Dataset Information

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

ABSTRACT:

Introduction

Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems.

Methods and analysis

The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems.

Ethics and dissemination

The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate.

Trial registration number

ISRCTN27624068.

SUBMITTER: Griffin J

PROVIDER: S-EPMC10277111 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

Griffin James J Davis Edward T ET Parsons Helen H Gemperle Mannion Elke E Khatri Chetan C Ellard David R DR Blyth Mark J MJ Clement Nicholas David ND Deehan David D Flynn Nicholas N Fox Josephine J Grant Nicholas J NJ Haddad Fares S FS Hutchinson Charles E CE Mason James J Mohindru Bishal B Scott Chloe E H CEH Smith Toby O TO Skinner John A JA Toms Andrew D AD Rees Sophie S Underwood Martin M Metcalfe Andrew A

BMJ open 20230609 6

<h4>Introduction</h4>Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective ...[more]

PMID: 37295832

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Project description:IntroductionThe number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology.Methods and analysisThe Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements.Ethics and disseminationThe trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners.Trial registration numberISRCTN13374625.

Project description:Purpose Total knee arthroplasty (TKA) is widely recognized as an effective treatment for end-stage knee osteoarthritis (OA). Compared with conventional TKA, robotic-arm assisted TKA may improve patients’ functionality and resulting quality of life by more accurate and precise component placement. Currently, the literature on cost-effectiveness of robotic-arm assisted TKA in the US is limited. The objective of this study was to assess the cost-effectiveness of robotic-arm assisted TKA relative to TKA in the Medicare-aged population including exploring the impact of hospital volume on cost-effectiveness outcomes. Methods We developed a decision-analytic model to evaluate the costs, health outcomes, and incremental cost-effectiveness ratio (ICER) of robotic-arm assisted TKA vs TKA in Medicare population with OA. We evaluated cost-effectiveness at a willingness-to-pay (WTP) threshold of $50,000 per quality-adjusted life-year (QALY). We sourced costs from the literature including episode-of-care (EOC) costs from a Medicare study. We assessed cost-effectiveness of robotic-arm assisted TKA by hospital procedure volume and conducted deterministic (DSA) and probabilistic sensitivity analysis (PSA). Results For the average patient treated in a hospital with an annual volume of 50 procedures, robotic-arm assisted TKA resulted in a total QALY of 6.18 relative to 6.17 under conventional TKA. Total discounted costs per patient were $32,535 and $31,917 for robotic-arm assisted TKA and conventional TKA, respectively. Robotic-arm assisted TKA was cost-effective in the base case with an ICER of $41,331/QALY. In univariate DSA, cost-effectiveness outcomes were most sensitive to the annual hospital procedure volume. Robotic-arm assisted TKA was cost-effective at a WTP of $50,000/QALY only when hospital volume exceeded 49 procedures per year. In PSA, robotic-arm assisted TKA was cost-effective at a $50,000/QALY WTP threshold in 50.4% of 10,000 simulations. Conclusions Despite high robotic purchase costs, robotic-arm assisted TKA is likely to be cost-effective relative to TKA in the Medicare population with knee OA in high-volume hospitals through lowering revision rates and decreasing post-acute care costs. Higher-volume hospitals may deliver higher value in performing in robotic-arm assisted TKA.

Project description:BackgroundThere remains a paucity of clinical studies assessing how any differences in accuracy of implant positioning between robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) and conventional jig-based unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, functional outcomes, and implant survivorship. The objectives of this study are to compare accuracy of implant positioning, limb alignment, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in CO UKA versus RO UKA. Computer navigation will be used to assess intraoperative knee kinematics in all patients undergoing CO UKA.Methods and analysisThis prospective randomised controlled trial will include 140 patients with symptomatic medial compartment knee arthritis undergoing primary UKA. Following informed consent, patients will be randomised to CO UKA (control group) or RO UKA (investigation group) at a ratio of 1:1 using an online random number generator. The primary objective of this study is to compare accuracy of implant positioning in CO UKA versus RO UKA. The secondary objectives are to compare the following outcomes between the two treatment groups: limb alignment, surgical efficiency, postoperative functional rehabilitation, functional outcomes, quality of life, range of motion, resource use, cost effectivness, and complications. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes pertaining to these objectives. Ethical approval was obtained from the London-Bloomsbury Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CO UKA versus RO UKA. The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.Trial registrationClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.

