TourniquetsNCT02830087
Tourniquet Pressure in Primary Total Knee Arthroplasty
A study testing Tourniquet Cuff Pressure in people with Tourniquets and Knee Arthroplasty, Total, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol by gaining a better understanding of the relationship between tourniquet pressure and time, and intraoperative performance and post-operative outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourniquets, Knee Arthroplasty, Total, Knee Replacement, Total
- What is being tested?
- Tourniquet Cuff Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to 20 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 80 years old
- primary TKA, not revision
Who cannot join
- systolic blood pressure (BP) ≥ 170 mmHg
- one-staged bilateral TKA or stages less than three months apart
- history of peripheral vascular disease
- history of thromboembolism
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Davie Medical Center
Bermuda Run, North Carolina, 27006
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effect of Tourniquet Time and Pressure on Intraoperative and Postoperative Performance, Function, Pain, and Complications in Primary Total Knee Arthroplasty.
This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol by gaining a better understanding of the relationship between tourniquet pressure and time, and intraoperative performance and post-operative outcomes. This study does not seek to answer the question of "tourniquet vs no tourniquet", but to seek a tourniquet usage that would maximize the intraoperative benefits for the surgeon and minimize the negative consequences for patient outcomes.
Specific Aim #1: enroll around 146 primary TKA patients.
Read more
Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in relation to intraoperative performance.
Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative pain and complications of short-term, intermediate, and long-term followup.
Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative function of short-term, intermediate, and long-term followup.
Read the detailed description
The overall goal of the project is to evaluate the relationship of two variables: 1) tourniquet cuff pressure (TCP); and 2) tourniquet time (i.e. duration of inflation) during primary TKA relative to three categories of outcomes: 1) intraoperative performance; 2) post-operative pain and complications; and 3) post-operative complications.
Design
This study will use a randomized controlled trial that is double-blinded. The co-investigator, Mark Nazal, along with the principal investigator, Dr. Maxwell Langfitt, will work with the Orthopaedic Clinic Research Coordinator to recruit around 146 patients. Mark Nazal will then randomize these patients into one of six tourniquet cuff pressure (TCP) groups:
- 220 mmHg 4) 300 mmHg
- 250 mmHg 5) 325 mmHg
- 275 mmHg 6) 350 mmHg
The primary TKA procedure will be performed by one of the three fellowship-trained orthopedic surgeons at Wake Forest Baptist Hospital (Dr. Maxwell Langfitt, Dr. Jason Lang, and Dr. John Shields). The orthopedic surgeon and the patient will be blinded to the TCP assignment and will not be told what tourniquet pressure is being applied. The OR nursing team will be told what the patient's assigned TCP is in order to perform the actual inflation.
Data collection will include short-term data: post-operative day 1 (POD1), post-operative day 2 (POD2), and 2-week followup; intermediate data: 6-week and 12-week followup; and long-term data: 1-year followup.
The data collection for the first category of outcomes, intraoperative performance, will begin preoperatively, with the recording of baseline characteristics: circumference of the thigh in centimeters, baseline hemoglobin levels, and thromboembolism risk evaluation.
Intraoperative data will include: the type of anesthesia, the tourniquet size in centimeters, and whether or not a drain is inserted into the joint. The time of inflation and time of deflation will be noted in order to determine the duration of tourniquet inflation.
Then preincisional blood pressure (BP) will be measured and will continue to be noted every 15 minutes. At the conclusion of the procedure the surgeon will rate intraoperative bloodlessness on a four-point scale: 1-bloodless, 2-nearly bloodless, some bleeding; 3-bloody, tourniquet is no better than not using; or 4-venous tourniquet, tourniquet is making the procedure more difficult. Intraoperative bloodlessness is being used to determine the functionality and effectiveness of the tourniquet, surgical field visualization, and surgical site dryness.
The data collection for the second category of outcomes, post-operative pain and complications, will begin on post-operative day 1 (POD1). Post-operative (post-op) pain will be assessed using a 0-10 pain rating visual analog scale for both the knee and the thigh, and will be measured at POD1, POD2, 2-week followup, 6-week followup, 12-week followup, and 1-year followup. Next, wound healing issues will be assessed at POD1, POD2, 2-week followup, 6-week followup, and 12-week followup. Wound healing issues include blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation.13 Estimated total blood loss will be assessed at POD2 using pre-operative Hgb-level compared to Hgb-level on post-op day 2. The patient's estimated blood volume (EBV) will be calculated using Nadler's formulas for men and women.16
Then Meunier's formula will be used to calculate estimated blood loss.16 If a drain was inserted, then the volume of drainage will be measured at POD1. Finally, aseptic loosing of the implant leading to the need for revision will be assessed at 1-year followup.
