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Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial.

ABSTRACT: BACKGROUND:There 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 ANALYSIS:This 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. DISCUSSION:This 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 REGISTRATION:ClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.

SUBMITTER: Kayani B

PROVIDER: S-EPMC7430022 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial.

Kayani Babar B Konan Sujith S Tahmassebi Jenni J Ayuob Atif A Moriarty Peter D PD Haddad Fares S FS

Trials 20200817 1

<h4>Background</h4>There 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 su ...[more]

PMID: 32807219

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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: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:ObjectiveThe primary objective of the trial was to assess the clinical effectiveness of medial unicompartmental knee arthroplasty versus total knee arthroplasty in patients with isolated medial osteoarthritis of the knee.DesignProspective, randomised, 2 years, assessor-blind, multicentre, superiority trial.SettingThe patients were enrolled between December 2015 and May 2018 from the outpatient clinics of three public high-volume arthroplasty hospitals (Finland).ParticipantsWe recruited 143 patients with symptomatic-isolated medial osteoarthritis of the knee needing an arthroplasty procedure. All the patients were suitable for both unicompartmental and total knee arthroplasties. Population was selected as the end-stage-isolated medial osteoarthritis.InterventionsAll patients, randomized 1:1, received a medial unicompartmental arthroplasty or a total knee arthroplasty through a similar midline skin incision. Patients were blinded to the type of arthroplasty for the whole 2 years of follow-up.Main outcome measuresPrimary outcome measure was between-group differences in the Oxford Knee Score (OKS) and secondary outcome Knee injury and Osteoarthritis Score (KOOS) at 2 years postoperatively. The changes within and between the groups were analysed with analysis of variance for repeated measurements.ResultsThe primary outcome was comparable for medial unicompartmental arthroplasty and total knee arthroplasty at 2 years. The mean difference in the OKS between the groups was 1.6 points (95% CI -0.7 to 3.9). In the KOOS subscales, the mean difference between the groups was 0.1 points (95% CI -4.8 to 5.0) for pain, 7.8 points (95% CI 1.5 to 14.0) for symptoms, 4.3 points (95% CI -0.6 to 9.2) for function in daily living, 4.3 points (95% CI -3.0 to 11.6) for function in sports, and 2.1 points (95% CI -4.8 to 9.1) for knee-related quality of life.ConclusionsThe recovery after unicompartmental knee arthroplasty was faster compared with total knee arthroplasty, but unicompartmental arthroplasty did not provide a better patient-reported outcome at 2 years.Trial registration numberNCT02481427.

Dataset Information

Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial.

Publications

Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial.

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