Project description:IntroductionKnee replacement (KR) is a clinically proven procedure typically offered to patients with severe knee osteoarthritis (OA) to relieve pain and improve quality of life. However, artificial joints fail over time, requiring revision associated with higher mortality and inferior outcomes. With more young people presenting with knee OA and increasing life expectancy, there is an unmet need to postpone time to first KR. Knee joint distraction (KJD), the practice of using external fixators to open up knee joint space, is proposed as potentially effective to preserve the joint following initial studies in the Netherlands, however, has not been researched within an NHS setting. The KARDS trial will investigate whether KJD is non-inferior to KR in terms of patient-reported postoperative pain 12 months post-surgery.Methods and analysisKARDS is a phase III, multicentre, pragmatic, open-label, individually randomised controlled non-inferiority trial comparing KJD with KR in patients with severe knee OA, employing a hybrid-expertise design, with internal pilot phase and process evaluation. 344 participants will be randomised (1:1) to KJD or KR. The primary outcome measure is the Knee Injury and Osteoarthritis Outcomes Score (KOOS) pain domain score at 12 months post-operation. Secondary outcome measures include patient-reported overall KOOS, Pain Visual Analogue Scale and Oxford Knee Scores, knee function assessments, joint space width, complications and further interventions over 24 months post-operation. Per patient cost difference between KR and KJD and cost per quality-adjusted life year (QALY) gained over 24 months will be estimated within trial, and incremental cost per QALY gained over 20 years by KJD relative to KR predicted using decision analytic modelling.Ethics and disseminationEthics approval was obtained from the Research Ethics Committee (REC) and Health Research Authority (HRA). Trial results will be disseminated at clinical conferences, through relevant patient groups and published in peer-reviewed journals.Trial registration numberISRCTN14879004; recruitment opened April 2021.

Project description:BackgroundPhysical rehabilitation is required to enhance functional outcomes and overall recovery following total knee arthroplasty (TKA). However, there are no universally accepted clinical guidelines available to consistently structure rehabilitation for TKA patients. A common method is rehabilitation provided in an outpatient setting, on a one-to-one treatment basis. This method is resource-intensive and outcomes must be compared to less costly alternatives such as home-based rehabilitation. The current study will analyse a novel home-based rehabilitation program. The Maxm skate is a portable, lower-limb, postoperative, rehabilitation exercise device for individual use in a hospital or home-based setting. This study was developed to compare the safety, efficacy and cost-effectiveness of the Maxm Skate rehabilitation program to standard rehabilitative care following TKA. The primary outcome is the range of motion (ROM) achieved by patients who received the Maxm Skate program compared to standard care at three months post TKA. Secondary outcomes include patient-reported outcomes, costs and functional evaluations which will be collected at multiple time-points up to 12 months after TKA.MethodsThis is a single-blinded, randomised controlled trial (RCT) in which 116 eligible participants consented for primary TKA will be randomly allocated to receive either the Maxm Skate rehabilitation program or standard rehabilitative care. Fifty-eight participants per group will provide 90% power (α = 0.05) to detect 10° of difference in ROM between groups at three months after TKA, assuming a within-group standard deviation of 16° and allowing for 5% loss to follow-up. Participants randomised to the Maxm Skate group will use the skate device and accompanying iOS App and sensors to complete rehabilitation exercises, as outlined in the Maxm Skate Rehabilitation Guide. Outcomes will be compared to those receiving standard rehabilitative care. A blinded physiotherapist will evaluate functional outcomes preoperatively and at 2, 4, 6, 12, 26 and 52 weeks after TKA. The functional assessment will include measures of knee ROM, pain, isometric knee strength, balance and knee/thigh circumference. Limited measures will also be assessed at day 2 postoperatively by an alternate, unblinded physiotherapist. Clinical outcome measures will be administered preoperatively and at 6, 12 and 52 weeks postoperatively. An economic evaluation will be conducted and participants will be screened for adverse event occurrences from the time of consent to 12 months postoperatively.DiscussionThis RCT will be the first to investigate the safety, efficacy and cost-effectiveness of the home-based Maxm Skate Rehabilitation program, in comparison to standard rehabilitative care following primary TKA.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616001081404p . Registered on 11 August 2016.

