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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: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.

Project description:BACKGROUND:Total 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 ANALYSIS:This 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. DISCUSSION:This 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. REGISTRATION:Clinical Trials.gov, NCT04092153. Registered on 17 September 2019.

Project description:BACKGROUND:More personalized implant designs for total knee arthroplasty might optimize the clinical outcome after surgery. One of these personalized implant designs is the Persona knee implant system (Zimmer Biomet, Warsaw, Indiana, USA). The primary objective of this study was to determine patient reported outcomes and implant survivorship of the Persona Knee system used in primary total knee arthroplasty, up to two years after surgery. METHODS:From November 2013 to July 2016 consecutive patients undergoing primary total knee arthroplasty were enrolled in a prospective observational cohort study at three centers. Preoperatively, at 6?weeks, 6?months, 1 and 2?years after surgery, patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), the Knee Society Score (KSS, 2011, modified version) and the EQ-5D. Adverse Events were captured, assessed for relationship to device, and recorded in the study database. Furthermore, physical functioning was assessed by the orthopedic surgeon. Repeated measures analyses were performed on PROM scores. Kaplan Meier was used to calculate survivorship of the Persona Knee Implant System. RESULTS:A total of 146 total knee arthroplasties were performed. 61% (89/146) of the patients were female and mean age was 64.7 (± 6.9) years. Two years after surgery, one patient had a revision of the polyethylene insert because of a periprosthetic joint infection. Therefore, the Kaplan-Meier survival estimate at 2?years was 0.99 (0.95-1.00 95% CI). OKS increased from 22.1 (95% CI 20.9-23.3) to 41.8 (95% CI 40.6-43.1) two years after surgery. Furthermore, all other PROMs also increased from before surgery to 2?year postoperatively. CONCLUSION:The Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good; pain, function and quality of life all improved greatly after TKA. Further studies are needed to determine the long term clinical performance of the Persona prosthesis. TRIAL REGISTRATION:Clinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.

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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