NCT02830087

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

July 7, 2016

Results QC Date

August 30, 2018

Last Update Submit

November 27, 2018

Conditions

TourniquetsKnee Arthroplasty, TotalKnee Replacement, Total

Keywords

randomized controlled trialtourniquettourniquet cuff pressuretotal knee arthroplastytotal knee replacementpain, postoperativerange of motion, articularblood loss, surgicalmuscle strength, quadricepswalkingmanipulation, orthopedic/therapeutic usewound healing/surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes

    Postoperative Day 1 through two weeks

Secondary Outcomes (8)

  • Estimated Blood Loss

    Postoperative Day 2

  • Range of Motion

    2-week follow-up

  • Intra-operative Bloodlessness

    Intraoperative

  • Number of Participants With Wound Healing Issues

    Postoperative Day 1 through 12 week follow-up

  • Need for Revision of Total Knee Arthroplasty

    One Year Follow-up

  • +3 more secondary outcomes

Study Arms (6)

220 mmHg tourniquet cuff pressure

ACTIVE COMPARATOR

Thigh tourniquet cuff inflated to 220 mmHg.

Procedure: Tourniquet Cuff Pressure

250 mmHg tourniquet cuff pressure

ACTIVE COMPARATOR

Thigh tourniquet cuff inflated to 250 mmHg

Procedure: Tourniquet Cuff Pressure

275 mmHg tourniquet cuff pressure

ACTIVE COMPARATOR

Thigh tourniquet cuff inflated to 275 mmHg

Procedure: Tourniquet Cuff Pressure

300 mmHg tourniquet cuff pressure

ACTIVE COMPARATOR

Thigh tourniquet cuff inflated to 300 mmHg

Procedure: Tourniquet Cuff Pressure

325 mmHg tourniquet cuff pressure

ACTIVE COMPARATOR

Thigh tourniquet cuff inflated to 325 mmHg

Procedure: Tourniquet Cuff Pressure

350 mmHg tourniquet cuff pressure

ACTIVE COMPARATOR

Thigh tourniquet cuff inflated to 350 mmHg

Procedure: Tourniquet Cuff Pressure

Interventions

Tourniquet Cuff PressurePROCEDURE

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.

220 mmHg tourniquet cuff pressure250 mmHg tourniquet cuff pressure275 mmHg tourniquet cuff pressure300 mmHg tourniquet cuff pressure325 mmHg tourniquet cuff pressure350 mmHg tourniquet cuff pressure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • primary TKA, not revision

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Davie Medical Center

Bermuda Run, North Carolina, 27006, United States

Location

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (14)

  • 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.

    PMID: 25373840BACKGROUND

  • 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.

    PMID: 21944371BACKGROUND

  • 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.

    PMID: 20580196BACKGROUND

  • 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.

    PMID: 21161177BACKGROUND

  • 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.

    PMID: 17403800BACKGROUND

  • 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.

    PMID: 22974220BACKGROUND

  • 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.

    PMID: 18751703BACKGROUND

  • 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.

    PMID: 25505702BACKGROUND

  • 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.

    PMID: 24602486BACKGROUND

  • 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.

    PMID: 24954487BACKGROUND

  • 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.

    PMID: 23318611BACKGROUND

  • 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.

    PMID: 19305279BACKGROUND

  • 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.

    PMID: 11245536BACKGROUND

  • 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.

    PMID: 23385607BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, PostoperativeBlood Loss, Surgical

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHemorrhageIntraoperative Complications

Limitations and Caveats

The trial had limited patient enrollment, randomization, and follow-up due to limited study staff.

Results Point of Contact

Title
Maxwell Langfit, MD
Organization
Wake Forest University Health Sciences
mlangfit@wakehealth.edu

Study Officials

  • Martha Holden

    Manager

    STUDY DIRECTOR

  • Maxwell K Langfitt, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

June 1, 2016

Primary Completion

September 20, 2016

Study Completion

September 20, 2016

Last Updated

December 19, 2018

Results First Posted

December 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)