The data collection for the third category of outcomes, post-operative function, will begin at POD1. Ability to ambulate will be measured in distance by feet at POD1 and POD2. Furthermore, assessment of any use of assisted device for ambulation (wheelchair, walker, 4-point cane, and 1-point cane) will be done at POD1, POD2, 2-week followup, 6-week followup, 12-week followup and 1-year followup. Quadriceps strength and range of motion (ROM) will be recorded at 2-week followup, 6-week followup, and 12-week followup. Quadriceps strength will be measured on a 5-point scale, where 0 is no movement and 5 is full strength. ROM will be measured in degrees of motion. Next, the necessity of performing a manipulation under anesthesia (MUA) due to limited joint motion will be recorded at 6-week followup and 12-week followup. The type of PT will be recorded at 2-week followup, 6-week followup, and 12-week followup. Types of PT include out-patient PT, home health PT, PT rehabilitation, and skilled nursing facility PT.
- Being tested
- Tourniquet Cuff Pressure
- Keywords
- randomized controlled trial, tourniquet, tourniquet cuff pressure, total knee arthroplasty, total knee replacement, pain, postoperative, range of motion, articular, blood loss, surgical, muscle strength, quadriceps, walking, manipulation, orthopedic/therapeutic use, wound healing/surgery
- Medical subject headings
- Pain, Postoperative, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet Cuff PressureProcedure or surgery
Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
| Study group | Role | What they receive |
|---|---|---|
| 220 mmHg tourniquet cuff pressure | Active comparator | Thigh tourniquet cuff inflated to 220 mmHg. Receives: Procedure: Tourniquet Cuff Pressure |
| 250 mmHg tourniquet cuff pressure | Active comparator | Thigh tourniquet cuff inflated to 250 mmHg Receives: Procedure: Tourniquet Cuff Pressure |
| 275 mmHg tourniquet cuff pressure | Active comparator | Thigh tourniquet cuff inflated to 275 mmHg Receives: Procedure: Tourniquet Cuff Pressure |
| 300 mmHg tourniquet cuff pressure | Active comparator | Thigh tourniquet cuff inflated to 300 mmHg Receives: Procedure: Tourniquet Cuff Pressure |
| 325 mmHg tourniquet cuff pressure | Active comparator | Thigh tourniquet cuff inflated to 325 mmHg Receives: Procedure: Tourniquet Cuff Pressure |
| 350 mmHg tourniquet cuff pressure | Active comparator | Thigh tourniquet cuff inflated to 350 mmHg Receives: Procedure: Tourniquet Cuff Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes
Measured: Postoperative Day 1 through two weeks
Secondary outcomes (8)
Estimated Blood Loss
Meunier's formula will be used to calculate estimated blood loss, comparing preoperative blood draw to postoperative day 2 blood draw.
Measured: Postoperative Day 2
Range of Motion
Measure degrees of knee flexion
Measured: 2-week follow-up
Intra-operative Bloodlessness
four-point scale:
- 1 = bloodless
- 2 = nearly bloodless, some bleeding
- 3 = bloody, tourniquet no better than not using
- 4 = venous tourniquet, tourniquet making things worse
Higher scores denotes worse outcome
Measured: Intraoperative
Number of Participants With Wound Healing Issues
Any wound issues including blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation
Measured: Postoperative Day 1 through 12 week follow-up
Need for Revision of Total Knee Arthroplasty
Number of participants that needed a revision was necessary within one year
Measured: One Year Follow-up
Ability to Ambulate
Distance Walked in Feet
Measured: Postoperative Day 1 through Postoperative Day 2
Quadriceps Strength
Six Point Strength Scale 0 - No muscle movement
- -Muscle movement, without movement at the joint
- -Movement at the joint, but not against gravity
- -Movement against gravity, but not against resistance
- -Movement against resistance, but less than full strength
- -Full Strength
Higher scores denotes better outcome
Measured: 2-week follow-up through 12-week follow-up
Need for Manipulation Under Anesthesia
Number of participants that needed a manipulation under anesthesia was necessary within 12 weeks
Measured: 6-week follow-up through 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion20 Sep 2016
- Study completion20 Sep 2016
Why it stopped: No patient follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for TourniquetsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Holden, Study director, ManagerMaxwell K Langfitt, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830087
- Sponsor's protocol ID
- IRB00038367
- Status last verified
- Nov 2018
- First submitted
- 7 Jul 2016
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jiang FZ, Zhong HM, Hong YC, Zhao GF. Use of a tourniquet in total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials. J Orthop Sci. 2015 Jan;20(1):110-23. doi: 10.1007/s00776-014-0664-6. Epub 2014 Nov 6.
