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Patient reported and clinical outcomes of robotic-arm assisted unicondylar knee arthroplasty: Minimum two year follow-up.

ABSTRACT: Background:Unicompartmental knee arthroplasty (UKA) originated in the 1950's. There have been many enhancements to the implants and the technique, improving the precision and accuracy of this challenging operation. Specifically for Robotic Arm Interactive Orthopedic System (Rio; Mako Stryker, Fort Lauderdale, FL), there are many studies reporting clinical outcomes, but our search offered nothing regarding patient reported outcomes using validated surveys. Methods:Patients with onlay tibial components presenting for routine follow-up of robotic-arm assisted UKA performed between May 2009 and September 2013 were invited to participate. Four joints had simultaneous patella femoral resurfacing. Knee Injury and Osteoarthritis Outcomes Score (KOOS) and the 2011 Knee Society Scores were collected. Radiographic evidence of osteoarthritis in the non-operative knee compartments was documented. Results:Eighty-one patients presented for follow-up and consented to participate. Mean follow up was 54 months. Mean patient reported KOOS activities of daily living and pain scores were each 90. Knee Society 2011 mean objective score was 96 and mean function score 81. There was one revision to total knee at 40 months post-op for pain after injury. Seventy-seven percent reported their knee always felt "Normal", 20% sometimes, and only 3% reported that it never felt normal. Conclusion:Literature on UKA failure rates suggests that UKA may be a less forgiving procedure than total knee arthroplasty. Robotic-arm assisted surgery is reported to improve the accuracy of implant placement. Based on our prospectively collected positive patient outcomes, the authors have achieved good results from performing robotic-arm assisted UKA on select patients.

SUBMITTER: Deese JM

PROVIDER: S-EPMC6104461 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Patient reported and clinical outcomes of robotic-arm assisted unicondylar knee arthroplasty: Minimum two year follow-up.

Deese J Melvin JM Gratto-Cox Gwen G Carter Denny A DA Sasser Thomas M TM Brown Karah L KL

Journal of orthopaedics 20180816 3

<h4>Background</h4>Unicompartmental knee arthroplasty (UKA) originated in the 1950's. There have been many enhancements to the implants and the technique, improving the precision and accuracy of this challenging operation. Specifically for Robotic Arm Interactive Orthopedic System (Rio; Mako Stryker, Fort Lauderdale, FL), there are many studies reporting clinical outcomes, but our search offered nothing regarding patient reported outcomes using validated surveys.<h4>Methods</h4>Patients with onl ...[more]

PMID: 30140132

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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: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.

Dataset Information

Patient reported and clinical outcomes of robotic-arm assisted unicondylar knee arthroplasty: Minimum two year follow-up.

Publications

Patient reported and clinical outcomes of robotic-arm assisted unicondylar knee arthroplasty: Minimum two year follow-up.

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