Abstract
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.
Highlights
There remains a paucity of clinical studies assessing how any differences in accuracy of implant positioning between robotic-arm assisted unicompartmental knee arthroplasty (RO Unicompartmental knee arthroplasty (UKA)) and conventional jig-based unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, functional outcomes, and implant survivorship
The findings of this study will provide an improved understanding of the differences in CO UKA versus robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, costeffectiveness, and complications
This study aims to build on the previous trials by Bell et al and Blyth et al by using threedimensional preoperative templating in both treatment groups, inserting navigation pins to assess knee kinematics and limb alignment in CO UKA, assessing a more comprehensive range of functional outcome scores, blinding patients and observers recording clinical outcomes, and recording study outcomes for a robust analysis of cost-effectiveness and resource use between the two treatment groups [4, 6, 14]
Summary
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. There are several advantages of performing UKA over total knee arthroplasty (TKA), including reduced operating time, decreased intraoperative blood loss, reduced periarticular soft tissue trauma, improved preservation of bone stock, better restoration of native kinematics, increased patient satisfaction, and improved functional outcomes [7, 16, 20, 21, 34, 35]. Conventional jig-based UKA (CO UKA) is performed using manually positioned alignment guides and cutting blocks, limited intraoperative data on knee kinematics, and handheld milling devices or sawblades for bone resection. These techniques are highly dependent on the skill and expertise of the operating surgeons [32, 34]. Surgeon-controlled errors in implant positioning are the most common reason for implant failure, and low case-volume has been identified as a risk factor for early revision surgery following UKA [30, 32]
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