scholarly journals Tourniquet use in total knee replacement surgery: a feasibility study and pilot randomised controlled trial (SAFE-TKR study)

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043564
Author(s):  
Peter David Henry Wall ◽  
Imran Ahmed ◽  
Claire Edwin ◽  
Muhamed M Farhan-Alanie ◽  
Helen Parsons ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Total Knee Replacement ◽  
Feasibility Study ◽  
Knee Replacement ◽  
Controlled Trial ◽  
Brain Mri ◽  
Thigh Pain ◽  
Pilot Randomised Controlled Trial ◽  
Total Knee ◽  
Randomised Controlled

IntroductionTourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible.MethodsIn a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months.ResultsWe randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated.ConclusionA full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial.Trial registration numberISRCTN20873088.

Five-year results of a randomised controlled trial comparing mobile and fixed bearings in total knee replacement

2013 ◽  
Vol 95-B (4) ◽  
pp. 486-492 ◽  
Author(s):  
S. Breeman ◽  
M. K. Campbell ◽  
H. Dakin ◽  
N. Fiddian ◽  
R. Fitzpatrick ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Total Knee Replacement ◽  
Knee Replacement ◽  
Controlled Trial ◽  
Total Knee ◽  
Randomised Controlled

scholarly journals Robotic and Orthosensor Assisted versus Manual (ROAM) Total Knee Replacement: A Study Protocol for a Randomised Controlled Trial

2021 ◽  
Author(s):  
Nicholas D Clement ◽  
Michelle Bardgett ◽  
Steven M Galloway ◽  
Yael J Baron ◽  
Karen M Smith ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Total Knee Replacement ◽  
Knee Replacement ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Robotic Arm ◽  
Specific Function ◽  
Total Knee ◽  
Randomised Controlled

Abstract BackgroundRobotic-arm assisted knee arthroplasty allows for more accurate component positioning and alignment and is associated with better patient reported outcomes comparted to manually performed jig-based knee arthroplasty. However, what is not known is whether the addition of an intra-articular sensor (VerasenseTM) to aid intraoperative balancing of the total knee replacement (TKR) offers improved functional outcomes for the patient. The purpose of this research is to compare the outcomes of patients undergoing a conventional manual knee replacement to those undergoing TKR using robotic assisted surgery and the VerasenseTM to optimise alignment and balance the knee joint, respectively, and assess the associated cost economics of such technology.Methods and AnalysisThis randomised controlled trial will include 90 patients with end stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the inclusion/exclusion criteria that consent to be in the study will be randomised at a ratio of 1:1 to either manual TKA (standard of care) or robotic-arm assisted TKA with VerasenseTM to aid balancing of the knee. The primary objective will be functional improvement at 6-months following surgery between the two groups. The secondary objectives are to compare changes in knee specific function, joint awareness, patient expectation and fulfilment, satisfaction, pain, stiffness and functional ability, health related quality of life, cost effectiveness, and gait patterns between the two groups. Ethical approval was obtained by the Tyne & Wear South Research Ethics Committee, UK. The study is sponsored by the Newcastle Hospitals NHS Foundation Trust.DiscussionThis study will assess whether the improved accuracy of component positioning using the robotic-arm assisted surgery and the VerasenseTM to aid balancing of the TKA offers improved outcome relative to standard manual jug-based systems that are currently the standard of care. This will be assessed primarily according to knee specific function, but several other measure will also be assessed including whether this is a cost effective intervention.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN47889316 https://doi.org/10.1186/ISRCTN47889316 (registered on 25/11/2019)Date and version for protocolROAM Protocol V1.0 (13-12-2018)

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