University Hospital Warwickshire and Coventry
Coventry, CV2 2DX, United Kingdom
NCT Number: NCT02240732
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?
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Coventry, CV2 2DX, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Intra-operative
2 independent technicians will verify the number of emboli detected. Non-invasive
Time frame: Post-operatively, prior to discharge
Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions
Time frame: Pre-operative vs Post-operative
Set of 30 questions which test cognitive function
University Hospitals Coventry and Warwickshire NHS Trust
Other
Surgical Tourniquets and Cerebral Emboli Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01595581
ACL Reconstruction, Arthritis
Los Angeles, California, United States
View Trial DetailsNCT00651625
Arthritis, Arthritis, Rheumatoid
Albuquerque, New Mexico, United States
View Trial DetailsNCT01379118
Arthritis, Connective Tissue Diseases
San Bernardino, California, United States
View Trial DetailsNCT03626038
Arthritis, Arthritis, Psoriatic
Tampa, Florida, United States
View Trial Details