Knee Arthroplasty, Total Clinical Trial
Official title:
The Effect of Tourniquet Time and Pressure on Intraoperative and Postoperative Performance, Function, Pain, and Complications in Primary Total Knee Arthroplasty.
Verified date | November 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 21 |
Est. completion date | September 20, 2016 |
Est. primary completion date | September 20, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Davie Medical Center | Bermuda Run | North Carolina |
United States | Wake Forest Baptist Hospital | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative Pain | Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes | Postoperative Day 1 through two weeks | |
Secondary | Estimated Blood Loss | Meunier's formula will be used to calculate estimated blood loss, comparing preoperative blood draw to postoperative day 2 blood draw. | Postoperative Day 2 | |
Secondary | Range of Motion | Measure degrees of knee flexion | 2-week follow-up | |
Secondary | 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 |
Intraoperative | |
Secondary | 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 | Postoperative Day 1 through 12 week follow-up | |
Secondary | Need for Revision of Total Knee Arthroplasty | Number of participants that needed a revision was necessary within one year | One Year Follow-up | |
Secondary | Ability to Ambulate | Distance Walked in Feet | Postoperative Day 1 through Postoperative Day 2 | |
Secondary | 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 |
2-week follow-up through 12-week follow-up | |
Secondary | Need for Manipulation Under Anesthesia | Number of participants that needed a manipulation under anesthesia was necessary within 12 weeks | 6-week follow-up through 12-week follow-up |
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