PubMed 25373840Alcelik I, Pollock RD, Sukeik M, Bettany-Saltikov J, Armstrong PM, Fismer P. A comparison of outcomes with and without a tourniquet in total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty. 2012 Mar;27(3):331-40. doi: 10.1016/j.arth.2011.04.046. Epub 2011 Sep 22.
PubMed 21944371Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2010 Sep;25(6 Suppl):2-4. doi: 10.1016/j.arth.2010.04.033. Epub 2010 Jul 1.
PubMed 20580196Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
PubMed 21161177Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Ledin H, Aspenberg P, Good L. Tourniquet use in total knee replacement does not improve fixation, but appears to reduce final range of motion. Acta Orthop. 2012 Oct;83(5):499-503. doi: 10.3109/17453674.2012.727078. Epub 2012 Sep 14.
PubMed 22974220Li B, Wen Y, Wu H, Qian Q, Lin X, Zhao H. The effect of tourniquet use on hidden blood loss in total knee arthroplasty. Int Orthop. 2009 Oct;33(5):1263-8. doi: 10.1007/s00264-008-0647-3. Epub 2008 Aug 27.
PubMed 18751703Liu D, Graham D, Gillies K, Gillies RM. Effects of tourniquet use on quadriceps function and pain in total knee arthroplasty. Knee Surg Relat Res. 2014 Dec;26(4):207-13. doi: 10.5792/ksrr.2014.26.4.207. Epub 2014 Dec 2.
PubMed 25505702Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13.
PubMed 24602486Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23.
PubMed 24954487Olivecrona C, Ponzer S, Hamberg P, Blomfeldt R. Lower tourniquet cuff pressure reduces postoperative wound complications after total knee arthroplasty: a randomized controlled study of 164 patients. J Bone Joint Surg Am. 2012 Dec 19;94(24):2216-21. doi: 10.2106/JBJS.K.01492.
PubMed 23318611Reilly CW, McEwen JA, Leveille L, Perdios A, Mulpuri K. Minimizing tourniquet pressure in pediatric anterior cruciate ligament reconstructive surgery: a blinded, prospective randomized controlled trial. J Pediatr Orthop. 2009 Apr-May;29(3):275-80. doi: 10.1097/BPO.0b013e31819bcd14.
PubMed 19305279Clarke MT, Longstaff L, Edwards D, Rushton N. Tourniquet-induced wound hypoxia after total knee replacement. J Bone Joint Surg Br. 2001 Jan;83(1):40-4. doi: 10.1302/0301-620x.83b1.10795.
PubMed 11245536Gibon E, Courpied JP, Hamadouche M. Total joint replacement and blood loss: what is the best equation? Int Orthop. 2013 Apr;37(4):735-9. doi: 10.1007/s00264-013-1801-0. Epub 2013 Feb 6.
PubMed 23385607
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tourniquet Time and Pressure on Intraoperative and Postoperative Performance, Function, Pain, and Complications in Primary Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT02830087
- Acronym / sponsor ID
- IRB00038367
- Keywords
- randomized controlled trial, tourniquet, tourniquet cuff pressure, total knee arthroplasty, total knee replacement, pain, postoperative, range of motion, articular, blood loss, surgical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patient follow-up
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol by gaining a better understanding of the relationship between tourniquet pressure and time, and intraoperative performance and post-operative outcomes. This study does not seek to answer the question of "tourniquet vs no tourniquet", but to seek a tourniquet usage that would maximize the intraoperative benefits for the surgeon and minimize the negative consequences for patient outcomes.
Specific Aim #1: enroll around 146 primary TKA patients.
Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in relation to intraoperative performance.
Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative pain and complications of short-term, intermediate, and long-term followup.
Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative function of short-term, intermediate, and long-term followup.
Detailed description
The overall goal of the project is to evaluate the relationship of two variables: 1) tourniquet cuff pressure (TCP); and 2) tourniquet time (i.e. duration of inflation) during primary TKA relative to three categories of outcomes: 1) intraoperative performance; 2) post-operative pain and complications; and 3) post-operative complications.
Design
This study will use a randomized controlled trial that is double-blinded. The co-investigator, Mark Nazal, along with the principal investigator, Dr. Maxwell Langfitt, will work with the Orthopaedic Clinic Research Coordinator to recruit around 146 patients. Mark Nazal will then randomize these patients into one of six tourniquet cuff pressure (TCP) groups:
- 220 mmHg 4) 300 mmHg
- 250 mmHg 5) 325 mmHg
- 275 mmHg 6) 350 mmHg
The primary TKA procedure will be performed by one of the three fellowship-trained orthopedic surgeons at Wake Forest Baptist Hospital (Dr. Maxwell Langfitt, Dr. Jason Lang, and Dr. John Shields). The orthopedic surgeon and the patient will be blinded to the TCP assignment and will not be told what tourniquet pressure is being applied. The OR nursing team will be told what the patient's assigned TCP is in order to perform the actual inflation.
