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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02240732
Other study ID # STCE2.0
Secondary ID
Status Completed
Phase N/A
First received September 15, 2014
Last updated June 28, 2015
Start date September 2014
Est. completion date April 2015

Study information

Verified date June 2015
Source University Hospitals Coventry and Warwickshire NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Observational

Clinical Trial Summary

BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England, Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative tourniquet can therefore help to improve the surgical field of view. Although the majority of surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are now not pursuing these devices.

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?


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- i.Aged >18

- ii.Undergoing elective TKR

- iii.Able to give written informed consent

- iv.No contraindications to MR imaging

Exclusion Criteria:

- i. Ages <16

- ii. Not able to give written informed consent

- iv. Contraindications to MR imaging

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom University Hospital Warwickshire and Coventry Coventry

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Arroyo JS, Garvin KL, McGuire MH. Fatal marrow embolization following a porous-coated bipolar hip endoprosthesis. J Arthroplasty. 1994 Aug;9(4):449-52. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Emboli on Transcranial Doppler 2 independent technicians will verify the number of emboli detected. Non-invasive Intra-operative No
Primary MRI brain scan - presence of Emboli Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions Post-operatively, prior to discharge No
Secondary Mini-mental state examination Set of 30 questions which test cognitive function Pre-operative vs Post-operative No
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