Tourniquet Pressure in Primary Total Knee Arthroplasty
Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Terminated
CT.gov ID
NCT02830087
Collaborator
(none)
21
2
6
3.6
10.5
2.9
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Type:
Interventional
Actual Enrollment
:
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Effect of Tourniquet Time and Pressure on Intraoperative and Postoperative Performance, Function, Pain, and Complications in Primary Total Knee Arthroplasty.
Study Start Date
:
Jun 1, 2016
Actual Primary Completion Date
:
Sep 20, 2016
Actual Study Completion Date
:
Sep 20, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 220 mmHg tourniquet cuff pressure Thigh tourniquet cuff inflated to 220 mmHg. |
Procedure: Tourniquet Cuff Pressure
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.
|
| Active Comparator: 250 mmHg tourniquet cuff pressure Thigh tourniquet cuff inflated to 250 mmHg |
Procedure: Tourniquet Cuff Pressure
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.
|
| Active Comparator: 275 mmHg tourniquet cuff pressure Thigh tourniquet cuff inflated to 275 mmHg |
Procedure: Tourniquet Cuff Pressure
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.
|
| Active Comparator: 300 mmHg tourniquet cuff pressure Thigh tourniquet cuff inflated to 300 mmHg |
Procedure: Tourniquet Cuff Pressure
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.
|
| Active Comparator: 325 mmHg tourniquet cuff pressure Thigh tourniquet cuff inflated to 325 mmHg |
Procedure: Tourniquet Cuff Pressure
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.
|
| Active Comparator: 350 mmHg tourniquet cuff pressure Thigh tourniquet cuff inflated to 350 mmHg |
Procedure: Tourniquet Cuff Pressure
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.
|
Outcome Measures
Primary Outcome Measures
- Postoperative Pain [Postoperative Day 1 through two weeks]
Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes
Secondary Outcome Measures
- Estimated Blood Loss [Postoperative Day 2]
Meunier's formula will be used to calculate estimated blood loss, comparing preoperative blood draw to postoperative day 2 blood draw.
- Range of Motion [2-week follow-up]
Measure degrees of knee flexion
- Intra-operative Bloodlessness [Intraoperative]
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
- Number of Participants With Wound Healing Issues [Postoperative Day 1 through 12 week follow-up]
Any wound issues including blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation
- Need for Revision of Total Knee Arthroplasty [One Year Follow-up]
Number of participants that needed a revision was necessary within one year
- Ability to Ambulate [Postoperative Day 1 through Postoperative Day 2]
Distance Walked in Feet
- Quadriceps Strength [2-week follow-up through 12-week follow-up]
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
- Need for Manipulation Under Anesthesia [6-week follow-up through 12-week follow-up]
Number of participants that needed a manipulation under anesthesia was necessary within 12 weeks
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
18 - 80 years old
-
primary TKA, not revision
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Davie Medical Center | Bermuda Run | North Carolina | United States | 27006 |
| 2 | Wake Forest Baptist Hospital | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Study Director: Martha Holden, Manager
- Principal Investigator: Maxwell K Langfitt, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Alcelik 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. Review.
- Berry 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.
- Clarke 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.
- Ejaz 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.
- Gibon 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. Review.
- 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. Review.
- Kurtz 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.
- Ledin 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.
- Li 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.
- Liu 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.
- Olivecrona 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.
- Reilly 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.
- Tai 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. Review.
- Zhang 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. Review.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02830087
Other Study ID Numbers:
- IRB00038367
First Posted:
Jul 12, 2016
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Wake Forest University Health Sciences
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Period Title: Overall Study | ||||||
| STARTED | 4 | 4 | 4 | 3 | 3 | 3 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 4 | 4 | 4 | 3 | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | 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 | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. | Total of all reporting groups |
| Overall Participants | 4 | 4 | 4 | 3 | 3 | 3 | 21 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
2
50%
|
4
100%
|
3
75%
|
2
66.7%
|
3
100%
|
0
0%
|
14
66.7%
|
| >=65 years |
2
50%
|
0
0%
|
1
25%
|
1
33.3%
|
0
0%
|
3
100%
|
7
33.3%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
63
(6.7)
|
58.3
(8.9)
|
59.5
(8.9)
|
63.7
(13.2)
|
50.7
(7.2)
|
73.7
(2.1)
|
61.3
(9.6)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
3
75%
|
1
25%
|
2
50%
|
2
66.7%
|
1
33.3%
|
2
66.7%
|
11
52.4%
|
| Male |
1
25%
|
3
75%
|
2
50%
|
1
33.3%
|
2
66.7%
|
1
33.3%
|
10
47.6%
|
| Region of Enrollment (Count of Participants) | |||||||
| United States |
4
100%
|
4
100%
|
4
100%
|
3
100%
|
3
100%
|
3
100%
|
21
100%
|
Outcome Measures
| Title | Postoperative Pain |
|---|---|
| Description | Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes |
| Time Frame | Postoperative Day 1 through two weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| data not collected for all participants |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 0 | 1 | 1 | 0 | 1 |
| Number [score on a scale] |
3
|
7
|
9
|
| Title | Estimated Blood Loss |
|---|---|
| Description | Meunier's formula will be used to calculate estimated blood loss, comparing preoperative blood draw to postoperative day 2 blood draw. |
| Time Frame | Postoperative Day 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| No data collected |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Range of Motion |
|---|---|
| Description | Measure degrees of knee flexion |
| Time Frame | 2-week follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| data not collected for all participants |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 0 | 1 | 1 | 0 | 0 |
| Number [Degrees] |
78
|
15
|
| Title | Intra-operative Bloodlessness |
|---|---|
| Description | 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 |
| Time Frame | Intraoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| data not collected for all participants |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 1 | 1 | 2 | 0 | 0 |
| Mean (Standard Deviation) [score on a scale] |
1
(NA)
|
1
(NA)
|
2
(1.4)
|
| Title | Number of Participants With Wound Healing Issues |
|---|---|
| Description | Any wound issues including blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation |
| Time Frame | Postoperative Day 1 through 12 week follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 4 | 4 | 4 | 3 | 3 | 3 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Need for Revision of Total Knee Arthroplasty |
|---|---|
| Description | Number of participants that needed a revision was necessary within one year |
| Time Frame | One Year Follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| No data collected |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Ability to Ambulate |
|---|---|
| Description | Distance Walked in Feet |
| Time Frame | Postoperative Day 1 through Postoperative Day 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| data not collected for all participants |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 0 | 1 | 0 | 0 | 0 |
| Number [Feet] |
208
|
| Title | Quadriceps Strength |
|---|---|
| Description | 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 |
| Time Frame | 2-week follow-up through 12-week follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| data not collected for all participants |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 0 | 1 | 0 | 0 | 0 |
| Number [score on a scale] |
4
|
| Title | Need for Manipulation Under Anesthesia |
|---|---|
| Description | Number of participants that needed a manipulation under anesthesia was necessary within 12 weeks |
| Time Frame | 6-week follow-up through 12-week follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| No data collected |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | up to 4 months | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | 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 | ||||||
| Arm/Group Description | Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: 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. | Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: 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. | ||||||
All Cause Mortality |
||||||||||||
| 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 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| 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 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| 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 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||
Limitations/Caveats
The trial had limited patient enrollment, randomization, and follow-up due to limited study staff.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Maxwell Langfit, MD |
|---|---|
| Organization | Wake Forest University Health Sciences |
| Phone | |
| mlangfit@wakehealth.edu |
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02830087
Other Study ID Numbers:
- IRB00038367
First Posted:
Jul 12, 2016
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018