Data collection will include short-term data: post-operative day 1 (POD1), post-operative day 2 (POD2), and 2-week followup; intermediate data: 6-week and 12-week followup; and long-term data: 1-year followup.
The data collection for the first category of outcomes, intraoperative performance, will begin preoperatively, with the recording of baseline characteristics: circumference of the thigh in centimeters, baseline hemoglobin levels, and thromboembolism risk evaluation.
Intraoperative data will include: the type of anesthesia, the tourniquet size in centimeters, and whether or not a drain is inserted into the joint. The time of inflation and time of deflation will be noted in order to determine the duration of tourniquet inflation.
Then preincisional blood pressure (BP) will be measured and will continue to be noted every 15 minutes. At the conclusion of the procedure the surgeon will rate intraoperative bloodlessness on a four-point scale: 1-bloodless, 2-nearly bloodless, some bleeding; 3-bloody, tourniquet is no better than not using; or 4-venous tourniquet, tourniquet is making the procedure more difficult. Intraoperative bloodlessness is being used to determine the functionality and effectiveness of the tourniquet, surgical field visualization, and surgical site dryness.
The data collection for the second category of outcomes, post-operative pain and complications, will begin on post-operative day 1 (POD1). Post-operative (post-op) pain will be assessed using a 0-10 pain rating visual analog scale for both the knee and the thigh, and will be measured at POD1, POD2, 2-week followup, 6-week followup, 12-week followup, and 1-year followup. Next, wound healing issues will be assessed at POD1, POD2, 2-week followup, 6-week followup, and 12-week followup. Wound healing issues include blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation.13 Estimated total blood loss will be assessed at POD2 using pre-operative Hgb-level compared to Hgb-level on post-op day 2. The patient's estimated blood volume (EBV) will be calculated using Nadler's formulas for men and women.16
Then Meunier's formula will be used to calculate estimated blood loss.16 If a drain was inserted, then the volume of drainage will be measured at POD1. Finally, aseptic loosing of the implant leading to the need for revision will be assessed at 1-year followup.
The data collection for the third category of outcomes, post-operative function, will begin at POD1. Ability to ambulate will be measured in distance by feet at POD1 and POD2. Furthermore, assessment of any use of assisted device for ambulation (wheelchair, walker, 4-point cane, and 1-point cane) will be done at POD1, POD2, 2-week followup, 6-week followup, 12-week followup and 1-year followup. Quadriceps strength and range of motion (ROM) will be recorded at 2-week followup, 6-week followup, and 12-week followup. Quadriceps strength will be measured on a 5-point scale, where 0 is no movement and 5 is full strength. ROM will be measured in degrees of motion. Next, the necessity of performing a manipulation under anesthesia (MUA) due to limited joint motion will be recorded at 6-week followup and 12-week followup. The type of PT will be recorded at 2-week followup, 6-week followup, and 12-week followup. Types of PT include out-patient PT, home health PT, PT rehabilitation, and skilled nursing facility PT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 220 mmHg tourniquet cuff pressure | Active comparator | Procedure: Tourniquet Cuff PressureThigh tourniquet cuff inflated to 220 mmHg. |
| 250 mmHg tourniquet cuff pressure | Active comparator | Procedure: Tourniquet Cuff PressureThigh tourniquet cuff inflated to 250 mmHg |
| 275 mmHg tourniquet cuff pressure | Active comparator | Procedure: Tourniquet Cuff PressureThigh tourniquet cuff inflated to 275 mmHg |
| 300 mmHg tourniquet cuff pressure | Active comparator | Procedure: Tourniquet Cuff PressureThigh tourniquet cuff inflated to 300 mmHg |
| 325 mmHg tourniquet cuff pressure | Active comparator | Procedure: Tourniquet Cuff PressureThigh tourniquet cuff inflated to 325 mmHg |
| 350 mmHg tourniquet cuff pressure | Active comparator | Procedure: Tourniquet Cuff PressureThigh tourniquet cuff inflated to 350 mmHg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 - 80 years old
- primary TKA, not revision
Key exclusion criteria (4 listed)
- systolic blood pressure (BP) ≥ 170 mmHg
- one-staged bilateral TKA or stages less than three months apart
- history of peripheral vascular disease
- history of thromboembolism
