Tourniquet Pressure in Primary Total Knee Arthroplasty

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-20

Brief Summary

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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

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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:

1. 220 mmHg 4) 300 mmHg
2. 250 mmHg 5) 325 mmHg
3. 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.

Conditions

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Tourniquets Knee Arthroplasty, Total Knee Replacement, Total

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 18 - 80 years old
2. primary TKA, not revision

Exclusion Criteria

1. systolic blood pressure (BP) ≥ 170 mmHg
2. one-staged bilateral TKA or stages less than three months apart
3. history of peripheral vascular disease
4. history of thromboembolism

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martha Holden

Role: STUDY_DIRECTOR

Manager

Maxwell K Langfitt, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Davie Medical Center

Bermuda Run, North Carolina, United States

Site Status

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Reference Type BACKGROUND

PMID: 23385607 (View on PubMed)

Other Identifiers

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IRB00038367

Identifier Type: -

Identifier Source: org_study_id

Tourniquet Pressure in Primary Total Knee Arthroplasty

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

220 mmHg tourniquet cuff pressure

Tourniquet Cuff Pressure

250 mmHg tourniquet cuff pressure

Tourniquet Cuff Pressure

275 mmHg tourniquet cuff pressure

Tourniquet Cuff Pressure

300 mmHg tourniquet cuff pressure

Tourniquet Cuff Pressure

325 mmHg tourniquet cuff pressure

Tourniquet Cuff Pressure

350 mmHg tourniquet cuff pressure

Tourniquet Cuff Pressure

Interventions

Tourniquet Cuff Pressure

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Wake Forest University Health Sciences

Responsible Party

Principal Investigators

Martha Holden

Maxwell K Langfitt, MD

Locations

Davie Medical Center

Wake Forest Baptist Hospital

Countries

References

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.

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.

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.

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. doi: 10.2106/JBJS.F.00222.

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.

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.

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.

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.

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. doi: 10.1302/0301-620x.83b1.10795.

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.

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Other Identifiers

IRB00038367