Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2014-09-30
2015-04-30
Brief Summary
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There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet is used for TKR surgery. In addition embolic material in the venous system have been observed following TKR surgery and have been noted to be present in the right atrium with transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood. Fat embolism syndrome and post-operative confusion in TKR patients may be the result of emboli formed during a TKR. ,
AIM
* Is there evidence of emboli entering the cerebral circulation following tourniquet deflation in TKR surgery?
* Is there evidence of MRI detectable brain lesions and or any clinical change in cognition compared in patients undergoing TKR surgery with a tourniquet compared to those that do not have a tourniquet?
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total knee replacement patients
Patients who are due to have a total knee replacement will be studied to look for the presence of Emboli.
Observational with imaging.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ii.Undergoing elective TKR
* iii.Able to give written informed consent
* iv.No contraindications to MR imaging
Exclusion Criteria
* ii. Not able to give written informed consent
* iv. Contraindications to MR imaging
18 Years
ALL
Yes
Sponsors
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University Hospitals Coventry and Warwickshire NHS Trust
OTHER
Responsible Party
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Victoria Gibbs
Doctor
Principal Investigators
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Victoria Gibbs, BA, MBBS
Role: PRINCIPAL_INVESTIGATOR
UHCW
Locations
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University Hospital Warwickshire and Coventry
Coventry, , United Kingdom
Countries
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References
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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.
Parmet JL, Horrow JC, Pharo G, Collins L, Berman AT, Rosenberg H. The incidence of venous emboli during extramedullary guided total knee arthroplasty. Anesth Analg. 1995 Oct;81(4):757-62. doi: 10.1097/00000539-199510000-00017.
Parmet JL, Berman AT, Horrow JC, Harding S, Rosenberg H. Thromboembolism coincident with tourniquet deflation during total knee arthroplasty. Lancet. 1993 Apr 24;341(8852):1057-8. doi: 10.1016/0140-6736(93)92414-o.
Arroyo JS, Garvin KL, McGuire MH. Fatal marrow embolization following a porous-coated bipolar hip endoprosthesis. J Arthroplasty. 1994 Aug;9(4):449-52. doi: 10.1016/0883-5403(94)90057-4.
Pugsley W, Klinger L, Paschalis C, Treasure T, Harrison M, Newman S. The impact of microemboli during cardiopulmonary bypass on neuropsychological functioning. Stroke. 1994 Jul;25(7):1393-9. doi: 10.1161/01.str.25.7.1393.
Riding G, Daly K, Hutchinson S, Rao S, Lovell M, McCollum C. Paradoxical cerebral embolisation. An explanation for fat embolism syndrome. J Bone Joint Surg Br. 2004 Jan;86(1):95-8.
Caillouette JT, Anzel SH. Fat embolism syndrome following the intramedullary alignment guide in total knee arthroplasty. Clin Orthop Relat Res. 1990 Feb;(251):198-9.
Other Identifiers
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STCE2.0
Identifier Type: -
Identifier Source: org_study_id