Project description:BackgroundTotal knee arthroplasty (TKA) with mechanical alignment (MA) aims to achieve neutral limb alignment in all patients, whereas TKA with functional alignment (FA) aims to restore native, patient-specific anatomy and knee kinematics by manipulating bone resections and fine-tuning implant positioning. The objective of this study is to determine the optimal alignment technique in TKA by comparing patient satisfaction, functional outcomes, implant survivorship, complications, and cost-effectiveness in MA TKA versus FA TKA. Robotic technology will be used to execute the planned implant positioning and limb alignment with high-levels of accuracy in all study patients.Methods and analysisThis prospective double-blinded randomised control trial will include 100 patients with symptomatic knee osteoarthritis undergoing primary robotic arm-assisted TKA. Following informed consent, patients will be randomised to MA TKA (the control group) or FA TKA (the investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning and limb alignment, gait, implant stability, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether FA TKA provides superior outcomes compared to MA TKA. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Surrey Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis is the first study to describe the use of robotic technology to achieve FA TKA, and the only existing clinical trial comparing robotic MA TKA versus robotic FA TKA. The findings of this study will enable an improved understanding of the optimal alignment technique in TKA for achieving high-levels of patient satisfaction, improving functional outcomes, increasing implant survivorship, improving cost-effectiveness, and reducing complications.RegistrationClinical Trials.gov, NCT04092153. Registered on 17 September 2019.

Project description:BackgroundPostoperative rehabilitation following total knee arthroplasty (TKA) varies worldwide. In Finland, patients receive guidance on safe walking and home exercises from a physiotherapist both before and after TKA. These are performed independently after surgery. However, a sedentary lifestyle is rather common among patients who have undergone TKA, with pain often limiting postoperative walking, training, and activities of daily living.ObjectiveThis randomized controlled trial aimed to investigate the effectiveness of anti-gravity exercise, precisely the AlterG anti-gravity treadmill, on postoperative rehabilitation following TKA and to obtain new knowledge on this form of rehabilitation to better use it in the future.MethodsThis randomized controlled trial study divided the patients into two groups: the intervention group and the control group. The follow-up period was 12 months. Research data were collected through questionnaires and functional tests. All patients in both groups responded to the questionnaires and participated in functional tests before surgery as well as 4 and 12 months after surgery. Patients in the intervention group exercised on the AlterG treadmill 10 times after the surgery. All the patients in this study performed the exercises as instructed when they were in the hospital. The primary outcomes were perceived pain, walking ability, and quality of life.ResultsThe data collection process began in 2018 and concluded in 2022, intending to obtain valuable information regarding the effect of AlterG training after TKA and determine whether it, along with traditional exercises, could be an effective form of rehabilitation that can be performed at home. We hypothesized that AlterG training would lead to faster rehabilitation, better walking quality, improved quality of life, improved physical activity, and improved overall functioning. The results of this study will be analyzed in 2025 and 2026.ConclusionsThis study provides information on how AlterG training can be used in rehabilitation after TKA, further enhancing the rehabilitation program for patients undergoing TKA in general.Trial registrationClinicalTrials.gov NCT03904030; https://clinicaltrials.gov/study/NCT03904030.International registered report identifier (irrid)DERR1-10.2196/59935.

Project description:BackgroundRobotic-arm-assisted knee arthroplasty allows for more accurate component positioning and alignment and is associated with better patient-reported outcomes compared 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 TKR (standard of care) or robotic-arm-assisted TKR 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 TKR offers improved outcome relative to standard manual jig-based systems that are currently the standard of care. This will be assessed primarily according to knee-specific function, but several other measures will also be assessed including whether these are cost-effective interventions.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN47889316 https://doi.org/10.1186/ISRCTN47889316 . Registered on 25 November 2019 DATE AND VERSION FOR PROTOCOL: ROAM Protocol V1.0 (13-12-2018).

Dataset Information

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

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