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 |
|---|---|---|
| Tourniquet Cuff PressureTourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery. | Procedure or surgery | 220 mmHg tourniquet cuff pressure, 250 mmHg tourniquet cuff pressure, 275 mmHg tourniquet cuff pressure, 300 mmHg tourniquet cuff pressure, 325 mmHg tourniquet cuff pressure, 350 mmHg tourniquet cuff pressure |
Primary outcome
Postoperative Pain
Time frame: Postoperative Day 1 through two weeks
Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes
8 secondary outcomes
Estimated Blood Loss
Time frame: Postoperative Day 2
Range of Motion
Time frame: 2-week follow-up
Intra-operative Bloodlessness
Time frame: Intraoperative
Number of Participants With Wound Healing Issues
Time frame: Postoperative Day 1 through 12 week follow-up
Need for Revision of Total Knee Arthroplasty
Time frame: One Year Follow-up
Ability to Ambulate
Time frame: Postoperative Day 1 through Postoperative Day 2
Quadriceps Strength
Time frame: 2-week follow-up through 12-week follow-up
Need for Manipulation Under Anesthesia
Time frame: 6-week follow-up through 12-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25373840Jiang FZ, Zhong HM, Hong YC, Zhao GF. Use of a tourniquet in total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials. J Orthop Sci. 2015 Jan;20(1):110-23. doi: 10.1007/s00776-014-0664-6. Epub 2014 Nov 6.
- Background: PubMed 21944371Alcelik I, Pollock RD, Sukeik M, Bettany-Saltikov J, Armstrong PM, Fismer P. A comparison of outcomes with and without a tourniquet in total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty. 2012 Mar;27(3):331-40. doi: 10.1016/j.arth.2011.04.046. Epub 2011 Sep 22.
- Background: PubMed 20580196Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2010 Sep;25(6 Suppl):2-4. doi: 10.1016/j.arth.2010.04.033. Epub 2010 Jul 1.
- Background: PubMed 21161177Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 22974220Ledin H, Aspenberg P, Good L. Tourniquet use in total knee replacement does not improve fixation, but appears to reduce final range of motion. Acta Orthop. 2012 Oct;83(5):499-503. doi: 10.3109/17453674.2012.727078. Epub 2012 Sep 14.
- Background: PubMed 18751703Li B, Wen Y, Wu H, Qian Q, Lin X, Zhao H. The effect of tourniquet use on hidden blood loss in total knee arthroplasty. Int Orthop. 2009 Oct;33(5):1263-8. doi: 10.1007/s00264-008-0647-3. Epub 2008 Aug 27.
- Background: PubMed 25505702Liu D, Graham D, Gillies K, Gillies RM. Effects of tourniquet use on quadriceps function and pain in total knee arthroplasty. Knee Surg Relat Res. 2014 Dec;26(4):207-13. doi: 10.5792/ksrr.2014.26.4.207. Epub 2014 Dec 2.
- Background: PubMed 24602486Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13.
- Background: PubMed 24954487Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23.
- Background: PubMed 23318611Olivecrona C, Ponzer S, Hamberg P, Blomfeldt R. Lower tourniquet cuff pressure reduces postoperative wound complications after total knee arthroplasty: a randomized controlled study of 164 patients. J Bone Joint Surg Am. 2012 Dec 19;94(24):2216-21. doi: 10.2106/JBJS.K.01492.
- Background: PubMed 19305279Reilly CW, McEwen JA, Leveille L, Perdios A, Mulpuri K. Minimizing tourniquet pressure in pediatric anterior cruciate ligament reconstructive surgery: a blinded, prospective randomized controlled trial. J Pediatr Orthop. 2009 Apr-May;29(3):275-80. doi: 10.1097/BPO.0b013e31819bcd14.
- Citation #1Link provided by the sponsor.
- Citation #6Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Tourniquets
Enrolling by invitation
Reducing Blood Loss During Myomectomy by Comparing Local Epinephrine and Uterine Artery Tourniquet During Procedure
Local Epinephrine in Myomectomy
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
Not yet recruiting
Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures
Hand Injuries and Disorders
Not yet recruiting
Effect of Tourniquet Use on the Pivot Shift Test
Anterior Cruciate Ligament Injury
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.
Martha Holden study director
Manager
Maxwell K Langfitt, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet Cuff Pressure in people with Tourniquets and Knee Arthroplasty, Total, run by Wake Forest University Health Sciences at 2 sites in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain (time frame: Postoperative Day 1 through two weeks). 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 NCT02830087, which also lists 14 linked publications.
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 19 Dec 2018.