Continuous Intra-articular Levobupivicaine after Unicondylar Knee Replacement - a Randomised Controlled Trial

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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Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): statistical analysis plan for a randomised controlled trial assessing the effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone

Trials ◽

10.1186/s13063-021-05293-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jamie R. Stokes ◽

Ariel Wang ◽

Lisa Poulton ◽

Ines Rombach ◽

Hemant Pandit ◽

...

Keyword(s):

Statistical Analysis ◽

Randomised Controlled Trial ◽

Pain Relief ◽

Knee Replacement ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Liposomal Bupivacaine ◽

Bupivacaine Hydrochloride ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Up to three quarters of surgical patients receive inadequate pain relief, with 40% of patients reporting severe pain following knee replacement, which may indicate the current pain relief strategies using opiate-based analgesia cannot achieve patient satisfaction. Liposomal bupivacaine is liposome-encapsulated bupivacaine which has been reported to be effective for up to 72 h. The study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK) trial has been designed to assess the effectiveness of peri-articular liposomal bupivacaine and bupivacaine hydrochloride compared with peri-articular bupivacaine hydrochloride alone in the management of post-operative pain following knee replacement. Methods/design The SPAARK trial is a multi-centre, patient-blinded, randomised controlled trial. The co-primary outcomes are post-operative recovery assessed by global QoR-40 scores at 72 h and cumulative pain VAS score from 6 to 72 h following surgery. Longer-term measures of the co-primary outcomes are collected at 6 weeks and 6 and 12 months post randomisation, together with secondary outcomes, i.e. the Oxford Knee Score, and the American Knee Society Score. Cumulative opiate use and fitness for discharge are measured up to 72 h post-surgery. The analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The full SPAARK protocol has already been published. Results The co-primary outcomes will be analysed using multivariate linear regression adjusting for stratification factors and other important prognostic variables, including baseline scores in the case of the QoR-40. The adjusted mean difference between the two groups together with 97.5% confidence intervals will be reported for each of the primary outcomes. Other continuous variables will be assessed using the same method. Binary outcomes will be assessed using chi-squared tests. Discussion The paper provides details of the planned statistical analyses for the SPAARK trial and aims to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. Trial registration ISRCTN54191675. Registered on 13 November 2017.

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