthoapedic and Traumatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926154
- Sponsor's protocol ID
- Low Extremity neuromonitoring
- Status last verified
- Jun 2023
- First submitted
- 7 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildirim AM, Bayram S, Kizilkurt T, Canbolat N, Baslo MB, Asik M. Low tourniquet pressure has less impact on lower extremity nerve innervation: comparison of different tourniquet pressures used with intraoperative neuromonitoring with a randomized controlled study. J Orthop Surg Res. 2024 Oct 23;19(1):684. doi: 10.1186/s13018-024-05176-y.
PubMed 39444003
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
- ClinicalTrials.gov ID
- NCT05926154
- Acronym / sponsor ID
- Low Extremity neuromonitoring
- Conditions
- Quadriceps Muscle Atrophy, Tourniquet, EMG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 3 Jul 2023 (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 compare two differential tourniquet pressure in lower extremity surgery cases. The main questions it aims to answer are:
- What are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet?
- Are the effects of two different tourniquet pressures on neuromonitoring significantly different?
- Can the ideal time of the reperfusion interval be evaluated by neuromonitoring?
- Are the effects of two different tourniquet pressures on the quadriceps denervation significantly different from each other? Participants meeting the inclusion criteria will be evaluated for parameters to be used preoperatively. It will be evaluated in the 1st day, 1st week and 1-month follow-ups in the postoperative period.
The investigators will compare two different tourniquet pressure ( Limb occlusion pressure +50 mmHg / + 100 mmHg) to see if it will be evaluated whether there is a significant difference in terms of quadriceps denervation, vas scores, total blood estimate volume loss, intraoperative MEP decrease, and recovery times, quadriceps tendon thickness, thigh circumfrences.
Detailed description
As a result of the power analysis for this study, the number of samples was determined as 24. The study was started after the approval of the ethics committee.
Participants who met the inclusion and exclusion criteria were randomized in terms of tourniquet pressure to be applied and divided into two groups. It was planned to evaluate quadriceps tendon thickness by USG and MRI, thigh circumference, VAS scores, CBC, and CK in blood samples in the preoperative period of all patients. It was planned to obtain parameters related to MEP by using intraoperative neuromonitorization during the surgery. In the postoperative period, all parameters that were evaluated preoperatively on the 1st day, 1st week, and 1st month were re-evaluated. Finally, EMG evaluation was planned for 1 month.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOP + 50 mmHg | Experimental | Procedure: Surgical tourniquet pressure selectionAs a result of randomization, the surgical tourniquet pressure is 50 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure |
| LOP + 100 mmHg | Experimental | Procedure: Surgical tourniquet pressure selectionAs a result of randomization, the surgical tourniquet pressure is 100 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Operation planning in the foot and ankle area
Key exclusion criteria (10 listed)
- Having a history of previous foot and ankle surgery,
- Having a history of previous knee surgery or spinal surgery,
- Diagnosis of diabetes mellitus,
- Having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.),
- Having a diagnosis of a disease affecting the known peripheral vascular system (Peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency),
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 |
|---|---|---|
| Surgical tourniquet pressure selectionLimb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure. One group is LOP + 50 mm Hg and other one is LOP + 100 mmHg | Procedure or surgery | LOP + 100 mmHg, LOP + 50 mmHg |
Primary outcome
MEP 50% reduction in intraoperative neuromonitorization
Time frame: Intraoperative
Time with more than 50% reduction in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
MEP full recovery intraoperative neuromonitorization
Time frame: Intraoperative
Time with full recovery in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
7 secondary outcomes
Quadriceps Tendon Thickness-USG
Time frame: Preoperative, Postoperative 1st day and 4th week will be evaluated
Quadriceps Tendon Thickness-MRI
Time frame: Preoperative, Postoperative third month
Thigh Diameter
Time frame: Preoperative, Postoperative 1st day, first week and 4th week will be evaluated
Total Blood Estimate Volume Loss
Time frame: Preoperative, Postoperative 1st day
CK levels
Time frame: Preoperative, Postoperative 1st day, Postoperative 1 st month
EMG
Time frame: Postoperative 1 st month
Surgical Area Pain
Time frame: Preoperative, Postoperative 1st day, Postoperative 1 st month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 39444003Yildirim AM, Bayram S, Kizilkurt T, Canbolat N, Baslo MB, Asik M. Low tourniquet pressure has less impact on lower extremity nerve innervation: comparison of different tourniquet pressures used with intraoperative neuromonitoring with a randomized controlled study. J Orthop Surg Res. 2024 Oct 23;19(1):684. doi: 10.1186/s13018-024-05176-y.
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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. This study is not recruiting at the moment.
Serkan BAYRAM, Ass. Prof. study director
Istanbul University Medicine Faculty Orthoapedic and Traumatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical tourniquet pressure selection in people with Quadriceps Muscle Atrophy and Tourniquet, run by Istanbul University at 1 site in Turkey (Türkiye).
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 10 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 3 Jul 2023. 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 Turkey (Türkiye). 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?
Contact Ahmet Muçteba YILDIRIM, Asistant Dr (090 534 303 8472, ahmet.yildirim.93@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEP 50% reduction in intraoperative neuromonitorization (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05926154, which also lists 1 linked publication.
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 3 Jul 2023.